US (United States) Code. Title 21. Chapter 9: Federal Food, Drug and Cosmetic Act

Codificación normativa de EEUU (Estados Unidos) Legislación Federal estadounidense # Food and drugs

  • Enviado por: El remitente no desea revelar su nombre
  • Idioma: inglés
  • País: Estados Unidos Estados Unidos
  • 171 páginas
publicidad

-CITE-

21 USC CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

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-HEAD-

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

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SUBCHAPTER I - SHORT TITLE

Sec.

301. Short title.

SUBCHAPTER II - DEFINITIONS

321. Definitions; generally.

321a. ''Butter'' defined.

321b. ''Package'' defined.

321c. Nonfat dry milk; ''milk'' defined.

321d. Market names for catfish and ginseng.

(a) Catfish labeling.

(b) Ginseng labeling.

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

331. Prohibited acts.

332. Injunction proceedings.

(a) Jurisdiction of courts.

(b) Violation of injunction.

333. Penalties.

(a) Violation of section 331 of this title; second

violation; intent to defraud or mislead.

(b) Prescription drug marketing violations.

(c) Exceptions in certain cases of good faith, etc.

(d) Exceptions involving misbranded food.

(e) Prohibited distribution of human growth hormone.

(f) Violations related to devices.

333a. Repealed.

334. Seizure.

(a) Grounds and jurisdiction.

(b) Procedure; multiplicity of pending proceedings.

(c) Availability of samples of seized goods prior to

trial.

(d) Disposition of goods after decree of

condemnation; claims for remission or

mitigation of forfeitures.

(e) Costs.

(f) Removal of case for trial.

(g) Administrative restraint; detention orders.

(h) Administrative detention of foods.

335. Hearing before report of criminal violation.

335a. Debarment, temporary denial of approval, and suspension.

(a) Mandatory debarment; certain drug applications.

(b) Permissive debarment; certain drug applications;

food imports.

(c) Debarment period and considerations.

(d) Termination of debarment.

(e) Publication and list of debarred persons.

(f) Temporary denial of approval.

(g) Suspension authority.

(h) Termination of suspension.

(i) Procedure.

(j) Judicial review.

(k) Certification.

(l) Applicability.

(m) Devices; mandatory debarment regarding

third-party inspections and reviews.

335b. Civil penalties.

(a) In general.

(b) Procedure.

(c) Judicial review.

(d) Recovery of penalties.

(e) Informants.

335c. Authority to withdraw approval of abbreviated drug

applications.

(a) In general.

(b) Procedure.

(c) Applicability.

(d) Judicial review.

336. Report of minor violations.

337. Proceedings in name of United States; provision as to

subpoenas.

SUBCHAPTER IV - FOOD

341. Definitions and standards for food.

342. Adulterated food.

(a) Poisonous, insanitary, etc., ingredients.

(b) Absence, substitution, or addition of

constituents.

(c) Color additives.

(d) Confectionery containing alcohol or nonnutritive

substance.

(e) Oleomargarine containing filthy, putrid, etc.,

matter.

(f) Dietary supplement or ingredient: safety.

(g) Dietary supplement: manufacturing practices.

(h) Reoffer of food previously denied admission.

343. Misbranded food.

(a) False or misleading label.

(b) Offer for sale under another name.

(c) Imitation of another food.

(d) Misleading container.

(e) Package form.

(f) Prominence of information on label.

(g) Representation as to definition and standard of

identity.

(h) Representation as to standards of quality and

fill of container.

(i) Label where no representation as to definition

and standard of identity.

(j) Representation for special dietary use.

(k) Artificial flavoring, artificial coloring, or

chemical preservatives.

(l) Pesticide chemicals on raw agricultural

commodities.

(m) Color additives.

(n) Packaging or labeling of drugs in violation of

regulations.

(o),

(p) Repealed.

(q) Nutrition information.

(r) Nutrition levels and health-related claims.

(s) Dietary supplements.

(t) Catfish.

(u) Ginseng.

(v) Failure to label; health threat.

343-1. National uniform nutrition labeling.

343-2. Dietary supplement labeling exemptions.

(a) In general.

(b) Application.

(c) Burden of proof.

343-3. Disclosure.

343a. Repealed.

344. Emergency permit control.

(a) Conditions on manufacturing, processing, etc., as

health measure.

(b) Violation of permit; suspension and

reinstatement.

(c) Inspection of permit-holding establishments.

345. Regulations making exemptions.

346. Tolerances for poisonous or deleterious substances in food;

regulations.

346a. Tolerances and exemptions for pesticide chemical residues.

(a) Requirement for tolerance or exemption.

(b) Authority and standard for tolerance.

(c) Authority and standard for exemptions.

(d) Petition for tolerance or exemption.

(e) Action on Administrator's own initiative.

(f) Special data requirements.

(g) Effective date, objections, hearings, and

administrative review.

(h) Judicial review.

(i) Confidentiality and use of data.

(j) Status of previously issued regulations.

(k) Transitional provision.

(l) Harmonization with action under other laws.

(m) Fees.

(n) National uniformity of tolerances.

(o) Consumer right to know.

(p) Estrogenic substances screening program.

(q) Schedule for review.

(r) Temporary tolerance or exemption.

(s) Savings clause.

346b. Authorization of appropriations.

347. Intrastate sales of colored oleomargarine.

(a) Law governing.

(b) Labeling and packaging requirements.

(c) Sales in public eating places.

(d) Exemption from labeling requirements.

(e) Color content of oleomargarine.

347a. Congressional declaration of policy regarding oleomargarine

sales.

347b. Contravention of State laws.

348. Food additives.

(a) Unsafe food additives; exception for conformity

with exemption or regulation.

(b) Petition for regulation prescribing conditions of

safe use; contents; description of production

methods and controls; samples; notice of

regulation.

(c) Approval or denial of petition; time for issuance

of order; evaluation of data; factors.

(d) Regulation issued on Secretary's initiative.

(e) Publication and effective date of orders.

(f) Objections and public hearing; basis and contents

of order; statement.

(g) Judicial review.

(h) Notification relating to food contact substance.

(i) Amendment or repeal of regulations.

(j) Exemptions for investigational use.

349. Bottled drinking water standards; publication in Federal

Register.

350. Vitamins and minerals.

(a) Authority and limitations of Secretary;

applicability.

(b) Labeling and advertising requirements for foods.

(c) Definitions.

350a. Infant formulas.

(a) Adulteration.

(b) Requirements for quality factors, good

manufacturing practices, and retention of

records.

(c) Registration of persons distributing new infant

formula.

(d) Submission of information about new infant

formula required.

(e) Additional notice requirements for manufacturer.

(f) Procedures applicable to recalls by manufacturer;

regulatory oversight.

(g) Recordkeeping requirements for manufacturer;

regulatory oversight and enforcement.

(h) Exemptions; regulatory oversight.

(i) Nutrient requirements.

350b. New dietary ingredients.

(a) In general.

(b) Petition.

(c) ''New dietary ingredient'' defined.

350c. Maintenance and inspection of records.

(a) Records inspection.

(b) Regulations concerning recordkeeping.

(c) Protection of sensitive information.

(d) Limitations.

350d. Registration of food facilities.

(a) Registration.

(b) Facility.

(c) Rule of construction.

SUBCHAPTER V - DRUGS AND DEVICES

PART A - DRUGS AND DEVICES

351. Adulterated drugs and devices.

(a) Poisonous, insanitary, etc., ingredients;

adequate controls in manufacture.

(b) Strength, quality, or purity differing from

official compendium.

(c) Misrepresentation of strength, etc., where drug

is unrecognized in compendium.

(d) Mixture with or substitution of another

substance.

(e) Devices not in conformity with performance

standards.

(f) Certain class III devices.

(g) Banned devices.

(h) Manufacture, packing, storage, or installation of

device not in conformity with applicable

requirements or conditions.

(i) Failure to comply with requirements under which

device was exempted for investigational use.

352. Misbranded drugs and devices.

(a) False or misleading label.

(b) Package form; contents of label.

(c) Prominence of information on label.

(d) Repealed.

(e) Designation of drugs or devices by established

names.

(f) Directions for use and warnings on label.

(g) Representations as recognized drug; packing and

labeling; inconsistent requirements for

designation of drug.

(h) Deteriorative drugs; packing and labeling.

(i) Drug; misleading container; imitation; offer for

sale under another name.

(j) Health-endangering when used as prescribed.

(k), (l) Repealed.

(m) Color additives; packing and labeling.

(n) Prescription drug advertisements: established

name; quantitative formula; side effects,

contraindications, and effectiveness; prior

approval; false advertising; labeling;

construction of the Convention on Psychotropic

Substances.

(o) Drugs or devices from nonregistered

establishments.

(p) Packaging or labeling of drugs in violation of

regulations.

(q) Restricted devices using false or misleading

advertising or used in violation of

regulations.

(r) Restricted devices not carrying requisite

accompanying statements in advertisements and

other descriptive printed matter.

(s) Devices subject to performance standards not

bearing requisite labeling.

(t) Devices for which there has been a failure or

refusal to give required notification or to

furnish required material or information.

(u) Identification of manufacturer.

(v) Reprocessed single-use devices.

353. Exemptions and consideration for certain drugs, devices, and

biological products.

(a) Regulations for goods to be processed, labeled,

or repacked elsewhere.

(b) Prescription by physician; exemption from

labeling and prescription requirements;

misbranded drugs; compliance with narcotic and

marihuana laws.

(c) Sales restrictions.

(d) Distribution of drug samples.

(e) Wholesale distributors; guidelines for licensing;

definitions.

(f) Veterinary prescription drugs.

(g) Regulation of combination products.

353a. Pharmacy compounding.

(a) In general.

(b) Compounded drug.

(c) Advertising and promotion.

(d) Regulations.

(e) Application.

(f) ''Compounding'' defined.

354. Veterinary feed directive drugs.

(a) Lawful veterinary feed directive requirement.

(b) Labeling and advertising.

(c) Nonprescription status.

355. New drugs.

(a) Necessity of effective approval of application.

(b) Filing application; contents.

(c) Period for approval of application; period for,

notice, and expedition of hearing; period for

issuance of order.

(d) Grounds for refusing application; approval of

application; ''substantial evidence'' defined.

(e) Withdrawal of approval; grounds; immediate

suspension upon finding imminent hazard to

public health.

(f) Revocation of order refusing, withdrawing or

suspending approval of application.

(g) Service of orders.

(h) Appeal from order.

(i) Exemptions of drugs for research; discretionary

and mandatory conditions; direct reports to

Secretary.

(j) Abbreviated new drug applications.

(k) Records and reports; required information;

regulations and orders; access to records.

(l) Public disclosure of safety and effectiveness

data.

(m) ''Patent'' defined.

(n) Scientific advisory panels.

355a. Pediatric studies of drugs.

(a) Definitions.

(b) Market exclusivity for new drugs.

(c) Market exclusivity for already-marketed drugs.

(d) Conduct of pediatric studies.

(e) Delay of effective date for certain application.

(f) Notice of determinations on studies requirement.

(g) Limitations.

(h) Relationship to regulations.

(i) Labeling supplements.

(j) Dissemination of pediatric information.

(k) Clarification of interaction of market

exclusivity under this section and market

exclusivity awarded to an applicant for

approval of a drug under section 355(j) of this

title.

(l) Prompt approval of drugs under section 355(j) of

this title when pediatric information is added

to labeling.

(m) Report.

(n) Sunset.

355b. Adverse-event reporting.

(a) Toll-free number in labeling.

(b) Drugs with pediatric market exclusivity.

356. Fast track products.

(a) Designation of drug as fast track product.

(b) Approval of application for fast track product.

(c) Review of incomplete applications for approval of

fast track product.

(d) Awareness efforts.

356-1. Accelerated approval of priority countermeasures.

(a) In general.

(b) Use of animal trials.

(c) Priority review of drugs and biological products.

(d) Definitions.

356a. Manufacturing changes.

(a) In general.

(b) Validation of effects of changes.

(c) Major manufacturing changes.

(d) Other manufacturing changes.

356b. Reports of postmarketing studies.

(a) Submission.

(b) Consideration of information as public

information.

(c) Status of studies and reports.

(d) Disclosure.

(e) Notification.

356c. Discontinuance of life saving product.

(a) In general.

(b) Reduction in notification period.

(c) Distribution.

357. Repealed.

358. Authority to designate official names.

(a) Necessity or desirability; use in official

compendiums; infringement of trademarks.

(b) Review of names in official compendiums.

(c) Determinations of complexity, usefulness,

multiplicity, or lack of name; designation by

Secretary.

(d) Revised official names; compilation, publication,

and public distribution of listings.

(e) Request by compiler of official compendium for

designation of name.

359. Nonapplicability of subchapter to cosmetics.

360. Registration of producers of drugs or devices.

(a) Definitions.

(b) Annual registration.

(c) New producers.

(d) Additional establishments.

(e) Registration number; uniform system for

identification of devices intended for human

use.

(f) Availability of registrations for inspection.

(g) Exclusions from application of section.

(h) Inspection of premises.

(i) Registration of foreign establishments.

(j) Filing of lists of drugs and devices

manufactured, prepared, propagated and

compounded by registrants; statements;

accompanying disclosures.

(k) Report preceding introduction of devices into

interstate commerce.

(l) Exemption from reporting requirements.

(m) List of exempt class II devices; determination by

Secretary; publication in Federal Register.

(n) Review of report; time for determination by

Secretary.

(o) Reprocessed single-use devices.

(p) Electronic registration.

360a. Repealed.

360b. New animal drugs.

(a) Unsafe new animal drugs and animal feed

containing such drugs; conditions of safety;

exemption of drugs for research; import

tolerances.

(b) Filing application for uses of new animal drug;

contents; patent information; abbreviated

application; presubmission conference.

(c) Period for submission and approval of

application; period for notice and expedition

of hearing; period for issuance of order;

abbreviated applications; withdrawal periods;

effective date of approval; relationship to

other applications; withdrawal or suspension of

approval; bioequivalence; filing of additional

patent information.

(d) Grounds for refusing application; approval of

application; factors; ''substantial evidence''

defined; combination drugs.

(e) Withdrawal of approval; grounds; immediate

suspension upon finding imminent hazard to

health of man or animals.

(f) Revocation of order refusing, withdrawing or

suspending approval of application.

(g) Service of orders.

(h) Appeal from order.

(i) Publication in Federal Register; effective date

and revocation or suspension of regulation.

(j) Exemption of drugs for research; discretionary

and mandatory conditions.

(k) Food containing new animal drug considered

unadulterated while approval of application for

such drug is effective.

(l) Records and reports; required information;

regulations and orders; examination of data;

access to records.

(m) Feed mill licenses.

(n) Abbreviated applications for new animal drugs;

contents, filing, etc.; lists of approved

drugs.

(o) ''Patent'' defined.

(p) Safety and effectiveness data.

360c. Classification of devices intended for human use.

(a) Classes of devices.

(b) Classification panels.

(c) Classification panel organization and operation.

(d) Panel recommendation; publication; priorities.

(e) Classification changes.

(f) Initial classification and reclassification of

certain devices.

(g) Information.

(h) Definitions.

(i) Substantial equivalence.

360d. Performance standards.

(a) Reasonable assurance of safe and effective

performance; periodic evaluation.

(b) Establishment of a standard.

(c) Recognition of standard.

360e. Premarket approval.

(a) General requirement.

(b) Regulation to require premarket approval.

(c) Application for premarket approval.

(d) Action on application for premarket approval.

(e) Withdrawal and temporary suspension of approval

of application.

(f) Product development protocol.

(g) Review.

(h) Service of orders.

(i) Revision.

360f. Banned devices.

(a) General rule.

(b) Special effective date.

360g. Judicial review.

(a) Petition; record.

(b) Additional data, views, and arguments.

(c) Standard for review.

(d) Finality of judgments.

(e) Remedies.

(f) Statement of reasons.

360h. Notification and other remedies.

(a) Notification.

(b) Repair, replacement, or refund.

(c) Reimbursement.

(d) Effect on other liability.

(e) Recall authority.

360i. Records and reports on devices.

(a) General rule.

(b) User reports.

(c) Persons exempt.

(d) Repealed.

(e) Device tracking.

(f) Reports of removals and corrections.

360j. General provisions respecting control of devices intended for

human use.

(a) General rule.

(b) Custom devices.

(c) Trade secrets.

(d) Notices and findings.

(e) Restricted devices.

(f) Good manufacturing practice requirements.

(g) Exemption for devices for investigational use.

(h) Release of information respecting safety and

effectiveness.

(i) Proceedings of advisory panels and committees.

(j) Traceability.

(k) Research and development.

(l) Transitional provisions for devices considered as

new drugs.

(m) Humanitarian device exemption.

360k. State and local requirements respecting devices.

(a) General rule.

(b) Exempt requirements.

360l. Postmarket surveillance.

(a) In general.

(b) Surveillance approval.

360m. Accredited persons.

(a) In general.

(b) Accreditation.

(c) Duration.

(d) Report.

PART B - DRUGS FOR RARE DISEASES OR CONDITIONS

360aa. Recommendations for investigations of drugs for rare

diseases or conditions.

(a) Request by sponsor; response by Secretary.

(b) Regulations.

360bb. Designation of drugs for rare diseases or conditions.

(a) Request by sponsor; preconditions; ''rare disease

or condition'' defined.

(b) Notification of discontinuance of drug or

application as condition.

(c) Notice to public.

(d) Regulations.

360cc. Protection for drugs for rare diseases or conditions.

(a) Exclusive approval, certification, or license.

(b) Exceptions.

360dd. Open protocols for investigations of drugs for rare diseases

or conditions.

360ee. Grants and contracts for development of drugs for rare

diseases and conditions.

(a) Authority of Secretary.

(b) Definitions.

(c) Authorization of appropriations.

PART C - ELECTRONIC PRODUCT RADIATION CONTROL

360hh. Definitions.

360ii. Program of control.

(a) Establishment.

(b) Powers of Secretary.

(c) Record keeping.

360jj. Studies by the Secretary.

(a) Report to Congress.

(b) Participation of other Federal agencies.

(c) Organization of studies and participation.

360kk. Performance standards for electronic products.

(a) Promulgation of regulations.

(b) Administrative procedure.

(c) Publication in Federal Register.

(d) Judicial review.

(e) Availability of record.

(f) Technical Electronic Product Radiation Safety

Standards Committee.

(g) Review and evaluation.

(h) Product certification.

360ll. Notification of defects in and repair or replacement of

electronic products.

(a) Notification; exemption.

(b) Method of notification.

(c) Requisite elements of notification.

(d) Copies to Secretary of communications by

manufacturers to dealers or distributors

regarding defects.

(e) Notice from Secretary to manufacturer of defects

or failure to comply with standards.

(f) Correction of defects.

(g) Effective date.

360mm. Imports.

(a) Refusal of admission to noncomplying electronic

products.

(b) Bond.

(c) Liability of owner or consignee for expenses

connected with refusal of admission.

(d) Designation of agent for purposes of service.

360nn. Inspection, records, and reports.

(a) Inspection of premises.

(b) Record keeping.

(c) Disclosure of technical data.

(d) Public nature of reports.

(e) Trade secrets.

(f) Information required to identify and locate first

purchasers of electronic products.

360oo. Prohibited acts.

360pp. Enforcement.

(a) Jurisdiction of courts.

(b) Penalties.

(c) Venue; process.

(d) Warnings.

(e) Compliance with regulations.

(f) Additional remedies.

360qq. Repealed.

360rr. Federal-State cooperation.

360ss. State standards.

PART D - DISSEMINATION OF TREATMENT INFORMATION

360aaa. Requirements for dissemination of treatment information on

drugs or devices.

(a) In general.

(b) Specific requirements.

(c) Additional information.

360aaa-1. Information authorized to be disseminated.

(a) Authorized information.

(b) Reference publication.

360aaa-2. Establishment of list of articles and publications

disseminated and list of providers that received articles and

reference publications.

(a) In general.

(b) Records.

360aaa-3. Requirement regarding submission of supplemental

application for new use; exemption from requirement.

(a) In general.

(b) Certification on supplemental application;

condition in case of completed studies.

(c) Certification on supplemental application;

condition in case of planned studies.

(d) Exemption from requirement of supplemental

application.

(e) Requirements regarding applications.

360aaa-4. Corrective actions; cessation of dissemination.

(a) Postdissemination data regarding safety and

effectiveness.

(b) Cessation of dissemination.

(c) Corrective actions by manufacturers.

360aaa-5. Definitions.

360aaa-6. Rules of construction.

(a) Unsolicited request.

(b) Dissemination of information on drugs or devices

not evidence of intended use.

(c) Patent protection.

(d) Authorization for dissemination of articles and

fees for reprints of articles.

PART E - GENERAL PROVISIONS RELATING TO DRUGS AND DEVICES

360bbb. Expanded access to unapproved therapies and diagnostics.

(a) Emergency situations.

(b) Individual patient access to investigational

products intended for serious diseases.

(c) Treatment investigational new drug applications

and treatment investigational device

exemptions.

(d) Termination.

(e) Definitions.

360bbb-1. Dispute resolution.

360bbb-2. Classification of products.

(a) Request.

(b) Statement.

(c) Inaction of Secretary.

SUBCHAPTER VI - COSMETICS

361. Adulterated cosmetics.

362. Misbranded cosmetics.

363. Regulations making exemptions.

364. Repealed.

SUBCHAPTER VII - GENERAL AUTHORITY

PART A - GENERAL ADMINISTRATIVE PROVISIONS

371. Regulations and hearings.

(a) Authority to promulgate regulations.

(b) Regulations for imports and exports.

(c) Conduct of hearings.

(d) Effectiveness of definitions and standards of

identity.

(e) Procedure for establishment.

(f) Review of order.

(g) Copies of records of hearings.

(h) Guidance documents.

372. Examinations and investigations.

(a) Authority to conduct.

(b) Availability to owner of part of analysis

samples.

(c) Records of other departments and agencies.

(d) Information on patents for drugs.

(e) Powers of enforcement personnel.

372a. Transferred.

373. Records of interstate shipment.

374. Inspection.

(a) Right of agents to enter; scope of inspection;

notice; promptness; exclusions.

(b) Written report to owner; copy to Secretary.

(c) Receipt for samples taken.

(d) Analysis of samples furnished owner.

(e) Accessibility of records.

(f) Recordkeeping.

(g) Inspections by accredited persons.

375. Publicity.

(a) Reports.

(b) Information regarding certain goods.

376. Examination of sea food on request of packer; marking food

with results; fees; penalties.

377. Revision of United States Pharmacopoeia; development of

analysis and mechanical and physical tests.

378. Advertising of foods.

(a) Determination of misbranding; notification of

Federal Trade Commission by Secretary;

contents.

(b) Action by Federal Trade Commission precluding

action by Secretary; exception.

(c) Secretary's determination of imminent hazard to

health as suspending applicability of

provisions.

(d) Coordination of action by Secretary with Federal

Trade Commission.

379. Confidential information.

379a. Presumption of existence of jurisdiction.

379b. Consolidated administrative and laboratory facility.

(a) Authority.

(b) Awarding of contract.

(c) Donations.

(d) Authorization of appropriations.

379c. Transferred.

379d. Automation of Food and Drug Administration.

(a) In general.

(b) Authorization of appropriations.

PART B - COLORS

379e. Listing and certification of color additives for foods,

drugs, devices, and cosmetics.

(a) Unsafe color additives.

(b) Listing of colors; regulations; issuance,

amendment or repeal; referral to advisory

committee; report and recommendations;

appointment and compensation of advisory

committee.

(c) Certification of colors.

(d) Procedure for issuance, amendment, or repeal of

regulations.

(e) Fees.

(f) Exemptions.

PART C - FEES

SUBPART 1 - FREEDOM OF INFORMATION FEES

379f. Recovery and retention of fees for freedom of information

requests.

(a) In general.

(b) Use of fees.

(c) Waiver of fees.

SUBPART 2 - FEES RELATING TO DRUGS

379g. Definitions.

379h. Authority to assess and use drug fees.

(a) Types of fees.

(b) Fee revenue amounts.

(c) Adjustments.

(d) Fee waiver or reduction.

(e) Effect of failure to pay fees.

(f) Limitations.

(g) Crediting and availability of fees.

(h) Collection of unpaid fees.

(i) Written requests for waivers, reductions, and

refunds.

(j) Construction.

SUBPART 3 - FEES RELATING TO DEVICES

379i. Definitions.

379j. Authority to assess and use device fees.

(a) Types of fees.

(b) Fee revenue amounts.

(c) Adjustments.

(d) Small businesses; fee waiver and fee reduction

regarding premarket approval fees.

(e) Small businesses; fee reduction regarding

premarket notification submissions.

(f) Effect of failure to pay fees.

(g) Conditions.

(h) Crediting and availability of fees.

(i) Collection of unpaid fees.

(j) Written requests for refunds.

(k) Construction.

PART D - INFORMATION AND EDUCATION

379k. Information system.

379l. Education.

(a) In general.

(b) Intramural fellowships and other training

programs.

PART E - ENVIRONMENTAL IMPACT REVIEW

379o. Environmental impact.

PART F - NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND

PREEMPTION FOR LABELING OR PACKAGING OF COSMETICS

379r. National uniformity for nonprescription drugs.

(a) In general.

(b) Exemption.

(c) Scope.

(d) Exceptions.

(e) No effort on product liability law.

(f) State enforcement authority.

379s. Preemption for labeling or packaging of cosmetics.

(a) In general.

(b) Exemption.

(c) Scope.

(d) No effect on product liability law.

(e) State initiative.

PART G - SAFETY REPORTS

379v. Safety report disclaimers.

SUBCHAPTER VIII - IMPORTS AND EXPORTS

381. Imports and exports.

(a) Imports; list of registered foreign

establishments; samples from unregistered

foreign establishments; examination and refusal

of admission.

(b) Disposition of refused articles.

(c) Charges concerning refused articles.

(d) Reimportation.

(e) Exports.

(f) Labeling of exported drugs.

(g) Warning notice of importation in violation of

chapter.

(h) Protection against adulteration of food.

(i) Testing for rapid detection of adulteration of

food.

(j) Temporary holds at ports of entry.

(k) Importation by debarred persons.

(l) Failure to register.

(m) Prior notice of imported food shipments.

(n) Labeling of food refused admission.

(o) Registration statement.

382. Exports of certain unapproved products.

(a) Drugs or devices intended for human or animal use

which require approval or licensing.

(b) List of eligible countries for export; criteria

for addition to list; direct export; petition

for exemption.

(c) Investigational use exemption.

(d) Anticipation of market authorization.

(e) Diagnosis, prevention, or treatment of tropical

disease.

(f) Prohibition of export of drug or device.

(g) Notification of Secretary.

(h) References to Secretary and term ''drug''.

(i) Exportation.

383. Office of International Relations.

(a) Establishment.

(b) Agreements with foreign countries.

(c) Harmonizing regulatory requirements.

384. Importation of covered products.

(a) Regulations.

(b) Limitation.

(c) Records.

(d) Importation.

(e) Testing.

(f) Country limitation.

(g) Suspension of importations.

(h) Prohibited agreements.

(i) Studies; reports.

(j) Construction.

(k) Definitions.

(l) Conditions.

(m) Sunset.

SUBCHAPTER IX - MISCELLANEOUS

391. Separability clause.

392. Exemption of meats and meat food products.

(a) Law determinative of exemption.

(b) Laws unaffected.

393. Food and Drug Administration.

(a) In general.

(b) Mission.

(c) Interagency collaboration.

(d) Commissioner.

(e) Technical and scientific review groups.

(f) Agency plan for statutory compliance.

(g) Annual report.

393a. Office of Pediatric Therapeutics.

(a) Establishment.

(b) Duties.

(c) Staff.

394. Scientific review groups.

395. Loan repayment program.

(a) In general.

(b) Applicability of certain provisions.

(c) Authorization of appropriations.

396. Practice of medicine.

397. Contracts for expert review.

(a) In general.

(b) Review of expert review.

398. Notices to States regarding imported food.

(a) In general.

(b) Rule of construction.

399. Grants to States for inspections.

(a) In general.

(b) Notices regarding adulterated imported food.

(c) Authorization of appropriations.

-SECREF-

CHAPTER REFERRED TO IN OTHER SECTIONS

This chapter is referred to in sections 321d, 355b, 453, 457,

466, 467, 467f, 601, 607, 620, 679, 802, 811, 823, 829, 830, 902,

1033, 1049, 1052, 1401, 1402, 1403, 1601 of this title; title 7

sections 136a-1, 136v, 138i, 1431c, 5341, 6519, 7653, 8401; title

15 sections 70j, 1261, 1263, 1277, 1459, 1460, 2057a, 2057b, 2079;

title 18 sections 42, 983; title 19 section 2578a; title 26

sections 170, 4817; title 35 sections 155, 156, 271, 287; title 42

sections 238q, 262, 262a, 284m, 300aa-22, 300aa-23, 1396r-8, 1786,

3512, 7671.

-CITE-

21 USC SUBCHAPTER I - SHORT TITLE 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER I - SHORT TITLE

.

-HEAD-

SUBCHAPTER I - SHORT TITLE

-CITE-

21 USC Sec. 301 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER I - SHORT TITLE

-HEAD-

Sec. 301. Short title

-STATUTE-

This chapter may be cited as the Federal Food, Drug, and Cosmetic

Act.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 1, 52 Stat. 1040.)

-MISC1-

EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES

Act June 23, 1939, ch. 242, Sec. 1, 2, 53 Stat. 853, 854,

provided that:

''(Sec. 1) (a) The effective date of the following provisions of

the Federal Food, Drug, and Cosmetic Act is hereby postponed until

January 1, 1940: Sections 402(c) (342(c) of this title); 403(e)(1)

(343(e)(1) of this title); 403(g), (h), (i), (j), and (k) (343(g)

to (k) of this title); 501(a), (4) (351(a)(4) of this title);

502(b), (d), (e), (f), (g), and (h) (352(b), (d) to (h) of this

title); 601(e) (361(e) of this title); and 602(b) (362(b) of this

title).

''(b) The Secretary of Agriculture shall promulgate regulations

further postponing to July 1, 1940 the effective date of the

provisions of sections 403(e)(1) (343(e)(1) of this title); 403(g),

(h), (i), (j), and (k) (343(g) to (k)); 502(b), (d), (e), (f), (g),

and (h) (352(b), (d) to (h) of this title); and 602(b) (362(b) of

this title) of such Act with respect to lithographed labeling which

was manufactured prior to February 1, 1939, and to containers

bearing labeling which, prior to February 1, 1939, was

lithographed, etched, stamped, pressed, printed, fused or blown on

or in such containers, where compliance with such provisions would

be unduly burdensome by reason of causing the loss of valuable

stocks of such labeling or containers, and where such postponement

would not prevent the public interest being adequately served:

Provided, That in no case shall such regulations apply to labeling

which would not have complied with the requirements of the Food and

Drugs Act of June 30, 1906, as amended.

''Sec. 2. (a) The provisions of section 8 (section 10 of this

title), paragraph fifth, under the heading 'In the case of food:',

of the Food and Drugs Act of June 30, 1906, as amended, and

regulations promulgated thereunder, and all other provisions of

such Act to the extent that they may relate to the enforcement of

such section 8 (section 10 of this title) and of such regulations,

shall remain in force until January 1, 1940.

''(b) The provisions of such Act of June 30, 1906, as amended,

(sections 1 to 5, 7 to 15, and 372a of this title) to the extent

that they impose, or authorize the imposition of, any requirement

imposed by section 403(k) of the Federal Food, Drug, and Cosmetic

Act (section 343(k) of this title), shall remain in force until

January 1, 1940.

''(c) Notwithstanding the provisions of section 1 of this Act,

such section shall not apply -

''(1) to the provisions of section 502(d) and (e) of the

Federal Food, Drug, and Cosmetic Act (352(d), (e) of this title),

insofar as such provisions relate to any substance named in

section 8 (section 10 of this title), paragraph second, under the

heading 'In the case of drugs:', of the Food and Drugs Act of

June 30, 1906, as amended, or a derivative of any such substance;

or

''(2) to the provisions of section 502(b), (d), (e), (f), (g),

and (h) of the Federal Food, Drug, and Cosmetic Act (352(b), (d)

to (h) of this title), insofar as such provisions relate to drugs

to which section 505 (355 of this title) of such Act applies.''

EFFECTIVE DATE

Section 902(a) of act June 25, 1938, provided that: ''This Act

(enacting this chapter and repealing sections 1 to 5 and 7 to 15 of

this title), shall take effect twelve months after the date of its

enactment (June 25, 1938). The Federal Food and Drugs Act of June

30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1-15),

shall remain in force until such effective date, and, except as

otherwise provided in this subsection, is hereby repealed effective

upon such date: Provided, That the provisions of section 701

(section 371 of this title) shall become effective on the enactment

of this Act, and thereafter the Secretary is authorized hereby to

(1) conduct hearings and to promulgate regulations which shall

become effective on or after the effective date of this Act as the

Secretary shall direct, and (2) designate prior to the effective

date of this Act food having common or usual names and exempt such

food from the requirements of clause (2) of section 403(i) (section

343(i) of this title) for a reasonable time to permit the

formulation, promulgation, and effective application of definitions

and standards of identity therefor as provided by section 401

(section 341 of this title): Provided further, That sections

502(j), 505, and 601(a) (sections 352(j), 355, 361(a), respectively

of this title), and all other provisions of this Act to the extent

that they may relate to the enforcement of such sections, shall

take effect on the date of the enactment of this Act, except that

in the case of a cosmetic to which the proviso of section 601(a)

(section 361(a) of this title), relates, such cosmetic shall not,

prior to the ninetieth day after such date of enactment, be deemed

adulterated by reason of the failure of its label to bear the

legend prescribed in such proviso: Provided further, That the Act

of March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 (section 321a

of this title); 42 Stat. 1500, ch. 268), defining butter and

providing a standard therefor; the Act of July 24, 1919 (U.S.C.,

1934 ed., title 21, sec. 10 (section 321b of this title); 41 Stat.

271, ch. 26), defining wrapped meats as in package form; and the

amendment to the Food and Drugs Act, section 10A, approved August

27, 1935 (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a (section

372a of this title)) shall remain in force and effect and be

applicable to the provisions of this Act.''

HAZARDOUS SUBSTANCES

Federal Hazardous Substances Act as not modifying this chapter,

see Pub. L. 86-613, Sec. 18, July 12, 1960, 74 Stat. 380, set out

as an Effect Upon Federal and State Laws note under section 1261 of

Title 15, Commerce and Trade.

SHORT TITLE OF 2002 AMENDMENTS

Pub. L. 107-281, Sec. 1, Nov. 6, 2002, 116 Stat. 1992, provided

that: ''This Act (amending sections 360cc and 360ee of this title

and enacting provisions set out as a note under section 360ee of

this title) may be cited as the 'Rare Diseases Orphan Product

Development Act of 2002'.''

Pub. L. 107-250, Sec. 1(a), Oct. 26, 2002, 116 Stat. 1588,

provided that: ''This Act (enacting sections 379i and 379j of this

title and section 289g-3 of Title 42, The Public Health and

Welfare, amending sections 321, 331, 333, 335a, 352, 353, 360,

360c, 360e, 360m, and 374 of this title, and enacting provisions

set out as notes under sections 352, 360e, 360j, 360l, 379i, and

379j of this title and section 289g-3 of Title 42) may be cited as

the 'Medical Device User Fee and Modernization Act of 2002'.''

Pub. L. 107-188, title V, Sec. 501, June 12, 2002, 116 Stat. 687,

provided that: ''This subtitle (subtitle A (Sec. 501-509) of title

V of Pub. L. 107-188, amending sections 356b, 379g, and 379h of

this title and enacting provisions set out as notes under sections

356b and 379g of this title) may be cited as the 'Prescription Drug

User Fee Amendments of 2002'.''

