509 § title 21.-food and drugs 225 · 346. tolerances for poisonous ingredients in food and...

TITLE 21.-FOOD AND DRUGS

§ 176. Same; masters of vessels; persons in chargeof railroad cars, etc.; liability of.

Advance of funds in connection with enforcement of sec-tion, see section 529a of Title 31, Money and Finance.

§ 177. Administration of law.Advance of funds in connection with enforcement of sec-

tion, see section 529a of Title 31, Money and Finance.

§ 178. Smoking opium; possession in transit; evi-dence.


§ 179. Same; masters of vessels; persons in chargeof railroad cars, and so forth; liability of; forfeiture.


§ 180. Smoking opium not admitted for transporta-tion to another country nor transferred from onevessel to another; other narcotic drugs.


§ 181. Presumption and burden of proof as to im-portation of smoking opium.


§ 182. Exportation of narcotic drugs prohibited;exception; requests for copies of laws of foreigngovernment; rules and regulations by board.


§ 183. Same; punishment; share of fine to in-former.

Additional punishment for subsequent offenses, see sections200-200b of this title.


§ 184. Seizure and forfeiture of narcotic drugsfound on vessel and not shown on manifest or landedfrom vessel without permit; penalty against masterof vessel; withholding clearance papers; mitigationand remission of forfeitures and penalties.


§ 185. Citation.Advance of funds in connection with enforcement of sec-

tion, see section 529a of Title 31, Money and Finance.

MISCELLANEOUS

§ 196. Studies and investigations by Surgeon Gen-eral of Public Health; annual report.

Public Health Service and its functions and personnel weretransferred to Federal Security Agency, and functions ofSecretary of Treasury, other than those relating to accept-ance and investment of gifts, were transferred to administra-tor of said agency by Reorg. Plan No. I, § § 201 and 205effective July 1, 1939, set out in note under section 133t ofTitle 5, Executive Departments and Government Officers andEmployees. See sections 208-211 of said plan for provisionsrelating to transfer of records, property, funds, and personnel.

§ 200. Additional punishment for second offenses.A person who, after having been convicted of selling,importing, or exporting, or conspiring to sell, import,or export, opium, coca leaves, cocaine, or any salt,derivative, or preparation of opium, coca leaves, or co-caine, again sells, imports, or exports, or conspires tosell, import, or export, any of the said narcotic drugs,in violation of the laws of the United States, shall,upon conviction of such second offense, be fined notmore than $5,000 or imprisoned in a Federal peniten-tiary for not more than ten years, or both, in the dis-cretion of the court, whenever the fact of such previousconviction is. established in the manner prescribed insection 200b of this title. (Aug. 12, 1937, c. 598, § 1,50 Stat. 627.)

§ 200a. Same; third and subsequent offenses. Aperson who, after having been two times convicted ofselling, importing, or exporting, or conspiring to sell,import, or export, opium, coca leaves, cocaine, or anysalt, derivative, or preparation of opium, coca leaves,or cocaine, again sells, imports, or exports or conspiresto sell, import, or export, any of the said narcotic drugs,in violation of the laws of the United States, shall,

upon conviction of such third offense, or any offensesubsequent thereto, be fined not more than $10,000 orimprisoned in a Federal penitentiary for not more thantwenty years, or both, in the discretion of the court,whenever the fact of such previous convictions is estab-lished in the manner prescribed in section 200b of thistitle. (Aug. 12, 1937, c. 598, § 2, 50 Stat. 627.)

§ 200b. Same; procedure. Whenever it shall ap-pear, after conviction and before or after sentence, thata person convicted of unlawfully selling, importing, orexporting, or conspiring unlawfully to sell, import, orexport, any of the narcotic drugs enumerated in sec-tions 200 to 200b of this title has previously been con-victed of unlawfully selling, importing, or exporting, orconspiring unlawfully to sell, import, or export, anyof said narcotic drugs, in violation of the laws of theUnited States, it shall be the duty of the United Statesdistrict attorney for the district in which such subse-quent conviction was had to file an information alleg-ing that the defendant has previously been so con-victed, and further alleging the number of such pre-vious convictions. The court in which the defendantwas convicted shall cause the said defendant, whetherconfined in prison or otherwise, to appear before itand shall apprise him of the allegations of the informa-tion and of his right to a trial by jury as to the truththereof. The court shall inquire of the defendantwhether he is the person who has previously beenconvicted. If the defendant states he is not such per-son, or if he refuses to answer or remains silent, aplea of not guilty shall be entered by the court, and ajury shall be empaneled to determine whether the de-fendant is the person alleged in the Information tohave previously been convicted, and the number ofsuch previous convictions. If after a trial on the soleissue of the truth of such allegations the jury de-termines that the defendant is in fact the person pre-viously convicted as charged in the information, or ifhe acknowledges in open court, after being duly cau-tioned as to his rights, that he is such person, he shallbe punished as prescribed in sections 200 or 200a ofthis title, as the case may be, and the previous sentenceof the court, if any, shall be vacated and there shallbe deducted from the new sentence the amount of timeactually served under the sentence so vacated. (Aug.12, 1937, c. 598, § 3, 50 Stat. 627.)