Pub. L. 107-109, Sec. 1, Jan. 4, 2002, 115 Stat. 1408, provided

that: ''This Act (enacting sections 355b and 393a of this title and

section 284m of Title 42, The Public Health and Welfare, amending

sections 321, 355, 355a, and 379h of this title and sections 282,

284k, 284l, 285a-2, and 290b of Title 42, and enacting provisions

set out as notes under sections 355 and 355a of this title and

sections 284m and 289 of Title 42) may be cited as the 'Best

Pharmaceuticals for Children Act'.''

SHORT TITLE OF 2000 AMENDMENT

Pub. L. 106-387, Sec. 1(a) (title VII, Sec. 745(a)), Oct. 28,

2000, 114 Stat. 1549, 1549A-35, provided that: ''This section

(enacting section 384 of this title, amending sections 331, 333,

and 381 of this title, and enacting provisions set out as a note

under section 384 of this title) may be cited as the 'Medicine

Equity and Drug Safety Act of 2000'.''

Pub. L. 106-387, Sec. 1(a) (title VII, Sec. 746(a)), Oct. 28,

2000, 114 Stat. 1549, 1549A-40, provided that: ''This section

(amending section 381 of this title and enacting provisions set out

as a note under section 381 of this title) may be cited as the

'Prescription Drug Import Fairness Act of 2000'.''

SHORT TITLE OF 1998 AMENDMENT

Pub. L. 105-324, Sec. 1, Oct. 30, 1998, 112 Stat. 3035, provided

that: ''This Act (amending sections 321 and 346a of this title) may

be cited as the 'Antimicrobial Regulation Technical Corrections Act

of 1998'.''

SHORT TITLE OF 1997 AMENDMENT

Pub. L. 105-115, Sec. 1(a), Nov. 21, 1997, 111 Stat. 2296,

provided that: ''This Act (enacting sections 343-3, 353a, 355a, 356

to 356c, 360m, 360aaa to 360aaa-6, 360bbb to 360bbb-2, 379k, 379l,

379o, 379r, 379s, 379v, 396, and 397 of this title and sections

247b-8 and 299a-3 of Title 42, The Public Health and Welfare,

amending sections 321, 331, 334, 335a, 343, 348, 351 to 353, 355,

360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee,

371, 374, 379a, 379g, 379h, 381 to 383, 393, and 802 of this title,

section 45C of Title 26, Internal Revenue Code, section 156 of

Title 35, Patents, section 8126 of Title 38, Veterans' Benefits,

and sections 262, 263a, and 282 of Title 42, repealing sections 356

and 357 of this title, and enacting provisions set out as notes

under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l,

360m, 360aaa, 371, 379g, 379h, 379k, and 393 of this title and

sections 247b-8 and 282 of Title 42) may be cited as the 'Food and

Drug Administration Modernization Act of 1997'.''

SHORT TITLE OF 1996 AMENDMENTS

Pub. L. 104-250, Sec. 1(a), Oct. 9, 1996, 110 Stat. 3151,

provided that: ''This Act (enacting section 354 of this title,

amending sections 331, 353, and 360b of this title, and enacting

provisions set out as notes under section 360b of this title) may

be cited as the 'Animal Drug Availability Act of 1996'.''

Pub. L. 104-170, title IV, Sec. 401(a), Aug. 3, 1996, 110 Stat.

1513, provided that: ''This title (amending sections 321, 331, 333,

342, and 346a of this title) may be cited as the 'Food Quality

Protection Act of 1996'.''

(Another ''Food Quality Protection Act of 1996'', was enacted by

Pub. L. 104-170, Sec. 1, 110 Stat. 1489, which is set out as a note

under section 136 of Title 7, Agriculture.)

Pub. L. 104-134, title II, Sec. 2101(a), Apr. 26, 1996, 110 Stat.

1321-313, provided that: ''This chapter (chapter 1A (Sec.

2101-2105) of title II of Pub. L. 104-134, enacting section 382 of

this title and amending sections 331 and 381 of this title and

section 262 of Title 42, The Public Health and Welfare) may be

cited as the 'FDA Export Reform and Enhancement Act of 1996'.''

SHORT TITLE OF 1994 AMENDMENTS

Pub. L. 103-417, Sec. 1(a), Oct. 25, 1994, 108 Stat. 4325,

provided that: ''This Act (enacting sections 343-2 and 350b of this

title and section 287c-11 of Title 42, The Public Health and

Welfare, amending sections 321, 331, 342, 343, and 350 of this

title and section 281 of Title 42, and enacting provisions set out

as notes under sections 321 and 343 of this title) may be cited as

the 'Dietary Supplement Health and Education Act of 1994'.''

Pub. L. 103-396, Sec. 1, Oct. 22, 1994, 108 Stat. 4153, provided

that: ''This Act (amending sections 331, 343-1, 360b, and 371 of

this title and enacting provisions set out as notes under section

360b of this title) may be cited as the 'Animal Medicinal Drug Use

Clarification Act of 1994'.''

SHORT TITLE OF 1993 AMENDMENT

Pub. L. 103-80, Sec. 1, Aug. 13, 1993, 107 Stat. 773, provided

that: ''This Act (amending sections 321, 331 to 333, 334, 335b, 341

to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc,

360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this

title and section 263b of Title 42, The Public Health and Welfare,

and enacting provisions set out as a note under section 343 of this

title) may be cited as the 'Nutrition Labeling and Education Act

Amendments of 1993'.''

SHORT TITLE OF 1992 AMENDMENTS

Pub. L. 102-571, title I, Sec. 101(a), Oct. 29, 1992, 106 Stat.

4491, provided that: ''This title (enacting sections 379g and 379h

of this title, transferring sections 372a, 376, and 379c of this

title to sections 376, 379e and 379f, respectively, of this title,

amending sections 321, 331, 342, 343, 346a, 351, 352, 360j, 361,

362, 453, 601, and 1033 of this title, enacting provisions set out

as notes under section 379g of this title, and amending provisions

set out as notes under sections 343 and 343-1 of this title) may be

cited as the 'Prescription Drug User Fee Act of 1992'.''

Pub. L. 102-571, title II, Sec. 201, Oct. 29, 1992, 106 Stat.

4500, provided that: ''This title (enacting provisions set out as

notes under sections 343 and 393 of this title and amending

provisions set out as notes under sections 343 and 343-1 of this

title) may be cited as the 'Dietary Supplement Act of 1992'.''

Pub. L. 102-353, Sec. 1(a), Aug. 26, 1992, 106 Stat. 941,

provided that: ''This Act (amending sections 333, 353, and 381 of

this title and enacting provisions set out as a note under section

353 of this title) may be cited as the 'Prescription Drug

Amendments of 1992'.''

Pub. L. 102-300, Sec. 1(a), June 16, 1992, 106 Stat. 238,

provided that: ''This Act (amending sections 321, 331, 334, 346a,

352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to

372a, 376, and 381 of this title and section 262 of Title 42, The

Public Health and Welfare and enacting and amending provisions set

out as notes under section 360i of this title) may be cited as the

'Medical Device Amendments of 1992'.''

Pub. L. 102-282, Sec. 1(a), May 13, 1992, 106 Stat. 149, provided

that: ''This Act (enacting sections 335a to 335c of this title,

amending sections 321, 336, 337, and 355 of this title, and

enacting provisions set out as notes under section 335a of this

title) may be cited as the 'Generic Drug Enforcement Act of

1992'.''

SHORT TITLE OF 1990 AMENDMENTS

Pub. L. 101-635, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4583,

provided that: ''This Act (enacting sections 379b to 379d and 394

of this title) may be cited as the 'Food and Drug Administration

Revitalization Act'.''

Pub. L. 101-629, Sec. 1(a), Nov. 28, 1990, 104 Stat. 4511,

provided that: ''This Act (enacting sections 360l and 383 of this

title, amending sections 321, 333, 351, 353, and 360c to 360j of

this title and sections 263b to 263n of Title 42, The Public Health

and Welfare, redesignating sections 263b to 263n of Title 42 as

sections 360gg to 360ss of this title, repealing section 263b of

Title 42, and enacting provisions set out as notes under sections

333, 360c, 360i, 360j, 360hh and 383 of this title) may be cited as

the 'Safe Medical Devices Act of 1990'.''

Pub. L. 101-535, Sec. 1(a), Nov. 8, 1990, 104 Stat. 2353,

provided that: ''This Act (enacting section 343-1 of this title,

amending sections 321, 337, 343, 345, and 371 of this title, and

enacting provisions set out as notes under sections 343 and 343-1

of this title) may be cited as the 'Nutrition Labeling and

Education Act of 1990'.''

SHORT TITLE OF 1988 AMENDMENTS

Pub. L. 100-670, Sec. 1(a), Nov. 16, 1988, 102 Stat. 3971,

provided that: ''This Act (amending sections 321, 353, and 360b of

this title, section 2201 of Title 28, Judiciary and Judicial

Procedure, and sections 156 and 271 of Title 35, Patents, and

enacting provisions set out as notes under section 360b of this

title) may be cited as the 'Generic Animal Drug and Patent Term

Restoration Act'.''

Pub. L. 100-607, title V, Sec. 501, Nov. 4, 1988, 102 Stat. 3120,

provided that: ''This title (enacting section 393 of this title,

amending sections 5315 and 5316 of Title 5, Government Organization

and Employees, and enacting provisions set out as notes under

section 393 of this title) may be cited as the 'Food and Drug

Administration Act of 1988'.''

Pub. L. 100-293, Sec. 1(a), Apr. 22, 1988, 102 Stat. 95, provided

that: ''This Act (amending sections 331, 333, 353, and 381 of this

title and enacting provisions set out as notes under section 353 of

this title) may be cited as the 'Prescription Drug Marketing Act of

1987'.''

Pub. L. 100-290, Sec. 1, Apr. 18, 1988, 102 Stat. 90, provided

that: ''This Act (amending sections 360bb and 360ee of this title,

enacting provisions set out as a note under section 360aa of this

title, and amending provisions set out as a note under section 236

of Title 42, The Public Health and Welfare) may be cited as the

'Orphan Drug Amendments of 1988'.''

SHORT TITLE OF 1986 AMENDMENT

Pub. L. 99-660, title I, Sec. 101(a), Nov. 14, 1986, 100 Stat.

3743, provided that: ''This title (enacting section 382 of this

title, amending sections 241 and 262 of Title 42, The Public Health

and Welfare, and enacting provisions set out as notes under section

333 of this title and section 262 of Title 42) may be cited as the

'Drug Export Amendments Act of 1986'.''

SHORT TITLE OF 1985 AMENDMENT

Pub. L. 99-91, Sec. 1, Aug. 15, 1985, 99 Stat. 387, provided

that: ''This Act (amending sections 360aa to 360cc, and 360ee of

this title, and sections 295g-1 and 6022 of Title 42, The Public

Health and Welfare, and enacting provisions set out as notes under

section 360aa of this title and section 236 of Title 42) may be

cited as the 'Orphan Drug Amendments of 1985'.''

SHORT TITLE OF 1984 AMENDMENT

Pub. L. 98-417, Sec. 1, Sept. 24, 1984, 98 Stat. 1585, provided:

''That this Act (enacting section 156 of Title 35, Patents,

amending sections 355 and 360cc of this title, sections 68b, 68c,

and 70b of Title 15, Commerce and Trade, section 2201 of Title 28,

Judiciary and Judicial Procedure, and sections 271 and 282 of Title

35, and enacting provisions set out as notes under section 355 of

this title and section 68b of Title 15) may be cited as the 'Drug

Price Competition and Patent Term Restoration Act of 1984'.''

SHORT TITLE OF 1983 AMENDMENTS

Pub. L. 98-22, Sec. 1, Apr. 22, 1983, 97 Stat. 173, provided:

''That this Act (amending provisions set out as a note under

section 348 of this title) may be cited as the 'Saccharin Study and

Labeling Act Amendment of 1983'.''

Pub. L. 97-414, Sec. 1(a), Jan. 4, 1983, 96 Stat. 2049, provided

that: ''This Act (enacting part B of subchapter V of chapter 9 of

this title, section 44H of Title 26, Internal Revenue Code, section

155 of Title 35, Patents, and sections 236, 255, and 298b-4 of

Title 42, The Public Health and Welfare, amending sections 1274,

1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and

Trade, section 904 of this title, sections 280C and 6096 of Title

26, and sections 209, 231, 242k, 242m, 243, 254c, 254j, 254m, 254o,

254p, 256, 294j, 295g-1, 295g-4, 295h, 295h-1a, 297-1, 300, 300a-1,

300a-3, 300b, 300e-1, 300m, 300n-5, 300q-2, 300u-5, 300w-3, 300x-1,

300x-4, 300y-11, 4577, and 4588 of Title 42, enacting provisions

set out as notes under section 360aa of this title, section 44H of

Title 26, and sections 241, 255, 287i, and 300x-1 of Title 42, and

repealing provisions set out as a note under section 300t-11 of

Title 42) may be cited as the 'Orphan Drug Act'.''

SHORT TITLE OF 1981 AMENDMENT

Pub. L. 97-42, Sec. 1, Aug. 14, 1981, 95 Stat. 946, provided:

''That this Act (amending provisions set out as a note under

section 348 of this title) may be cited as the 'Saccharin Study and

Labeling Act Amendment of 1981'.''

SHORT TITLE OF 1980 AMENDMENT

Pub. L. 96-359, Sec. 1, Sept. 26, 1980, 94 Stat. 1190, provided:

''That this Act (enacting section 350a of this title, amending

sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and

enacting a provision set out as a note under section 350a of this

title) may be cited as the 'Infant Formula Act of 1980'.''

SHORT TITLE OF 1977 AMENDMENT

Pub. L. 95-203, Sec. 1, Nov. 23, 1977, 91 Stat. 1451, provided

that: ''This Act (enacting section 343a of this title, amending

sections 321 and 343 of this title, enacting provisions set out as

notes under sections 343 and 348 of this title, and amending

provisions set out as notes under sections 218 and 289l-1 of Title

42, The Public Health and Welfare) may be cited as the 'Saccharin

Study and Labeling Act'.''

SHORT TITLE OF 1976 AMENDMENT

Pub. L. 94-295, Sec. 1(a), May 28, 1976, 90 Stat. 539, provided

that: ''This Act (enacting sections 360c to 360k, 379, and 379a of

this title and section 3512 of Title 42, The Public Health and

Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360,

374, 379e, and 381 of this title and section 55 of Title 15,

Commerce and Trade) may be cited as the 'Medical Device Amendments

of 1976'.''

SHORT TITLE OF 1972 AMENDMENT

Pub. L. 92-387, Sec. 1, Aug. 16, 1972, 86 Stat. 559, provided

that: ''This Act (amending sections 331, 335, and 360 of this title

and enacting provisions set out as notes under section 360 of this

title) may be cited as the 'Drug Listing Act of 1972'.''

SHORT TITLE OF 1968 AMENDMENTS

Pub. L. 90-602, Sec. 1, Oct. 18, 1968, 82 Stat. 1173, provided

that: ''This Act (enacting provisions now comprising part C (Sec.

360hh-360ss) of subchapter III of this chapter and provisions set

out as notes under section 360hh of this title) may be cited as the

'Radiation Control for Health and Safety Act of 1968'.''

Pub. L. 90-399, Sec. 1, July 13, 1968, 82 Stat. 342, provided:

''That this Act (enacting section 360b of this title, amending

sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title,

and enacting provisions set out as a note under section 360b of

this title) may be cited as the 'Animal Drug Amendments of 1968'.''

SHORT TITLE OF 1965 AMENDMENT

Pub. L. 89-74, Sec. 1, July 15, 1965, 79 Stat. 226, provided:

''That this Act (amending sections 321, 331, 333, 334, 360, and 372

of this title and section 1114 of Title 18, Crimes and Criminal

Procedure, and enacting provisions set out as notes under sections

321 and 352 of this title) may be cited as the 'Drug Abuse Control

Amendments of 1965'.''

SHORT TITLE OF 1962 AMENDMENT

Pub. L. 87-781, Sec. 1, Oct. 10, 1962, 76 Stat. 780, provided in

part that such Act (enacting sections 358 to 360 of this title,

amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,

374, 379e, and 381 of this title, and enacting provisions set out

as notes under sections 321, 331, 332, 352, 355, 358, 360, and 374

of this title) may be cited as the 'Drug Amendments of 1962'.''

SHORT TITLE OF 1960 AMENDMENT

Pub. L. 86-618, Sec. 1, July 12, 1960, 74 Stat. 397, provided:

''That this Act (amending sections 321, 331, 333, 342, 346, 351,

352, 361, 362, 371, and 379e of this title, repealing sections 354

and 364 of this title, and enacting notes set out under this

section) may be cited as the 'Color Additive Amendments of 1960'.''

SHORT TITLE OF 1958 AMENDMENT

Pub. L. 85-929, Sec. 1, Sept. 6, 1958, 72 Stat. 1784, provided:

''That this Act (amending sections 321, 331, 342, 346, 348 of this

title and section 210 of Title 42, The Public Health and Welfare,

and enacting provisions set out as notes under sections 321, 342,

and 451 of this title) may be cited as the 'Food Additives

Amendment of 1958'.''

-CITE-

21 USC SUBCHAPTER II - DEFINITIONS 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS

.

-HEAD-

SUBCHAPTER II - DEFINITIONS

-CITE-

21 USC Sec. 321 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS

-HEAD-

Sec. 321. Definitions; generally

-STATUTE-

For the purposes of this chapter -

(a)(1) The term ''State'', except as used in the last sentence of

section 372(a) of this title, means any State or Territory of the

United States, the District of Columbia, and the Commonwealth of

Puerto Rico.

(2) The term ''Territory'' means any Territory or possession of

the United States, including the District of Columbia, and

excluding the Commonwealth of Puerto Rico and the Canal Zone.

(b) The term ''interstate commerce'' means (1) commerce between

any State or Territory and any place outside thereof, and (2)

commerce within the District of Columbia or within any other

Territory not organized with a legislative body.

(c) The term ''Department'' means Department of Health and Human

Services.

(d) The term ''Secretary'' means the Secretary of Health and

Human Services.

(e) The term ''person'' includes individual, partnership,

corporation, and association.

(f) The term ''food'' means (1) articles used for food or drink

for man or other animals, (2) chewing gum, and (3) articles used

for components of any such article.

(g)(1) The term ''drug'' means (A) articles recognized in the

official United States Pharmacopoeia, official Homoeopathic

Pharmacopoeia of the United States, or official National Formulary,

or any supplement to any of them; and (B) articles intended for use

in the diagnosis, cure, mitigation, treatment, or prevention of

disease in man or other animals; and (C) articles (other than food)

intended to affect the structure or any function of the body of man

or other animals; and (D) articles intended for use as a component

of any article specified in clause (A), (B), or (C). A food or

dietary supplement for which a claim, subject to sections

343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)

and 343(r)(5)(D) of this title, is made in accordance with the

requirements of section 343(r) of this title is not a drug solely

because the label or the labeling contains such a claim. A food,

dietary ingredient, or dietary supplement for which a truthful and

not misleading statement is made in accordance with section

343(r)(6) of this title is not a drug under clause (C) solely

because the label or the labeling contains such a statement.

(2) The term ''counterfeit drug'' means a drug which, or the

container or labeling of which, without authorization, bears the

trademark, trade name, or other identifying mark, imprint, or

device, or any likeness thereof, of a drug manufacturer, processor,

packer, or distributor other than the person or persons who in fact

manufactured, processed, packed, or distributed such drug and which

thereby falsely purports or is represented to be the product of, or

to have been packed or distributed by, such other drug

manufacturer, processor, packer, or distributor.

(h) The term ''device'' (except when used in paragraph (n) of

this section and in sections 331(i), 343(f), 352(c), and 362(c) of

this title) means an instrument, apparatus, implement, machine,

contrivance, implant, in vitro reagent, or other similar or related

article, including any component, part, or accessory, which is -

(1) recognized in the official National Formulary, or the

United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other

conditions, or in the cure, mitigation, treatment, or prevention

of disease, in man or other animals, or

(3) intended to affect the structure or any function of the

body of man or other animals, and

which does not achieve its primary intended purposes through

chemical action within or on the body of man or other animals and

which is not dependent upon being metabolized for the achievement

of its primary intended purposes.

(i) The term ''cosmetic'' means (1) articles intended to be

rubbed, poured, sprinkled, or sprayed on, introduced into, or

otherwise applied to the human body or any part thereof for

cleansing, beautifying, promoting attractiveness, or altering the

appearance, and (2) articles intended for use as a component of any

such articles; except that such term shall not include soap.

(j) The term ''official compendium'' means the official United

States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the

United States, official National Formulary, or any supplement to

any of them.

(k) The term ''label'' means a display of written, printed, or

graphic matter upon the immediate container of any article; and a

requirement made by or under authority of this chapter that any

word, statement, or other information appear on the label shall not

be considered to be complied with unless such word, statement, or

other information also appears on the outside container or wrapper,

if any there be, of the retail package of such article, or is

easily legible through the outside container or wrapper.

(l) The term ''immediate container'' does not include package

liners.

(m) The term ''labeling'' means all labels and other written,

printed, or graphic matter (1) upon any article or any of its

containers or wrappers, or (2) accompanying such article.

(n) If an article is alleged to be misbranded because the

labeling or advertising is misleading, then in determining whether

the labeling or advertising is misleading there shall be taken into

account (among other things) not only representations made or

suggested by statement, word, design, device, or any combination

thereof, but also the extent to which the labeling or advertising

fails to reveal facts material in the light of such representations

or material with respect to consequences which may result from the

use of the article to which the labeling or advertising relates

under the conditions of use prescribed in the labeling or

advertising thereof or under such conditions of use as are

customary or usual.

(o) The representation of a drug, in its labeling, as an

antiseptic shall be considered to be a representation that it is a

germicide, except in the case of a drug purporting to be, or

represented as, an antiseptic for inhibitory use as a wet dressing,

ointment, dusting powder, or such other use as involves prolonged

contact with the body.

(p) The term ''new drug'' means -

(1) Any drug (except a new animal drug or an animal feed

bearing or containing a new animal drug) the composition of which

is such that such drug is not generally recognized, among experts

qualified by scientific training and experience to evaluate the

safety and effectiveness of drugs, as safe and effective for use

under the conditions prescribed, recommended, or suggested in the

labeling thereof, except that such a drug not so recognized shall

not be deemed to be a ''new drug'' if at any time prior to June

25, 1938, it was subject to the Food and Drugs Act of June 30,

1906, as amended, and if at such time its labeling contained the

same representations concerning the conditions of its use; or

(2) Any drug (except a new animal drug or an animal feed

bearing or containing a new animal drug) the composition of which

is such that such drug, as a result of investigations to

determine its safety and effectiveness for use under such

conditions, has become so recognized, but which has not,

otherwise than in such investigations, been used to a material

extent or for a material time under such conditions.

(q)(1)(A) Except as provided in clause (B), the term ''pesticide

chemical'' means any substance that is a pesticide within the

meaning of the Federal Insecticide, Fungicide, and Rodenticide Act

(7 U.S.C. 136 et seq.), including all active and inert ingredients

of such pesticide. Notwithstanding any other provision of law, the

term ''pesticide'' within such meaning includes ethylene oxide and

propylene oxide when such substances are applied on food.

(B) In the case of the use, with respect to food, of a substance

described in clause (A) to prevent, destroy, repel, or mitigate

microorganisms (including bacteria, viruses, fungi, protozoa,

algae, and slime), the following applies for purposes of clause

(A):

(i) The definition in such clause for the term ''pesticide

chemical'' does not include the substance if the substance is

applied for such use on food, or the substance is included for

such use in water that comes into contact with the food, in the

preparing, packing, or holding of the food for commercial

purposes. The substance is not excluded under this subclause

from such definition if the substance is ethylene oxide or

propylene oxide, and is applied for such use on food. The

substance is not so excluded if the substance is applied for such

use on a raw agricultural commodity, or the substance is included

for such use in water that comes into contact with the commodity,

as follows:

(I) The substance is applied in the field.

(II) The substance is applied at a treatment facility where

raw agricultural commodities are the only food treated, and the

treatment is in a manner that does not change the status of the

food as a raw agricultural commodity (including treatment

through washing, waxing, fumigating, and packing such

commodities in such manner).

(III) The substance is applied during the transportation of

such commodity between the field and such a treatment facility.

(ii) The definition in such clause for the term ''pesticide

chemical'' does not include the substance if the substance is a

food contact substance as defined in section 348(h)(6) of this

title, and any of the following circumstances exist: The

substance is included for such use in an object that has a food

contact surface but is not intended to have an ongoing effect on

any portion of the object; the substance is included for such use

in an object that has a food contact surface and is intended to

have an ongoing effect on a portion of the object but not on the

food contact surface; or the substance is included for such use

in or is applied for such use on food packaging (without regard

to whether the substance is intended to have an ongoing effect on

any portion of the packaging). The food contact substance is not

excluded under this subclause from such definition if any of the

following circumstances exist: The substance is applied for such

use on a semipermanent or permanent food contact surface (other

than being applied on food packaging); or the substance is

included for such use in an object that has a semipermanent or

permanent food contact surface (other than being included in food

packaging) and the substance is intended to have an ongoing

effect on the food contact surface.

With respect to the definition of the term ''pesticide'' that is

applicable to the Federal Insecticide, Fungicide, and Rodenticide

Act (7 U.S.C. 136 et seq.), this clause does not exclude any

substance from such definition.

(2) The term ''pesticide chemical residue'' means a residue in or

on raw agricultural commodity or processed food of -

(A) a pesticide chemical; or

(B) any other added substance that is present on or in the

commodity or food primarily as a result of the metabolism or

other degradation of a pesticide chemical.

(3) Notwithstanding subparagraphs (1) and (2), the Administrator

may by regulation except a substance from the definition of

''pesticide chemical'' or ''pesticide chemical residue'' if -

(A) its occurrence as a residue on or in a raw agricultural

commodity or processed food is attributable primarily to natural

causes or to human activities not involving the use of any

substances for a pesticidal purpose in the production, storage,

processing, or transportation of any raw agricultural commodity

or processed food; and

(B) the Administrator, after consultation with the Secretary,

determines that the substance more appropriately should be

regulated under one or more provisions of this chapter other than

sections 342(a)(2)(B) and 346a of this title.

(r) The term ''raw agricultural commodity'' means any food in its

raw or natural state, including all fruits that are washed,

colored, or otherwise treated in their unpeeled natural form prior

to marketing.

(s) The term ''food additive'' means any substance the intended

use of which results or may reasonably be expected to result,

directly or indirectly, in its becoming a component or otherwise

affecting the characteristics of any food (including any substance

intended for use in producing, manufacturing, packing, processing,

preparing, treating, packaging, transporting, or holding food; and

including any source of radiation intended for any such use), if

such substance is not generally recognized, among experts qualified

by scientific training and experience to evaluate its safety, as

having been adequately shown through scientific procedures (or, in

the case of a substance used in food prior to January 1, 1958,

through either scientific procedures or experience based on common

use in food) to be safe under the conditions of its intended use;

except that such term does not include -

(1) a pesticide chemical residue in or on a raw agricultural

commodity or processed food; or

(2) a pesticide chemical; or

(3) a color additive; or

(4) any substance used in accordance with a sanction or

approval granted prior to September 6, 1958, pursuant to this

chapter, the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.) or the Meat Inspection Act of March 4, 1907, as amended and

extended (21 U.S.C. 601 et seq.);

(5) a new animal drug; or

(6) an ingredient described in paragraph (ff) in, or intended

for use in, a dietary supplement.

(t)(1) The term ''color additive'' means a material which -

(A) is a dye, pigment, or other substance made by a process of

synthesis or similar artifice, or extracted, isolated, or

otherwise derived, with or without intermediate or final change

of identity, from a vegetable, animal, mineral, or other source,

and

(B) when added or applied to a food, drug, or cosmetic, or to

the human body or any part thereof, is capable (alone or through

reaction with other substance) of imparting color thereto;

except that such term does not include any material which the

Secretary, by regulation, determines is used (or intended to be

used) solely for a purpose or purposes other than coloring.

(2) The term ''color'' includes black, white, and intermediate

grays.

(3) Nothing in subparagraph (1) of this paragraph shall be

construed to apply to any pesticide chemical, soil or plant

nutrient, or other agricultural chemical solely because of its

effect in aiding, retarding, or otherwise affecting, directly or

indirectly, the growth or other natural physiological processes of

produce of the soil and thereby affecting its color, whether before

or after harvest.

(u) The term ''safe'' as used in paragraph (s) of this section

and in sections 348, 360b, and 379e of this title, has reference to

the health of man or animal.

(v) The term ''new animal drug'' means any drug intended for use

for animals other than man, including any drug intended for use in

animal feed but not including such animal feed, -

(1) the composition of which is such that such drug is not

generally recognized, among experts qualified by scientific

training and experience to evaluate the safety and effectiveness

of animal drugs, as safe and effective for use under the

conditions prescribed, recommended, or suggested in the labeling

thereof; except that such a drug not so recognized shall not be

deemed to be a ''new animal drug'' if at any time prior to June

25, 1938, it was subject to the Food and Drug Act of June 30,

1906, as amended, and if at such time its labeling contained the

same representations concerning the conditions of its use; or

(2) the composition of which is such that such drug, as a

result of investigations to determine its safety and

effectiveness for use under such conditions, has become so

recognized but which has not, otherwise than in such

investigations, been used to a material extent or for a material

time under such conditions.

(w) The term ''animal feed'', as used in paragraph (w) (FOOTNOTE

1) of this section, in section 360b of this title, and in

provisions of this chapter referring to such paragraph or section,

means an article which is intended for use for food for animals

other than man and which is intended for use as a substantial

source of nutrients in the diet of the animal, and is not limited

to a mixture intended to be the sole ration of the animal.

(FOOTNOTE 1) So in original. Probably should be paragraph

''(v)''.

(x) The term ''informal hearing'' means a hearing which is not

subject to section 554, 556, or 557 of title 5 and which provides

for the following:

(1) The presiding officer in the hearing shall be designated by

the Secretary from officers and employees of the Department who

have not participated in any action of the Secretary which is the

subject of the hearing and who are not directly responsible to an

officer or employee of the Department who has participated in any

such action.

(2) Each party to the hearing shall have the right at all times

to be advised and accompanied by an attorney.

(3) Before the hearing, each party to the hearing shall be

given reasonable notice of the matters to be considered at the

hearing, including a comprehensive statement of the basis for the

action taken or proposed by the Secretary which is the subject of

the hearing and a general summary of the information which will

be presented by the Secretary at the hearing in support of such

action.

(4) At the hearing the parties to the hearing shall have the

right to hear a full and complete statement of the action of the

Secretary which is the subject of the hearing together with the

information and reasons supporting such action, to conduct

reasonable questioning, and to present any oral or written

information relevant to such action.

(5) The presiding officer in such hearing shall prepare a

written report of the hearing to which shall be attached all

written material presented at the hearing. The participants in

the hearing shall be given the opportunity to review and correct

or supplement the presiding officer's report of the hearing.

(6) The Secretary may require the hearing to be transcribed. A

party to the hearing shall have the right to have the hearing

transcribed at his expense. Any transcription of a hearing shall

be included in the presiding officer's report of the hearing.

(y) The term ''saccharin'' includes calcium saccharin, sodium

saccharin, and ammonium saccharin.

(z) The term ''infant formula'' means a food which purports to be

or is represented for special dietary use solely as a food for

infants by reason of its simulation of human milk or its

suitability as a complete or partial substitute for human milk.

(aa) The term ''abbreviated drug application'' means an

application submitted under section 355(j) of this title for the

approval of a drug that relies on the approved application of

another drug with the same active ingredient to establish safety

and efficacy, and -

(1) in the case of section 335a of this title, includes a

supplement to such an application for a different or additional

use of the drug but does not include a supplement to such an

application for other than a different or additional use of the

drug, and

(2) in the case of sections 335b and 335c of this title,

includes any supplement to such an application.

(bb) The term ''knowingly'' or ''knew'' means that a person, with

respect to information -

(1) has actual knowledge of the information, or

(2) acts in deliberate ignorance or reckless disregard of the

truth or falsity of the information.

(cc) For purposes of section 335a of this title, the term ''high

managerial agent'' -

(1) means -

(A) an officer or director of a corporation or an

association,

(B) a partner of a partnership, or

(C) any employee or other agent of a corporation,

association, or partnership,

having duties such that the conduct of such officer, director,

partner, employee, or agent may fairly be assumed to represent

the policy of the corporation, association, or partnership, and

(2) includes persons having management responsibility for -

(A) submissions to the Food and Drug Administration regarding

the development or approval of any drug product,

(B) production, quality assurance, or quality control of any

drug product, or

(C) research and development of any drug product.

(dd) For purposes of sections 335a and 335b of this title, the

term ''drug product'' means a drug subject to regulation under

section 355, 360b, or 382 of this title or under section 262 of

title 42.

(ee) The term ''Commissioner'' means the Commissioner of Food and

Drugs.

(ff) The term ''dietary supplement'' -

(1) means a product (other than tobacco) intended to supplement

the diet that bears or contains one or more of the following

dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet

by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or

combination of any ingredient described in clause (A), (B),

(C), (D), or (E);

(2) means a product that -

(A)(i) is intended for ingestion in a form described in

section 350(c)(1)(B)(i) of this title; or

(ii) complies with section 350(c)(1)(B)(ii) of this title;

(B) is not represented for use as a conventional food or as a

sole item of a meal or the diet; and

(C) is labeled as a dietary supplement; and

(3) does -

(A) include an article that is approved as a new drug under

section 355 of this title or licensed as a biologic under

section 262 of title 42 and was, prior to such approval,

certification, or license, marketed as a dietary supplement or

as a food unless the Secretary has issued a regulation, after

notice and comment, finding that the article, when used as or

in a dietary supplement under the conditions of use and dosages

set forth in the labeling for such dietary supplement, is

unlawful under section 342(f) of this title; and

(B) not include -

(i) an article that is approved as a new drug under section

355 of this title, certified as an antibiotic under section

357 of this title, or licensed as a biologic under section

262 of title 42, or

(ii) an article authorized for investigation as a new drug,

antibiotic, or biological for which substantial clinical

investigations have been instituted and for which the

existence of such investigations has been made public,

which was not before such approval, certification, licensing, or

authorization marketed as a dietary supplement or as a food

unless the Secretary, in the Secretary's discretion, has issued a

regulation, after notice and comment, finding that the article

would be lawful under this chapter.

Except for purposes of paragraph (g), a dietary supplement shall be

deemed to be a food within the meaning of this chapter.

(gg) The term ''processed food'' means any food other than a raw

agricultural commodity and includes any raw agricultural commodity

that has been subject to processing, such as canning, cooking,

freezing, dehydration, or milling.

(hh) The term ''Administrator'' means the Administrator of the

United States Environmental Protection Agency.

(ii) The term ''compounded positron emission tomography drug'' -

(1) means a drug that -

(A) exhibits spontaneous disintegration of unstable nuclei by

the emission of positrons and is used for the purpose of

providing dual photon positron emission tomographic diagnostic

images; and

(B) has been compounded by or on the order of a practitioner

who is licensed by a State to compound or order compounding for

a drug described in subparagraph (A), and is compounded in

accordance with that State's law, for a patient or for

research, teaching, or quality control; and

(2) includes any nonradioactive reagent, reagent kit,

ingredient, nuclide generator, accelerator, target material,

electronic synthesizer, or other apparatus or computer program to

be used in the preparation of such a drug.

(jj) The term ''antibiotic drug'' means any drug (except drugs

for use in animals other than humans) composed wholly or partly of

any kind of penicillin, streptomycin, chlortetracycline,

chloramphenicol, bacitracin, or any other drug intended for human

use containing any quantity of any chemical substance which is

produced by a micro-organism and which has the capacity to inhibit

or destroy micro-organisms in dilute solution (including a

chemically synthesized equivalent of any such substance) or any

derivative thereof.

(kk) Priority supplement. - The term ''priority supplement''

means a drug application referred to in section 101(4) of the Food

and Drug Administration Modernization Act of 1997 (111 Stat. 2298).

(ll)(1) The term ''single-use device'' means a device that is

intended for one use, or on a single patient during a single

procedure.

(2)(A) The term ''reprocessed'', with respect to a single-use

device, means an original device that has previously been used on a

patient and has been subjected to additional processing and

manufacturing for the purpose of an additional single use on a

patient. The subsequent processing and manufacture of a

reprocessed single-use device shall result in a device that is

reprocessed within the meaning of this definition.

(B) A single-use device that meets the definition under clause

(A) shall be considered a reprocessed device without regard to any

description of the device used by the manufacturer of the device or

other persons, including a description that uses the term

''recycled'' rather than the term ''reprocessed''.

(3) The term ''original device'' means a new, unused single-use

device.

(mm)(1) The term ''critical reprocessed single-use device'' means

a reprocessed single-use device that is intended to contact

normally sterile tissue or body spaces during use.

(2) The term ''semi-critical reprocessed single-use device''

means a reprocessed single-use device that is intended to contact

intact mucous membranes and not penetrate normally sterile areas of

the body.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 201, 52 Stat. 1040; July 22, 1954,

ch. 559, Sec. 1, 68 Stat. 511; Pub. L. 85-929, Sec. 2, Sept. 6,

1958, 72 Stat. 1784; Pub. L. 86-618, title I, Sec. 101, July 12,

1960, 74 Stat. 397; Pub. L. 87-781, title I, Sec. 102(a), title

III, Sec. 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74,

Sec. 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399,

Sec. 102, July 13, 1968, 82 Stat. 351; Pub. L. 90-639, Sec. 1,

4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513, title II,

Sec. 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L.

92-516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278,

title V, Sec. 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L.

94-295, Sec. 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L.

95-203, Sec. 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96-359,

Sec. 3, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100-670, title I,

Sec. 107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101-535,

Sec. 5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101-629, Sec.

16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102-282, Sec. 6, May

13, 1992, 106 Stat. 161; Pub. L. 102-300, Sec. 6(a), (b), June 16,

1992, 106 Stat. 240; Pub. L. 102-571, title I, Sec. 107(1), Oct.

29, 1992, 106 Stat. 4499; Pub. L. 103-80, Sec. 3(b), (dd)(1), 4(b),

Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103-417, Sec. 3(a), (b),

10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104-170, title

IV, Sec. 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105-115, title

I, Sec. 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111 Stat. 2320,

2325, 2327; Pub. L. 105-324, Sec. 2(a), (c), Oct. 30, 1998, 112

Stat. 3035, 3037; Pub. L. 107-109, Sec. 5(b)(1), Jan. 4, 2002, 115

Stat. 1413; Pub. L. 107-250, title III, Sec. 302(d), Oct. 26, 2002,

116 Stat. 1619.)

-REFTEXT-

REFERENCES IN TEXT

The Food and Drugs Act of June 30, 1906, as amended, referred to

in par. (p)(1), and the Food and Drug Act of June 30, 1906, as

amended, referred to in par. (v)(1), is act June 30, 1906, ch.

3915, 34 Stat. 768, as amended, which was classified to subchapter

I (Sec. 1 et seq.) of chapter 1 of this title, was repealed (except

for section 14a which was transferred to section 372a of this

title) by act June 25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059,

and is covered by this chapter.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred

to in par. (q)(1), is act June 25, 1947, ch. 125, as amended

generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973, which is

classified generally to subchapter II (Sec. 136 et seq.) of chapter

6 of Title 7, Agriculture. For complete classification of this Act

to the Code, see Short Title note set out under section 136 of

Title 7 and Tables.

The Poultry Products Inspection Act, referred to in par. (s)(4),

is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which

is classified generally to chapter 10 (Sec. 451 et seq.) of this

title. For complete classification of this Act to the Code, see

Short Title note set out under section 451 of this title and

Tables.

The Meat Inspection Act of March 4, 1907, as amended and

extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch.

2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90-201, 81

Stat. 584, which are classified generally to subchapters I to IV

(Sec. 601 et seq.) of chapter 12 of this title. For complete

classification of this Act to the Code, see Short Title note set

out under section 601 of this title and Tables.

Section 101(4) of the Food and Drug Administration Modernization

Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L.

105-115, which is set out as a note under section 379g of this

title.

-MISC2-

AMENDMENTS

2002 - Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and

(mm).

Par. (kk). Pub. L. 107-109 added par. (kk).

1998 - Par. (q)(1). Pub. L. 105-324, Sec. 2(a), added subpar. (1)

and struck out former subpar. (1) which read as follows: ''The term

'pesticide chemical' means any substance that is a pesticide within

the meaning of the Federal Insecticide, Fungicide, and Rodenticide

Act, including all active and inert ingredients of such

pesticide.''

Par. (q)(3). Pub. L. 105-324, Sec. 2(c), substituted

''subparagraphs (1) and (2)'' for ''paragraphs (1) and (2)'' in

introductory provisions.

1997 - Par. (aa). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out

''or 357'' after ''section 355(j)''.

Par. (dd). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out

''357,'' after ''section 355,''.

Par. (ff)(3)(A). Pub. L. 105-115, Sec. 125(b)(2)(A), struck out

'', certified as an antibiotic under section 357 of this title,''

before ''or licensed as a biologic''.

Par. (ii). Pub. L. 105-115, Sec. 121(a), added par. (ii).

Par. (jj). Pub. L. 105-115, Sec. 125(e), added par. (jj).

1996 - Par. (q). Pub. L. 104-170, Sec. 402(a), amended par. (q)

generally. Prior to amendment, par. (q) read as follows: ''The

term 'pesticide chemical' means any substance which, alone, in

chemical combination or in formulation with one or more other

substances, is 'a pesticide' within the meaning of the Federal

Insecticide, Fungicide, and Rodenticide Act as now in force or as

hereafter amended, and which is used in the production, storage, or

transportation of raw agricultural commodities.''

Par. (s)(1), (2). Pub. L. 104-170, Sec. 402(b), amended subpars.

(1) and (2) generally. Prior to amendment, subpars. (1) and (2)

read as follows:

''(1) a pesticide chemical in or on a raw agricultural commodity;

or

''(2) a pesticide chemical to the extent that it is intended for

use or is used in the production, storage, or transportation of any

raw agricultural commodity; or''.

Pars. (gg), (hh). Pub. L. 104-170, Sec. 402(c), added pars. (gg)

and (hh).

1994 - Par. (g)(1). Pub. L. 103-417, Sec. 10(a), amended last

sentence generally. Prior to amendment, last sentence read as

follows: ''A food for which a claim, subject to sections

343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B)

and 343(r)(5)(D) of this title, is made in accordance with the

requirements of section 343(r) of this title is not a drug under

clause (B) solely because the label or labeling contains such a

claim.''

Par. (s)(6). Pub. L. 103-417, Sec. 3(b), added subpar. (6).

Par. (ff). Pub. L. 103-417, Sec. 3(a), added par. (ff).

1993 - Pars. (c), (d). Pub. L. 103-80, Sec. 3(dd)(1), substituted

''Health and Human Services'' for ''Agriculture''.

Par. (h). Pub. L. 103-80, Sec. 4(b), amended directory language

of Pub. L. 102-300, Sec. 6(a)(1). See 1992 amendment note below.

Pars. (v) to (ff). Pub. L. 103-80, Sec. 3(b), redesignated pars.

(w) to (ff) as (v) to (ee), respectively.

1992 - Pars. (c), (d). Pub. L. 102-300, Sec. 6(b)(1), which

directed the substitution of ''Health and Human Services'' for

''Health, Education, and Welfare'', could not be executed because

such words did not appear in the original statutory text. See 1993

Amendment note above and Transfer of Functions notes below.

Par. (h). Pub. L. 102-300, Sec. 6(a)(1), as amended by Pub. L.

103-80, Sec. 4(b), substituted ''its primary'' for ''any of its

principal'' in two places in concluding provisions.

Par. (u). Pub. L. 102-571 substituted ''379e'' for ''376''.

Par. (y)(1). Pub. L. 102-300, Sec. 6(b)(2), struck out ''of

Health, Education, and Welfare'' after ''employees of the

Department''.

Pars. (bb) to (ee). Pub. L. 102-282 added pars. (bb) to (ee).

Par. (ff). Pub. L. 102-300, Sec. 6(a)(2), added par. (ff).

1990 - Par. (g)(1). Pub. L. 101-629, Sec. 16(b)(1), struck out

''; but does not include devices or their components, parts, or

accessories'' after ''clause (A), (B), or (C)''.

Pub. L. 101-535 inserted at end ''A food for which a claim,

subject to sections 343(r)(1)(B) and 343(r)(3) of this title or

sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in

accordance with the requirements of section 343(r) of this title is

not a drug under clause (B) solely because the label or labeling

contains such a claim.''

Par. (h)(3). Pub. L. 101-629, Sec. 16(b)(2), which directed the

amendment of subpar. (3) by substituting ''its primary'' for ''any

of its principal'', could not be executed because ''any of its

principal'' did not appear in subpar. (3).

1988 - Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which

read as follows: ''which drug is composed wholly or partly of any

kind of penicillin, streptomycin, chlortetracycline,

chloramphenicol, or bacitracin, or any derivative thereof, except

when there is in effect a published order of the Secretary

declaring such drug not to be a new animal drug on the grounds that

(A) the requirement of certification of batches of such drug, as

provided for in section 360b(n) of this title, is not necessary to

insure that the objectives specified in paragraph (3) thereof are

achieved and (B) that neither subparagraph (1) nor (2) of this

paragraph (w) applies to such drug.''

1980 - Par. (aa). Pub. L. 96-359 added par. (aa).

1977 - Par. (z). Pub. L. 95-203 added par. (z).

1976 - Par. (h). Pub. L. 94-295, Sec. 3(a)(1)(A), expanded

definition of ''device'' to include implements, machines, implants,

in vitro reagents, and other similar or related articles, added

recognition in the National Formulary or the United States

Pharmacopeia, or any supplement to the Formulary or Pharmacopeia,

to the enumeration of conditions under which a device may qualify

for inclusion under this chapter, and inserted requirements that a

device be one which does not achieve any of its principal intended

purposes through chemical action within or on the body of man or

other animals and which is not dependent upon being metabolized for

the achievement of any of its principal intended purposes.

Par. (n). Pub. L. 94-278 inserted ''or advertising'' after

''labeling'' wherever appearing.

Par. (y). Pub. L. 94-295, Sec. 3(a)(2), added par. (y).

1972 - Par. (q). Pub. L. 92-516 substituted reference to

pesticide for reference to economic poison.

1970 - Par. (a)(2). Pub. L. 91-513, Sec. 701(g), struck out

reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334,

337, 360, 360a, 372, 373, 374, and 375 of this title as they apply

to depressant or stimulant drugs.

Par. (v). Pub. L. 91-513, Sec. 701(a), struck out par. (v) which

defined ''depressant or stimulant drug''.

1968 - Par. (a)(2). Pub. L. 90-639, Sec. 4(a), extended

provisions to cover depressant and stimulant drugs, the containers

thereof, and equipment used in manufacturing, compounding, or

processing such drugs, to the Canal Zone.

Par. (p). Pub. L. 90-399, Sec. 102(a), (b), inserted ''(except a

new animal drug or an animal feed bearing or containing a new

animal drug)'' after ''Any drug'' in subpars. (1) and (2),

respectively.

Par. (s)(5). Pub. L. 90-399, Sec. 102(c), added subpar. (5).

Par. (u). Pub. L. 90-399, Sec. 102(d), inserted reference to

section 360b of this title.

Par. (v)(3). Pub. L. 90-639, Sec. 1, inserted reference to

lysergic acid diethylamide.

Pars. (w), (x). Pub. L. 90-399, Sec. 102(e), added pars. (w) and

(x).

1965 - Par. (g). Pub. L. 89-74, Sec. 9(b), designated existing

provisions as subpar. (1), redesignated cls. (1) to (4) thereof as

(A) to (D), substituted ''(A), (B), or (C)'' for ''(1), (2), or

(3)'' and added subpar. (2).

Par. (v). Pub. L. 89-74, Sec. 3(a), added par. (v).

1962 - Par. (a). Pub. L. 87-781, Sec. 307(a), designated existing

provisions as subpar. (2), inserted ''Commonwealth of Puerto Rico

and the'', and added subpar. (1).

Par. (p)(1). Pub. L. 87-781, Sec. 102(a)(1), inserted ''and

effectiveness'' after ''to evaluate the safety'', and ''and

effective'' after ''as safe''.

Par. (p)(2). Pub. L. 87-781, Sec. 102(a)(2), inserted ''and

effectiveness'' after ''safety''.

1960 - Par. (s). Pub. L. 86-618, Sec. 101(a), excluded color

additives from definition of ''food additive''.

Par. (t). Pub. L. 86-618, Sec. 101(c), added par. (t). Former

par. (t) redesignated (u).

Par. (u). Pub. L. 86-618, Sec. 101(b), redesignated par. (t) as

(u) and inserted reference to section 376 of this title.

1958 - Pars. (s), (t). Pub. L. 85-929 added pars. (s) and (t).

1954 - Pars. (q), (r). Act July 22, 1954, added pars. (q) and

(r).

EFFECTIVE DATE OF 1997 AMENDMENT

Section 501 of Pub. L. 105-115 provided that: ''Except as

otherwise provided in this Act (see Short Title of 1997 Amendment

note set out under section 301 of this title), this Act and the

amendments made by this Act, other than the provisions of and the

amendments made by sections 111, 121, 125, and 307 (enacting

section 355a of this title, amending this section and sections 331,

335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381,

and 382 of this title, section 45C of Title 26, Internal Revenue

Code, section 156 of Title 35, Patents, and section 8126 of Title

38, Veterans' Benefits, repealing sections 356 and 357 of this

title, and enacting provisions set out as notes under sections 351

and 355 of this title), shall take effect 90 days after the date of

enactment of this Act (Nov. 21, 1997).''

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-535 effective six months after the date

of the promulgation of final regulations to implement section

343(r) of this title, or if such regulations are not promulgated,

the date proposed regulations are to be considered as such final

regulations (Nov. 8, 1992), with exception for persons marketing

food the brand name of which contains a term defined by the

Secretary under section 343(r)(2)(A)(i) of this title, see section

10(a) of Pub. L. 101-535, set out as a note under section 343 of

this title.

EFFECTIVE DATE OF 1976 AMENDMENT

Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,

1976, see section 502(c) of Pub. L. 94-278, set out as a note under

section 334 of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92-516 effective at the close of Oct. 21,

1972, except if regulations are necessary for the implementation of

any provision that becomes effective on Oct. 21, 1972, and

continuation in effect of subchapter I of chapter 6 of Title 7, and

regulations thereunder, relating to the control of economic

poisons, as in existence prior to Oct. 21, 1972, until superseded

by provisions of Pub. L. 92-516, and regulations thereunder, see

section 4 of Pub. L. 92-516, set out as an Effective Date note

under section 136 of Title 7, Agriculture.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-513 effective on first day of seventh

calendar month that begins after Oct. 26, 1970, see section 704 of

Pub. L. 91-513, set out as an Effective Date note under section 801

of this title.

EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS

Section 6 of Pub. L. 90-639 provided that: ''The amendments made

by this Act (amending this section, sections 331, 333, 334, and

360a of this title, and provisions set out as a note under section

289a of Title 42, The Public Health and Welfare) shall apply only

with respect to violations of the Federal Food, Drug, and Cosmetic

Act (this chapter) committed after the date of the enactment of

this Act (Oct. 24, 1968).''

Amendment by Pub. L. 90-399 effective on first day of thirteenth

calendar month after July 13, 1968, except that in the case of a

drug (other than one subject to section 360b(n) of this title)

intended for use in animals other than man which, on Oct. 9, 1962,

was commercially used or sold in the United States, was not a new

drug as defined in par. (p) of this section then in force, and was

not covered by an effective application under section 355 of this

title, the words ''effectiveness'' and ''effective'' contained in

par. (w) of this section not applicable to such drug when intended

solely for use under conditions prescribed, recommended, or

suggested in labeling with respect to such drug on that day, see

section 108(a), (b)(3) of Pub. L. 90-399, set out as an Effective

Date and Transitional Provisions note under section 360b of this

title.

EFFECTIVE DATE OF 1965 AMENDMENT

Section 11 of Pub. L. 89-74 provided that: ''The foregoing

provisions of this Act (see Short Title of 1965 Amendment note set

out under section 301 of this title) shall take effect on the first

day of the seventh calendar month (Feb. 1, 1966) following the

month in which this Act is enacted (July 15, 1965); except that (1)

the Secretary shall permit persons, owning or operating any

establishment engaged in manufacturing, preparing, propagating,

compounding, processing, wholesaling, jobbing, or distributing any

depressant or stimulant drug, as referred to in the amendments made

by section 4 of this Act to section 510 of the Federal Food, Drug,

and Cosmetic Act (section 360 of this title), to register their

name, places of business, and establishments, and other information

prescribed by such amendments, with the Secretary prior to such

effective date, and (2) sections 201(v) and 511(g) of the Federal

Food, Drug, and Cosmetic Act, as added by this act (par. (v) of

this section and par. (g) of section 360a of this title), and the

provisions of sections 8 (amending section 372 of this title and

section 1114 of Title 18, Crimes and Criminal Procedure) and 10

(set out as a note under this section) shall take effect upon the

date of enactment of this Act (July 15, 1965).''

EFFECTIVE DATE OF 1962 AMENDMENT

Section 107 of Pub. L. 87-781 provided that:

''(a) Except as otherwise provided in this section, the

amendments made by the foregoing sections of this part A (amending

this section and sections 331, 332, 348, 351 to 353, 355, 357, 379e

of this title, and enacting provisions set out as a note under

section 355 of this title) shall take effect on the date of

enactment of this Act (Oct. 10, 1962).

''(b) The amendments made by sections 101, 103, 105, and 106 of

this part A (amending sections 331, 332, 351, 352, 355, and 357 of

this title) shall, with respect to any drug, take effect on the

first day of the seventh calendar month following the month in

which this Act is enacted (Oct. 1962).

''(c)(1) As used in this subsection, the term 'enactment date'

means the date of enactment of this Act; and the term 'basic Act'

means the Federal Food, Drug, and Cosmetic Act (this chapter).

''(2) An application filed pursuant to section 505(b) of the

basic Act (section 355(b) of this title) which was 'effective'

within the meaning of that Act on the day immediately preceding the

enactment date shall be deemed as of the enactment date, to be an

application 'approved' by the Secretary within the meaning of the

basic Act as amended by this Act.

''(3) In the case of any drug with respect to which an

application filed under section 505(b) of the basic Act is deemed

to be an approved application on the enactment date by virtue of

paragraph (2) of this subsection -

''(A) the amendments made by this Act to section 201(p), and to

subsections (b) and (d) of section 505, of the basic Act (par.

(p) of this section, and subsecs. (b) and (d) of section 355 of

this title), insofar as such amendments relate to the

effectiveness of drugs, shall not, so long as approval of such

application is not withdrawn or suspended pursuant to section

505(e) of that Act (section 355(e) of this title), apply to such

drug when intended solely for use under conditions prescribed,

recommended, or suggested in labeling covered by such approved

application, but shall apply to any changed use, or conditions of

use, prescribed, recommended, or suggested in its labeling,

including such conditions of use as are the subject of an

amendment or supplement to such application pending on, or filed

after, the enactment date; and

''(B) clause (3) of the first sentence of section 505(e) of the

basic Act, as amended by this Act (section 355(e) of this title),

shall not apply to such drug when intended solely for use under

conditions prescribed, recommended, or suggested in labeling

covered by such approved application (except with respect to such

use, or conditions of use, as are the subject of an amendment or

supplement to such approved application, which amendment or

supplement has been approved after the enactment date under

section 505 of the basic Act as amended by this Act (section 355

of this title)) until whichever of the following first occurs:

(i) the expiration of the two-year period beginning with the

enactment date; (ii) the effective date of an order under section

505(e) of the basic Act (section 355(e) of this title), other

than clause (3) of the first sentence of such section 505(e)

(section 355(e) of this title), withdrawing or suspending the

approval of such application.

''(4) In the case of any drug which, on the day immediately

preceding the enactment date, (A) was commercially used or sold in

the United States, (B) was not a new drug as defined by section

201(p) of the basic Act as then in force (par. (p) of this

section), and (C) was not covered by an effective application under

section 505 of that Act (section 355 of this title), the amendments

to section 201(p) (par. (p) of this section) made by this Act shall

not apply to such drug when intended solely for use under

conditions prescribed, recommended, or suggested in labeling with

respect to such drug on that day.''

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE OF 1958 AMENDMENT

Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section

6(a) of Pub. L. 85-929, set out as a note under section 342 of this

title.

EFFECTIVE DATE OF 1954 AMENDMENT

For effective date of amendment by act July 22, 1954, see section

5 of that act, set out as a note under section 342 of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 102-282

Amendment by Pub. L. 102-282 not to preclude any other civil,

criminal, or administrative remedy provided under Federal or State

law, including any private right of action against any person for

the same action subject to any action or civil penalty under an

amendment made by Pub. L. 102-282, see section 7 of Pub. L.

102-282, set out as a note under section 335a of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535

Amendments by Pub. L. 101-535 not to be construed to alter

authority of Secretary of Health and Human Services and Secretary

of Agriculture under the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601

et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et

seq.), see section 9 of Pub. L. 101-535, set out as a note under

section 343 of this title.

SAVINGS PROVISION

Section 702 of Pub. L. 91-513, as amended by Pub. L. 93-481, Sec.

2, Oct. 26, 1974, 88 Stat. 1455, provided that:

''(a) Prosecutions for any violation of law occurring prior to

the effective date (see Effective Date of 1970 Amendment note

above) of section 701 (repealing section 360a of this title, and

amending sections 321, 331, 333, 334, 360, 372, and 381 of this

title, sections 1114 and 1952 of Title 18, Crimes and Criminal

Procedure, and section 242 of Title 42, The Public Health and

Welfare) shall not be affected by the repeals or amendments made by

such section, or abated by reason thereof.

''(b) Civil seizures or forfeitures and injunctive proceedings

commenced prior to the effective date of section 701 shall not be

affected by the repeals or amendments made by such section, or

abated by reason thereof.

''(c) All administrative proceedings pending before the Bureau of

Narcotics and Dangerous Drugs (now the Drug Enforcement

Administration) on the date of enactment of this Act (Oct. 27,

1970) shall be continued and brought to final determination in

accord with laws and regulations in effect prior to such date of

enactment. Where a drug is finally determined under such

proceedings to be a depressant or stimulant drug, as defined in

section 201(v) of the Federal Food, Drug, and Cosmetic Act (par.

(v) of this section), such drug shall automatically be controlled

under this title (subchapter I of chapter 13 of this title) by the

Attorney General without further proceedings and listed in the

appropriate schedule after he has obtained the recommendation of

the Secretary. Any drug with respect to which such a final

determination has been made prior to the date of enactment of this

Act which is not listed in section 202 (section 812 of this title)

within schedules I through V shall automatically be controlled

under this title (subchapter I of chapter 13 of this title) by the

Attorney General without further proceedings, and be listed in the

appropriate schedule, after he has obtained the recommendations of

the Secretary.

''(d) Notwithstanding subsection (a) of this section or section

1103 (of Pub. L. 91-513, set out as a note under sections 171 to

174 of this title), section 4202 of title 18, United States Code,

shall apply to any individual convicted under any of the laws

repealed by this title or title III (subchapter I or subchapter II

of chapter 13 of this title) without regard to the terms of any

sentence imposed on such individual under such law.''

-TRANS-

TRANSFER OF FUNCTIONS

Secretary and Department of Health, Education, and Welfare

redesignated Secretary and Department of Health and Human Services

by Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat.

695, which is classified to section 3508(b) of Title 20, Education.

Functions of Secretary of Health, Education, and Welfare (now

Health and Human Services) under Federal Food, Drug, and Cosmetic

Act, to the extent such functions related to administration and

enforcement of the Poison Prevention Packaging Act of 1970 (15

U.S.C. 1471 et seq.), transferred to Consumer Product Safety

Commission by section 2079 of Title 15, Commerce and Trade.

Functions of Secretary of Health, Education, and Welfare (now

Health and Human Services) under Drug Abuse Control Amendments of

1965 (see Short Title of 1965 Amendment note set out under section

301 of this title) transferred to Attorney General except function

of regulating counterfeiting of those drugs which are not

''depressant or stimulant'' drugs, see section 2 of Reorg. Plan No.

1 of 1968, set out in the Appendix to Title 5, Government

Organization and Employees.

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

REGULATION OF TOBACCO

Section 422 of Pub. L. 105-115 provided that: ''Nothing in this

Act (see Short Title of 1997 Amendment note set out under section

301 of this title) or the amendments made by this Act shall be

construed to affect the question of whether the Secretary of Health

and Human Services has any authority to regulate any tobacco

product, tobacco ingredient, or tobacco additive. Such authority,

if any, shall be exercised under the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on the day before

the date of the enactment of this Act (Nov. 21, 1997).''

CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103-417

Section 2 of Pub. L. 103-417 provided that: ''Congress finds that

-

''(1) improving the health status of United States citizens

ranks at the top of the national priorities of the Federal

Government;

''(2) the importance of nutrition and the benefits of dietary

supplements to health promotion and disease prevention have been

documented increasingly in scientific studies;

''(3)(A) there is a link between the ingestion of certain

nutrients or dietary supplements and the prevention of chronic

diseases such as cancer, heart disease, and osteoporosis; and

''(B) clinical research has shown that several chronic diseases

can be prevented simply with a healthful diet, such as a diet

that is low in fat, saturated fat, cholesterol, and sodium, with

a high proportion of plant-based foods;

''(4) healthful diets may mitigate the need for expensive

medical procedures, such as coronary bypass surgery or

angioplasty;

''(5) preventive health measures, including education, good

nutrition, and appropriate use of safe nutritional supplements

will limit the incidence of chronic diseases, and reduce

long-term health care expenditures;

''(6)(A) promotion of good health and healthy lifestyles

improves and extends lives while reducing health care

expenditures; and

''(B) reduction in health care expenditures is of paramount

importance to the future of the country and the economic

well-being of the country;

''(7) there is a growing need for emphasis on the dissemination

of information linking nutrition and long-term good health;

''(8) consumers should be empowered to make choices about

preventive health care programs based on data from scientific

studies of health benefits related to particular dietary

supplements;

''(9) national surveys have revealed that almost 50 percent of

the 260,000,000 Americans regularly consume dietary supplements

of vitamins, minerals, or herbs as a means of improving their

nutrition;

''(10) studies indicate that consumers are placing increased

reliance on the use of nontraditional health care providers to

avoid the excessive costs of traditional medical services and to

obtain more holistic consideration of their needs;

''(11) the United States will spend over $1,000,000,000,000 on

health care in 1994, which is about 12 percent of the Gross

National Product of the United States, and this amount and

percentage will continue to increase unless significant efforts

are undertaken to reverse the increase;

''(12)(A) the nutritional supplement industry is an integral

part of the economy of the United States;

''(B) the industry consistently projects a positive trade

balance; and

''(C) the estimated 600 dietary supplement manufacturers in the

United States produce approximately 4,000 products, with total

annual sales of such products alone reaching at least

$4,000,000,000;

''(13) although the Federal Government should take swift action

against products that are unsafe or adulterated, the Federal

Government should not take any actions to impose unreasonable

regulatory barriers limiting or slowing the flow of safe products

and accurate information to consumers;

''(14) dietary supplements are safe within a broad range of

intake, and safety problems with the supplements are relatively

rare; and

''(15)(A) legislative action that protects the right of access

of consumers to safe dietary supplements is necessary in order to

promote wellness; and

''(B) a rational Federal framework must be established to

supersede the current ad hoc, patchwork regulatory policy on

dietary supplements.''

DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE

Section 5 of Pub. L. 90-639 provided that: ''It is the sense of

the Congress that, because of the inadequate knowledge on the part

of the people of the United States of the substantial adverse

effects of misuse of depressant and stimulant drugs, and of other

drugs liable to abuse, on the individual, his family, and the

community, the highest priority should be given to Federal programs

to disseminate information which may be used to educate the public,

particularly young persons, regarding the dangers of drug abuse.''

CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY

Section 2 of Pub. L. 89-74 provided that: ''The Congress hereby

finds and declares that there is a widespread illicit traffic in

depressant and stimulant drugs moving in or otherwise affecting

interstate commerce; that the use of such drugs, when not under the

supervision of a licensed practitioner, often endangers safety on

the highways (without distinction of interstate and intrastate

traffic thereon) and otherwise has become a threat to the public

health and safety, making additional regulation of such drugs

necessary regardless of the intrastate or interstate origin of such

drugs; that in order to make regulation and protection of

interstate commerce in such drugs effective, regulation of

intrastate commerce is also necessary because, among other things,

such drugs, when held for illicit sale, often do not bear labeling

showing their place of origin and because in the form in which they

are so held or in which they are consumed a determination of their

place of origin is often extremely difficult or impossible; and

that regulation of interstate commerce without the regulation of

intrastate commerce in such drugs, as provided in this Act (see

Short Title of 1965 Amendment note set out under section 301 of

this title), would discriminate against and adversely affect

interstate commerce in such drugs.''

EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS

Section 10 of Pub. L. 89-74 provided that:

''(a) Nothing in this Act (enacting section 360a of this title,

amending sections 321, 331, 333, 334, 360, and 372 of this title

and section 1114 of Title 18, Crimes and Criminal Procedure, and

enacting provisions set out as notes under sections 321, 352, and

360a of this title) shall be construed as authorizing the

manufacture, compounding, processing, possession, sale, delivery,

or other disposal of any drug in any State in contravention of the

laws of such State.

''(b) No provision of this Act nor any amendment made by it shall

be construed as indicating an intent on the part of the Congress to

occupy the field in which such provision or amendment operates to

the exclusion of any State law on the same subject matter, unless

there is a direct and positive conflict between such provision or

amendment and such State law so that the two cannot be reconciled

or consistently stand together.

''(c) No amendment made by this Act shall be construed to prevent

the enforcement in the courts of any State of any statute of such

State prescribing any criminal penalty for any act made criminal by

any such amendment.''

EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS

Section 202 of Pub. L. 87-781 provided that: ''Nothing in the

amendments made by this Act (enacting sections 358 to 360, amending

sections 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e,

and 381 of this title, and enacting provisions set out as notes

under sections 321, 331, 332, 352, 355, 360, and 374 of this title)

to the Federal Food, Drug, and Cosmetic Act (this chapter) shall be

construed as invalidating any provision of State law which would be

valid in the absence of such amendments unless there is a direct

and positive conflict between such amendments and such provision of

State law.''

-CROSS-

DEFINITIONS

Section 2 of Pub. L. 105-115 provided that: ''In this Act (see

Short Title of 1997 Amendment note set out under section 301 of

this title), the terms 'drug', 'device', 'food', and 'dietary

supplement' have the meaning given such terms in section 201 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 343, 343-3, 346a, 346b,

350, 352, 353a, 355, 360b, 379e, 383, 802, 825, 1602 of this title;

title 7 section 136; title 15 sections 1454, 1456, 1471, 2052,

2602; title 18 section 1365; title 22 section 7201; title 35

section 156; title 42 sections 274e, 287c-11, 289g-2, 300cc-12,

1396r-8; title 49 section 5702.

-CITE-

21 USC Sec. 321a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS

-HEAD-

Sec. 321a. ''Butter'' defined

-STATUTE-

For the purposes of the Food and Drug Act of June 30, 1906

(Thirty-fourth Statutes at Large, page 768) ''butter'' shall be

understood to mean the food product usually known as butter, and

which is made exclusively from milk or cream, or both, with or

without common salt, and with or without additional coloring

matter, and containing not less than 80 per centum by weight of

milk fat, all tolerances having been allowed for.

-SOURCE-

(Mar. 4, 1923, ch. 268, 42 Stat. 1500.)

-REFTEXT-

REFERENCES IN TEXT

The Food and Drug Act of June 30, 1906, referred to in text, is

act June 30, 1906, ch. 3915, 34 Stat. 768, as amended, which was

classified to subchapter I (Sec. 1 et seq.) of chapter 1 of this

title, was repealed (except for section 14a which was transferred

to section 376 of this title) by act June 25, 1938, ch. 675, Sec.

902(a), 52 Stat. 1059, and is covered by this chapter.

-COD-

CODIFICATION

Section, which was not enacted as part of the Federal Food, Drug,

and Cosmetic Act which comprises this chapter, was formerly

classified to section 6 of this title. Section 902(a) of act June

25, 1938, set out as an Effective Date note under section 301 of

this title, provided that this section should remain in force and

effect and be applicable to the provisions of this chapter.

-CITE-

21 USC Sec. 321b 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS

-HEAD-

Sec. 321b. ''Package'' defined

-STATUTE-

The word ''package'' where it occurs the second and last time in

the act entitled ''An act to amend section 8 of an act entitled,

'An act for preventing the manufacture, sale, or transportation of

adulterated or misbranded or poisonous deleterious foods, drugs,

medicines, and liquors, and for regulating traffic therein, and for

other purposes,' '' approved March 3, 1913, shall include and shall

be construed to include wrapped meats inclosed in papers or other

materials as prepared by the manufacturers thereof for sale.

-SOURCE-

(July 24, 1919, ch. 26, 41 Stat. 271.)

-REFTEXT-

REFERENCES IN TEXT

An act approved March 3, 1913, referred to in text, is act Mar.

3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this

title. For complete classification of this Act to the Code, see

Tables.

''An act for preventing the manufacture, sale, or transportation

of adulterated or misbranded or poisonous deleterious foods, drugs,

medicines, and liquors, and for regulating traffic therein, and for

other purposes,'', referred to in text, is act June 30, 1906, ch.

3915, 34 Stat. 768, which was classified to subchapter I (Sec. 1 et

seq.) of chapter 1 of this title, was repealed (except for section

14a which was transferred to section 376 of this title) by act June

25, 1938, ch. 675, Sec. 902(a), 52 Stat. 1059, and is covered by

this chapter.

-COD-

CODIFICATION

Section, which was not enacted as part of the Federal Food, Drug,

and Cosmetic Act which comprises this chapter, was formerly

classified to the last sentence of paragraph third of section 10 of

this title. Section 902(a) of act June 25, 1938, set out as an

Effective Date note under section 301 of this title, provided that

this section should remain in force and effect and be applicable to

the provisions of this chapter.

-CITE-

21 USC Sec. 321c 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS

-HEAD-

Sec. 321c. Nonfat dry milk; ''milk'' defined

-STATUTE-

For the purposes of the Federal Food, Drug, and Cosmetic Act of

June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) (21 U.S.C. 301 et

seq.) nonfat dry milk is the product resulting from the removal of

fat and water from milk, and contains the lactose, milk proteins,

and milk minerals in the same relative proportions as in the fresh

milk from which made. It contains not over 5 per centum by weight

of moisture. The fat content is not over 1 1/2 per centum by

weight unless otherwise indicated.

The term ''milk'', when used herein, means sweet milk of cows.

-SOURCE-

(Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70

Stat. 486.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch.

675, sec. 1, 52 Stat. 1040), referred to in text, probably means

act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is

classified generally to this chapter (Sec. 301 et seq.). For

complete classification of this Act to the Code, see section 301 of

this title and Tables.

-COD-

CODIFICATION

Section was not enacted as a part of the Federal Food, Drug, and

Cosmetic Act which comprises this chapter, but was made applicable

thereto.