Chapter 8.-NARCOTIC FARMS

§ 225. Same; control and management; Division ofMental Hygiene; in Bureau of Public Health Service;creation; duties; rank, pay, and allowances of medicalofficer in charge of division.

Public Health Service and its functions and personnel weretransferred to Federal Security Agency, and functions ofSecretary of Treasury, other than those relating to accept-ance and investment of gifts, were transferred to administra-tor of said agency by Reorg. Plan No. I §§ 201 and 205effective July 1, 1939, set out in note under section 133t ofTItle 5, Executive Departments and Government Officers andEmployees. See sections 208-211 of said plan for provisionsrelating to transfer of records, property, funds, and personnel.

Chapter 9.-FEDERAL FOOD, DRUG, ANDCOSMETIC ACT

SUBCHAPTER I.-SHORT TITLESec.301. Short title.

SUBCHAPTER IT.-DEFINITIONS

321. Definitions; generally.321a. Same; butter.321b. Same; package.

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.(h Same; with intent to defraud or mislead.(c) Exceptions in certain cases of good faith, etc.334. Seizure.(a) Grounds and Jurisdiction.(b) Procedure; multiplicity of pending proceed-

ings.

§ 225Page 509


Sec.334. Seizure--Continued.

(c) Availability of samples or seized goods priorto trial.

(d) Disposition of goods after decree of con-demnation.(e) Costs.

M Removal of case for trial.335. Hearing before report of criminal violation.336. Report of minor violations.337. Proceedings In name of United States; provision as to

subpenas.

SUBCHAPTER IV.-FOOD

341. Definitions and standards for food.342. Adulterated food.

(a) Poisonous, insanitary, etc., ingredients.(b Absence, substitution, or addition of constitu-

ents.c) Uncertified coal tar coloring.

Confectionery containing alcohol or nonnutri-tive substance.

343. Misbranded food.( False or misleading label.(b) Offer for sale under another name.(e) Imitation of another food.

Misleading container.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.(1) Label where no representation as to definition

and standard of Identity.(J

) Representation for special dietary use.Artificial flavoring, etc. ; exception of articles

from (g), (1), and (k).344. Emergency permit control.

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

(b) Violation of permit; suspension and reinstate-ment.

(c) Inspection of permit-holding establishments.345. Regulations making exemptions.346. Tolerances for poisonous ingredients In food and certifi-

cation of coal-tar colors for food.(a) Regulations for tolerating unavoidable poison-

ous ingredients.(b) Regulations for coal tar colors.

SUBCHAPTER V.-DRUGS AND DEVICES

351. Adulterated drugs and devices.(a) Poisonous, insanitary, etc., Ingredients.(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 sub-

stance.352. Misbranded drugs and devices.

(a) False or misleading label.

( Package form ; contents of label.d) Habit forming substances.

e) Designation of drug by name not In com-pendium.

(f) Directions for use and warnings on label.(g) Representation as recognized drug; packing

and labeling.(h) Deteriorative drugs; packing and labeling.(i) Drug; misleading container; imitation ; offer

for sale under another name.(j) Health-endangering when used as prescribed.

353. Exemptions in case of drugs and devices.(a) Regulations for goods to be processed, labeled,

or repacked elsewhere.(b) Prescription by physician, etc.

354. Certification of coal-tar colors for drugs.355. New Drugs.

1a) Necessity effective application.b) Filing application; contents.c) Effective date of application.d) Grounds for refusing application to become

effective.IP Suspension of effectiveness of application.

Revocation of order refusing effectiveness.l Service of orders.

Appeal from order.(i) Exemption of drugs for research.

SUBCHAPTER VI.-COSMETICS

361. Adulterated cosmetics.362. Misbranded cosmetics.363. Regulations making exemptions.364. Certification of coal-tar colors for cosmetics.