-MISC3-

AMENDMENTS

1956 - Act July 2, 1956, substituted ''nonfat dry milk'' for

''nonfat dry milk solids or defatted milk solids''.

-CITE-

21 USC Sec. 321d 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER II - DEFINITIONS

-HEAD-

Sec. 321d. Market names for catfish and ginseng

-STATUTE-

(a) Catfish labeling

(1) In general

Notwithstanding any other provision of law, for purposes of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) -

(A) the term ''catfish'' may only be considered to be a

common or usual name (or part thereof) for fish classified

within the family Ictaluridae; and

(B) only labeling or advertising for fish classified within

that family may include the term ''catfish''.

(2) Omitted

(b) Ginseng labeling

(1) In general

Notwithstanding any other provision of law, for purposes of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) -

(A) the term ''ginseng'' may only be considered to be a

common or usual name (or part thereof) for any herb or herbal

ingredient derived from a plant classified within the genus

Panax; and

(B) only labeling or advertising for herbs or herbal

ingredients classified within that genus may include the term

''ginseng''.

(2) Omitted

-SOURCE-

(Pub. L. 107-171, title X, Sec. 10806, May 13, 2002, 116 Stat.

526.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.

(a)(1), (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, as

amended, which is classified generally to this chapter. For

complete classification of this Act to the Code, see section 301 of

this title and Tables.

-COD-

CODIFICATION

Section is comprised of section 10806 of Pub. L. 107-171.

Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107-171

amended section 343 of this title.

Section was enacted as part of the Farm Security and Rural

Investment Act of 2002, and not as part of Federal Food, Drug, and

Cosmetic Act which comprises this chapter.

-CITE-

21 USC SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

.

-HEAD-

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-SECREF-

SUBCHAPTER REFERRED TO IN OTHER SECTIONS

This subchapter is referred to in sections 343, 378 of this

title; title 15 section 1456.

-CITE-

21 USC Sec. 331 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 331. Prohibited acts

-STATUTE-

The following acts and the causing thereof are prohibited:

(a) The introduction or delivery for introduction into interstate

commerce of any food, drug, device, or cosmetic that is adulterated

or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or

cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food, drug, device,

or cosmetic that is adulterated or misbranded, and the delivery or

proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate

commerce of any article in violation of section 344 or 355 of this

title.

(e) The refusal to permit access to or copying of any record as

required by section 350a, 350c, 354, 373, or 374(a) of this title;

or the failure to establish or maintain any record, or make any

report, required under section 350a, 350c(b), 354, 355(i) or (k),

360b(a)(4)(C), 360b(j), (l), or (m), 360e(f), or 360i of this

title, or the refusal to permit access to or verification or

copying of any such required record.

(f) The refusal to permit entry or inspection as authorized by

section 374 of this title.

(g) The manufacture within any Territory of any food, drug,

device, or cosmetic that is adulterated or misbranded.

(h) The giving of a guaranty or undertaking referred to in

section 333(c)(2) of this title, which guaranty or undertaking is

false, except by a person who relied upon a guaranty or undertaking

to the same effect signed by, and containing the name and address

of, the person residing in the United States from whom he received

in good faith the food, drug, device, or cosmetic; or the giving of

a guaranty or undertaking referred to in section 333(c)(3) of this

title, which guaranty or undertaking is false.

(i)(1) Forging, counterfeiting, simulating, or falsely

representing, or without proper authority using any mark, stamp,

tag, label, or other identification device authorized or required

by regulations promulgated under the provisions of section 344 or

379e of this title.

(2) Making, selling, disposing of, or keeping in possession,

control, or custody, or concealing any punch, die, plate, stone, or

other thing designed to print, imprint, or reproduce the trademark,

trade name, or other identifying mark, imprint, or device of

another or any likeness of any of the foregoing upon any drug or

container or labeling thereof so as to render such drug a

counterfeit drug.

(3) The doing of any act which causes a drug to be a counterfeit

drug, or the sale or dispensing, or the holding for sale or

dispensing, of a counterfeit drug.

(j) The using by any person to his own advantage, or revealing,

other than to the Secretary or officers or employees of the

Department, or to the courts when relevant in any judicial

proceeding under this chapter, any information acquired under

authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c,

360d, 360e, 360f, 360h, 360i, 360j, 374, 379, or 379e of this title

concerning any method or process which as a trade secret is

entitled to protection; or the violating of section 346a(i)(2) of

this title or any regulation issued under that section.. (FOOTNOTE

1) This paragraph does not authorize the withholding of information

from either House of Congress or from, to the extent of matter

within its jurisdiction, any committee or subcommittee of such

committee or any joint committee of Congress or any subcommittee of

such joint committee.

(FOOTNOTE 1) So in original.

(k) The alteration, mutilation, destruction, obliteration, or

removal of the whole or any part of the labeling of, or the doing

of any other act with respect to, a food, drug, device, or

cosmetic, if such act is done while such article is held for sale

(whether or not the first sale) after shipment in interstate

commerce and results in such article being adulterated or

misbranded.

(l) Repealed. Pub. L. 105-115, title IV, Sec. 421, Nov. 21, 1997,

111 Stat. 2380.

(m) The sale or offering for sale of colored oleomargarine or

colored margarine, or the possession or serving of colored

oleomargarine or colored margarine in violation of subsections (b)

or (c) of section 347 of this title.

(n) The using, in labeling, advertising or other sales promotion

of any reference to any report or analysis furnished in compliance

with section 374 of this title.

(o) In the case of a prescription drug distributed or offered for

sale in interstate commerce, the failure of the manufacturer,

packer, or distributor thereof to maintain for transmittal, or to

transmit, to any practitioner licensed by applicable State law to

administer such drug who makes written request for information as

to such drug, true and correct copies of all printed matter which

is required to be included in any package in which that drug is

distributed or sold, or such other printed matter as is approved by

the Secretary. Nothing in this paragraph shall be construed to

exempt any person from any labeling requirement imposed by or under

other provisions of this chapter.

(p) The failure to register in accordance with section 360 of

this title, the failure to provide any information required by

section 360(j) or 360(k) of this title, or the failure to provide a

notice required by section 360(j)(2) of this title.

(q)(1) The failure or refusal to (A) comply with any requirement

prescribed under section 360h or 360j(g) of this title, (B) furnish

any notification or other material or information required by or

under section 360i or 360j(g) of this title, or (C) comply with a

requirement under section 360l of this title.

(2) With respect to any device, the submission of any report that

is required by or under this chapter that is false or misleading in

any material respect.

(r) The movement of a device in violation of an order under

section 334(g) of this title or the removal or alteration of any

mark or label required by the order to identify the device as

detained.

(s) The failure to provide the notice required by section 350a(c)

or 350a(e) of this title, the failure to make the reports required

by section 350a(f)(1)(B) of this title, the failure to retain the

records required by section 350a(b)(4) of this title, or the

failure to meet the requirements prescribed under section

350a(f)(3) of this title.

(t) The importation of a drug in violation of section 381(d)(1)

of this title, the sale, purchase, or trade of a drug or drug

sample or the offer to sell, purchase, or trade a drug or drug

sample in violation of section 353(c) of this title, the sale,

purchase, or trade of a coupon, the offer to sell, purchase, or

trade such a coupon, or the counterfeiting of such a coupon in

violation of section 353(c)(2) of this title, the distribution of a

drug sample in violation of section 353(d) of this title or the

failure to otherwise comply with the requirements of section 353(d)

of this title, or the distribution of drugs in violation of section

353(e) of this title or the failure to otherwise comply with the

requirements of section 353(e) of this title.

(u) The failure to comply with any requirements of the provisions

of, or any regulations or orders of the Secretary, under section

360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title.

(v) The introduction or delivery for introduction into interstate

commerce of a dietary supplement that is unsafe under section 350b

of this title.

(w) The making of a knowingly false statement in any statement,

certificate of analysis, record, or report required or requested

under section 381(d)(3) of this title; the failure to submit a

certificate of analysis as required under such section; the failure

to maintain records or to submit records or reports as required by

such section; the release into interstate commerce of any article

or portion thereof imported into the United States under such

section or any finished product made from such article or portion,

except for export in accordance with section 381(e) or 382 of this

title, or with section 262(h) of title 42; or the failure to so

export or to destroy such an article or portions thereof, or such a

finished product.

(x) The falsification of a declaration of conformity submitted

under section 360d(c) of this title or the failure or refusal to

provide data or information requested by the Secretary under

paragraph (3) of such section.

(y) In the case of a drug, device, or food -

(1) the submission of a report or recommendation by a person

accredited under section 360m of this title that is false or

misleading in any material respect;

(2) the disclosure by a person accredited under section 360m of

this title of confidential commercial information or any trade

secret without the express written consent of the person who

submitted such information or secret to such person; or

(3) the receipt by a person accredited under section 360m of

this title of a bribe in any form or the doing of any corrupt act

by such person associated with a responsibility delegated to such

person under this chapter.

(z) The dissemination of information in violation of section

360aaa of this title.

(aa) The importation of a covered product in violation of section

384 of this title, the falsification of any record required to be

maintained or provided to the Secretary under such section, or any

other violation of regulations under such section.

(bb) The transfer of an article of food in violation of an order

under section 334(h) of this title, or the removal or alteration of

any mark or label required by the order to identify the article as

detained.

(cc) The importing or offering for import into the United States

of an article of food by, with the assistance of, or at the

direction of, a person debarred under section 335a(b)(3) of this

title.

(dd) The failure to register in accordance with section 350d of

this title.

(ee) The importing or offering for import into the United States

of an article of food in violation of the requirements under

section 381(m) of this title.

(ff) The importing or offering for import into the United States

of a drug or device with respect to which there is a failure to

comply with a request of the Secretary to submit to the Secretary a

statement under section 381(o) of this title.

(gg) The knowing failure of a person accredited under paragraph

(2) of section 374(g) of this title to comply with paragraph (7)(E)

of such section; the knowing inclusion by such a person of false

information in an inspection report under paragraph (7)(A) of such

section; or the knowing failure of such a person to include

material facts in such a report.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 301, 52 Stat. 1042; Dec. 22, 1941,

ch. 613, Sec. 1, 55 Stat. 851; July 6, 1945, ch. 281, Sec. 1, 59

Stat. 463; Mar. 10, 1947, ch. 16, Sec. 1, 61 Stat. 11; June 24,

1948, ch. 613, Sec. 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, Sec.

3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, Sec. 2, 67 Stat. 477;

Pub. L. 85-929, Sec. 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L.

86-618, title I, Sec. 104, 105(a), July 12, 1960, 74 Stat. 403;

Pub. L. 87-781, title I, Sec. 103(c), 104(e)(1), 106(c), 114(a),

title III, Sec. 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791,

795; Pub. L. 89-74, Sec. 5, 9(c), July 15, 1965, 79 Stat. 232, 235;

Pub. L. 90-399, Sec. 103, July 13, 1968, 82 Stat. 352; Pub. L.

90-639, Sec. 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91-513,

title II, Sec. 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L.

92-387, Sec. 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94-295,

Sec. 3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582;

Pub. L. 96-359, Sec. 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L.

99-570, title IV, Sec. 4014(b)(2), Oct. 27, 1986, 100 Stat.

3207-120; Pub. L. 100-293, Sec. 7(a), Apr. 22, 1988, 102 Stat. 99;

Pub. L. 101-502, Sec. 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L.

101-508, title IV, Sec. 4755(c)(2), Nov. 5, 1990, 104 Stat.

1388-210; Pub. L. 102-300, Sec. 3(a)(1), June 16, 1992, 106 Stat.

238; Pub. L. 102-571, title I, Sec. 107(2), (3), Oct. 29, 1992, 106

Stat. 4499; Pub. L. 103-80, Sec. 3(c), Aug. 13, 1993, 107 Stat.

775; Pub. L. 103-396, Sec. 2(b)(1), Oct. 22, 1994, 108 Stat. 4154;

Pub. L. 103-417, Sec. 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L.

104-134, title II, Sec. 2103, Apr. 26, 1996, 110 Stat. 1321-319;

Pub. L. 104-170, title IV, Sec. 403, Aug. 3, 1996, 110 Stat. 1514;

Pub. L. 104-250, Sec. 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L.

105-115, title I, Sec. 125(a)(2)(A), (C), (b)(2)(B), title II, Sec.

204(b), 210(c), title IV, Sec. 401(b), 421, Nov. 21, 1997, 111

Stat. 2325, 2336, 2345, 2364, 2380; Pub. L. 106-387, Sec. 1(a)

(title VII, Sec. 745(d)(1)), Oct. 28, 2000, 114 Stat. 1549,

1549A-39; Pub. L. 107-188, title III, Sec. 303(b), 304(d), 305(b),

306(c), 307(b), 321(b)(2), 322(b), June 12, 2002, 116 Stat. 664,

666, 668, 670, 672, 676, 677; Pub. L. 107-250, title II, Sec.

201(d), Oct. 26, 2002, 116 Stat. 1609.)

-STATAMEND-

AMENDMENT OF SECTION

For termination of amendment by section 401(e) of Pub. L.

105-115, see Effective and Termination Dates of 1997 Amendment

note below.

-MISC1-

AMENDMENTS

2002 - Par. (e). Pub. L. 107-188, Sec. 306(c)(1), substituted

''by section 350a, 350c, 354, 373, or 374(a) of this title'' for

''by section 350a, 354, or 373 of this title'' and ''under section

350a, 350c(b)'' for ''under section 350a''.

Par. (j). Pub. L. 107-188, Sec. 306(c)(2), inserted ''350c,''

after ''350a,''.

Par. (w). Pub. L. 107-188, Sec. 322(b), amended par. (w)

generally. Prior to amendment, par. (w) read as follows: ''The

making of a knowingly false statement in any record or report

required or requested under subparagraph (A) or (B) of section

381(d)(3) of this title, the failure to submit or maintain records

as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this

title, the release into interstate commerce of any article imported

into the United States under section 381(d)(3) of this title or any

finished product made from such article (except for export in

accordance with section 381(e) or 382 of this title or section

262(h) of title 42), or the failure to export or destroy any

component, part or accessory not incorporated into a drug,

biological product or device that will be exported in accordance

with section 381(e) or 382 of this title or section 262(h) of title

42.''

Par. (bb). Pub. L. 107-188, Sec. 303(b), added par. (bb).

Par. (cc). Pub. L. 107-188, Sec. 304(d), added par. (cc).

Par. (dd). Pub. L. 107-188, Sec. 305(b), added par. (dd).

Par. (ee). Pub. L. 107-188, Sec. 307(b), added par. (ee).

Par. (ff). Pub. L. 107-188, Sec. 321(b)(2), added par. (ff).

Par. (gg). Pub. L. 107-250 added par. (gg).

2000 - Par. (aa). Pub. L. 106-387 added par. (aa).

1997 - Par. (e). Pub. L. 105-115, Sec. 125(b)(2)(B), struck out

''357(d) or (g),'' after ''355(i) or (k),''.

Par. (i)(1). Pub. L. 105-115, Sec. 125(a)(2)(C), struck out '',

356, 357,'' before ''or 379e of this title''.

Par. (j). Pub. L. 105-115, Sec. 125(a)(2)(A), struck out ''356,

357,'' before ''360,''.

Par. (l). Pub. L. 105-115, Sec. 421, struck out par. (l) which

read as follows: ''The using, on the labeling of any drug or device

or in any advertising relating to such drug or device, of any

representation or suggestion that approval of an application with

respect to such drug or device is in effect under section 355,

360e, or 360j(g) of this title, as the case may be, or that such

drug or device complies with the provisions of such section.''

Par. (x). Pub. L. 105-115, Sec. 204(b), added par. (x).

Par. (y). Pub. L. 105-115, Sec. 210(c), added par. (y).

Par. (z). Pub. L. 105-115, Sec. 401(b), (e), temporarily added

par. (z). See Effective and Termination Dates of 1997 Amendment

note below.

1996 - Par. (e). Pub. L. 104-250 inserted '', 354,'' before ''or

373 of this title'' and ''354,'' before ''355(i) or (k)''.

Par. (j). Pub. L. 104-170 inserted before period at end of first

sentence ''; or the violating of section 346a(i)(2) of this title

or any regulation issued under that section.''

Pars. (u) to (w). Pub. L. 104-134 redesignated par. (u) relating

to introduction into interstate commerce of unsafe dietary

supplement as (v) and added par. (w).

1994 - Par. (e). Pub. L. 103-396, Sec. 2(b)(1)(A), substituted

''357(d) or (g), 360b(a)(4)(C),'' for ''357(d) or (g),''.

Par. (u). Pub. L. 103-417 added par. (u) relating to introduction

into interstate commerce of unsafe dietary supplement.

Pub. L. 103-396, Sec. 2(b)(1)(B), added par. (u) relating to

failure to comply with regulations or orders of Secretary.

1993 - Par. (j). Pub. L. 103-80, Sec. 3(c)(1), substituted ''379,

or 379e'' for ''379e, or 379''.

Par. (s). Pub. L. 103-80, Sec. 3(c)(2), substituted ''350a(e)''

for ''350a(d)''.

1992 - Pars. (i)(1), (j). Pub. L. 102-571 substituted ''379e''

for ''376''.

Par. (q)(1)(C). Pub. L. 102-300 added cl. (C).

1990 - Par. (e). Pub. L. 101-502 substituted ''or (k)'' for ''or

(j)''.

Par. (j). Pub. L. 101-508 inserted at end ''This paragraph does

not authorize the withholding of information from either House of

Congress or from, to the extent of matter within its jurisdiction,

any committee or subcommittee of such committee or any joint

committee of Congress or any subcommittee of such joint

committee.''

1988 - Par. (t). Pub. L. 100-293 added par. (t).

1986 - Par. (s). Pub. L. 99-570 amended par. (s) generally.

Prior to amendment, par. (s) read as follows: ''The failure to

provide the notice required by section 350a(b) or 350a(c), the

failure to make the reports required by section 350a(d)(1)(B), or

the failure to meet the requirements prescribed under section

350a(d)(2).''

1980 - Par. (e). Pub. L. 96-359, Sec. 5(b), inserted reference to

section 350a of this title in two places.

Par. (j). Pub. L. 96-359, Sec. 5(c), inserted reference to

section 350a of this title.

Par. (s). Pub. L. 96-359, Sec. 5(a), added par. (s).

1976 - Par. (e). Pub. L. 94-295, Sec. 3(b)(2), inserted

references to sections 360e(f) and 360i of this title.

Par. (j). Pub. L. 94-295, Sec. 3(b)(3), inserted references to

sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of

this title.

Par. (l). Pub. L. 94-295, Sec. 3(b)(4), substituted ''drug or

device'' for ''drug'' wherever appearing, and inserted references

to sections 360e and 360j(g) of this title.

Par. (p). Pub. L. 94-295, Sec. 4(b)(1), substituted ''section

360(j) or 360(k) of this title,'' for ''section 360(j) of this

title,''.

Par. (q). Pub. L. 94-295, Sec. 3(b)(1), added par. (q).

Par. (r). Pub. L. 94-295, Sec. 7(b), added par. (r).

1972 - Par. (p). Pub. L. 92-387 added failure to provide

information required by section 360(j) of this title, and failure

to provide notice required by section 360(j)(2) of this title as

prohibited acts.

1970 - Par. (q). Pub. L. 91-513 struck out par. (q) which set out

penalties for illegal manufacture, sale, disposition, possession

and other traffic in stimulant and depressant drugs. See section

801 et seq. of this title.

1968 - Par. (e). Pub. L. 90-399, Sec. 103(1), inserted reference

to section 360b(j), (l), and (m) of this title.

Par. (j). Pub. L. 90-399, Sec. 103(2), inserted reference to

section 360b of this title.

Par. (q). Pub. L. 90-639 divided cl. (3), which referred simply

to possession in violation of section 360a(c) of this title, into

subcls. (A) and (B) which refer, respectively, to possession in

violation of section 360a(c)(1) of this title and possession in

violation of section 360a(c)(2) of this title.

1965 - Par. (i). Pub. L. 89-74, Sec. 9(c), designated existing

provisions as subpar. (1) and added subpars. (2) and (3).

Par. (q). Pub. L. 89-74, Sec. 5, added par. (q).

1962 - Par. (e). Pub. L. 87-781, Sec. 103(c), 106(c), prohibited

the failure to establish or maintain any record, or make any

report, required under sections 355(i) or (j) and 507(d) or (g) of

this title, or the refusal to permit access to, or verification or

copying of, any such required record.

Par. (l). Pub. L. 87-781, Sec. 104(e)(1), inserted ''approval

of'' before ''an application'', and substituted ''in effect'' for

''effective''.

Par. (o). Pub. L. 87-781, Sec. 114(a), added par. (o).

Par. (p). Pub. L. 87-781, Sec. 304, added par. (p).

1960 - Par. (i). Pub. L. 86-618, Sec. 105(a), struck out

references to sections 346(b), 354, and 364 of this title and

inserted reference to section 376 of this title.

Par. (j). Pub. L. 86-618, Sec. 104, inserted reference to section

376 of this title.

1958 - Par. (j). Pub. L. 85-929, inserted reference to section

348 of this title.

1953 - Par. (n). Act Aug. 7, 1953, added par. (n).

1950 - Par. (m). Act Mar. 16, 1950, added par. (m).

1948 - Par. (k). Act June 24, 1948, inserted ''(whether or not

the first sale)'' so as to make it clear that this subsection is

not limited to the case where the act occurs while the article is

held for the first sale after interstate shipment, and extended

coverage of subsection to acts which result in adulteration.

1947 - Par. (j). Act Mar. 10, 1947, inserted reference to

sections 356 and 357 of this title.

1945 - Par. (i). Act July 6, 1945, inserted reference to section

357 of this title.

1941 - Par. (i). Act Dec. 22, 1941, inserted reference to section

356 of this title.

EFFECTIVE DATE OF 2002 AMENDMENT

Pub. L. 107-188, title III, Sec. 321(c), June 12, 2002, 116 Stat.

676, provided that: ''The amendments made by this section (amending

this section and sections 360 and 381 of this title) take effect

upon the expiration of the 180-day period beginning on the date of

the enactment of this Act (June 12, 2002).''

Pub. L. 107-188, title III, Sec. 322(c), June 12, 2002, 116 Stat.

678, provided that: ''The amendments made by this section (amending

this section and section 381 of this title) take effect upon the

expiration of the 90-day period beginning on the date of the

enactment of this Act (June 12, 2002).''

EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT

Amendment by sections 204, 210, and 421 of Pub. L. 105-115

effective 90 days after Nov. 21, 1997, except as otherwise

provided, see section 501 of Pub. L. 105-115, set out as a note

under section 321 of this title.

Amendment by section 401(b) of Pub. L. 105-115 effective 1 year

after Nov. 21, 1997, or upon Secretary's issuance of final

regulations pursuant to section 401(c) of Pub. L. 105-115,

whichever is sooner, and ceases to be effective Sept. 30, 2006, or

7 years after date Secretary promulgates regulations under section

401(c) of Pub. L. 105-115, whichever is later, see section 401(d),

(e) of Pub. L. 105-115, set out as an Effective and Termination

Dates note under section 360aaa of this title.

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-396 effective upon adoption of final

regulations under section 2(c) of Pub. L. 103-396, set out as a

Regulations note under section 360b of this title, see section 2(d)

of Pub. L. 103-396, set out as a note under section 360b of this

title.

EFFECTIVE DATE OF 1990 AMENDMENT

Section 4755(c)(2) of Pub. L. 101-508 provided that the amendment

made by that section is effective as if included in subtitle D of

title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L.

101-239, title VI, Sec. 6601, 6602, Dec. 19, 1989, 103 Stat. 2285,

see 42 U.S.C. 300aa-1 note, 300aa-10 note.

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-293 effective upon expiration of 90 days

after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out

as a note under section 353 of this title.

EFFECTIVE DATE OF 1972 AMENDMENT

Amendment by Pub. L. 92-387 effective on first day of sixth month

beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set

out as a note under section 360 of this title.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-513 effective on first day of seventh

calendar month that begins after Oct. 26, 1970, see section 704 of

Pub. L. 91-513, set out as an Effective Date note under section 801

of this title.

EFFECTIVE DATE OF 1968 AMENDMENTS

Amendment by Pub. L. 90-399 effective on first day of thirteenth

calendar month after July 13, 1968, see section 108(a) of Pub. L.

90-399, set out as an Effective Date and Transitional Provisions

note under section 360b of this title.

Amendment by Pub. L. 90-639 applicable only with respect to

violations of this chapter committed after Oct. 24, 1968, see

section 6 of Pub. L. 90-639, set out as an Effective Date of 1968

Amendments; Transitional Provisions note under section 321 of this

title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11

of Pub. L. 89-74, set out as a note under section 321 of this

title.

EFFECTIVE DATE OF 1962 AMENDMENT

Amendment by sections 103(c) and 106(c) of Pub. L. 87-781

effective on first day of seventh calendar month following Oct.

1962, and amendment by section 104(e)(1) of Pub. L. 87-781

effective Oct. 10, 1962, see section 107 of Pub. L. 87-781, set out

as a note under section 321 of this title.

Section 114(b) of Pub. L. 87-781 provided that: ''This section

(amending this section) shall take effect on the first day of the

seventh calendar month following the month in which this Act is

enacted (October 1962).''

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE OF 1958 AMENDMENT

Amendment by Pub. L. 85-929 effective Sept. 6, 1958, see section

6(a) of Pub. L. 85-929, set out as a note under section 342 of this

title.

EFFECTIVE DATE OF 1950 AMENDMENT

Amendment by act Mar. 16, 1950, effective July 1, 1950, see

section 7 of that act, set out as an Effective Date note under

section 347 of this title.

REGULATIONS

Secretary of Health and Human Services to promulgate regulations

to implement amendments made by section 401 of Pub. L. 105-115 not

later than 1 year after Nov. 21, 1997, see section 401(c) of Pub.

L. 105-115, set out as a note under section 360aaa of this title.

SAVINGS PROVISION

Amendment by Pub. L. 91-513 not to affect or abate any

prosecutions for violation of law or any civil seizures or

forfeitures and injunctive proceedings commenced prior to the

effective date of such amendment, and all administrative

proceedings pending before the Bureau of Narcotics and Dangerous

Drugs (now the Drug Enforcement Administration) on Oct. 27, 1970,

to be continued and brought to final determination in accord with

laws and regulations in effect prior to Oct. 27, 1970, see section

702 of Pub. L. 91-513, set out as a note under section 321 of this

title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 107-188

Pub. L. 107-188, title III, Sec. 315, June 12, 2002, 116 Stat.

675, provided that: ''Nothing in this title (enacting sections

350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354,

8319, and 8320 of Title 7, Agriculture, and section 247b-20 of

Title 42, The Public Health and Welfare, amending this section,

sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title,

and section 43 of Title 18, Crimes and Criminal Procedure, and

enacting provisions set out as notes under this section and

sections 341, 350c, 350d, and 381 of this title), or an amendment

made by this title, shall be construed to alter the jurisdiction

between the Secretaries of Agriculture and of Health and Human

Services, under applicable statutes and regulations.''

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 332, 333, 335a,

347b, 355a, 360, 360i, 360j, 360aaa of this title; title 42 section

1396r-8.

-CITE-

21 USC Sec. 332 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 332. Injunction proceedings

-STATUTE-

(a) Jurisdiction of courts

The district courts of the United States and the United States

courts of the Territories shall have jurisdiction, for cause shown

(FOOTNOTE 1) to restrain violations of section 331 of this title,

except paragraphs (h), (i), and (j).

(FOOTNOTE 1) So in original. Probably should be followed by a

comma.

(b) Violation of injunction

In case of violation of an injunction or restraining order issued

under this section, which also constitutes a violation of this

chapter, trial shall be by the court, or, upon demand of the

accused, by a jury.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 302, 52 Stat. 1043; Pub. L. 87-781,

title I, Sec. 103(d), title II, Sec. 201(c), Oct. 10, 1962, 76

Stat. 784, 793; Pub. L. 103-80, Sec. 3(d), Aug. 13, 1993, 107 Stat.

775.)

-MISC1-

AMENDMENTS

1993 - Subsec. (a). Pub. L. 103-80, Sec. 3(d)(1), struck out '',

and subject to the provisions of section 17 (relating to notice to

opposite party) of the Act entitled 'An Act to supplement existing

laws against unlawful restraints and monopolies, and for other

purposes', approved October 15, 1914, as amended (U.S.C., 1934 ed.,

title 28, sec. 381),'' after ''for cause shown''.

Subsec. (b). Pub. L. 103-80, Sec. 3(d)(2), struck out at end

''Such trial shall be conducted in accordance with the practice and

procedure applicable in the case of proceedings subject to the

provisions of section 22 of such Act of October 15, 1914, as

amended (U.S.C., 1934 ed., title 28, sec. 387).''

1962 - Subsec. (a). Pub. L. 87-781, Sec. 103(d), struck out

''(e),'' after ''paragraphs''.

Pub. L. 87-781, Sec. 201(c), struck out ''(f),'' after

''paragraphs''.

EFFECTIVE DATE OF 1962 AMENDMENT

Amendment by section 103(c) of Pub. L. 87-781 effective on first

day of seventh calendar month following October 1962, see section

107 of Pub. L. 87-781, set out as a note under section 321 of this

title.

Section 203 of title II of Pub. L. 87-781 provided that: ''The

amendments made by this title (amending this section and section

374 of this title and enacting provisions set out as notes under

sections 321 and 374 of this title) shall take effect on the date

of enactment of this Act (Oct. 10, 1962).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 333, 334, 360j of this

title; title 42 section 1396r-8.

-CITE-

21 USC Sec. 333 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 333. Penalties

-STATUTE-

(a) Violation of section 331 of this title; second violation;

intent to defraud or mislead

(1) Any person who violates a provision of section 331 of this

title shall be imprisoned for not more than one year or fined not

more than $1,000, or both.

(2) Notwithstanding the provisions of paragraph (1) of this

section, (FOOTNOTE 1) if any person commits such a violation after

a conviction of him under this section has become final, or commits

such a violation with the intent to defraud or mislead, such person

shall be imprisoned for not more than three years or fined not more

than $10,000, or both.

(FOOTNOTE 1) So in original. Words ''of this section'' probably

should not appear.

(b) Prescription drug marketing violations

(1) Notwithstanding subsection (a) of this section, any person

who violates section 331(t) of this title by -

(A) knowingly importing a drug in violation of section

381(d)(1) of this title,

(B) knowingly selling, purchasing, or trading a drug or drug

sample or knowingly offering to sell, purchase, or trade a drug

or drug sample, in violation of section 353(c)(1) of this title,

(C) knowingly selling, purchasing, or trading a coupon,

knowingly offering to sell, purchase, or trade such a coupon, or

knowingly counterfeiting such a coupon, in violation of section

353(c)(2) of this title, or

(D) knowingly distributing drugs in violation of section

353(e)(2)(A) of this title,

shall be imprisoned for not more than 10 years or fined not more

than $250,000, or both.

(2) Any manufacturer or distributor who distributes drug samples

by means other than the mail or common carrier whose

representative, during the course of the representative's

employment or association with that manufacturer or distributor,

violated section 331(t) of this title because of a violation of

section 353(c)(1) of this title or violated any State law

prohibiting the sale, purchase, or trade of a drug sample subject

to section 353(b) of this title or the offer to sell, purchase, or

trade such a drug sample shall, upon conviction of the

representative for such violation, be subject to the following

civil penalties:

(A) A civil penalty of not more than $50,000 for each of the

first two such violations resulting in a conviction of any

representative of the manufacturer or distributor in any 10-year

period.

(B) A civil penalty of not more than $1,000,000 for each

violation resulting in a conviction of any representative after

the second conviction in any 10-year period.

For the purposes of this paragraph, multiple convictions of one or

more persons arising out of the same event or transaction, or a

related series of events or transactions, shall be considered as

one violation.

(3) Any manufacturer or distributor who violates section 331(t)

of this title because of a failure to make a report required by

section 353(d)(3)(E) of this title shall be subject to a civil

penalty of not more than $100,000.

(4)(A) If a manufacturer or distributor or any representative of

such manufacturer or distributor provides information leading to

the institution of a criminal proceeding against, and conviction

of, any representative of that manufacturer or distributor for a

violation of section 331(t) of this title because of a sale,

purchase, or trade or offer to purchase, sell, or trade a drug

sample in violation of section 353(c)(1) of this title or for a

violation of State law prohibiting the sale, purchase, or trade or

offer to sell, purchase, or trade a drug sample, the conviction of

such representative shall not be considered as a violation for

purposes of paragraph (2).

(B) If, in an action brought under paragraph (2) against a

manufacturer or distributor relating to the conviction of a

representative of such manufacturer or distributor for the sale,

purchase, or trade of a drug or the offer to sell, purchase, or

trade a drug, it is shown, by clear and convincing evidence -

(i) that the manufacturer or distributor conducted, before the

institution of a criminal proceeding against such representative

for the violation which resulted in such conviction, an

investigation of events or transactions which would have led to

the reporting of information leading to the institution of a

criminal proceeding against, and conviction of, such

representative for such purchase, sale, or trade or offer to

purchase, sell, or trade, or

(ii) that, except in the case of the conviction of a

representative employed in a supervisory function, despite

diligent implementation by the manufacturer or distributor of an

independent audit and security system designed to detect such a

violation, the manufacturer or distributor could not reasonably

have been expected to have detected such violation,

the conviction of such representative shall not be considered as a

conviction for purposes of paragraph (2).

(5) If a person provides information leading to the institution

of a criminal proceeding against, and conviction of, a person for a

violation of section 331(t) of this title because of the sale,

purchase, or trade of a drug sample or the offer to sell, purchase,

or trade a drug sample in violation of section 353(c)(1) of this

title, such person shall be entitled to one-half of the criminal

fine imposed and collected for such violation but not more than

$125,000.

(6) Notwithstanding subsection (a) of this section, any person

who is a manufacturer or importer of a covered product pursuant to

section 384(a) of this title and knowingly fails to comply with a

requirement of section 384(e) of this title that is applicable to

such manufacturer or importer, respectively, shall be imprisoned

for not more than 10 years or fined not more than $250,000, or

both.

(c) Exceptions in certain cases of good faith, etc.

No person shall be subject to the penalties of subsection (a)(1)

of this section, (1) for having received in interstate commerce any

article and delivered it or proffered delivery of it, if such

delivery or proffer was made in good faith, unless he refuses to

furnish on request of an officer or employee duly designated by the

Secretary the name and address of the person from whom he purchased

or received such article and copies of all documents, if any there

be, pertaining to the delivery of the article to him; or (2) for

having violated section 331(a) or (d) of this title, if he

establishes a guaranty or undertaking signed by, and containing the

name and address of, the person residing in the United States from

whom he received in good faith the article, to the effect, in case

of an alleged violation of section 331(a) of this title, that such

article is not adulterated or misbranded, within the meaning of

this chapter designating this chapter or to the effect, in case of

an alleged violation of section 331(d) of this title, that such

article is not an article which may not, under the provisions of

section 344 or 355 of this title, be introduced into interstate

commerce; or (3) for having violated section 331(a) of this title,

where the violation exists because the article is adulterated by

reason of containing a color additive not from a batch certified in

accordance with regulations promulgated by the Secretary under this

chapter, if such person establishes a guaranty or undertaking

signed by, and containing the name and address of, the manufacturer

of the color additive, to the effect that such color additive was

from a batch certified in accordance with the applicable

regulations promulgated by the Secretary under this chapter; or (4)

for having violated section 331(b), (c) or (k) of this title by

failure to comply with section 352(f) of this title in respect to

an article received in interstate commerce to which neither section

353(a) nor 353(b)(1) of this title is applicable, if the delivery

or proffered delivery was made in good faith and the labeling at

the time thereof contained the same directions for use and warning

statements as were contained in the labeling at the time of such

receipt of such article; or (5) for having violated section

331(i)(2) of this title if such person acted in good faith and had

no reason to believe that use of the punch, die, plate, stone, or

other thing involved would result in a drug being a counterfeit

drug, or for having violated section 331(i)(3) of this title if the

person doing the act or causing it to be done acted in good faith

and had no reason to believe that the drug was a counterfeit drug.

(d) Exceptions involving misbranded food

No person shall be subject to the penalties of subsection (a)(1)

of this section for a violation of section 331 of this title

involving misbranded food if the violation exists solely because

the food is misbranded under section 343(a)(2) of this title

because of its advertising.

(e) Prohibited distribution of human growth hormone

(1) Except as provided in paragraph (2), whoever knowingly

distributes, or possesses with intent to distribute, human growth

hormone for any use in humans other than the treatment of a disease

or other recognized medical condition, where such use has been

authorized by the Secretary of Health and Human Services under

section 355 of this title and pursuant to the order of a physician,

is guilty of an offense punishable by not more than 5 years in

prison, such fines as are authorized by title 18, or both.

(2) Whoever commits any offense set forth in paragraph (1) and

such offense involves an individual under 18 years of age is

punishable by not more than 10 years imprisonment, such fines as

are authorized by title 18, or both.

(3) Any conviction for a violation of paragraphs (1) and (2) of

this subsection shall be considered a felony violation of the

Controlled Substances Act (21 U.S.C. 801 et seq.) for the purposes

of forfeiture under section 413 of such Act (21 U.S.C. 853).

(4) As used in this subsection the term ''human growth hormone''

means somatrem, somatropin, or an analogue of either of them.

(5) The Drug Enforcement Administration is authorized to

investigate offenses punishable by this subsection.

(f) Redesignated (g)

(g) Violations related to devices

(1)(A) Except as provided in subparagraph (B), any person who

violates a requirement of this chapter which relates to devices

shall be liable to the United States for a civil penalty in an

amount not to exceed $15,000 for each such violation, and not to

exceed $1,000,000 for all such violations adjudicated in a single

proceeding. For purposes of the preceding sentence, a person

accredited under paragraph (2) of section 374(g) of this title who

is substantially not in compliance with the standards of

accreditation under such section, or who poses a threat to public

health or fails to act in a manner that is consistent with the

purposes of such section, shall be considered to have violated a

requirement of this chapter that relates to devices.

(B) Subparagraph (A) shall not apply -

(i) to any person who violates the requirements of section

360i(a) or 360j(f) of this title unless such violation

constitutes (I) a significant or knowing departure from such

requirements, or (II) a risk to public health,

(ii) to any person who commits minor violations of section

360i(e) or 360i(f) of this title (only with respect to correction

reports) if such person demonstrates substantial compliance with

such section, or

(iii) to violations of section 351(a)(2)(A) of this title which

involve one or more devices which are not defective.

(2)(A) Any person who introduces into interstate commerce or

delivers for introduction into interstate commerce an article of

food that is adulterated within the meaning of section 342(a)(2)(B)

of this title shall be subject to a civil money penalty of not more

than $50,000 in the case of an individual and $250,000 in the case

of any other person for such introduction or delivery, not to

exceed $500,000 for all such violations adjudicated in a single

proceeding.

(B) This paragraph shall not apply to any person who grew the

article of food that is adulterated. If the Secretary assesses a

civil penalty against any person under this paragraph, the

Secretary may not use the criminal authorities under this section

to sanction such person for the introduction or delivery for

introduction into interstate commerce of the article of food that

is adulterated. If the Secretary assesses a civil penalty against

any person under this paragraph, the Secretary may not use the

seizure authorities of section 334 of this title or the injunction

authorities of section 332 of this title with respect to the

article of food that is adulterated.

(C) In a hearing to assess a civil penalty under this paragraph,

the presiding officer shall have the same authority with regard to

compelling testimony or production of documents as a presiding

officer has under section 346a(g)(2)(B) of this title. The third

sentence of paragraph (3)(A) shall not apply to any investigation

under this paragraph.

(3)(A) A civil penalty under paragraph (1) or (2) shall be

assessed by the Secretary by an order made on the record after

opportunity for a hearing provided in accordance with this

subparagraph and section 554 of title 5. Before issuing such an

order, the Secretary shall give written notice to the person to be

assessed a civil penalty under such order of the Secretary's

proposal to issue such order and provide such person an opportunity

for a hearing on the order. In the course of any investigation,

the Secretary may issue subpoenas requiring the attendance and

testimony of witnesses and the production of evidence that relates

to the matter under investigation.

(B) In determining the amount of a civil penalty, the Secretary

shall take into account the nature, circumstances, extent, and

gravity of the violation or violations and, with respect to the

violator, ability to pay, effect on ability to continue to do

business, any history of prior such violations, the degree of

culpability, and such other matters as justice may require.

(C) The Secretary may compromise, modify, or remit, with or

without conditions, any civil penalty which may be assessed under

paragraph (1) or (2). The amount of such penalty, when finally

determined, or the amount agreed upon in compromise, may be

deducted from any sums owing by the United States to the person

charged.

(4) Any person who requested, in accordance with paragraph

(3)(A), a hearing respecting the assessment of a civil penalty and

who is aggrieved by an order assessing a civil penalty may file a

petition for judicial review of such order with the United States

Court of Appeals for the District of Columbia Circuit or for any

other circuit in which such person resides or transacts business.

Such a petition may only be filed within the 60-day period

beginning on the date the order making such assessment was issued.

(5) If any person fails to pay an assessment of a civil penalty -

(A) after the order making the assessment becomes final, and if

such person does not file a petition for judicial review of the

order in accordance with paragraph (4), or

(B) after a court in an action brought under paragraph (4) has

entered a final judgment in favor of the Secretary,

the Attorney General shall recover the amount assessed (plus

interest at currently prevailing rates from the date of the

expiration of the 60-day period referred to in paragraph (4) or the

date of such final judgment, as the case may be) in an action

brought in any appropriate district court of the United States. In

such an action, the validity, amount, and appropriateness of such

penalty shall not be subject to review.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 303, 52 Stat. 1043; Oct. 26, 1951,

ch. 578, Sec. 2, 65 Stat. 649; Pub. L. 86-618, title I, Sec.

105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89-74, Sec. 7, 9(d),

July 15, 1965, 79 Stat. 233, 235; Pub. L. 90-639, Sec. 3, Oct. 24,

1968, 82 Stat. 1361; Pub. L. 91-513, title II, Sec. 701(b), Oct.

27, 1970, 84 Stat. 1281; Pub. L. 94-278, title V, Sec.

502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100-293, Sec.

7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100-690, title II, Sec.

2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101-629, Sec. 17(a),

Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101-647, title XIX, Sec.

1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102-353, Sec. 3, Aug.

26, 1992, 106 Stat. 941; Pub. L. 103-80, Sec. 3(e), Aug. 13, 1993,

107 Stat. 775; Pub. L. 103-322, title XXXIII, Sec. 330015, Sept.

13, 1994, 108 Stat. 2146; Pub. L. 104-170, title IV, Sec. 407, Aug.

3, 1996, 110 Stat. 1535; Pub. L. 106-387, Sec. 1(a) (title VII,

Sec. 745(d)(2)), Oct. 28, 2000, 114 Stat. 1549, 1549A-40; Pub. L.

107-250, title II, Sec. 201(c), Oct. 26, 2002, 116 Stat. 1609.)

-REFTEXT-

REFERENCES IN TEXT

The Controlled Substances Act, referred to in subsec. (e)(3), is

title II of Pub. L. 91-513, Oct. 27, 1970, 84 Stat. 1242, as

amended, which is classified principally to subchapter I (Sec. 801

et seq.) of chapter 13 of this title. For complete classification

of this Act to the Code, see Short Title note set out under section

801 of this title and Tables.

-MISC2-

AMENDMENTS

2002 - Subsec. (g)(1)(A). Pub. L. 107-250 inserted at end ''For

purposes of the preceding sentence, a person accredited under

paragraph (2) of section 374(g) of this title who is substantially

not in compliance with the standards of accreditation under such

section, or who poses a threat to public health or fails to act in

a manner that is consistent with the purposes of such section,

shall be considered to have violated a requirement of this chapter

that relates to devices.''

2000 - Subsec. (b)(6). Pub. L. 106-387 added par. (6).

1996 - Subsec. (g)(2). Pub. L. 104-170, Sec. 407(1), (2), added

par. (2). Former par. (2) redesignated (3).

Subsec. (g)(3). Pub. L. 104-170, Sec. 407(1), (3), redesignated

par. (2) as (3) and substituted ''paragraph (1) or (2)'' for

''paragraph (1)'' in subpars. (A) and (C). Former par. (3)

redesignated (4).

Subsec. (g)(4). Pub. L. 104-170, Sec. 407(1), (4), redesignated

par. (3) as (4) and substituted ''paragraph (3)(A)'' for

''paragraph (2)(A)''. Former par. (4) redesignated (5).

Subsec. (g)(5). Pub. L. 104-170, Sec. 407(1), (5), redesignated

par. (4) as (5) and substituted ''paragraph (4)'' for ''paragraph

(3)'' wherever appearing.

1994 - Subsec. (e). Pub. L. 103-322 amended directory language of

Pub. L. 101-647. See 1990 Amendment note below.

1993 - Subsecs. (e) to (g). Pub. L. 103-80, which directed the

amendment of this section by redesignating the second subsec. (e)

and subsec. (f) as subsecs. (f) and (g), respectively, could only

be executed by designating subsec. (f) as (g) because this section

did not contain a second subsec. (e) subsequent to amendment of

Pub. L. 101-647 by Pub. L. 103-322. See 1990 and 1994 amendment

notes for subsec. (e) under this section.

1992 - Subsec. (b)(1). Pub. L. 102-353, Sec. 3(a), amended par.

(1) generally. Prior to amendment, par. (1) read as follows:

''Notwithstanding subsection (a) of this section, any person who

violates section 331(t) of this title because of an importation of

a drug in violation of section 381(d)(1) of this title, because of

a sale, purchase, or trade of a drug or drug sample or the offer to

sell, purchase, or trade a drug or drug sample in violation of

section 353(c) of this title, because of the sale, purchase, or

trade of a coupon, the offer to sell, purchase, or trade such a

coupon, or the counterfeiting of such a coupon in violation of

section 353(c)(2) of this title, or the distribution of drugs in

violation of section 353(e)(2)(A) of this title shall be imprisoned

for not more than 10 years or fined not more than $250,000, or

both.''

Subsec. (b)(4)(A). Pub. L. 102-353, Sec. 3(b)(1), substituted

''the institution of a criminal proceeding against, and conviction

of,'' for ''the arrest and conviction of''.

Subsec. (b)(4)(B)(i). Pub. L. 102-353, Sec. 3(b)(1), (2),

substituted ''before the institution of a criminal proceeding

against'' for ''before the arrest of'' and ''the institution of a

criminal proceeding against, and conviction of,'' for ''the arrest

and conviction of''.

Subsec. (b)(5). Pub. L. 102-353, Sec. 3(b)(3), substituted ''the

institution of a criminal proceeding against, and conviction of,''

for ''the arrest and conviction of''.

Subsec. (c). Pub. L. 102-353, Sec. 3(b)(4), substituted

''subsection (a)(1) of this section'' for ''subsection (a) of this

section''.

Subsec. (d). Pub. L. 102-353, Sec. 3(b)(4), (5), substituted

''subsection (a)(1) of this section'' for ''subsection (a) of this

section'' and struck out '', and no person shall be subject to the

penalties of subsection (b) of this section for such a violation

unless the violation is committed with the intent to defraud or

mislead'' after ''advertising''.

1990 - Subsec. (e). Pub. L. 101-647, as amended by Pub. L.

103-322, amended subsec. (e) generally. Prior to amendment,

subsec. (e) read as follows:

''(e)(1) Except as provided in paragraph (2), any person who

distributes or possesses with the intent to distribute any anabolic

steroid for any use in humans other than the treatment of disease

pursuant to the order of a physician shall be imprisoned for not

more than three years or fined under title 18, or both.

''(2) Any person who distributes or possesses with the intent to

distribute to an individual under 18 years of age, any anabolic

steroid for any use in humans other than the treatment of disease

pursuant to the order of a physician shall be imprisoned for not

more than six years or fined under title 18, or both.''

Subsec. (f). Pub. L. 101-629 added subsec. (f).

1988 - Subsecs. (a), (b). Pub. L. 100-293 designated existing

subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a),

substituted ''paragraph (1)'' for ''subsection (a)'' in par. (2),

and added subsec. (b).

Subsec. (e). Pub. L. 100-690 added subsec. (e).

1976 - Subsec. (d). Pub. L. 94-278 added subsec. (d).

1970 - Subsec. (a). Pub. L. 91-513 struck out reference to

subsec. (b) and transferred to subsec. (b) provisions covering

second offenses and offenses committed with intent to defraud or

mislead.

Subsec. (b). Pub. L. 91-513 inserted provisions covering second

offenses and offenses committed with intent to defraud or mislead

formerly set out in subsec. (a) and struck out provisions covering

violations involving depressant and stimulant drugs. See section

801 et seq. of this title.

1968 - Subsecs. (a), (b). Pub. L. 90-639 made a general revision

in the penalties prescribed for offenses involving depressant or

stimulant drugs, set a fine of not to exceed $10,000 or

imprisonment of not more than 5 years for offenses involving the

unlawful manufacturing of, sale, or disposal of, or possession with

intent to sell, a depressant or stimulant drug or involving

counterfeit depressant or stimulant drugs, stiffened the penalties

for unlawful sales or other disposals by persons over 18 to persons

under 21, and set new penalties for possession of a depressant or

stimulant drug for purposes other than sale or other disposal.

1965 - Subsec. (a). Pub. L. 89-74, Sec. 7(a), inserted proviso

limiting the penalties for depressant or stimulant drug violations

to two years imprisonment or $5,000 fine or both for first offense

and to two years imprisonment or $15,000 fine or both for

subsequent offenses.

Subsec. (b). Pub. L. 89-74, Sec. 7(b), inserted parenthetical

exception provision.

Subsec. (c)(5). Pub. L. 89-74, Sec. 9(d), added cl. (5).

1960 - Subsec. (c)(3). Pub. L. 86-618 substituted ''a color

additive'' for ''a coal-tar color'', ''the color additive'' for

''the coal-tar color'' and ''such color additive was'' for ''such

color was''.

1951 - Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).

EFFECTIVE DATE OF 1994 AMENDMENT

Section 330015 of Pub. L. 103-322 provided that the amendment

made by that section is effective as of the date on which section

1904 of Pub. L. 101-647, which amended this section, took effect.

EFFECTIVE DATE OF 1990 AMENDMENT

Section 17(b) of Pub. L. 101-629 provided that:

''(b) Effective Date of Application to Device User Facilities. -

''(1) The Secretary of Health and Human Services shall conduct

a study to determine whether there has been substantial

compliance with the requirements of section 519(b) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 360i(b)) by device user

facilities (as defined in section 519(b)(5)(A) of such Act). The

Secretary shall report the results of the study to the Congress

after the expiration of 45 months after the date of the enactment

of this Act (Nov. 28, 1990).

''(2)(A) If upon the expiration of 48 months after the date of

the enactment of this Act (Nov. 28, 1990) the Secretary has not

made the report required by paragraph (1), section 303(f) of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as added

by the amendment made by subsection (a), shall take effect with

respect to device user facilities (as defined in section

519(b)(5)(A) of such Act). (Secretary of Health and Human

Services had not made the report required by par. (1) on the

expiration of 48 months after Nov. 28, 1990.)

''(B) If in the report under paragraph (1) the Secretary

reports that there has been substantial compliance with the

requirements of such section 519(b) by a type of device user

facility and if the Secretary does not make a determination under

subparagraph (C) with respect to such type of facility, such

section 303(f) shall not take effect with respect to such type of

facility.

''(C) If the Secretary determines in the report under paragraph

(1) that there is not substantial compliance with the

requirements of such section 519(b) by a type of device user

facility or if the Secretary makes such a determination after

making the report under paragraph (1), such section 303(f) shall

take effect with respect to such type of facility upon the

effective date of the report.''

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-293 effective upon expiration of 90 days

after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out

as a note under section 353 of this title.

EFFECTIVE DATE OF 1976 AMENDMENT

Amendment by Pub. L. 94-278 effective 180 days after Apr. 22,

1976, see section 502(c) of Pub. L. 94-278, set out as a note under

section 334 of this title.

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-513 effective on first day of seventh

calendar month that begins after Oct. 26, 1970, see section 704 of

Pub. L. 91-513, set out as an Effective Date note under section 801

of this title.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by Pub. L. 90-639 applicable only with respect to

violations of this chapter committed after Oct. 24, 1968, see

section 6 of Pub. L. 90-639, set out as an Effective Date of 1968

Amendments; Transitional Provisions note under section 321 of this

title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11

of Pub. L. 89-74, set out as a note under section 321 of this

title.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE OF 1951 AMENDMENT

Section 3 of act Oct. 26, 1951, provided that: ''The provisions

of this Act (amending this section and section 353 of this title)

shall take effect six months after the date of its enactment (Oct.

26, 1951).''

SAVINGS PROVISION

Amendment by Pub. L. 91-513 not to affect or abate any

prosecutions for violation of law or any civil seizures or

forfeitures and injunctive proceedings commenced prior to the

effective date of such amendment, and all administrative

proceedings pending before the Bureau of Narcotics and Dangerous

Drugs (now the Drug Enforcement Administration) on Oct. 27, 1970,

to be continued and brought to final determination in accord with

laws and regulations in effect prior to Oct. 27, 1970, see section

702 of Pub. L. 91-513, set out as a note under section 321 of this

title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

ENFORCEMENT

Pub. L. 99-660, title I, Sec. 103, Nov. 14, 1986, 100 Stat. 3751,

provided that: ''For the fines authorized to be imposed under

section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

333), see section 3623 of title 18, United States Code, for the

period ending October 31, 1986 (probably should be October 31,

1987), and sections 3559 and 3571 of such title for the period

beginning November 1, 1986 (probably should be November 1, 1987).''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 360j, 859 of this

title; title 15 section 1456.

-CITE-

21 USC Sec. 333a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 333a. Repealed. Pub. L. 101-647, title XIX, Sec. 1905, Nov.

29, 1990, 104 Stat. 4853

-MISC1-

Section, Pub. L. 100-690, title II, Sec. 2401, Nov. 18, 1988, 102

Stat. 4230, related to forfeiture and illegal trafficking in

steroids or human growth hormones.

-CITE-

21 USC Sec. 334 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 334. Seizure

-STATUTE-

(a) Grounds and jurisdiction

(1) Any article of food, drug, or cosmetic that is adulterated or

misbranded when introduced into or while in interstate commerce or

while held for sale (whether or not the first sale) after shipment

in interstate commerce, or which may not, under the provisions of

section 344 or 355 of this title, be introduced into interstate

commerce, shall be liable to be proceeded against while in

interstate commerce, or at any time thereafter, on libel of

information and condemned in any district court of the United

States or United States court of a Territory within the

jurisdiction of which the article is found. No libel for

condemnation shall be instituted under this chapter, for any

alleged misbranding if there is pending in any court a libel for

condemnation proceeding under this chapter based upon the same

alleged misbranding, and not more than one such proceeding shall be

instituted if no such proceeding is so pending, except that such

limitations shall not apply (A) when such misbranding has been the

basis of a prior judgment in favor of the United States, in a

criminal, injunction, or libel for condemnation proceeding under

this chapter, or (B) when the Secretary has probable cause to

believe from facts found, without hearing, by him or any officer or

employee of the Department that the misbranded article is dangerous

to health, or that the labeling of the misbranded article is

fraudulent, or would be in a material respect misleading to the

injury or damage of the purchaser or consumer. In any case where

the number of libel for condemnation proceedings is limited as

above provided the proceeding pending or instituted shall, on

application of the claimant, seasonably made, be removed for trial

to any district agreed upon by stipulation between the parties, or,

in case of failure to so stipulate within a reasonable time, the

claimant may apply to the court of the district in which the

seizure has been made, and such court (after giving the United

States attorney for such district reasonable notice and opportunity

to be heard) shall by order, unless good cause to the contrary is

shown, specify a district of reasonable proximity to the claimant's

principal place of business, to which the case shall be removed for

trial.

(2) The following shall be liable to be proceeded against at any

time on libel of information and condemned in any district court of

the United States or United States court of a Territory within the

jurisdiction of which they are found: (A) Any drug that is a

counterfeit drug, (B) Any container of a counterfeit drug, (C) Any

punch, die, plate, stone, labeling, container, or other thing used

or designed for use in making a counterfeit drug or drugs, and (D)

Any adulterated or misbranded device.

(3)(A) Except as provided in subparagraph (B), no libel for

condemnation may be instituted under paragraph (1) or (2) against

any food which -

(i) is misbranded under section 343(a)(2) of this title because

of its advertising, and

(ii) is being held for sale to the ultimate consumer in an

establishment other than an establishment owned or operated by a

manufacturer, packer, or distributor of the food.

(B) A libel for condemnation may be instituted under paragraph

(1) or (2) against a food described in subparagraph (A) if -

(i)(I) the food's advertising which resulted in the food being

misbranded under section 343(a)(2) of this title was disseminated

in the establishment in which the food is being held for sale to

the ultimate consumer,

(II) such advertising was disseminated by, or under the

direction of, the owner or operator of such establishment, or

(III) all or part of the cost of such advertising was paid by

such owner or operator; and

(ii) the owner or operator of such establishment used such

advertising in the establishment to promote the sale of the food.

(b) Procedure; multiplicity of pending proceedings

The article, equipment, or other thing proceeded against shall be

liable to seizure by process pursuant to the libel, and the

procedure in cases under this section shall conform, as nearly as

may be, to the procedure in admiralty; except that on demand of

either party any issue of fact joined in any such case shall be

tried by jury. When libel for condemnation proceedings under this

section, involving the same claimant and the same issues of

adulteration or misbranding, are pending in two or more

jurisdictions, such pending proceedings, upon application of the

claimant seasonably made to the court of one such jurisdiction,

shall be consolidated for trial by order of such court, and tried

in (1) any district selected by the claimant where one of such

proceedings is pending; or (2) a district agreed upon by

stipulation between the parties. If no order for consolidation is

so made within a reasonable time, the claimant may apply to the

court of one such jurisdiction and such court (after giving the

United States attorney for such district reasonable notice and

opportunity to be heard) shall by order, unless good cause to the

contrary is shown, specify a district of reasonable proximity to

the claimant's principal place of business, in which all such

pending proceedings shall be consolidated for trial and tried.

Such order of consolidation shall not apply so as to require the

removal of any case the date for trial of which has been fixed.

The court granting such order shall give prompt notification

thereof to the other courts having jurisdiction of the cases

covered thereby.

(c) Availability of samples of seized goods prior to trial

The court at any time after seizure up to a reasonable time

before trial shall by order allow any party to a condemnation

proceeding, his attorney or agent, to obtain a representative

sample of the article seized and a true copy of the analysis, if

any, on which the proceeding is based and the identifying marks or

numbers, if any, of the packages from which the samples analyzed

were obtained.

(d) Disposition of goods after decree of condemnation; claims for

remission or mitigation of forfeitures

(1) Any food, drug, device, or cosmetic condemned under this

section shall, after entry of the decree, be disposed of by

destruction or sale as the court may, in accordance with the

provisions of this section, direct and the proceeds thereof, if

sold, less the legal costs and charges, shall be paid into the

Treasury of the United States; but such article shall not be sold

under such decree contrary to the provisions of this chapter or the

laws of the jurisdiction in which sold. After entry of the decree

and upon the payment of the costs of such proceedings and the

execution of a good and sufficient bond conditioned that such

article shall not be sold or disposed of contrary to the provisions

of this chapter or the laws of any State or Territory in which

sold, the court may by order direct that such article be delivered

to the owner thereof to be destroyed or brought into compliance

with the provisions of this chapter, under the supervision of an

officer or employee duly designated by the Secretary, and the

expenses of such supervision shall be paid by the person obtaining

release of the article under bond. If the article was imported

into the United States and the person seeking its release

establishes (A) that the adulteration, misbranding, or violation

did not occur after the article was imported, and (B) that he had

no cause for believing that it was adulterated, misbranded, or in

violation before it was released from customs custody, the court

may permit the article to be delivered to the owner for exportation

in lieu of destruction upon a showing by the owner that all of the

conditions of section 381(e) of this title can and will be met.

The provisions of this sentence shall not apply where condemnation

is based upon violation of section 342(a)(1), (2), or (6), section

351(a)(3), section 352(j), or section 361(a) or (d) of this title.

Where such exportation is made to the original foreign supplier,

then subparagraphs (A) and (B) of section 381(e)(1) of this title

and the preceding sentence shall not be applicable; and in all

cases of exportation the bond shall be conditioned that the article

shall not be sold or disposed of until the applicable conditions of

section 381(e) of this title have been met. Any person seeking to

export an imported article pursuant to any of the provisions of

this subsection shall establish that the article was intended for

export at the time the article entered commerce. Any article

condemned by reason of its being an article which may not, under

section 344 or 355 of this title, be introduced into interstate

commerce, shall be disposed of by destruction.

(2) The provisions of paragraph (1) of this subsection shall, to

the extent deemed appropriate by the court, apply to any equipment

or other thing which is not otherwise within the scope of such

paragraph and which is referred to in paragraph (2) of subsection

(a) of this section.

(3) Whenever in any proceeding under this section, involving

paragraph (2) of subsection (a) of this section, the condemnation

of any equipment or thing (other than a drug) is decreed, the court

shall allow the claim of any claimant, to the extent of such

claimant's interest, for remission or mitigation of such forfeiture

if such claimant proves to the satisfaction of the court (i) that

he has not committed or caused to be committed any prohibited act

referred to in such paragraph (2) and has no interest in any drug

referred to therein, (ii) that he has an interest in such equipment

or other thing as owner or lienor or otherwise, acquired by him in

good faith, and (iii) that he at no time had any knowledge or

reason to believe that such equipment or other thing was being or

would be used in, or to facilitate, the violation of laws of the

United States relating to counterfeit drugs.

(e) Costs

When a decree of condemnation is entered against the article,

court costs and fees, and storage and other proper expenses, shall

be awarded against the person, if any, intervening as claimant of

the article.

(f) Removal of case for trial

In the case of removal for trial of any case as provided by

subsection (a) or (b) of this section -

(1) The clerk of the court from which removal is made shall

promptly transmit to the court in which the case is to be tried

all records in the case necessary in order that such court may

exercise jurisdiction.

(2) The court to which such case was removed shall have the

powers and be subject to the duties, for purposes of such case,

which the court from which removal was made would have had, or to

which such court would have been subject, if such case had not

been removed.

(g) Administrative restraint; detention orders

(1) If during an inspection conducted under section 374 of this

title of a facility or a vehicle, a device which the officer or

employee making the inspection has reason to believe is adulterated

or misbranded is found in such facility or vehicle, such officer or

employee may order the device detained (in accordance with

regulations prescribed by the Secretary) for a reasonable period

which may not exceed twenty days unless the Secretary determines

that a period of detention greater than twenty days is required to

institute an action under subsection (a) of this section or section

332 of this title, in which case he may authorize a detention

period of not to exceed thirty days. Regulations of the Secretary

prescribed under this paragraph shall require that before a device

may be ordered detained under this paragraph the Secretary or an

officer or employee designated by the Secretary approve such

order. A detention order under this paragraph may require the

labeling or marking of a device during the period of its detention

for the purpose of identifying the device as detained. Any person

who would be entitled to claim a device if it were seized under

subsection (a) of this section may appeal to the Secretary a

detention of such device under this paragraph. Within five days of

the date an appeal of a detention is filed with the Secretary, the

Secretary shall after affording opportunity for an informal hearing

by order confirm the detention or revoke it.

(2)(A) Except as authorized by subparagraph (B), a device subject

to a detention order issued under paragraph (1) shall not be moved

by any person from the place at which it is ordered detained until

-

(i) released by the Secretary, or

(ii) the expiration of the detention period applicable to such

order,

whichever occurs first.

(B) A device subject to a detention order under paragraph (1) may

be moved -

(i) in accordance with regulations prescribed by the Secretary,

and

(ii) if not in final form for shipment, at the discretion of

the manufacturer of the device for the purpose of completing the

work required to put it in such form.

(h) Administrative detention of foods

(1) Detention authority

(A) In general

An officer or qualified employee of the Food and Drug

Administration may order the detention, in accordance with this

subsection, of any article of food that is found during an

inspection, examination, or investigation under this chapter

conducted by such officer or qualified employee, if the officer

or qualified employee has credible evidence or information

indicating that such article presents a threat of serious

adverse health consequences or death to humans or animals.

(B) Secretary's approval

An article of food may be ordered detained under subparagraph

(A) only if the Secretary or an official designated by the

Secretary approves the order. An official may not be so

designated unless the official is the director of the district

under this chapter in which the article involved is located, or

is an official senior to such director.

(2) Period of detention

An article of food may be detained under paragraph (1) for a

reasonable period, not to exceed 20 days, unless a greater

period, not to exceed 30 days, is necessary, to enable the

Secretary to institute an action under subsection (a) of this

section or section 332 of this title. The Secretary shall by

regulation provide for procedures for instituting such action on

an expedited basis with respect to perishable foods.

(3) Security of detained article

An order under paragraph (1) with respect to an article of food

may require that such article be labeled or marked as detained,

and shall require that the article be removed to a secure

facility, as appropriate. An article subject to such an order

shall not be transferred by any person from the place at which

the article is ordered detained, or from the place to which the

article is so removed, as the case may be, until released by the

Secretary or until the expiration of the detention period

applicable under such order, whichever occurs first. This

subsection may not be construed as authorizing the delivery of

the article pursuant to the execution of a bond while the article

is subject to the order, and section 381(b) of this title does

not authorize the delivery of the article pursuant to the

execution of a bond while the article is subject to the order.

(4) Appeal of detention order

(A) In general

With respect to an article of food ordered detained under

paragraph (1), any person who would be entitled to be a

claimant for such article if the article were seized under

subsection (a) of this section may appeal the order to the

Secretary. Within five days after such an appeal is filed, the

Secretary, after providing opportunity for an informal hearing,

shall confirm or terminate the order involved, and such

confirmation by the Secretary shall be considered a final

agency action for purposes of section 702 of title 5. If during

such five-day period the Secretary fails to provide such an

opportunity, or to confirm or terminate such order, the order

is deemed to be terminated.

(B) Effect of instituting court action

The process under subparagraph (A) for the appeal of an order

under paragraph (1) terminates if the Secretary institutes an

action under subsection (a) of this section or section 332 of

this title regarding the article of food involved.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 304, 52 Stat. 1044; June 24, 1948,

ch. 613, Sec. 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, Sec. 3, 67

Stat. 477; Pub. L. 85-250, Aug. 31, 1957, 71 Stat. 567; Pub. L.

89-74, Sec. 6, July 15, 1965, 79 Stat. 232; Pub. L. 90-639, Sec.

4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91-513, title II, Sec.

701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94-278,

title V, Sec. 502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L.

94-295, Sec. 3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L.

102-300, Sec. 6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103-80,

Sec. 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105-115, title IV,

Sec. 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107-188, title

III, Sec. 303(a), June 12, 2002, 116 Stat. 663.)

-MISC1-

AMENDMENTS

2002 - Subsec. (h). Pub. L. 107-188 added subsec. (h).

1997 - Subsec. (d)(1). Pub. L. 105-115 substituted

''subparagraphs (A) and (B) of section 381(e)(1) of this title''

for ''paragraphs (1) and (2) of section 381(e) of this title'' and

inserted ''Any person seeking to export an imported article

pursuant to any of the provisions of this subsection shall

establish that the article was intended for export at the time the

article entered commerce.'' before ''Any article condemned by

reason''.

1993 - Subsec. (a)(1). Pub. L. 103-80, Sec. 3(f)(1), substituted

''found. No libel'' for ''found: Provided, however, That no

libel''.

Subsec. (d)(1). Pub. L. 103-80, Sec. 3(f)(2), substituted ''sold.

After entry'' for ''sold: Provided, That after entry'', ''met. The

provisions of this sentence'' for ''met: Provided, however, That

the provisions of this sentence'', ''title. Where such

exportation'' for ''title: And provided further, That where such

exportation'', and ''the preceding sentence shall not be

applicable'' for ''the foregoing proviso shall not be applicable''.

1992 - Subsec. (d)(1). Pub. L. 102-300 substituted ''381(e)'' for

''381(d)'' in three places and ''paragraphs'' for ''clauses''

before ''(1) and (2) of section 381(e)''.

1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 3(c)(1), struck out

''device,'' after ''Any article of food, drug,''.

Subsec. (a)(2). Pub. L. 94-295, Sec. 3(c)(2), (3), added cl. (D)

covering adulterated or misbranded devices.

Subsec. (a)(3). Pub. L. 94-278 added par. (3).

Subsec. (g). Pub. L. 94-295, Sec. 7(a), added subsec. (g).

1970 - Subsec. (a)(2). Pub. L. 91-513, Sec. 701(c), struck out

cls. (A) and (D) which dealt with depressant or stimulant drugs,

struck out reference to depressant or stimulant drugs in cl. (C),

and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C),

respectively.

Subsec. (d)(3)(iii). Pub. L. 91-513, Sec. 701(d), struck out

reference to depressant or stimulant drugs.

1968 - Subsec. (a). Pub. L. 90-639 inserted references to the

United States courts of Territories.

1965 - Subsec. (a). Pub. L. 89-74, Sec. 6(a), designated existing

provisions as par. (1), redesignated cls. (1) and (2) of proviso as

(A) and (B), and added par. (2).

Subsec. (b). Pub. L. 89-74, Sec. 6(b)(1), inserted ''equipment,

or other thing proceeded against'' after ''article'' in first

sentence.

Subsec. (d). Pub. L. 89-74, Sec. 6(b)(2), designated existing

provisions as par. (1), redesignated cls. (1) and (2) of the second

sentence thereof as (A) and (B), and added pars. (2) and (3).

1957 - Subsec. (d). Pub. L. 85-250 permitted, under certain

circumstances, reexportation of articles condemned at places other

than original port of entry.

1953 - Subsec. (c). Act Aug. 7, 1953, provided that a true copy

of the analysis in any case shall be furnished the owner.

1948 - Subsec. (a). Act June 24, 1948, inserted ''or while held

for sale (whether or not the first sale) after shipment in

interstate commerce'' to make this subsection coextensive with

section 331(k) of this title.

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of this title.

EFFECTIVE DATE OF 1976 AMENDMENT

Section 502(c) of Pub. L. 94-278 provided that: ''The amendments

made by subsection (a) (amending this section and sections 321,

333, and 343 of this title) shall take effect 180 days after the

date of the enactment of this Act (Apr. 22, 1976).''

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-513 effective on first day of seventh

calendar month that begins after Oct. 26, 1970, see section 704 of

Pub. L. 91-513, set out as an Effective Date note under section 801

of this title.

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by Pub. L. 90-639 applicable only with respect to

violations of this chapter committed after Oct. 24, 1968, see

section 6 of Pub. L. 90-639, set out as an Effective Date of 1968

Amendments; Transitional Provisions note under section 321 of this

title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-74 effective Feb. 1, 1966, see section 11

of Pub. L. 89-74, set out as a note under section 321 of this

title.

SAVINGS PROVISION

Amendment by Pub. L. 91-513 not to affect or abate any

prosecutions for any violation of law or any civil seizures or

forfeitures and injunctive proceedings commenced prior to the

effective date of such amendment, and all administrative

proceedings pending before the Bureau of Narcotics and Dangerous

Drugs (now the Drug Enforcement Administration) on Oct. 27, 1970,

to be continued and brought to final determination in accord with

laws and regulations in effect prior to Oct. 27, 1970, see section

702 of Pub. L. 91-513, set out as a note under section 321 of this

title.