SUBCHAPTER VII.-GENERAL ADMINISTRATIVEPROVISIONS

371. Regulations and hearings.(a Authority to promulgate regulations.(b Regulations for Imports and exports.

c) Conduct of hearings.Effectiveness of definitions and standards of

identity.

See.371. Regulations and hearings-Continued.

(e) Hearings of proposed changes in regulations;orders.

(f) Review of order.(g) Copies of records of hearings.

372. Examinations and investigations.a Authority to conduct.b) Availability to owner of part of analysis

samples.(c) Records of other departments and agencies.

372a. Examination of sea food on request of packer; markingfood with results; fees; penalties.

373. Records of interstate shipment.374. Factory inspection.375. Publicity.

a Reports.b) Information regarding certain goods.

376. Cost of certification of coal-tar colors.'

SUBCHAPTER VIII.-IMPORTS AND EXPORTS381. Imports and exports.

(a) Imports; examination and refusal of admis-sion.

(b) Same; disposition of refused articles.c) Same; charges concerning refused articles.d) Exports.

SUBCHAPTER IX.-MISCELLANEOUS

391. Separability clause.392. Effective date and repeals.

(a) Effective date; repeal of 1906 Act; laws un-affected.

Eb xemption of meats and meat food products.Laws unaffected.

() Availability of appropriations.

SUBCHAPTER I.-SHORT TITLE

§ 301. Short title. This chapter may be cited as theFederal Food, Drug, and Cosmetic Act. (June 25,1938, c. 675, § 1, 52 Stat. 1040.)

Effective twelve months after date of enactment, by section392 (a), post.

SUBCHAPTER I.-DEFINITIONS

§ 321. Definitions; generally. For the purposes ofthis chapter-

(a) The term "Territory" means any Territory orpossession of the United States, including the Districtof Columbia and excluding the Canal Zone.

(b) The term "interstate commerce" means (1)commerce between any State or Territory and anyplace outside thereof, and (2) commerce within theDistrict of Columbia or within any other Territorynot organized with a legislative body.

(c) The term "Department" means the Departmentof Agriculture of the United States.

(d) The term "Secretary" means the Secretary ofAgriculture.

(c) The term "person" includes individual, partner-ship, corporation, and association.

(f) The term "food" means (1) articles used forfood or drink for man or other animals, (2) chewinggum, and (3) articles used for components of any sucharticle.

(g) The term "drug" means (1) articles recognizedin the official United States Pharmacopoeia, officialHomceopathic Pharmacopoeia of the United States,or official National Formulary, or any supplement toany of them; and (2) articles intended for use in thediagnosis, cure, mitigation, treatment, or preventionof disease in man or other animals; and (3) articles(other than food) intended to affect the structure orany function of the body of man or other animals;and (4) articles Intended for use as a component ofany article specified in clause (1), (2), or (3); butdoes not include devices or their components, parts, oraccessories.

(h) The term "device" (except when used in para-graph (n) of this section and in sections 331 (i), 343(f), 352 (c), and 362 (c)) means instruments, ap-paratus, and contrivances, including their components,parts, and accessories, intended (1) for use in thediagnosis, cure, mitigation, treatment, or prevention ofdisease in man or other animals; or (2) to affect thestructure or any function of the body of man or otheranimals.

(i) The term "cosmetic" means (1) articles in-tended to be rubbed, poured, sprinkled, or sprayed on,introduced into, or otherwise applied to the human body

Page 510§ 301


or any part thereof for cleansing, beautifying, promot-ing attractiveness, or altering the appearance, and(2) articles intended for use as a component of anysuch articles; except that such term shall not includesoap.

(j) The term "official compendium " means the offi-cial United States Pharmacopoeia, official HomoeopathicPharmacopoeia of the United States, official NationalFormulary, or any supplement to any of them.

(k) The term "label'" means a display of written,printed, or graphic matter upon the immediate con-tainer of any article; and a requirement made by orunder authority of this chapter that any word, state-ment, or other information appear on the label shallnot be considered to be complied with unless suchword, statement, or other information also appears onthe outside container or wrapper, if any there be, of theretail package of such article, or is easily legiblethrough the outside container or wrapper.

(1) The term "immediate container" does not in-clude package liners.

(in) The term "labeling" means all labels and otherwritten, printed, or graphic matter (1) upon any articleor any of its containers or wrappers, or (2) accom-panying such article.

(n) If an article is alleged to be misbranded becausethe labeling is misleading, then in determining whetherthe labeling is misleading there shall be taken intoaccount (among other things) not only representationsmade or suggested by statement, word, design, device,or any combination thereof, but also the extent to whichthe labeling fails to reveal facts material in the lightof such representations or material with respect toconsequences which may result from the use of thearticle to which the labeling relates under the condi-tions of use prescribed in the labeling thereof or undersuch 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 representationthat it is a germicide, except In the case of a drugpurporting to be, or represented as, an antiseptic forinhibitory use as a wet dressing, ointment, dustingpowder, or such other use as involves prolonged contactwith the body.

(p) The term "new drug" means-(1) Any drug the composition of which is such that

such drug Is not generally recognized, among expertsqualified by scientific training and experience to evalu-ate the safety of drugs, as safe for use under the con-ditions prescribed, recommended, or suggested in thelabeling thereof, except that such a drug not so recog-nized shall not be deemed to be a "new drug" if atany time prior to the enactment of this Act it wassubject to the Food and Drugs Act of June 30, 1906,as amended,' and if at such time its labeling containedthe same representations concerning the conditions ofits use; or

(2) Any drug the composition of which is such thatsuch drug, as a result of investigations to determineits safety for use under such conditiops, has becomeso recognized, but which has not, otherwise than insuch Investigations, been used to a material extent orfor a material time under such conditions. (June 25,1938, c. 675, § 201, 52 Stat. 1041.)

1 See sections 1-5, 7-15, and 372a of this title.Effective twelve months after date of enactment, by section

392 (a) post.§ 321a. Same; butter. For the purposes of the Food

and Drugs Act of June 30, 1906 (Thirty-fourth Statutesat Large, page 768),' "butter" shall be understood tomean the food product usually known as butter, andwhich is made exclusively from milk or cream, or both,with or without common salt, and with or without addi-tional coloring matter, and containing not less than 80per centum by weight of milk fat, all tolerances havingbeen allowed for. (Mar. 4, 1923, c. 268, 42 Stat. 1500;June 25, 1938, c. 675, § 902 (a), 52 Stat. 1059.)

See sections 1-5, 7-15, and 372 a of this title, and note tothis section.

This section, which Is not a provision of the Federal Food,Drug, and Cosmetic Act, was formerly section 6 of this title.Act June 25, 1938 cited to the text, provided that the sectionshould remain in iorce and effect and be applicable to the pro-visions of this chapter. See section 392 (a), post.

§ 321b. Same; package. The word "package"wher6 it occurs the second and last time in the actentitled "An act to amend section 8 of an act entitled,'An act for preventing the manufacture, sale, or trans-portation of adulterated or misbranded or poisonousdeleterious foods, drugs, medicines, and liquors, and forregulating traffic therein, and for other purposes,'approved March 3, 1913,1 shall include and shall be con-strued to include wrapped meats inclosed in papers orother materials as prepared by the manufacturersthereof for sale. (July 24, 1919, c. 26, 41 Stat. 271;June 25, 1938, c. 675, § 902 (a), 52 Stat. 1059.)

3 See historical note to this section.This section, which is not a provision of the Federal Food,

Drug, and Cosmetic Act, was made applicable to that Act byAct June 25, 1938, cited to the text. See section 392 (a) post.

This section was formerly the last sentence of paragraphthird of section 10 of this title.

Act March 3, 1913 [c. 117, 37 Stat. 732], mentioned in thetext of this section, amended paragraph third of the Food andDrugs Act of June 30, 1906, c. 3915, § 8 34 Stat. 771 [firsttwo sentences of paragraph Third of section 10 of this title],to read as follows: "Third. If In package form, the quantityof the contents be not plainly and conspicuously marked on theoutside of the package in terms of weight, measure, or numeri-cal count: Provided, however, That reasonable variations shallbe permitted, and tolerances and also exemptions as to smallpackages shall be established by rules and regulations made inaccordance with the provisions of Section three of this Act[section 3 of this title]."

SUBCHAPTER III.-PROHIBITED ACTS ANDPENALTIES

§ 331. Prohibited acts. The following acts and thecausing thereof are hereby prohibited:

(a) The introduction or delivery for introductioninto interstate commerce of any food, drug, device, orcosmetic 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 anyfood, drug, device, or cosmetic that is adulterated ormisbranded, and the delivery or proffered deliverythereof for pay or otherwise.

(d) The introduction or delivery for introductioninto interstate commerce of any article in violationof section 344 or 355.

(e) The refusal to permit access to or copying ofany record as required by section 373.