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 331, 333, 360j, 372 of

this title; title 42 section 1396r-8.

-CITE-

21 USC Sec. 335 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 335. Hearing before report of criminal violation

-STATUTE-

Before any violation of this chapter is reported by the Secretary

to any United States attorney for institution of a criminal

proceeding, the person against whom such proceeding is contemplated

shall be given appropriate notice and an opportunity to present his

views, either orally or in writing, with regard to such

contemplated proceeding.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 305, 52 Stat. 1045.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-CITE-

21 USC Sec. 335a 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 335a. Debarment, temporary denial of approval, and suspension

-STATUTE-

(a) Mandatory debarment; certain drug applications

(1) Corporations, partnerships, and associations

If the Secretary finds that a person other than an individual

has been convicted, after May 13, 1992, of a felony under Federal

law for conduct relating to the development or approval,

including the process for development or approval, of any

abbreviated drug application, the Secretary shall debar such

person from submitting, or assisting in the submission of, any

such application.

(2) Individuals

If the Secretary finds that an individual has been convicted of

a felony under Federal law for conduct -

(A) relating to the development or approval, including the

process for development or approval, of any drug product, or

(B) otherwise relating to the regulation of any drug product

under this chapter,

the Secretary shall debar such individual from providing services

in any capacity to a person that has an approved or pending drug

product application.

(b) Permissive debarment; certain drug applications; food imports

(1) In general

The Secretary, on the Secretary's own initiative or in response

to a petition, may, in accordance with paragraph (2), debar -

(A) a person other than an individual from submitting or

assisting in the submission of any abbreviated drug

application,

(B) an individual from providing services in any capacity to

a person that has an approved or pending drug product

application, or

(C) a person from importing an article of food or offering

such an article for import into the United States.

(2) Persons subject to permissive debarment; certain drug

applications

The following persons are subject to debarment under

subparagraph (A) or (B) of paragraph (1):

(A) Corporations, partnerships, and associations

Any person other than an individual that the Secretary finds

has been convicted -

(i) for conduct that -

(I) relates to the development or approval, including the

process for the development or approval, of any abbreviated

drug application; and

(II) is a felony under Federal law (if the person was

convicted before May 13, 1992), a misdemeanor under Federal

law, or a felony under State law, or

(ii) of a conspiracy to commit, or aiding or abetting, a

criminal offense described in clause (i) or a felony

described in subsection (a)(1) of this section,

if the Secretary finds that the type of conduct which served as

the basis for such conviction undermines the process for the

regulation of drugs.

(B) Individuals

(i) Any individual whom the Secretary finds has been

convicted of -

(I) a misdemeanor under Federal law or a felony under State

law for conduct relating to the development or approval,

including the process for development or approval, of any

drug product or otherwise relating to the regulation of drug

products under this chapter, or

(II) a conspiracy to commit, or aiding or abetting, such

criminal offense or a felony described in subsection (a)(2)

of this section,

if the Secretary finds that the type of conduct which served as

the basis for such conviction undermines the process for the

regulation of drugs.

(ii) Any individual whom the Secretary finds has been

convicted of -

(I) a felony which is not described in subsection (a)(2) of

this section or clause (i) of this subparagraph and which

involves bribery, payment of illegal gratuities, fraud,

perjury, false statement, racketeering, blackmail, extortion,

falsification or destruction of records, or interference

with, obstruction of an investigation into, or prosecution

of, any criminal offense, or

(II) a conspiracy to commit, or aiding or abetting, such

felony,

if the Secretary finds, on the basis of the conviction of such

individual and other information, that such individual has

demonstrated a pattern of conduct sufficient to find that there

is reason to believe that such individual may violate

requirements under this chapter relating to drug products.

(iii) Any individual whom the Secretary finds materially

participated in acts that were the basis for a conviction for

an offense described in subsection (a) of this section or in

clause (i) or (ii) for which a conviction was obtained, if the

Secretary finds, on the basis of such participation and other

information, that such individual has demonstrated a pattern of

conduct sufficient to find that there is reason to believe that

such individual may violate requirements under this chapter

relating to drug products.

(iv) Any high managerial agent whom the Secretary finds -

(I) worked for, or worked as a consultant for, the same

person as another individual during the period in which such

other individual took actions for which a felony conviction

was obtained and which resulted in the debarment under

subsection (a)(2) of this section, or clause (i), of such

other individual,

(II) had actual knowledge of the actions described in

subclause (I) of such other individual, or took action to

avoid such actual knowledge, or failed to take action for the

purpose of avoiding such actual knowledge,

(III) knew that the actions described in subclause (I) were

violative of law, and

(IV) did not report such actions, or did not cause such

actions to be reported, to an officer, employee, or agent of

the Department or to an appropriate law enforcement officer,

or failed to take other appropriate action that would have

ensured that the process for the regulation of drugs was not

undermined, within a reasonable time after such agent first

knew of such actions,

if the Secretary finds that the type of conduct which served as

the basis for such other individual's conviction undermines the

process for the regulation of drugs.

(3) Persons subject to permissive debarment; food importation

A person is subject to debarment under paragraph (1)(C) if -

(A) the person has been convicted of a felony for conduct

relating to the importation into the United States of any food;

or

(B) the person has engaged in a pattern of importing or

offering for import adulterated food that presents a threat of

serious adverse health consequences or death to humans or

animals.

(4) Stay of certain orders

An order of the Secretary under clause (iii) or (iv) of

paragraph (2)(B) shall not take effect until 30 days after the

order has been issued.

(c) Debarment period and considerations

(1) Effect of debarment

The Secretary -

(A) shall not accept or review (other than in connection with

an audit under this section) any abbreviated drug application

submitted by or with the assistance of a person debarred under

subsection (a)(1) or (b)(2)(A) of this section during the

period such person is debarred,

(B) shall, during the period of a debarment under subsection

(a)(2) or (b)(2)(B) of this section, debar an individual from

providing services in any capacity to a person that has an

approved or pending drug product application and shall not

accept or review (other than in connection with an audit under

this section) an abbreviated drug application from such

individual, and

(C) shall, if the Secretary makes the finding described in

paragraph (6) or (7) of section 335b(a) of this title, assess a

civil penalty in accordance with section 335b of this title.

(2) Debarment periods

(A) In general

The Secretary shall debar a person under subsection (a) or

(b) of this section for the following periods:

(i) The period of debarment of a person (other than an

individual) under subsection (a)(1) of this section shall not

be less than 1 year or more than 10 years, but if an act

leading to a subsequent debarment under subsection (a) of

this section occurs within 10 years after such person has

been debarred under subsection (a)(1) of this section, the

period of debarment shall be permanent.

(ii) The debarment of an individual under subsection (a)(2)

of this section shall be permanent.

(iii) The period of debarment of any person under paragraph

(2) or (3) of subsection (b) of this section shall not be

more than 5 years.

The Secretary may determine whether debarment periods shall run

concurrently or consecutively in the case of a person debarred

for multiple offenses.

(B) Notification

Upon a conviction for an offense described in subsection (a)

or (b) of this section or upon execution of an agreement with

the United States to plead guilty to such an offense, the

person involved may notify the Secretary that the person

acquiesces to debarment and such person's debarment shall

commence upon such notification.

(3) Considerations

In determining the appropriateness and the period of a

debarment of a person under subsection (b) of this section and

any period of debarment beyond the minimum specified in

subparagraph (A)(i) of paragraph (2), the Secretary shall

consider where applicable -

(A) the nature and seriousness of any offense involved,

(B) the nature and extent of management participation in any

offense involved, whether corporate policies and practices

encouraged the offense, including whether inadequate

institutional controls contributed to the offense,

(C) the nature and extent of voluntary steps to mitigate the

impact on the public of any offense involved, including the

recall or the discontinuation of the distribution of suspect

drugs, full cooperation with any investigations (including the

extent of disclosure to appropriate authorities of all

wrongdoing), the relinquishing of profits on drug approvals

fraudulently obtained, and any other actions taken to

substantially limit potential or actual adverse effects on the

public health,

(D) whether the extent to which changes in ownership,

management, or operations have corrected the causes of any

offense involved and provide reasonable assurances that the

offense will not occur in the future,

(E) whether the person to be debarred is able to present

adequate evidence that current production of drugs subject to

abbreviated drug applications and all pending abbreviated drug

applications are free of fraud or material false statements,

and

(F) prior convictions under this chapter or under other Acts

involving matters within the jurisdiction of the Food and Drug

Administration.

(d) Termination of debarment

(1) Application

Any person that is debarred under subsection (a) of this

section (other than a person permanently debarred) or any person

that is debarred under subsection (b) of this section may apply

to the Secretary for termination of the debarment under this

subsection. Any information submitted to the Secretary under

this paragraph does not constitute an amendment or supplement to

pending or approved abbreviated drug applications.

(2) Deadline

The Secretary shall grant or deny any application respecting a

debarment which is submitted under paragraph (1) within 180 days

of the date the application is submitted.

(3) Action by the Secretary

(A) Corporations

(i) Conviction reversal

If the conviction which served as the basis for the

debarment of a person under subsection (a)(1) of this section

or paragraph (2)(A) or (3) of subsection (b) of this section

is reversed, the Secretary shall withdraw the order of

debarment.

(ii) Application

Upon application submitted under paragraph (1), the

Secretary shall terminate the debarment of a person if the

Secretary finds that -

(I) changes in ownership, management, or operations have

fully corrected the causes of the offense involved and

provide reasonable assurances that the offense will not

occur in the future, and

(II) in applicable cases, sufficient audits, conducted by

the Food and Drug Administration or by independent experts

acceptable to the Food and Drug Administration, demonstrate

that pending applications and the development of drugs

being tested before the submission of an application are

free of fraud or material false statements.

In the case of persons debarred under subsection (a)(1) of

this section, such termination shall take effect no earlier

than the expiration of one year from the date of the

debarment.

(B) Individuals

(i) Conviction reversal

If the conviction which served as the basis for the

debarment of an individual under subsection (a)(2) of this

section or clause (i), (ii), (iii), or (iv) of subsection

(b)(2)(B) or subsection (b)(3) of this section is reversed,

the Secretary shall withdraw the order of debarment.

(ii) Application

Upon application submitted under paragraph (1), the

Secretary shall terminate the debarment of an individual who

has been debarred under subsection (b)(2)(B) or subsection

(b)(3) of this section if such termination serves the

interests of justice and adequately protects the integrity of

the drug approval process or the food importation process, as

the case may be.

(4) Special termination

(A) Application

Any person that is debarred under subsection (a)(1) of this

section (other than a person permanently debarred under

subsection (c)(2)(A)(i) of this section) or any individual who

is debarred under subsection (a)(2) of this section may apply

to the Secretary for special termination of debarment under

this subsection. Any information submitted to the Secretary

under this subparagraph does not constitute an amendment or

supplement to pending or approved abbreviated drug

applications.

(B) Corporations

Upon an application submitted under subparagraph (A), the

Secretary may take the action described in subparagraph (D) if

the Secretary, after an informal hearing, finds that -

(i) the person making the application under subparagraph

(A) has demonstrated that the felony conviction which was the

basis for such person's debarment involved the commission of

an offense which was not authorized, requested, commanded,

performed, or recklessly tolerated by the board of directors

or by a high managerial agent acting on behalf of the person

within the scope of the board's or agent's office or

employment,

(ii) all individuals who were involved in the commission of

the offense or who knew or should have known of the offense

have been removed from employment involving the development

or approval of any drug subject to sections (FOOTNOTE 1) 355

of this title,

(FOOTNOTE 1) So in original. Probably should be ''section''.

(iii) the person fully cooperated with all investigations

and promptly disclosed all wrongdoing to the appropriate

authorities, and

(iv) the person acted to mitigate any impact on the public

of any offense involved, including the recall, or the

discontinuation of the distribution, of any drug with respect

to which the Secretary requested a recall or discontinuation

of distribution due to concerns about the safety or efficacy

of the drug.

(C) Individuals

Upon an application submitted under subparagraph (A), the

Secretary may take the action described in subparagraph (D) if

the Secretary, after an informal hearing, finds that such

individual has provided substantial assistance in the

investigations or prosecutions of offenses which are described

in subsection (a) or (b) of this section or which relate to any

matter under the jurisdiction of the Food and Drug

Administration.

(D) Secretarial action

The action referred to in subparagraphs (B) and (C) is -

(i) in the case of a person other than an individual -

(I) terminating the debarment immediately, or

(II) limiting the period of debarment to less than one

year, and

(ii) in the case of an individual, limiting the period of

debarment to less than permanent but to no less than 1 year,

whichever best serves the interest of justice and protects the

integrity of the drug approval process.

(e) Publication and list of debarred persons

The Secretary shall publish in the Federal Register the name of

any person debarred under subsection (a) or (b) of this section,

the effective date of the debarment, and the period of the

debarment. The Secretary shall also maintain and make available to

the public a list, updated no less often than quarterly, of such

persons, of the effective dates and minimum periods of such

debarments, and of the termination of debarments.

(f) Temporary denial of approval

(1) In general

The Secretary, on the Secretary's own initiative or in response

to a petition, may, in accordance with paragraph (3), refuse by

order, for the period prescribed by paragraph (2), to approve any

abbreviated drug application submitted by any person -

(A) if such person is under an active Federal criminal

investigation in connection with an action described in

subparagraph (B),

(B) if the Secretary finds that such person -

(i) has bribed or attempted to bribe, has paid or attempted

to pay an illegal gratuity, or has induced or attempted to

induce another person to bribe or pay an illegal gratuity to

any officer, employee, or agent of the Department of Health

and Human Services or to any other Federal, State, or local

official in connection with any abbreviated drug application,

or has conspired to commit, or aided or abetted, such

actions, or

(ii) has knowingly made or caused to be made a pattern or

practice of false statements or misrepresentations with

respect to material facts relating to any abbreviated drug

application, or the production of any drug subject to an

abbreviated drug application, to any officer, employee, or

agent of the Department of Health and Human Services, or has

conspired to commit, or aided or abetted, such actions, and

(C) if a significant question has been raised regarding -

(i) the integrity of the approval process with respect to

such abbreviated drug application, or

(ii) the reliability of data in or concerning such person's

abbreviated drug application.

Such an order may be modified or terminated at any time.

(2) Applicable period

(A) In general

Except as provided in subparagraph (B), a denial of approval

of an application of a person under paragraph (1) shall be in

effect for a period determined by the Secretary but not to

exceed 18 months beginning on the date the Secretary finds that

the conditions described in subparagraphs (A), (B), and (C) of

paragraph (1) exist. The Secretary shall terminate such denial

-

(i) if the investigation with respect to which the finding

was made does not result in a criminal charge against such

person, if criminal charges have been brought and the charges

have been dismissed, or if a judgment of acquittal has been

entered, or

(ii) if the Secretary determines that such finding was in

error.

(B) Extension

If, at the end of the period described in subparagraph (A),

the Secretary determines that a person has been criminally

charged for an action described in subparagraph (B) of

paragraph (1), the Secretary may extend the period of denial of

approval of an application for a period not to exceed 18

months. The Secretary shall terminate such extension if the

charges have been dismissed, if a judgment of acquittal has

been entered, or if the Secretary determines that the finding

described in subparagraph (A) was in error.

(3) Informal hearing

Within 10 days of the date an order is issued under paragraph

(1), the Secretary shall provide such person with an opportunity

for an informal hearing, to be held within such 10 days, on the

decision of the Secretary to refuse approval of an abbreviated

drug application. Within 60 days of the date on which such

hearing is held, the Secretary shall notify the person given such

hearing whether the Secretary's refusal of approval will be

continued, terminated, or otherwise modified. Such notification

shall be final agency action.

(g) Suspension authority

(1) In general

If -

(A) the Secretary finds -

(i) that a person has engaged in conduct described in

subparagraph (B) of subsection (f)(1) of this section in

connection with 2 or more drugs under abbreviated drug

applications, or

(ii) that a person has engaged in flagrant and repeated,

material violations of good manufacturing practice or good

laboratory practice in connection with the development,

manufacturing, or distribution of one or more drugs approved

under an abbreviated drug application during a 2-year period,

and -

(I) such violations may undermine the safety and efficacy

of such drugs, and

(II) the causes of such violations have not been

corrected within a reasonable period of time following

notice of such violations by the Secretary, and

(B) such person is under an active investigation by a Federal

authority in connection with a civil or criminal action

involving conduct described in subparagraph (A),

the Secretary shall issue an order suspending the distribution of

all drugs the development or approval of which was related to

such conduct described in subparagraph (A) or suspending the

distribution of all drugs approved under abbreviated drug

applications of such person if the Secretary finds that such

conduct may have affected the development or approval of a

significant number of drugs which the Secretary is unable to

identify. The Secretary shall exclude a drug from such order if

the Secretary determines that such conduct was not likely to have

influenced the safety or efficacy of such drug.

(2) Public health waiver

The Secretary shall, on the Secretary's own initiative or in

response to a petition, waive the suspension under paragraph (1)

(involving an action described in paragraph (1)(A)(i)) with

respect to any drug if the Secretary finds that such waiver is

necessary to protect the public health because sufficient

quantities of the drug would not otherwise be available. The

Secretary shall act on any petition seeking action under this

paragraph within 180 days of the date the petition is submitted

to the Secretary.

(h) Termination of suspension

The Secretary shall withdraw an order of suspension of the

distribution of a drug under subsection (g) of this section if the

person with respect to whom the order was issued demonstrates in a

petition to the Secretary -

(1)(A) on the basis of an audit by the Food and Drug

Administration or by experts acceptable to the Food and Drug

Administration, or on the basis of other information, that the

development, approval, manufacturing, and distribution of such

drug is in substantial compliance with the applicable

requirements of this chapter, and

(B) changes in ownership, management, or operations -

(i) fully remedy the patterns or practices with respect to

which the order was issued, and

(ii) provide reasonable assurances that such actions will not

occur in the future, or

(2) the initial determination was in error.

The Secretary shall act on a submission of a petition under this

subsection within 180 days of the date of its submission and the

Secretary may consider the petition concurrently with the

suspension proceeding. Any information submitted to the Secretary

under this subsection does not constitute an amendment or

supplement to a pending or approved abbreviated drug application.

(i) Procedure

The Secretary may not take any action under subsection (a), (b),

(c), (d)(3), (g), or (h) of this section with respect to any person

unless the Secretary has issued an order for such action made on

the record after opportunity for an agency hearing on disputed

issues of material fact. In the course of any investigation or

hearing under this subsection, the Secretary may administer oaths

and affirmations, examine witnesses, receive evidence, and issue

subpoenas requiring the attendance and testimony of witnesses and

the production of evidence that relates to the matter under

investigation.

(j) Judicial review

(1) In general

Except as provided in paragraph (2), any person that is the

subject of an adverse decision under subsection (a), (b), (c),

(d), (f), (g), or (h) of this section may obtain a review of such

decision by the United States Court of Appeals for the District

of Columbia or for the circuit in which the person resides, by

filing in such court (within 60 days following the date the

person is notified of the Secretary's decision) a petition

requesting that the decision be modified or set aside.

(2) Exception

Any person that is the subject of an adverse decision under

clause (iii) or (iv) of subsection (b)(2)(B) of this section may

obtain a review of such decision by the United States District

Court for the District of Columbia or a district court of the

United States for the district in which the person resides, by

filing in such court (within 30 days following the date the

person is notified of the Secretary's decision) a complaint

requesting that the decision be modified or set aside. In such

an action, the court shall determine the matter de novo.

(k) Certification

Any application for approval of a drug product shall include -

(1) a certification that the applicant did not and will not use

in any capacity the services of any person debarred under

subsection (a) or (b) of this section, in connection with such

application, and

(2) if such application is an abbreviated drug application, a

list of all convictions, described in subsections (a) and (b) of

this section which occurred within the previous 5 years, of the

applicant and affiliated persons responsible for the development

or submission of such application.

(l) Applicability

(1) Conviction

For purposes of this section, a person is considered to have

been convicted of a criminal offense -

(A) when a judgment of conviction has been entered against

the person by a Federal or State court, regardless of whether

there is an appeal pending,

(B) when a plea of guilty or nolo contendere by the person

has been accepted by a Federal or State court, or

(C) when the person has entered into participation in a first

offender, deferred adjudication, or other similar arrangement

or program where judgment of conviction has been withheld.

(2) Effective dates

Subsection (a) of this section, subparagraph (A) of subsection

(b)(2) of this section, clauses (i) and (ii) of subsection

(b)(2)(B) of this section, and subsection (b)(3)(A) of this

section shall not apply to a conviction which occurred more than

5 years before the initiation of an agency action proposed to be

taken under subsection (a) or (b) of this section. Clauses (iii)

and (iv) of subsection (b)(2)(B) of this section, subsection

(b)(3)(B) of this section, and subsections (f) and (g) of this

section shall not apply to an act or action which occurred more

than 5 years before the initiation of an agency action proposed

to be taken under subsection (b), (f), or (g) of this section.

Clause (iv) of subsection (b)(2)(B) of this section shall not

apply to an action which occurred before June 1, 1992. Subsection

(k) of this section shall not apply to applications submitted to

the Secretary before June 1, 1992.

(m) Devices; mandatory debarment regarding third-party inspections

and reviews

(1) In general

If the Secretary finds that a person has been convicted of a

felony under section 331(gg) of this title, the Secretary shall

debar such person from being accredited under section 360m(b) or

374(g)(2) of this title and from carrying out activities under an

agreement described in section 383(b) of this title.

(2) Debarment period

The Secretary shall debar a person under paragraph (1) for the

following periods:

(A) The period of debarment of a person (other than an

individual) shall not be less than 1 year or more than 10

years, but if an act leading to a subsequent debarment under

such paragraph occurs within 10 years after such person has

been debarred under such paragraph, the period of debarment

shall be permanent.

(B) The debarment of an individual shall be permanent.

(3) Termination of debarment; judicial review; other matters

Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this

section apply with respect to a person (other than an individual)

or an individual who is debarred under paragraph (1) to the same

extent and in the same manner as such subsections apply with

respect to a person who is debarred under subsection (a)(1) of

this section, or an individual who is debarred under subsection

(a)(2) of this section, respectively.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 306, as added Pub. L. 102-282, Sec.

2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105-115, title I,

Sec. 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107-188,

title III, Sec. 304(a)-(c), June 12, 2002, 116 Stat. 665, 666; Pub.

L. 107-250, title II, Sec. 203, Oct. 26, 2002, 116 Stat. 1610.)

-MISC1-

PRIOR PROVISIONS

A prior section 306 of act June 25, 1938, was renumbered section

309 and is classified to section 336 of this title.

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-188, Sec. 304(b)(1), substituted

''Mandatory debarment; certain drug applications'' for ''Mandatory

debarment'' in heading.

Subsec. (b). Pub. L. 107-188, Sec. 304(b)(2)(A), substituted

''Permissive debarment; certain drug applications; food imports''

for ''Permissive debarment'' in heading.

Subsec. (b)(1)(C). Pub. L. 107-188, Sec. 304(a)(1), added subpar.

(C).

Subsec. (b)(2). Pub. L. 107-188, Sec. 304(b)(2)(B), substituted

''permissive debarment; certain drug applications'' for

''permissive debarment'' in heading.

Pub. L. 107-188, Sec. 304(a)(2)(A), inserted ''subparagraph (A)

or (B) of'' before ''paragraph (1)'' in introductory provisions.

Subsec. (b)(3), (4). Pub. L. 107-188, Sec. 304(a)(2)(B), (C),

added par. (3) and redesignated former par. (3) as (4).

Subsec. (c)(2)(A)(iii). Pub. L. 107-188, Sec. 304(b)(3),

substituted ''paragraph (2) or (3) of subsection (b)'' for

''subsection (b)(2)''.

Subsec. (d)(3)(A)(i). Pub. L. 107-188, Sec. 304(b)(4)(A),

substituted ''subsection (a)(1) of this section or paragraph (2)(A)

or (3) of subsection (b)'' for ''subsection (a)(1) or (b)(2)(A)''.

Subsec. (d)(3)(A)(ii)(II). Pub. L. 107-188, Sec. 304(b)(4)(B),

inserted ''in applicable cases,'' before ''sufficient audits''.

Subsec. (d)(3)(B)(i). Pub. L. 107-188, Sec. 304(b)(4)(C),

inserted ''or subsection (b)(3)'' after ''subsection (b)(2)(B)''.

Subsec. (d)(3)(B)(ii). Pub. L. 107-188, Sec. 304(b)(4)(C), (D),

inserted ''or subsection (b)(3)'' after ''subsection (b)(2)(B)''

and ''or the food importation process, as the case may be'' before

period.

Subsec. (l)(2). Pub. L. 107-188, Sec. 304(c), in first sentence

struck out ''and'' after ''subsection (b)(2) of this section,'' and

inserted '', and subsection (b)(3)(A) of this section'' after

''subsection (b)(2)(B) of this section'' and in second sentence

inserted '', subsection (b)(3)(B) of this section,'' after

''subsection (b)(2)(B) of this section''.

Subsec. (m). Pub. L. 107-250 added subsec. (m).

1997 - Subsec. (d)(4)(B)(ii). Pub. L. 105-115 struck out ''or

357'' after ''355''.

CONSTRUCTION

Section 7 of Pub. L. 102-282 provided that: ''No amendment made

by this Act (enacting this section and sections 335b and 335c of

this title and amending sections 321, 336, 337, and 355 of this

title) shall preclude any other civil, criminal, or administrative

remedy provided under Federal or State law, including any private

right of action against any person for the same action subject to

any action or civil penalty under an amendment made by this Act.''

CONGRESSIONAL FINDINGS

Section 1(c) of Pub. L. 102-282 provided that: ''The Congress

finds that -

''(1) there is substantial evidence that significant corruption

occurred in the Food and Drug Administration's process of

approving drugs under abbreviated drug applications,

''(2) there is a need to establish procedures designed to

restore and to ensure the integrity of the abbreviated drug

application approval process and to protect the public health,

and

''(3) there is a need to establish procedures to bar

individuals who have been convicted of crimes pertaining to the

regulation of drug products from working for companies that

manufacture or distribute such products.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 331, 335b, 381 of

this title.

-CITE-

21 USC Sec. 335b 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 335b. Civil penalties

-STATUTE-

(a) In general

Any person that the Secretary finds -

(1) knowingly made or caused to be made, to any officer,

employee, or agent of the Department of Health and Human

Services, a false statement or misrepresentation of a material

fact in connection with an abbreviated drug application,

(2) bribed or attempted to bribe or paid or attempted to pay an

illegal gratuity to any officer, employee, or agent of the

Department of Health and Human Services in connection with an

abbreviated drug application,

(3) destroyed, altered, removed, or secreted, or procured the

destruction, alteration, removal, or secretion of, any material

document or other material evidence which was the property of or

in the possession of the Department of Health and Human Services

for the purpose of interfering with that Department's discharge

of its responsibilities in connection with an abbreviated drug

application,

(4) knowingly failed to disclose, to an officer or employee of

the Department of Health and Human Services, a material fact

which such person had an obligation to disclose relating to any

drug subject to an abbreviated drug application,

(5) knowingly obstructed an investigation of the Department of

Health and Human Services into any drug subject to an abbreviated

drug application,

(6) is a person that has an approved or pending drug product

application and has knowingly -

(A) employed or retained as a consultant or contractor, or

(B) otherwise used in any capacity the services of,

a person who was debarred under section 335a of this title, or

(7) is an individual debarred under section 335a of this title

and, during the period of debarment, provided services in any

capacity to a person that had an approved or pending drug product

application,

shall be liable to the United States for a civil penalty for each

such violation in an amount not to exceed $250,000 in the case of

an individual and $1,000,000 in the case of any other person.

(b) Procedure

(1) In general

(A) Action by the Secretary

A civil penalty under subsection (a) of this section shall be

assessed by the Secretary on a person by an order made on the

record after an opportunity for an agency hearing on disputed

issues of material fact and the amount of the penalty. In the

course of any investigation or hearing under this subparagraph,

the Secretary may administer oaths and affirmations, examine

witnesses, receive evidence, and issue subpoenas requiring the

attendance and testimony of witnesses and the production of

evidence that relates to the matter under investigation.

(B) Action by the Attorney General

In lieu of a proceeding under subparagraph (A), the Attorney

General may, upon request of the Secretary, institute a civil

action to recover a civil money penalty in the amount and for

any of the acts set forth in subsection (a) of this section.

Such an action may be instituted separately from or in

connection with any other claim, civil or criminal, initiated

by the Attorney General under this chapter.

(2) Amount

In determining the amount of a civil penalty under paragraph

(1), the Secretary or the court shall take into account the

nature, circumstances, extent, and gravity of the act subject to

penalty, the person's ability to pay, the effect on the person's

ability to continue to do business, any history of prior, similar

acts, and such other matters as justice may require.

(3) Limitation on actions

No action may be initiated under this section -

(A) with respect to any act described in subsection (a) of

this section that occurred before May 13, 1992, or

(B) more than 6 years after the date when facts material to

the act are known or reasonably should have been known by the

Secretary but in no event more than 10 years after the date the

act took place.

(c) Judicial review

Any person that is the subject of an adverse decision under

subsection (b)(1)(A) of this section may obtain a review of such

decision by the United States Court of Appeals for the District of

Columbia or for the circuit in which the person resides, by filing

in such court (within 60 days following the date the person is

notified of the Secretary's decision) a petition requesting that

the decision be modified or set aside.

(d) Recovery of penalties

The Attorney General may recover any civil penalty (plus interest

at the currently prevailing rates from the date the penalty became

final) assessed under subsection (b)(1)(A) of this section in an

action brought in the name of the United States. The amount of such

penalty may be deducted, when the penalty has become final, from

any sums then or later owing by the United States to the person

against whom the penalty has been assessed. In an action brought

under this subsection, the validity, amount, and appropriateness of

the penalty shall not be subject to judicial review.

(e) Informants

The Secretary may award to any individual (other than an officer

or employee of the Federal Government or a person who materially

participated in any conduct described in subsection (a) of this

section) who provides information leading to the imposition of a

civil penalty under this section an amount not to exceed -

(1) $250,000, or

(2) one-half of the penalty so imposed and collected,

whichever is less. The decision of the Secretary on such award

shall not be reviewable.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 307, as added Pub. L. 102-282, Sec.

3, May 13, 1992, 106 Stat. 159; amended Pub. L. 103-80, Sec. 3(g),

Aug. 13, 1993, 107 Stat. 776.)

-MISC1-

PRIOR PROVISIONS

A prior section 307 of act June 25, 1938, was renumbered section

310 and is classified to section 337 of this title.

AMENDMENTS

1993 - Subsec. (b)(3)(A). Pub. L. 103-80 made technical amendment

to reference to May 13, 1992, to reflect correction of

corresponding provision of original act.

CONSTRUCTION

This section not to preclude any other civil, criminal, or

administrative remedy provided under Federal or State law,

including any private right of action against any person for the

same action subject to any action or civil penalty under an

amendment made by Pub. L. 102-282, see section 7 of Pub. L.

102-282, set out as a note under section 335a of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 335a of this title.

-CITE-

21 USC Sec. 335c 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 335c. Authority to withdraw approval of abbreviated drug

applications

-STATUTE-

(a) In general

The Secretary -

(1) shall withdraw approval of an abbreviated drug application

if the Secretary finds that the approval was obtained, expedited,

or otherwise facilitated through bribery, payment of an illegal

gratuity, or fraud or material false statement, and

(2) may withdraw approval of an abbreviated drug application if

the Secretary finds that the applicant has repeatedly

demonstrated a lack of ability to produce the drug for which the

application was submitted in accordance with the formulations or

manufacturing practice set forth in the abbreviated drug

application and has introduced, or attempted to introduce, such

adulterated or misbranded drug into commerce.

(b) Procedure

The Secretary may not take any action under subsection (a) of

this section with respect to any person unless the Secretary has

issued an order for such action made on the record after

opportunity for an agency hearing on disputed issues of material

fact. In the course of any investigation or hearing under this

subsection, the Secretary may administer oaths and affirmations,

examine witnesses, receive evidence, and issue subpoenas requiring

the attendance and testimony of witnesses and the production of

evidence that relates to the matter under investigation.

(c) Applicability

Subsection (a) of this section shall apply with respect to

offenses or acts regardless of when such offenses or acts occurred.

(d) Judicial review

Any person that is the subject of an adverse decision under

subsection (a) of this section may obtain a review of such decision

by the United States Court of Appeals for the District of Columbia

or for the circuit in which the person resides, by filing in such

court (within 60 days following the date the person is notified of

the Secretary's decision) a petition requesting that the decision

be modified or set aside.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 308, as added Pub. L. 102-282, Sec.

4, May 13, 1992, 106 Stat. 160.)

-MISC1-

CONSTRUCTION

This section not to preclude any other civil, criminal, or

administrative remedy provided under Federal or State law,

including any private right of action against any person for the

same action subject to any action or civil penalty under an

amendment made by Pub. L. 102-282, see section 7 of Pub. L.

102-282, set out as a note under section 335a of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 321 of this title.

-CITE-

21 USC Sec. 336 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 336. Report of minor violations

-STATUTE-

Nothing in this chapter shall be construed as requiring the

Secretary to report for prosecution, or for the institution of

libel or injunction proceedings, minor violations of this chapter

whenever he believes that the public interest will be adequately

served by a suitable written notice or warning.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 309, formerly Sec. 306, 52 Stat.

1045; renumbered Sec. 309, Pub. L. 102-282, Sec. 2, May 13, 1992,

106 Stat. 150.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-CITE-

21 USC Sec. 337 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER III - PROHIBITED ACTS AND PENALTIES

-HEAD-

Sec. 337. Proceedings in name of United States; provision as to

subpoenas

-STATUTE-

(a) Except as provided in subsection (b) of this section, all

such proceedings for the enforcement, or to restrain violations, of

this chapter shall be by and in the name of the United States.

Subpoenas for witnesses who are required to attend a court of the

United States, in any district, may run into any other district in

any proceeding under this section.

(b)(1) A State may bring in its own name and within its

jurisdiction proceedings for the civil enforcement, or to restrain

violations, of section 341, 343(b), 343(c), 343(d), 343(e), 343(f),

343(g), 343(h), 343(i), 343(k), 343(q), or 343(r) of this title if

the food that is the subject of the proceedings is located in the

State.

(2) No proceeding may be commenced by a State under paragraph (1)

-

(A) before 30 days after the State has given notice to the

Secretary that the State intends to bring such proceeding,

(B) before 90 days after the State has given notice to the

Secretary of such intent if the Secretary has, within such 30

days, commenced an informal or formal enforcement action

pertaining to the food which would be the subject of such

proceeding, or

(C) if the Secretary is diligently prosecuting a proceeding in

court pertaining to such food, has settled such proceeding, or

has settled the informal or formal enforcement action pertaining

to such food.

In any court proceeding described in subparagraph (C), a State may

intervene as a matter of right.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 310, formerly Sec. 307, 52 Stat.

1046; Sept. 3, 1954, ch. 1263, Sec. 37, 68 Stat. 1239; Pub. L.

101-535, Sec. 4, Nov. 8, 1990, 104 Stat. 2362; renumbered Sec. 310,

Pub. L. 102-282, Sec. 2, May 13, 1992, 106 Stat. 150.)

-MISC1-

AMENDMENTS

1990 - Pub. L. 101-535 substituted ''(a) Except as provided in

subsection (b) of this section, all'' for ''All'' and ''any

proceeding under this section'' for ''any such proceeding'' and

added subsec. (b).

1954 - Act Sept. 3, 1954, struck out reference to section 654 of

title 28.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-535 effective 24 months after Nov. 8,

1990, except that such amendment effective Dec. 31, 1993, with

respect to dietary supplements of vitamins, minerals, herbs, or

other similar nutritional substances, see section 10(a)(1)(C) of

Pub. L. 101-535, set out as a note under section 343 of this title.

CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535

Amendments by Pub. L. 101-535 not to be construed to alter

authority of Secretary of Health and Human Services and Secretary

of Agriculture under the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601

et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et

seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et

seq.), see section 9 of Pub. L. 101-535, set out as a note under

section 343 of this title.

-CITE-

21 USC SUBCHAPTER IV - FOOD 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

.

-HEAD-

SUBCHAPTER IV - FOOD

-CITE-

21 USC Sec. 341 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 341. Definitions and standards for food

-STATUTE-

Whenever in the judgment of the Secretary such action will

promote honesty and fair dealing in the interest of consumers, he

shall promulgate regulations fixing and establishing for any food,

under its common or usual name so far as practicable, a reasonable

definition and standard of identity, a reasonable standard of

quality, or reasonable standards of fill of container. No

definition and standard of identity and no standard of quality

shall be established for fresh or dried fruits, fresh or dried

vegetables, or butter, except that definitions and standards of

identity may be established for avocadoes, cantaloupes, citrus

fruits, and melons. In prescribing any standard of fill of

container, the Secretary shall give due consideration to the

natural shrinkage in storage and in transit of fresh natural food

and to need for the necessary packing and protective material. In

the prescribing of any standard of quality for any canned fruit or

canned vegetable, consideration shall be given and due allowance

made for the differing characteristics of the several varieties of

such fruit or vegetable. In prescribing a definition and standard

of identity for any food or class of food in which optional

ingredients are permitted, the Secretary shall, for the purpose of

promoting honesty and fair dealing in the interest of consumers,

designate the optional ingredients which shall be named on the

label. Any definition and standard of identity prescribed by the

Secretary for avocadoes, cantaloupes, citrus fruits, or melons

shall relate only to maturity and to the effects of freezing.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 401, 52 Stat. 1046; Apr. 15, 1954,

ch. 143, Sec. 1, 68 Stat. 54; Aug. 1, 1956, ch. 861, Sec. 1, 70

Stat. 919; Pub. L. 103-80, Sec. 3(h), Aug. 13, 1993, 107 Stat.

776.)

-MISC1-

AMENDMENTS

1993 - Pub. L. 103-80 substituted ''or reasonable standards of

fill of container. No definition'' for ''and/or reasonable

standards of fill of container: Provided, That no definition''.

1956 - Act Aug. 1, 1956, designated provisions constituting

subsec. (a) as entire section and repealed subsec. (b) which

provided the procedure for establishment of regulations and is

covered by section 371(e) of this title.

1954 - Act Apr. 15, 1954, designated existing provisions as

subsec. (a) and added subsec. (b).

SAVINGS PROVISION

Section 3 of act Aug. 1, 1956, provided that: ''In any case in

which, prior to the enactment of this Act (Aug. 1, 1956), a public

hearing has been begun in accordance with section 401 of the

Federal Food, Drug, and Cosmetic Act (341 of this title) upon a

proposal to issue, amend, or repeal any regulation contemplated by

such section, or has been begun in accordance with section 701(e)

of such Act (section 371(e) of this title) upon a proposal to

issue, amend, or repeal any regulation contemplated by section

403(j), 404(a), 406(a) or (b), 501(b), 502(d), 502(h), 504 or 604

of such Act (section 343(j), 344(a), 346(a) or (b), 351(b), 352(d),

352(h), 354, or 364 of this title), the provisions of such section

401 or 701(e), as the case may be, as in force immediately prior to

the date of the enactment of this Act (Aug. 1, 1956), shall be

applicable as though this Act (amending this section and section

371(e) of this title) had not been enacted.''

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

FOOD SAFETY AND SECURITY STRATEGY

Pub. L. 107-188, title III, Sec. 301, June 12, 2002, 116 Stat.

662, provided that:

''(a) In General. - The President's Council on Food Safety (as

established by Executive Order No. 13100 (set out below)) shall, in

consultation with the Secretary of Transportation, the Secretary of

the Treasury, other relevant Federal agencies, the food industry,

consumer and producer groups, scientific organizations, and the

States, develop a crisis communications and education strategy with

respect to bioterrorist threats to the food supply. Such strategy

shall address threat assessments; technologies and procedures for

securing food processing and manufacturing facilities and modes of

transportation; response and notification procedures; and risk

communications to the public.

''(b) Authorization of Appropriations. - For the purpose of

implementing the strategy developed under subsection (a), there are

authorized to be appropriated $750,000 for fiscal year 2002, and

such sums as may be necessary for each subsequent fiscal year.''

FOOD SAFETY COMMISSION

Pub. L. 107-171, title X, Sec. 10807, May 13, 2002, 116 Stat.

527, provided that:

''(a) Establishment. -

''(1) In general. - There is established a commission to be

known as the 'Food Safety Commission' (referred to in this

section as the 'Commission').

''(2) Membership. -

''(A) Composition. - The Commission shall be composed of 15

members (including a Chairperson, appointed by the

President()).

''(B) Eligibility. -

''(i) In general. - Members of the Commission -

''(I) shall have specialized training or significant experience in

matters under the jurisdiction of the Commission; and

''(II) shall represent, at a minimum -

''(aa) consumers;

''(bb) food scientists;

''(cc) the food industry; and

''(dd) health professionals.

''(ii) Federal employees. - Not more than 3 members of the

Commission may be Federal employees.

''(C) Date of appointments. - The appointment of the members

of the Commission shall be made as soon as practicable after

the date on which funds authorized to be appropriated under

subsection (e)(1) are made available.

''(D) Vacancies. - A vacancy on the Commission -

''(i) shall not affect the powers of the Commission; and

''(ii) shall be filled -

''(I) not later than 60 days after the date on which the vacancy

occurs; and

''(II) in the same manner as the original appointment was made.

''(3) Meetings. -

''(A) Initial meeting. - The initial meeting of the

Commission shall be conducted not later than 30 days after the

date of appointment of the final member of the Commission.

''(B) Other meetings. - The Commission shall meet at the call

of the Chairperson.

''(4) Quorum; standing rules. -

''(A) Quorum. - A majority of the members of the Commission

shall constitute a quorum to conduct business.

''(B) Standing rules. - At the first meeting of the

Commission, the Commission shall adopt standing rules of the

Commission to guide the conduct of business and decisionmaking

of the Commission.

''(b) Duties. -

''(1) Recommendations. - The Commission shall make specific

recommendations to enhance the food safety system of the United

States, including a description of how each recommendation would

improve food safety.

''(2) Components. - Recommendations made by the Commission

under paragraph (1) shall address all food available commercially

in the United States.

''(3) Report. - Not later than 1 year after the date on which

the Commission first meets, the Commission shall submit to the

President and Congress -

''(A) the findings, conclusions, and recommendations of the

Commission, including a description of how each recommendation

would improve food safety;

''(B) a summary of any other material used by the Commission

in the preparation of the report under this paragraph; and

''(C) if requested by 1 or more members of the Commission, a

statement of the minority views of the Commission.

''(c) Powers of the Commission. -

''(1) Hearings. - The Commission may, for the purpose of

carrying out this section, hold such hearings, meet and act at

such times and places, take such testimony, and receive such

evidence as the Commission considers advisable.

''(2) Information from federal agencies. -

''(A) In general. - The Commission may secure directly, from

any Federal agency, such information as the Commission

considers necessary to carry out this section.

''(B) Provision of information. -

''(i) In general. - Subject to subparagraph (C), on the

request of the Commission, the head of a Federal agency

described in subparagraph (A) may furnish information

requested by the Commission to the Commission.

''(ii) Administration. - The furnishing of information by a

Federal agency to the Commission shall not be considered a

waiver of any exemption available to the agency under section

552 of title 5, United States Code.

''(C) Information to be kept confidential. -

''(i) In general. - For purposes of section 1905 of title

18, United States Code -

''(I) the Commission shall be considered an agency of the Federal

Government; and

''(II) any individual employed by an individual, entity, or

organization that is a party to a contract with the

Commission under this section shall be considered an

employee of the Commission.

''(ii) Prohibition on disclosure. - Information obtained by

the Commission, other than information that is available to

the public, shall not be disclosed to any person in any

manner except to an employee of the Commission as described

in clause (i), for the purpose of receiving, reviewing, or

processing the information.

''(d) Commission Personnel Matters. -

''(1) Members. -

''(A) Compensation. - A member of the Commission shall serve

without compensation for the services of the member on the

Commission.

''(B) Travel expenses. - A member of the Commission shall be

allowed travel expenses, including per diem in lieu of

subsistence, at rates authorized for an employee of an agency

under subchapter I of chapter 57 of title 5, United States

Code, while away from the home or regular place of business of

the member in the performance of the duties of the Commission.

''(2) Staff. -

''(A) In general. - The Chairperson of the Commission may,

without regard to the civil service laws (including

regulations), appoint and terminate the appointment of an

executive director and such other additional personnel as are

necessary to enable the Commission to perform the duties of the

Commission.

''(B) Confirmation of executive director. - The employment of

an executive director shall be subject to confirmation by the

Commission.

''(C) Compensation. -

''(i) In general. - Except as provided in clause (ii), the

Chairperson of the Commission may fix the compensation of the

executive director and other personnel without regard to the

provisions of chapter 51 and subchapter III of chapter 53 of

title 5, United States Code, relating to classification of

positions and General Schedule pay rates.

''(ii) Maximum rate of pay. - The rate of pay for the

executive director and other personnel shall not exceed the

rate payable for level II of the Executive Schedule under

section 5316 of title 5, United States Code.

''(3) Detail of federal government employees. -

''(A) In general. - An employee of the Federal Government may

be detailed to the Commission, without reimbursement, for such

period of time as is permitted by law.

''(B) Civil service status. - The detail of the employee

shall be without interruption or loss of civil service status

or privilege.

''(4) Procurement of temporary and intermittent services. - The

Chairperson of the Commission may procure temporary and

intermittent services in accordance with section 3109(b) of title

5, United States Code, at rates for individuals that do not

exceed the daily equivalent of the annual rate of basic pay

prescribed for level II of the Executive Schedule under section

5316 of that title.

''(e) Authorization of Appropriations. -

''(1) In general. - There is authorized to be appropriated such

sums as are necessary to carry out this section.

''(2) Limitation. - No payment may be made under subsection (d)

except to the extent provided for in advance in an appropriations

Act.

''(f) Termination. - The Commission shall terminate on the date

that is 60 days after the date on which the Commission submits the

recommendations and report under subsection (b)(3).''

-EXEC-

EX. ORD. NO. 13100. PRESIDENT'S COUNCIL ON FOOD SAFETY

Ex. Ord. No. 13100, Aug. 25, 1998, 63 F.R. 45661, as amended by

Ex. Ord. No. 13286, Sec. 16, Feb. 28, 2003, 68 F.R. 10623,

provided:

By the authority vested in me as President by the Constitution

and the laws of the United States of America, and in order to

improve the safety of the food supply through science-based

regulation and well-coordinated inspection, enforcement, research,

and education programs, it is hereby ordered as follows:

Section 1. Establishment of President's Council on Food Safety.

(a) There is established the President's Council on Food Safety

(''Council''). The Council shall comprise the Secretaries of

Agriculture, Commerce, Health and Human Services, and Homeland

Security, the Director of the Office of Management and Budget

(OMB), the Administrator of the Environmental Protection Agency,

the Assistant to the President for Science and Technology/Director

of the Office of Science and Technology Policy, the Assistant to

the President for Domestic Policy, and the Director of the National

Partnership for Reinventing Government. The Council shall consult

with other Federal agencies and State, local, and tribal government

agencies, and consumer, producer, scientific, and industry groups,

as appropriate.

(b) The Secretaries of Agriculture and of Health and Human

Services and the Assistant to the President for Science and

Technology/Director of the Office of Science and Technology Policy

shall serve as Joint Chairs of the Council.

Sec. 2. Purpose. The purpose of the Council shall be to develop a

comprehensive strategic plan for Federal food safety activities,

taking into consideration the findings and recommendations of the

National Academy of Sciences report ''Ensuring Safe Food from

Production to Consumption'' and other input from the public on how

to improve the effectiveness of the current food safety system.

The Council shall make recommendations to the President on how to

advance Federal efforts to implement a comprehensive science-based

strategy to improve the safety of the food supply and to enhance

coordination among Federal agencies, State, local, and tribal

governments, and the private sector. The Council shall advise

Federal agencies in setting priority areas for investment in food

safety.

Sec. 3. Specific Activities and Functions. (a) The Council shall

develop a comprehensive strategic Federal food safety plan that

contains specific recommendations on needed changes, including

measurable outcome goals. The principal goal of the plan should be

the establishment of a seamless, science-based food safety system.

The plan should address the steps necessary to achieve this goal,

including the key public health, resource, and management issues

regarding food safety. The planning process should consider both

short-term and long-term issues including new and emerging threats

and the special needs of vulnerable populations such as children

and the elderly. In developing this plan, the Council shall

consult with all interested parties, including State and local

agencies, tribes, consumers, producers, industry, and academia.

(b) Consistent with the comprehensive strategic Federal food

safety plan described in section 3(a) of this order, the Council

shall advise agencies of priority areas for investment in food

safety and ensure that Federal agencies annually develop

coordinated food safety budgets for submission to the OMB that

sustain and strengthen existing capacities, eliminate duplication,

and ensure the most effective use of resources for improving food

safety. The Council shall also ensure that Federal agencies

annually develop a unified budget for submission to the OMB for the

President's Food Safety Initiative and such other food safety

issues as the Council determines appropriate.

(c) The Council shall ensure that the Joint Institute for Food

Safety Research (JIFSR), in consultation with the National Science

and Technology Council, establishes mechanisms to guide Federal

research efforts toward the highest priority food safety needs.

The JIFSR shall report to the Council on a regular basis on its

efforts: (i) to develop a strategic plan for conducting food safety

research activities consistent with the President's Food Safety

Initiative and such other food safety activities as the JIFSR

determines appropriate; and (ii) to coordinate efficiently, within

the executive branch and with the private sector and academia, all

Federal food safety research.

Sec. 4. Cooperation. All actions taken by the Council shall, as

appropriate, promote partnerships and cooperation with States,

tribes, and other public and private sector efforts wherever

possible to improve the safety of the food supply.

Sec. 5. General Provisions. This order is intended only to

improve the internal management of the executive branch and is not

intended to, nor does it, create any right or benefit, substantive

or procedural, enforceable at law by a party against the United

States, its agencies, its officers or any person. Nothing in this

order shall affect or alter the statutory responsibilities of any

Federal agency charged with food safety responsibilities.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 337, 343, 343-1, 350, 371

of this title.

-CITE-

21 USC Sec. 342 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 342. Adulterated food

-STATUTE-

A food shall be deemed to be adulterated -

(a) Poisonous, insanitary, etc., ingredients

(1) If it bears or contains any poisonous or deleterious

substance which may render it injurious to health; but in case the

substance is not an added substance such food shall not be

considered adulterated under this clause if the quantity of such

substance in such food does not ordinarily render it injurious to

health. (FOOTNOTE 1) (2)(A) if it bears or contains any added

poisonous or added deleterious substance (other than a substance

that is a pesticide chemical residue in or on a raw agricultural

commodity or processed food, a food additive, a color additive, or

a new animal drug) that is unsafe within the meaning of section 346

of this title; or (B) if it bears or contains a pesticide chemical

residue that is unsafe within the meaning of section 346a(a) of

this title; or (C) if it is or if it bears or contains (i) any food

additive that is unsafe within the meaning of section 348 of this

title; or (ii) a new animal drug (or conversion product thereof)

that is unsafe within the meaning of section 360b of this title; or

(3) if it consists in whole or in part of any filthy, putrid, or

decomposed substance, or if it is otherwise unfit for food; or (4)

if it has been prepared, packed, or held under insanitary

conditions whereby it may have become contaminated with filth, or

whereby it may have been rendered injurious to health; or (5) if it

is, in whole or in part, the product of a diseased animal or of an

animal which has died otherwise than by slaughter; or (6) if its

container is composed, in whole or in part, of any poisonous or

deleterious substance which may render the contents injurious to

health; or (7) if it has been intentionally subjected to radiation,

unless the use of the radiation was in conformity with a regulation

or exemption in effect pursuant to section 348 of this title.

(FOOTNOTE 1) So in original. The period probably should be '';

or''.

(b) Absence, substitution, or addition of constituents

(1) If any valuable constituent has been in whole or in part

omitted or abstracted therefrom; or (2) if any substance has been

substituted wholly or in part therefor; or (3) if damage or

inferiority has been concealed in any manner; or (4) if any

substance has been added thereto or mixed or packed therewith so as

to increase its bulk or weight, or reduce its quality or strength,

or make it appear better or of greater value than it is.

(c) Color additives

If it is, or it bears or contains, a color additive which is

unsafe within the meaning of section 379e(a) of this title.

(d) Confectionery containing alcohol or nonnutritive substance

If it is confectionery, and -

(1) has partially or completely imbedded therein any

nonnutritive object, except that this subparagraph shall not

apply in the case of any nonnutritive object if, in the judgment

of the Secretary as provided by regulations, such object is of

practical functional value to the confectionery product and would

not render the product injurious or hazardous to health;

(2) bears or contains any alcohol other than alcohol not in

excess of one-half of 1 per centum by volume derived solely from

the use of flavoring extracts, except that this clause shall not

apply to confectionery which is introduced or delivered for

introduction into, or received or held for sale in, interstate

commerce if the sale of such confectionery is permitted under the

laws of the State in which such confectionery is intended to be

offered for sale;

(3) bears or contains any nonnutritive substance, except that

this subparagraph shall not apply to a safe nonnutritive

substance which is in or on confectionery by reason of its use

for some practical functional purpose in the manufacture,

packaging, or storage of such confectionery if the use of the

substance does not promote deception of the consumer or otherwise

result in adulteration or misbranding in violation of any

provision of this chapter, except that the Secretary may, for the

purpose of avoiding or resolving uncertainty as to the

application of this subparagraph, issue regulations allowing or

prohibiting the use of particular nonnutritive substances.

(e) Oleomargarine containing filthy, putrid, etc., matter

If it is oleomargarine or margarine or butter and any of the raw

material used therein consisted in whole or in part of any filthy,

putrid, or decomposed substance, or such oleomargarine or margarine

or butter is otherwise unfit for food.

(f) Dietary supplement or ingredient: safety

(1) If it is a dietary supplement or contains a dietary

ingredient that -

(A) presents a significant or unreasonable risk of illness or

injury under -

(i) conditions of use recommended or suggested in labeling,

or

(ii) if no conditions of use are suggested or recommended in

the labeling, under ordinary conditions of use;

(B) is a new dietary ingredient for which there is inadequate

information to provide reasonable assurance that such ingredient

does not present a significant or unreasonable risk of illness or

injury;

(C) the Secretary declares to pose an imminent hazard to public

health or safety, except that the authority to make such

declaration shall not be delegated and the Secretary shall

promptly after such a declaration initiate a proceeding in

accordance with sections 554 and 556 of title 5 to affirm or

withdraw the declaration; or

(D) is or contains a dietary ingredient that renders it

adulterated under paragraph (a)(1) under the conditions of use

recommended or suggested in the labeling of such dietary

supplement.

In any proceeding under this subparagraph, the United States shall

bear the burden of proof on each element to show that a dietary

supplement is adulterated. The court shall decide any issue under

this paragraph on a de novo basis.

(2) Before the Secretary may report to a United States attorney a

violation of paragraph (FOOTNOTE 2) (1)(A) for a civil proceeding,

the person against whom such proceeding would be initiated shall be

given appropriate notice and the opportunity to present views,

orally and in writing, at least 10 days before such notice, with

regard to such proceeding.

(FOOTNOTE 2) So in original. Probably should be

''subparagraph''.

(g) Dietary supplement: manufacturing practices

(1) If it is a dietary supplement and it has been prepared,

packed, or held under conditions that do not meet current good

manufacturing practice regulations, including regulations

requiring, when necessary, expiration date labeling, issued by the

Secretary under subparagraph (2).

(2) The Secretary may by regulation prescribe good manufacturing

practices for dietary supplements. Such regulations shall be

modeled after current good manufacturing practice regulations for

food and may not impose standards for which there is no current and

generally available analytical methodology. No standard of current

good manufacturing practice may be imposed unless such standard is

included in a regulation promulgated after notice and opportunity

for comment in accordance with chapter 5 of title 5.

(h) Reoffer of food previously denied admission

If it is an article of food imported or offered for import into

the United States and the article of food has previously been

refused admission under section 381(a) of this title, unless the

person reoffering the article affirmatively establishes, at the

expense of the owner or consignee of the article, that the article

complies with the applicable requirements of this chapter, as

determined by the Secretary.

-SOURCE-

(June 25, 1938, ch. 675, Sec. 402, 52 Stat. 1046; Mar. 16, 1950,

ch. 61, Sec. 3(d), 64 Stat. 21; July 22, 1954, ch. 559, Sec. 2, 68

Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Pub. L. 85-929,

Sec. 3(a), (b), Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-2, Mar.

17, 1959, 73 Stat. 3; Pub. L. 86-618, title I, Sec. 102(a)(1), (2),

105(c), July 12, 1960, 74 Stat. 397, 398, 404; Pub. L. 89-477, June

29, 1966, 80 Stat. 231; Pub. L. 90-399, Sec. 104, July 13, 1968, 82

Stat. 352; Pub. L. 99-252, Sec. 10, Feb. 27, 1986, 100 Stat. 35;

Pub. L. 102-571, title I, Sec. 107(4), Oct. 29, 1992, 106 Stat.

4499; Pub. L. 103-80, Sec. 3(i), Aug. 13, 1993, 107 Stat. 776; Pub.

L. 103-417, Sec. 4, 9, Oct. 25, 1994, 108 Stat. 4328, 4332; Pub. L.

104-170, title IV, Sec. 404, Aug. 3, 1996, 110 Stat. 1514; Pub. L.

107-188, title III, Sec. 309, June 12, 2002, 116 Stat. 673.)

-MISC1-

AMENDMENTS

2002 - Subsec. (h). Pub. L. 107-188 added subsec. (h).

1996 - Par. (a). Pub. L. 104-170 added subpar. (2) and struck out

former subpar. (2) which read as follows: ''(2)(A) if it bears or

contains any added poisonous or added deleterious substance (other

than one which is (i) a pesticide chemical in or on a raw

agricultural commodity; (ii) a food additive; (iii) a color

additive; or (iv) a new animal drug) which is unsafe within the

meaning of section 346 of this title, or (B) if it is a raw

agricultural commodity and it bears or contains a pesticide

chemical which is unsafe within the meaning of section 346a(a) of

this title, or (C) if it is, or if it bears or contains, any food

additive which is unsafe within the meaning of section 348 of this

title: Provided, That where a pesticide chemical has been used in

or on a raw agricultural commodity in conformity with an exemption

granted or a tolerance prescribed under section 346a of this title

and such raw agricultural commodity has been subjected to

processing such as canning, cooking, freezing, dehydrating, or

milling, the residue of such pesticide chemical remaining in or on

such processed food shall, notwithstanding the provisions of

sections 346 and 348 of this title, not be deemed unsafe if such

residue in or on the raw agricultural commodity has been removed to

the extent possible in good manufacturing practice and the

concentration of such residue in the processed food when ready to

eat is not greater than the tolerance prescribed for the raw

agricultural commodity, or (D) if it is, or it bears or contains, a

new animal drug (or conversion product thereof) which is unsafe

within the meaning of section 360b of this title;''. That part of

Pub. L. 104-170 which directed the substitution of ''or (3) if it

consists'' for ''(3) if it consists'' was executed by making the

substitution for ''(3) If it consists'' to reflect the probable

intent of Congress.

1994 - Par. (f). Pub. L. 103-417, Sec. 4, added par. (f).

Par. (g). Pub. L. 103-417, Sec. 9, added par. (g).

1993 - Par. (a). Pub. L. 103-80, Sec. 3(i)(1), substituted a

period for ''; or'' at end of subpar. (1) and ''If it'' for ''if

it'' at beginning of par. (3). That part of Pub. L. 103-80, Sec.

3(i)(1), which directed the substitution of a period for ''; or''

at end of subpar. (2) could not be executed because ''; or'' did

not appear.

Par. (d)(1). Pub. L. 103-80, Sec. 3(i)(2), substituted '', except

that this subparagraph'' for '': Provided, That this clause''.

Par. (d)(3). Pub. L. 103-80, Sec. 3(i)(3), substituted '', except

that this subparagraph shall not apply'' for '': Provided, That

this clause shall not apply'' and '', except that the Secretary

may, for the purpose of avoiding or resolving uncertainty as to the

application of this subparagraph'' for '': And provided further,

That the Secretary may, for the purpose of avoiding or resolving

uncertainty as to the application of this clause''.

1992 - Par. (c). Pub. L. 102-571 substituted ''379e(a)'' for

''376(a)''.

1986 - Par. (d)(2). Pub. L. 99-252 inserted provision that this

clause not apply to confectionery introduced or delivered for

introduction into or received or held for sale in, interstate

commerce if the sale is permitted under the laws of the State in

which the confectionery is intended to be offered for sale.

1968 - Par. (a)(2). Pub. L. 90-399 added cls. (A)(iv) and (D).

1966 - Par. (d). Pub. L. 89-477 permitted the imbedding of

nonnutritive objects in confectionery foods if in the judgment of

the Secretary of Health, Education, and Welfare, as provided by

regulation, the imbedding of the object is of practical functional

value to the confectionery product and would not render it

injurious or hazardous to health, raised to one-half of 1 per

centum by volume the upper limit for the allowable use of alcohol

derived solely from the use of flavoring extracts, allowed the use

of safe nonnutritive substances in and on confectionery foods by

reason of their use for some practical and functional purpose in

the manufacture, packaging, or storage of the confectionery foods

if the use of the substances does not promote deception of the

consumer or otherwise result in adulteration or misbranding,

authorized the Secretary to issue regulations on the use of

particular nonnutritive substances, and removed reference to

nonnutritive masticatory substances added to chewing gum and

harmless flavoring, harmless resinous glaze not in excess of

four-tenths of 1 per centum, natural gum, authorized coloring, and

pectin.

1960 - Par. (a). Pub. L. 86-618, Sec. 102(a)(1), substituted

''other than one which is (i) a pesticide chemical in or on a raw

agricultural commodity; (ii) a food additive; or (iii) a color

additive'' for ''(except a pesticide chemical in or on a raw

agricultural commodity and except a food additive)'' in cl. (2)(A).

Par. (c). Pub. L. 86-618, Sec. 102(a)(2), amended par. (c)

generally, substituting provisions deeming a food adulterated if it

is, or it bears or contains, a color additive which is unsafe

within the meaning of section 376 of this title for provisions

which related to food that bears or contains a coal-tar color other

than one from a batch that has been certified in accordance with

regulations as provided by section 346 of this title, and struck

out provisos which related to the use of color on oranges.

Par. (d). Pub. L. 86-618, Sec. 105(c), substituted ''authorized

coloring'' for ''harmless coloring''.

1959 - Par. (c). Pub. L. 86-2 extended from Mar. 1, 1959, to May

1, 1959, the period during which subsection is inapplicable to

oranges which have been colored with F.D. & C. Red 32, and inserted

proviso requiring Secretary to establish regulations prescribing

the conditions under which Citrus Red No. 2 may be safely used in

coloring certain mature oranges, and providing for separately

listing and for certification of batches of such color.

1958 - Par. (a). Pub. L. 85-929, among other changes, inserted

cl. (2)(C) relating to food additive unsafe within the meaning of

section 348 of this title, and to pesticide chemical, and added cl.

(7) relating to radiated food.

1956 - Par. (c). Act July 9, 1956, inserted second proviso

relating to coloring of oranges.

1954 - Par. (a)(2). Act July 22, 1954, provided in the case of

any raw agricultural commodity bearing or containing a pesticide

chemical, that such commodity shall be deemed to be adulterated if

such pesticide chemical is unsafe within the meaning of section

346a of this title.

1950 - Par. (e). Act Mar. 16, 1950, added par. (e).

EFFECTIVE DATE OF 1968 AMENDMENT

Amendment by Pub. L. 90-399 effective on first day of thirteenth

calendar month after July 13, 1968, see section 108(a) of Pub. L.

90-399, set out as an Effective Date and Transitional Provisions

note under section 360b of this title.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-618 effective July 12, 1960, subject to

the provisions of section 203 of Pub. L. 86-618, see section 202 of

Pub. L. 86-618, set out as a note under section 379e of this title.

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND

DESICCANT AMENDMENT OF 1959

Effective date of par. (a)(2) as in force prior to July 22, 1954,

with respect to particular commercial use of a nematocide, plant

regulator, defoliant, or desiccant in or on a raw agricultural

commodity made before Jan. 1, 1958, see section 3(b) of Pub. L.

86-139, Aug. 7, 1959, 73 Stat. 288.

EFFECTIVE DATE OF 1958 AMENDMENT

Section 6 of Pub. L. 85-929, as amended by Pub. L. 87-19, Sec. 2,

Apr. 7, 1961, 75 Stat. 42; Pub. L. 88-625, Sec. 2, Oct. 3, 1964, 78

Stat. 1002, provided that:

''(a) Except as provided in subsections (b) and (c) of this

section, this Act (amending this section, sections 321, 331, 346,

and 348 of this title, and section 210 of Title 42, The Public

Health and Welfare, and enacting provisions set out as notes under

sections 321 and 451 of this title) shall take effect on the date

of its enactment (Sept. 6, 1958).

''(b) Except as provided in subsection (c) of this section,

section 3 of this Act (amending this section and section 346 of

this title) shall take effect on the one hundred and eightieth day

after the date of enactment of this Act (Sept. 6, 1958).

''(c) With respect to any particular commercial use of a food

additive, if such use was made of such additive before January 1,

1958, section 3 of this Act (amending this section and section 346

of this title) shall take effect -

''(1) Either (A) one year after the effective date established

in subsection (b) of this section, or (B) at the end of such

additional period (but not later than two years from such

effective date established in subsection (b)) as the Secretary of

Health, Education, and Welfare (now Health and Human Services)

may prescribe on the basis of a finding that such extension

involves no undue risk to the public health and that conditions

exist which necessitate the prescribing of such an additional

period, or

''(2) on the date on which an order with respect to such use

under section 409 of the Federal Food, Drug, and Cosmetic Act

(section 348 of this title) becomes effective,

whichever date first occurs. Whenever the Secretary has, pursuant

to clause (1)(B) of this subsection, extended the effective date of

section 3 of this Act (amending this section) to March 5, 1961, or

has on that date a request for such extension pending before him,

with respect to any such particular use of a food additive, he may,

notwithstanding the parenthetical time limitation in that clause,

further extend such effective date, not beyond June 30, 1964, under

the authority of that clause (but subject to clause (2)) with

respect to such use of the additive (or a more limited specified

use or uses thereof) if, in addition to making the findings

required by clause (1)(B), he finds (i) that bona fide action to

determine the applicability of such section 409 (section 348 of

this title) to such use or uses, or to develop the scientific data

necessary for action under such section, was commenced by an

interested person before March 6, 1960, and was thereafter pursued

with reasonable diligence, and (ii) that in the Secretary's

judgment such extension is consistent with the objective of

carrying to completion in good faith, as soon as reasonably

practicable, the scientific investigations necessary as a basis for

action under such section 409 (section 348 of this title):

Provided, That if the Secretary has, pursuant to this sentence,

granted an extension to June 30, 1964, he may, upon making the

findings required by clause (1)(B) of this subsection and clauses

(i) and (ii) of this sentence, further extend such effective date,

but not beyond December 31, 1965. The Secretary may at any time

terminate an extension so granted if he finds that it should not

have been granted, or that by reason of a change in circumstances

the basis for such extension no longer exists, or that there has

been a failure to comply with a requirement for submission of

progress reports or with other conditions attached to such

extension.''

EFFECTIVE DATE OF 1954 AMENDMENT

Section 5 of act July 22, 1954, provided that: ''This Act

(amending this section and section 321 of this title and enacting

sections 346a and 346b of this title) shall take effect upon the

date of its enactment (July 22, 1954), except that with respect to

pesticide chemicals for which tolerances or exemptions have not

been established under section 408 of the Federal Food, Drug, and

Cosmetic Act (section 346a of this title), the amendment to section

402(a) of such Act (par. (a) of this section) made by section 2 of

this Act shall not be effective -

''(1) for the period of one year following the date of the

enactment of this Act (July 22, 1954); or

''(2) for such additional period following such period of one

year, but not extending beyond two years after the date of the

enactment of this Act (July 22, 1954) as the Secretary of Health,

Education, and Welfare (now Health and Human Services) may

prescribe on the basis of a finding that conditions exist which

necessitate the prescribing of such additional period.''

EFFECTIVE DATE OF 1950 AMENDMENT

Amendment by act Mar. 16, 1950, effective July 1, 1950, see

section 7 of act Mar. 16, 1950, set out as an Effective Date note

under section 347 of this title.

EFFECTIVE DATE; POSTPONEMENT

Par. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242,

53 Stat. 853, set out as an Effective Date; Postponement in Certain

Cases note under section 301 of this title.

SHORT TITLE

Pub. L. 88-625, Sec. 1, Oct. 3, 1964, 78 Stat. 1002, provided:

''That this Act (amending provisions set out as a note under this

section and section 135 of Title 7, Agriculture) may be cited as

the 'Food Additives Transitional Provisions Amendment of 1964'.''

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of functions of Federal Security Administrator to

Secretary of Health, Education, and Welfare (now Health and Human

Services), and of Food and Drug Administration in the Department of

Agriculture to Federal Security Agency, see note set out under

section 41 of this title.

-MISC5-

DOMESTIC FISH OR FISH PRODUCT COMPLIANCE WITH FOOD SAFETY STANDARDS

OR PROCEDURES DEEMED TO HAVE MET REQUIREMENTS FOR FEDERAL COMMODITY

PURCHASE PROGRAMS

Pub. L. 104-180, title VII, Sec. 733, Aug. 6, 1996, 110 Stat.

1601, provided that: ''Hereafter, notwithstanding any other

provision of law, any domestic fish or fish product produced in

compliance with food safety standards or procedures accepted by the

Food and Drug Administration as satisfying the requirements of the

'Procedures for the Safe and Sanitary Processing and Importing of

Fish and Fish Products' (published by the Food and Drug

Administration as a final regulation in the Federal Register of

December 18, 1995), shall be deemed to have met any inspection

requirements of the Department of Agriculture or other Federal

agency for any Federal commodity purchase program, including the

program authorized under section 32 of the Act of August 24, 1935

(7 U.S.C. 612c) except that the Department of Agriculture or other

Federal agency may utilize lot inspection to establish a reasonable

degree of certainty that fish or fish products purchased under a

Federal commodity purchase program, including the program

authorized under section 32 of the Act of August 24, 1935 (7 U.S.C.

612c), meet Federal product specifications.''

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 333, 334, 346, 346a,

346b, 347b, 348, 350a, 350b, 360b, 379e of this title.

-CITE-

21 USC Sec. 343 01/06/03

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 343. Misbranded food

-STATUTE-

A food shall be deemed to be misbranded -

(a) False or misleading label

If (1) its labeling is false or misleading in any particular, or

(2) in the case of a food to which section 350 of this title

applies, its advertising is false or misleading in a material

respect or its labeling is in violation of section 350(b)(2) of

this title.

(b) Offer for sale under another name

If it is offered for sale under the name of another food.

(c) Imitation of another food

If it is an imitation of another food, unless its label bears, in

type of uniform size and prominence, the word ''imitation'' and,

immediately thereafter, the name of the food imitated.

(d) Misleading container

If its container is so made, formed, or filled as to be

misleading.

(e) Package form

If in package form unless it bears a label containing (1) the

name and place of business of the manufacturer, packer, or

distributor; and (2) an accurate statement of the quantity of the

contents in terms of weight, measure, or numerical count, except

that under clause (2) of this paragraph reasonable variations shall

be permitted, and exemptions as to small packages shall be

established, by regulations prescribed by the Secretary.

(f) Prominence of information on label

If any word, statement, or other information required by or under

authority of this chapter to appear on the label or labeling is not

prominently placed thereon with such conspicuousness (as compared

with other words, statements, designs, or devices, in the labeling)

and in such terms as to render it likely to be read and understood

by the ordinary individual under customary conditions of purchase

and use.

(g) Representation as to definition and standard of identity

If it purports to be or is represented as a food for which a

definition and standard of identity has been prescribed by

regulations as provided by section 341 of this title, unless (1) it

conforms to such definition and standard, and (2) its label bears

the name of the food specified in the definition and standard, and,

insofar as may be required by such regulations, the common names of

optional ingredients (other than spices, flavoring, and coloring)

present in such food.

(h) Representation as to standards of quality and fill of container

If it purports to be or is represented as -

(1) a food for which a standard of quality has been prescribed

by regulations as provided by section 341 of this title, and its

quality falls below such standard, unless its label bears, in

such manner and form as such regulations specify, a statement

that it falls below such standard;

(2) a food for which a standard or standards of fill of

container have been prescribed by regulations as provided by

section 341 of this title, and it falls below the standard of

fill of container applicable thereto, unless its label bears, in

such manner and form as such regulations specify, a statement

that it falls below such standard; or

(3) a food that is pasteurized unless -

(A) such food has been subjected to a safe process or

treatment that is prescribed as pasteurization for such food in

a regulation promulgated under this chapter; or

(B)(i) such food has been subjected to a safe process or

treatment that -

(I) is reasonably certain to achieve destruction or

elimination in the food of the most resistant microorganisms

of public health significance that are likely to occur in the

food;

(II) is at least as protective of the public health as a

process or treatment described in subparagraph (A);

(III) is effective for a period that is at least as long as

the shelf life of the food when stored under normal and

moderate abuse conditions; and

(IV) is the subject of a notification to the Secretary,

including effectiveness data regarding the process or

treatment; and

(ii) at least 120 days have passed after the date of receipt

of such notification by the Secretary without the Secretary

making a determination that the process or treatment involved

has not been shown to meet the requirements of subclauses (I)

through (III) of clause (i).

For purposes of paragraph (3), a determination by the Secretary

that a process or treatment has not been shown to meet the

requirements of subclauses (I) through (III) of subparagraph (B)(i)

shall constitute final agency action under such subclauses.

(i) Label where no representation as to definition and standard of

identity

Unless its label bears (1) the common or usual name of the food,

if any there be, and (2) in case it is fabricated from two or more

ingredients, the common or usual name of each such ingredient and

if the food purports to be a beverage containing vegetable or fruit

juice, a statement with appropriate prominence on the information

panel of the total percentage of such fruit or vegetable juice

contained in the food; except that spices, flavorings, and colors

not required to be certified under section 379e(c) of this title

(FOOTNOTE 1) unless sold as spices, flavorings, or such colors, may

be designated as spices, flavorings, and colorings without naming

each. To the extent that compliance with the requirements of

clause (2) of this paragraph is impracticable, or results in

deception or unfair competition, exemptions shall be established by

regulations promulgated by the Secretary.

(FOOTNOTE 1) So in original. Probably should be followed by a

comma.

(j) Representation for special dietary use

If it purports to be or is represented for special dietary uses,

unless its label bears such information concerning its vitamin,

mineral, and other dietary properties as the Secretary determines

to be, and by regulations prescribes as, necessary in order fully

to inform purchasers as to its value for such uses.

(k) Artificial flavoring, artificial coloring, or chemical

preservatives

If it bears or contains any artificial flavoring, artificial

coloring, or chemical preservative, unless it bears labeling

stating that fact, except that to the extent that compliance with

the requirements of this paragraph is impracticable, exemptions

shall be established by regulations promulgated by the Secretary.

The provisions of this paragraph and paragraphs (g) and (i) with

respect to artificial coloring shall not apply in the case of

butter, cheese, or ice cream. The provisions of this paragraph

with respect to chemical preservatives shall not apply to a

pesticide chemical when used in or on a raw agricultural commodity

which is the produce of the soil.

(l) Pesticide chemicals on raw agricultural commodities

If it is a raw agricultural commodity which is the produce of the

soil, bearing or containing a pesticide chemical applied after

harvest, unless the shipping container of such commodity bears

labeling which declares the presence of such chemical in or on such

commodity and the common or usual name and the function of such

chemical, except that no such declaration shall be required while

such commodity, having been removed from the shipping container, is

being held or displayed for sale at retail out of such container in

accordance with the custom of the trade.

(m) Color additives

If it is a color additive, unless its packaging and labeling are

in conformity with such packaging and labeling requirements,

applicable to such color additive, as may be contained in

regulations issued under section 379e of this title.

(n) Packaging or labeling of drugs in violation of regulations

If its packaging or labeling is in violation of an applicable

regulation issued pursuant to section 1472 or 1473 of title 15.

(o) Repealed. Pub. L. 106-554, Sec. 1(a)(1) (title V, Sec. 517),

Dec. 21, 2000, 114 Stat. 2763, 2763A-73

(p) Repealed. Pub. L. 104-124, Sec. 1, Apr. 1, 1996, 110 Stat. 882

(q) Nutrition information

(1) Except as provided in subparagraphs (3), (4), and (5), if it

is a food intended for human consumption and is offered for sale,

unless its label or labeling bears nutrition information that

provides -

(A)(i) the serving size which is an amount customarily consumed

and which is expressed in a common household measure that is

appropriate to the food, or

(ii) if the use of the food is not typically expressed in a

serving size, the common household unit of measure that expresses

the serving size of the food,

(B) the number of servings or other units of measure per

container,

(C) the total number of calories -

(i) derived from any source, and

(ii) derived from the total fat,

in each serving size or other unit of measure of the food,

(D) the amount of the following nutrients: Total fat, saturated

fat, cholesterol, sodium, total carbohydrates, complex

carbohydrates, sugars, dietary fiber, and total protein contained

in each serving size or other unit of measure,

(E) any vitamin, mineral, or other nutrient required to be

placed on the label and labeling of food under this chapter

before October 1, 1990, if the Secretary determines that such

information will assist consumers in maintaining healthy dietary

practices.

The Secretary may by regulation require any information required to

be placed on the label or labeling by this subparagraph or

subparagraph (2)(A) to be highlighted on the label or labeling by

larger type, bold type, or contrasting color if the Secretary

determines that such highlighting will assist consumers in

maintaining healthy dietary practices.

(2)(A) If the Secretary determines that a nutrient other than a

nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) should

be included in the label or labeling of food subject to

subparagraph (1) for purposes of providing information regarding

the nutritional value of such food that will assist consumers in

maintaining healthy dietary practices, the Secretary may by

regulation require that information relating to such additional

nutrient be included in the label or labeling of such food.

(B) If the Secretary determines that the information relating to

a nutrient required by subparagraph (1)(C), (1)(D), or (1)(E) or

clause (A) of this subparagraph to be included in the label or

labeling of food is not necessary to assist consumers in

maintaining healthy dietary practices, the Secretary may by

regulation remove information relating to such nutrient from such

requirement.

(3) For food that is received in bulk containers at a retail

establishment, the Secretary may, by regulation, provide that the

nutrition information required by subparagraphs (1) and (2) be

displayed at the location in the retail establishment at which the

food is offered for sale.

(4)(A) The Secretary shall provide for furnishing the nutrition

information required by subparagraphs (1) and (2) with respect to

raw agricultural commodities and raw fish by issuing voluntary

nutrition guidelines, as provided by clause (B) or by issuing

regulations that are mandatory as provided by clause (D).

(B)(i) Upon the expiration of 12 months after November 8, 1990,

the Secretary, after providing an opportunity for comment, shall

issue guidelines for food retailers offering raw agricultural

commodities or raw fish to provide nutrition information specified

in subparagraphs (1) and (2). Such guidelines shall take into

account the actions taken by food retailers during such 12-month

period to provide to consumers nutrition information on raw

agricultural commodities and raw fish. Such guidelines shall only

apply -

(I) in the case of raw agricultural commodities, to the 20

varieties of vegetables most frequently consumed during a year

and the 20 varieties of fruit most frequently consumed during a

year, and

(II) to the 20 varieties of raw fish most frequently consumed

during a year.

The vegetables, fruits, and raw fish to which such guidelines apply

shall be determined by the Secretary by regulation and the

Secretary may apply such guidelines regionally.

(ii) Upon the expiration of 12 months after November 8, 1990, the

Secretary shall issue a final regulation defining the circumstances

that constitute substantial compliance by food retailers with the

guidelines issued under subclause (i). The regulation shall provide

that there is not substantial compliance if a significant number of

retailers have failed to comply with the guidelines. The size of

the retailers and the portion of the market served by retailers in

compliance with the guidelines shall be considered in determining

whether the substantial-compliance standard has been met.

(C)(i) Upon the expiration of 30 months after November 8, 1990,

the Secretary shall issue a report on actions taken by food

retailers to provide consumers with nutrition information for raw

agricultural commodities and raw fish under the guidelines issued

under clause (A). Such report shall include a determination of

whether there is substantial compliance with the guidelines.

(ii) If the Secretary finds that there is substantial compliance

with the guidelines, the Secretary shall issue a report and make a

determination of the type required in subclause (i) every two

years.

(D)(i) If the Secretary determines that there is not substantial

compliance with the guidelines issued under clause (A), the

Secretary shall at the time such determination is made issue

proposed regulations requiring that any person who offers raw

agricultural commodities or raw fish to consumers provide, in a

manner prescribed by regulations, the nutrition information

required by subparagraphs (1) and (2). The Secretary shall issue

final regulations imposing such requirements 6 months after issuing

the proposed regulations. The final regulations shall become

effective 6 months after the date of their promulgation.

(ii) Regulations issued under subclause (i) may require that the

nutrition information required by subparagraphs (1) and (2) be

provided for more than 20 varieties of vegetables, 20 varieties of

fruit, and 20 varieties of fish most frequently consumed during a

year if the Secretary finds that a larger number of such products

are frequently consumed. Such regulations shall permit such

information to be provided in a single location in each area in

which raw agricultural commodities and raw fish are offered for

sale. Such regulations may provide that information shall be

expressed as an average or range per serving of the same type of

raw agricultural commodity or raw fish. The Secretary shall

develop and make available to the persons who offer such food to

consumers the information required by subparagraphs (1) and (2).

(iii) Regulations issued under subclause (i) shall permit the

required information to be provided in each area of an

establishment in which raw agricultural commodities and raw fish

are offered for sale. The regulations shall permit food retailers

to display the required information by supplying copies of the

information provided by the Secretary, by making the information

available in brochure, notebook or leaflet form, or by posting a

sign disclosing the information. Such regulations shall also

permit presentation of the required information to be supplemented

by a video, live demonstration, or other media which the Secretary

approves.

(E) For purposes of this subparagraph, the term ''fish'' includes

freshwater or marine fin fish, crustaceans, and mollusks, including

shellfish, amphibians, and other forms of aquatic animal life.

(F) No person who offers raw agricultural commodities or raw fish

to consumers may be prosecuted for minor violations of this

subparagraph if there has been substantial compliance with the

requirements of this paragraph.

(5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to

food -

(i) which is served in restaurants or other establishments in

which food is served for immediate human consumption or which is

sold for sale or use in such establishments,

(ii) which is processed and prepared primarily in a retail

establishment, which is ready for human consumption, which is of

the type described in subclause (i), and which is offered for

sale to consumers but not for immediate human consumption in such

establishment and which is not offered for sale outside such

establishment,

(iii) which is an infant formula subject to section 350a of

this title,

(iv) which is a medical food as defined in section 360ee(b) of

this title, or

(v) which is described in section 345(2) of this title.

(B) Subparagraphs (1) and (2) shall not apply to the label of a

food if the Secretary determines by regulations that compliance

with such subparagraphs is impracticable because the package of

such food is too small to comply with the requirements of such

subparagraphs and if the label of such food does not contain any

nutrition information.

(C) If a food contains insignificant amounts, as determined by

the Secretary, of all the nutrients required by subparagraphs (1)

and (2) to be listed in the label or labeling of food, the

requirements of such subparagraphs shall not apply to such food if

the label, labeling, or advertising of such food does not make any

claim with respect to the nutritional value of such food. If a

food contains insignificant amounts, as determined by the

Secretary, of more than one-half the nutrients required by

subparagraphs (1) and (2) to be in the label or labeling of the

food, the Secretary shall require the amounts of such nutrients to

be stated in a simplified form prescribed by the Secretary.

(D) If a person offers food for sale and has annual gross sales

made or business done in sales to consumers which is not more than

$500,000 or has annual gross sales made or business done in sales

of food to consumers which is not more than $50,000, the

requirements of subparagraphs (1), (2), (3), and (4) shall not

apply with respect to food sold by such person to consumers unless

the label or labeling of food offered by such person provides

nutrition information or makes a nutrition claim.

(E)(i) During the 12-month period for which an exemption from

subparagraphs (1) and (2) is claimed pursuant to this subclause,

the requirements of such subparagraphs shall not apply to any food

product if -

(I) the labeling for such product does not provide nutrition

information or make a claim subject to paragraph (r),

(II) the person who claims for such product an exemption from

such subparagraphs employed fewer than an average of 100

full-time equivalent employees,

(III) such person provided the notice described in subclause

(iii), and

(IV) in the case of a food product which was sold in the

12-month period preceding the period for which an exemption was

claimed, fewer than 100,000 units of such product were sold in

the United States during such preceding period, or in the case of

a food product which was not sold in the 12-month period

preceding the period for which such exemption is claimed, fewer

than 100,000 units of such product are reasonably anticipated to

be sold in the United States during the period for which such

exemption is claimed.

(ii) During the 12-month period after the applicable date

referred to in this sentence, the requirements of subparagraphs (1)

and (2) shall not apply to any food product which was first

introduced into interstate commerce before May 8, 1994, if the

labeling for such product does not provide nutrition information or

make a claim subject to paragraph (r), if such person provided the

notice described in subclause (iii), and if -

(I) during the 12-month period preceding May 8, 1994, the

person who claims for such product an exemption from such

subparagraphs employed fewer than an average of 300 full-time

equivalent employees and fewer than 600,000 units of such product

were sold in the United States,

(II) during the 12-month period preceding May 8, 1995, the

person who claims for such product an exemption from such

subparagraphs employed fewer than an average of 300 full-time

equivalent employees and fewer than 400,000 units of such product

were sold in the United States, or

(III) during the 12-month period preceding May 8, 1996, the

person who claims for such product an exemption from such

subparagraphs employed fewer than an average of 200 full-time

equivalent employees and fewer than 200,000 units of such product

were sold in the United States.

(iii) The notice referred to in subclauses (i) and (ii) shall be

given to the Secretary prior to the beginning of the period during

which the exemption under subclause (i) or (ii) is to be in effect,

shall state that the person claiming such exemption for a food

product has complied with the applicable requirements of subclause

(i) or (ii), and shall -

(I) state the average number of full-time equivalent employees

such person employed during the 12 months preceding the date such

person claims such exemption,

(II) state the approximate number of units the person claiming

the exemption sold in the United States,

(III) if the exemption is claimed for a food product which was

sold in the 12-month period preceding the period for which the

exemption was claimed, state the approximate number of units of

such product which were sold in the United States during such

preceding period, and, if the exemption is claimed for a food

product which was not sold in such preceding period, state the

number of units of such product which such person reasonably

anticipates will be sold in the United States during the period

for which the exemption was claimed, and

(IV) contain such information as the Secretary may require to

verify the information required by the preceding provisions of

this subclause if the Secretary has questioned the validity of

such information.

If a person is not an importer, has fewer than 10 full-time

equivalent employees, and sells fewer than 10,000 units of any food

product in any year, such person is not required to file a notice

for such product under this subclause for such year.

(iv) In the case of a person who claimed an exemption under

subclause (i) or (ii), if, during the period of such exemption, the

number of full-time equivalent employees of such person exceeds the

number in such subclause or if the number of food products sold in

the United States exceeds the number in such subclause, such

exemption shall extend to the expiration of 18 months after the

date the number of full-time equivalent employees or food products

sold exceeded the applicable number.

(v) For any food product first introduced into interstate

commerce after May 8, 2002, the Secretary may by regulation lower

the employee or units of food products requirement of subclause (i)

if the Secretary determines that the cost of compliance with such

lower requirement will not place an undue burden on persons subject

to such lower requirement.

(vi) For purposes of subclauses (i), (ii), (iii), (iv), and (v) -

(I) the term ''unit'' means the packaging or, if there is no

packaging, the form in which a food product is offered for sale

to consumers,

(II) the term ''food product'' means food in any sized package

which is manufactured by a single manufacturer or which bears the

same brand name, which bears the same statement of identity, and

which has similar preparation methods, and

(III) the term ''person'' in the case of a corporation includes

all domestic and foreign affiliates of the corporation.

(F) A dietary supplement product (including a food to which

section 350 of this title applies) shall comply with the

requirements of subparagraphs (1) and (2) in a manner which is

appropriate for the product and which is specified in regulations

of the Secretary which shall provide that -

(i) nutrition information shall first list those dietary

ingredients that are present in the product in a significant

amount and for which a recommendation for daily consumption has

been established by the Secretary, except that a dietary

ingredient shall not be required to be listed if it is not

present in a significant amount, and shall list any other dietary

ingredient present and identified as having no such

recommendation;

(ii) the listing of dietary ingredients shall include the

quantity of each such ingredient (or of a proprietary blend of

such ingredients) per serving;

(iii) the listing of dietary ingredients may include the source

of a dietary ingredient; and

(iv) the nutrition information shall immediately precede the

ingredient information required under subclause (i), except that

no ingredient identified pursuant to subclause (i) shall be

required to be identified a second time.

(G) Subparagraphs (1), (2), (3), and (4) shall not apply to food

which is sold by a food distributor if the food distributor

principally sells food to restaurants or other establishments in

which food is served for immediate human consumption and does not

manufacture, process, or repackage the food it sells.

(r) Nutrition levels and health-related claims

(1) Except as provided in clauses (A) through (C) of subparagraph

(5), if it is a food intended for human consumption which is

offered for sale and for which a claim is made in the label or

labeling of the food which expressly or by implication -

(A) characterizes the level of any nutrient which is of the

type required by paragraph (q)(1) or (q)(2) to be in the label or

labeling of the food unless the claim is made in accordance with

subparagraph (2), or

(B) characterizes the relationship of any nutrient which is of

the type required by paragraph (q)(1) or (q)(2) to be in the

label or labeling of the food to a disease or a health-related

condition unless the claim is made in accordance with

subparagraph (3) or (5)(D).

A statement of the type required by paragraph (q) that appears as

part of the nutrition information required or permitted by such

paragraph is not a claim which is subject to this paragraph and a

claim subject to clause (A) is not subject to clause (B).

(2)(A) Except as provided in subparagraphs (4)(A)(ii) and

(4)(A)(iii) and clauses (A) through (C) of subparagraph (5), a

claim described in subparagraph (1)(A) -

(i) may be made only if the characterization of the level made

in the claim uses terms which are defined in regulations of the

Secretary,

(ii) may not state the absence of a nutrient unless -

(I) the nutrient is usually present in the food or in a food

which substitutes for the food as defined by the Secretary by

regulation, or

(II) the Secretary by regulation permits such a statement on

the basis of a finding that such a statement would assist

consumers in maintaining healthy dietary practices and the

statement discloses that the nutrient is not usually present in

the food,

(iii) may not be made with respect to the level of cholesterol

in the food if the food contains, as determined by the Secretary

by regulation, fat or saturated fat in an amount which increases

to persons in the general population the risk of disease or a

health related condition which is diet related unless -

(I) the Secretary finds by regulation that the level of

cholesterol is substantially less than the level usually

present in the food or in a food which substitutes for the food

and which has a significant market share, or the Secretary by

regulation permits a statement regarding the absence of

cholesterol on the basis of a finding that cholesterol is not

usually present in the food and that such a statement would

assist consumers in maintaining healthy dietary practices and

the regulation requires that the statement disclose that

cholesterol is not usually present in the food, and

(II) the label or labeling of the food discloses the level of

such fat or saturated fat in immediate proximity to such claim

and with appropriate prominence which shall be no less than

one-half the size of the claim with respect to the level of

cholesterol,

(iv) may not be made with respect to the level of saturated fat

in the food if the food contains cholesterol unless the label or

labeling of the food discloses the level of cholesterol in the

food in immediate proximity to such claim and with appropriate

prominence which shall be no less than one-half the size of the

claim with respect to the level of saturated fat,

(v) may not state that a food is high in dietary fiber unless

the food is low in total fat as defined by the Secretary or the

label or labeling discloses the level of total fat in the food in

immediate proximity to such statement and with appropriate

prominence which shall be no less than one-half the size of the

claim with respect to the level of dietary fiber, and

(vi) may not be made if the Secretary by regulation prohibits

the claim because the claim is misleading in light of the level

of another nutrient in the food.

(B) If a claim described in subparagraph (1)(A) is made with

respect to a nutrient in a food and the Secretary makes a

determination that the food contains a nutrient at a level that

increases to persons in the general population the risk of a

disease or health-related condition that is diet related, the label

or labeling of such food shall contain, prominently and in

immediate proximity to such claim, the following statement: ''See

nutrition information for _ _ _ content.'' The blank shall identify

the nutrient associated with the increased disease or

health-related condition risk. In making the determination

described in this clause, the Secretary shall take into account the

significance of the food in the total daily diet.

(C) Subparagraph (2)(A) does not apply to a claim described in

subparagraph (1)(A) and contained in the label or labeling of a

food if such claim is contained in the brand name of such food and

such brand name was in use on such food before October 25, 1989,

unless the brand name contains a term defined by the Secretary

under subparagraph (2)(A)(i). Such a claim is subject to paragraph

(a).

(D) Subparagraph (2) does not apply to a claim described in

subparagraph (1)(A) which uses the term ''diet'' and is contained

in the label or labeling of a soft drink if (i) such claim is

contained in the brand name of such soft drink, (ii) such brand

name was in use on such soft drink before October 25, 1989, and

(iii) the use of the term ''diet'' was in conformity with section

105.66 of title 21 of the Code of Federal Regulations. Such a claim

is subject to paragraph (a).

(E) Subclauses (i) through (v) of subparagraph (2)(A) do not

apply to a statement in the label or labeling of food which

describes the percentage of vitamins and minerals in the food in

relation to the amount of such vitamins and minerals recommended

for daily consumption by the Secretary.

(F) Subclause (i) clause (A) does not apply to a statement in the

labeling of a dietary supplement that characterizes the percentage

level of a dietary ingredient for which the Secretary has not

established a reference daily intake, daily recommended value, or

other recommendation for daily consumption.

(G) A claim of the type described in subparagraph (1)(A) for a

nutrient, for which the Secretary has not promulgated a regulation

under clause (A)(i), shall be authorized and may be made with

respect to a food if -

(i) a scientific body of the United States Government with

official responsibility for public health protection or research

directly relating to human nutrition (such as the National

Institutes of Health or the Centers for Disease Control and

Prevention) or the National Academy of Sciences or any of its

subdivisions has published an authoritative statement, which is

currently in effect, which identifies the nutrient level to which

the claim refers;

(ii) a person has submitted to the Secretary, at least 120 days

(during which the Secretary may notify any person who is making a

claim as authorized by clause (C) that such person has not

submitted all the information required by such clause) before the

first introduction into interstate commerce of the food with a

label containing the claim, (I) a notice of the claim, which

shall include the exact words used in the claim and shall include

a concise description of the basis upon which such person relied

for determining that the requirements of subclause (i) have been

satisfied, (II) a copy of the statement referred to in subclause

(i) upon which such person relied in making the claim, and (III)

a balanced representation of the scientific literature relating

to the nutrient level to which the claim refers;

(iii) the claim and the food for which the claim is made are in

compliance with clauses (A) and (B), and are otherwise in

compliance with paragraph (a) and section 321(n) of this title;

and

(iv) the claim is stated in a manner so that the claim is an

accurate representation of the authoritative statement referred

to in subclause (i) and so that the claim enables the public to

comprehend the information provided in the claim and to

understand the relative significance of such information in the

context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an

authoritative statement of a scientific body described in subclause

(i) only if the statement is published by the scientific body and

shall not include a statement of an employee of the scientific body

made in the individual capacity of the employee.

(H) A claim submitted under the requirements of clause (G) may be

made until -

(i) such time as the Secretary issues a regulation -

(I) prohibiting or modifying the claim and the regulation has

become effective, or

(II) finding that the requirements of clause (G) have not

been met, including finding that the petitioner had not

submitted all the information required by such clause; or

(ii) a district court of the United States in an enforcement

proceeding under subchapter III of this chapter has determined

that the requirements of clause (G) have not been met.

(3)(A) Except as provided in subparagraph (5), a claim described

in subparagraph (1)(B) may only be made -

(i) if the claim meets the requirements of the regulations of

the Secretary promulgated under clause (B), and

(ii) if the food for which the claim is made does not contain,

as determined by the Secretary by regulation, any nutrient in an

amount which increases to persons in the general population the

risk of a disease or health-related condition which is diet

related, taking into account the significance of the food in the

total daily diet, except that the Secretary may by regulation

permit such a claim based on a finding that such a claim would

assist consumers in maintaining healthy dietary practices and

based on a requirement that the label contain a disclosure of the

type required by subparagraph (2)(B).

(B)(i) The Secretary shall promulgate regulations authorizing

claims of the type described in subparagraph (1)(B) only if the

Secretary determines, based on the totality of publicly available

scientific evidence (including evidence from well-designed studies

conducted in a manner which is consistent with generally recognized

scientific procedures and principles), that there is significant

scientific agreement, among experts qualified by scientific

training and experience to evaluate such claims, that the claim is

supported by such evidence.

(ii) A regulation described in subclause (i) shall describe -

(I) the relationship between a nutrient of the type required in

the label or labeling of food by paragraph (q)(1) or (q)(2) and a

disease or health-related condition, and

(II) the significance of each such nutrient in affecting such

disease or health-related condition.

(iii) A regulation described in subclause (i) shall require such

claim to be stated in a manner so that the claim is an accurate

representation of the matters set out in subclause (ii) and so that

the claim enables the public to comprehend the information provided

in the claim and to understand the relative significance of such

information in the context of a total daily diet.

(C) Notwithstanding the provisions of clauses (A)(i) and (B), a

claim of the type described in subparagraph (1)(B) which is not

authorized by the Secretary in a regulation promulgated in

accordance with clause (B) shall be authorized and may be made with

respect to a food if -

(i) a scientific body of the United States Government with

official responsibility for public health protection or research

directly relating to human nutrition (such as the National

Institutes of Health or the Centers for Disease Control and

Prevention) or the National Academy of Sciences or any of its

subdivisions has published an authoritative statement, which is

currently in effect, about the relationship between a nutrient

and a disease or health-related condition to which the claim

refers;

(ii) a person has submitted to the Secretary, at least 120 days

(during which the Secretary may notify any person who is making a

claim as authorized by clause (C) that such person has not

submitted all the information required by such clause) before the

first introduction into interstate commerce of the food with a

label containing the claim, (I) a notice of the claim, which

shall include the exact words used in the claim and shall include

a concise description of the basis upon which such person relied

for determining that the requirements of subclause (i) have been

satisfied, (II) a copy of the statement referred to in subclause

(i) upon which such person relied in making the claim, and (III)

a balanced representation of the scientific literature relating

to the relationship between a nutrient and a disease or

health-related condition to which the claim refers;

(iii) the claim and the food for which the claim is made are in

compliance with clause (A)(ii) and are otherwise in compliance

with paragraph (a) and section 321(n) of this title; and

(iv) the claim is stated in a manner so that the claim is an

accurate representation of the authoritative statement referred

to in subclause (i) and so that the claim enables the public to

comprehend the information provided in the claim and to

understand the relative significance of such information in the

context of a total daily diet.

For purposes of this clause, a statement shall be regarded as an

authoritative statement of a scientific body described in subclause

(i) only if the statement is published by the scientific body and

shall not include a statement of an employee of the scientific body

made in the individual capacity of the employee.

(D) A claim submitted under the requirements of clause (C) may be

made until -

(i) such time as the Secretary issues a regulation under the

standard in clause (B)(i) -

(I) prohibiting or modifying the claim and the regulation has

become effective, or

(II) finding that the requirements of clause (C) have not

been met, including finding that the petitioner has not

submitted all the information required by such clause; or

(ii) a district court of the United States in an enforcement

proceeding under subchapter III of this chapter has determined

that the requirements of clause (C) have not been met.

(4)(A)(i) Any person may petition the Secretary to issue a

regulation under subparagraph (2)(A)(i) or (3)(B) relating to a

claim described in subparagraph (1)(A) or (1)(B). Not later than

100 days after the petition is received by the Secretary, the

Secretary shall issue a final decision denying the petition or file

the petition for further action by the Secretary. If the Secretary

does not act within such 100 days, the petition shall be deemed to

be denied unless an extension is mutually agreed upon by the

Secretary and the petitioner. If the Secretary denies the petition

or the petition is deemed to be denied, the petition shall not be

made available to the public. If the Secretary files the petition,

the Secretary shall deny the petition or issue a proposed

regulation to take the action requested in the petition not later

than 90 days after the date of such decision. If the Secretary

does not act within such 90 days, the petition shall be deemed to

be denied unless an extension is mutually agreed upon by the

Secretary and the petitioner. If the Secretary issues a proposed

regulation, the rulemaking shall be completed within 540 days of

the date the petition is received by the Secretary. If the

Secretary does not issue a regulation within such 540 days, the

Secretary shall provide the Committee on Commerce of the House of

Representatives and the Committee on Labor and Human Resources of

the Senate the reasons action on the regulation did not occur

within such 540 days.

(ii) Any person may petition the Secretary for permission to use

in a claim described in subparagraph (1)(A) terms that are

consistent with the terms defined by the Secretary under

subparagraph (2)(A)(i). Within 90 days of the submission of such a

petition, the Secretary shall issue a final decision denying the

petition or granting such permission.

(iii) Any person may petition the Secretary for permission to use

an implied claim described in subparagraph (1)(A) in a brand name.

After publishing notice of an opportunity to comment on the

petition in the Federal Register and making the petition available

to the public, the Secretary shall grant the petition if the

Secretary finds that such claim is not misleading and is consistent

with terms defined by the Secretary under subparagraph (2)(A)(i).

The Secretary shall grant or deny the petition within 100 days of

the date it is submitted to the Secretary and the petition shall be

considered granted if the Secretary does not act on it within such

100 days.

(B) A petition under clause (A)(i) respecting a claim described

in subparagraph (1)(A) or (1)(B) shall include an explanation of

the reasons why the claim meets the requirements of this paragraph

and a summary of the scientific data which supports such reasons.

(C) If a petition for a regulation under subparagraph (3)(B)

relies on a report from an authoritative scientific body of the

United States, the Secretary shall consider such report and shall

justify any decision rejecting the conclusions of such report.

(5)(A) This paragraph does not apply to infant formulas subject

to section 350a(h) of this title and medical foods as defined in

section 360ee(b) of this title.

(B) Subclauses (iii) through (v) of subparagraph (2)(A) and

subparagraph (2)(B) do not apply to food which is served in

restaurants or other establishments in which food is served for

immediate human consumption or which is sold for sale or use in

such establishments.

(C) A subparagraph (1)(A) claim made with respect to a food which

claim is required by a standard of identity issued under section

341 of this title shall not be subject to subparagraph (2)(A)(i) or

(2)(B).

(D) A subparagraph (1)(B) claim made with respect to a dietary

supplement of vitamins, minerals, herbs, or other similar

nutritional substances shall not be subject to subparagraph (3) but

shall be subject to a procedure and standard, respecting the

validity of such claim, established by regulation of the Secretary.

(6) For purposes of paragraph (r)(1)(B), a statement for a

dietary supplement may be made if -

(A) the statement claims a benefit related to a classical

nutrient deficiency disease and discloses the prevalence of such

disease in the United States, describes the role of a nutrient or

dietary ingredient intended to affect the structure or function

in humans, characterizes the documented mechanism by which a

nutrient or dietary ingredient acts to maintain such structure or

function, or describes general well-being from consumption of a

nutrient or dietary ingredient,

(B) the manufacturer of the dietary supplement has

substantiation that such statement is truthful and not

misleading, and

(C) the statement contains, prominently displayed and in

boldface type, the following: ''This statement has not been

evaluated by the Food and Drug Administration. This product is

not intended to diagnose, treat, cure, or prevent any disease.''.

A statement under this subparagraph may not claim to diagnose,

mitigate, treat, cure, or prevent a specific disease or class of

diseases. If the manufacturer of a dietary supplement proposes to

make a statement described in the first sentence of this

subparagraph in the labeling of the dietary supplement, the

manufacturer shall notify the Secretary no later than 30 days after

the first marketing of the dietary supplement with such statement

that such a statement is being made.

(7) The Secretary may make proposed regulations issued under this

paragraph effective upon publication pending consideration of

public comment and publication of a final regulation if the

Secretary determines that such action is necessary -

(A) to enable the Secretary to review and act promptly on

petitions the Secretary determines provide for information

necessary to -

(i) enable consumers to develop and maintain healthy dietary

practices;

(ii) enable consumers to be informed promptly and effectively

of important new knowledge regarding nutritional and health

benefits of food; or

(iii) ensure that scientifically sound nutritional and health

information is provided to consumers as soon as possible; or

(B) to enable the Secretary to act promptly to ban or modify a

claim under this paragraph.

Such proposed regulations shall be deemed final agency action for

purposes of judicial review.

(s) Dietary supplements

If -

(1) it is a dietary supplement; and

(2)(A) the label or labeling of the supplement fails to list -

(i) the name of each ingredient of the supplement that is

described in section 321(ff) of this title; and

(ii)(I) the quantity of each such ingredient; or

(II) with respect to a proprietary blend of such ingredients,

the total quantity of all ingredients in the blend;

(B) the label or labeling of the dietary supplement fails to

identify the product by using the term ''dietary supplement'',

which term may be modified with the name of such an ingredient;

(C) the supplement contains an ingredient described in section

321(ff)(1)(C) of this title, and the label or labeling of the

supplement fails to identify any part of the plant from which the

ingredient is derived;

(D) the supplement -

(i) is covered by the specifications of an official

compendium;

(ii) is represented as conforming to the specifications of an

official compendium; and

(iii) fails to so conform; or

(E) the supplement -

(i) is not covered by the specifications of an official

compendium; and

(ii)(I) fails to have the identity and strength that the

supplement is represented to have; or

(II) fails to meet the quality (including tablet or capsule

disintegration), purity, or compositional specifications, based

on validated assay or other appropriate methods, that the

supplement is represented to meet.

A dietary supplement shall not be deemed misbranded solely because

its label or labeling contains directions or conditions of use or

warnings.

(t) Catfish

If it purports to be or is represented as catfish, unless it is

fish classified within the family Ictaluridae.

(u) Ginseng

If it purports to be or is represented as ginseng, unless it is

an herb or herbal ingredient derived from a plant classified within

the genus Panax.

(v) Failure to label; health threat

If -

(1) it fails to bear a label required by the Secretary under

section 381(n)(1) of this title (relating to food refused

admission into the United States);

(2) the Secretary finds that the food presents a threat of

serious adverse health consequences or death to humans or

animals; and

(3) upon or after notifying the owner or consignee involved

that the label is required under section 381 of this title, the

Secretary informs the owner or consignee that the food presents

such a threat.