(f) The refusal to permit entry or inspection asauthorized by section 374.

(g) The manufacture within any Territory of anyfood, drug, device, or cosmetic that is adulterated ormisbranded.

(h) The. giving of a guaranty or undertaking re-ferred to in section 333 (c) (2), which guaranty or un-dertaking is false, except by a person who relied upona guaranty or undertaking to the same effect signedby, and containing the name and address of, the per-son residing In the United States from whom he re-ceived in good faith the food, drug, device, or cos-metic; or the giving of a guaranty or undertakingreferred to in section 333 (c) (3), which guaranty orundertaking is false.

(i) Forging, counterfeiting, simulating, or falselyrepresenting, or without proper authority using anymark, stamp, tag, label, or other identification de-vice authorized or required by regulations promul-gated under the provisions of section 344, 346 (b),354, or 364.

(j) The using by any person to his own advantage, orrevealing, other than to the Secretary or officers oremployees of the Department, or to the courts whenrelevant in any judicial proceeding under this Act, anyinformation acquired under authority of section 344,355, or 374 concerning any method or process Which asa trade secret is entitled to protection.

(k) The alteration, mutilation, destruction, obliter-ation, or removal of the whole or any part of the label-ing of, or the doing of any other act with respect to, afood, drug, device, or cosmetic, if such act is done whilesuch article is held for sale after shipment in interstatecommerce and results in such article being misbranded.

(1) The using, on the labeling of any drug or in anyadvertising relating to such drug, of any representationor suggestion that an application with respect to such

§ 331Page 511


drug is effective under section 355, or that such drugcomplies with the provisions of such section. (June25, 1938, C. 675, § 301, 52 Stat. 1042.)

Violation of injunction or restraining order as violation ofchapter, see section 332 (b), post.

Effective twelve months after date of enactment, by section392 (a) post.

§ 332. Injunction proceedings-(a) Jurisdiction ofcourts. The district courts of the United States andthe United States courts of the Territories shall havejurisdiction, for cause shown, and subject to the provi-sions of section 381 (relating to notice to oppositeparty) of Title 28, as amended, to restrain violations ofsection 331, except paragraphs (e), (f), (h), (i), and(j).

(b) Violation of injunction. In case of violationof an injunction or restraining order issued under thissection, which also constitutes a violation of this chap-ter, trial shall be by the court, or, upon demand of theaccused, by a jury. Such trial shall be conducted inaccordance with the practice and procedure applicablein the case of proceedings subject to the provisions ofsection 387 of Title 28, as amended. (June 25, 1938,c. 675, § 302, 52 Stat. 1043.)


§ 333. Penalties-(a) Violation of section 331. Anyperson who violates any of the provisions of section331 shall be guilty of a misdemeanor and shall on con-viction thereof be subject to imprisonment for not morethan one year, or a fine of not more than $1,000, orboth such imprisonment and fine; but if the violationis committed after a conviction of such person underthis section has become final such person shall besubject to imprisonment for not more than three years,or a fine of not more than $10,000, or both such im-prisonment and fine.

(b) Same; with intent to defraud or mislead. Not-withstanding the provisions of subsection (a) of thissection, in case of a violation of any of the provisionsof section 331, with intent to defraud or mislead, thepenalty shall be Imprisonment for not more than threeyears, or a fine of not more than $10,000, or both suchimprisonment and fine.

(c) Exceptions in certain cases of good faith, etc.No person shall be subject to the penalties of subsection(a) of this section, (1) for having received in inter-state commerce any article and delivered it or proffereddelivery of it, if such delivery or proffer was made ingood faith, unless he refuses to furnish on request of anofficer or employee duly designated by the Secretarythe name and address of the petson from whom hepurchased or received such article and copies of alldocuments, if any there be, pertaining to the deliveryof the article to him; or (2) for having violated section331 (a) or (d), if he establishes a guaranty or under-taking signed by, and containing the name and addressof, the person residing in the United States from whomhe received in good faith the article, to the effect, incase of an alleged violation of section &31 (a), thatsuch article is not adulterated or misbranded, withinthe meaning of this chapter designating this chapteror to the effect, in case of an alleged violation of section331 (d), that such article is not an article which maynot, under the provisions of section 344 or 355, beintroduced into interstate commerce; or (3) for havingviolated section 331 (a), where the violation existsbecause the article is adulterated by reasen of contain-ing a coal-tar color not from a batch certified in ac-cordance with regulations promulgated by the Secre-tary under this chapter, if such person establishesa guaranty or undertaking signed by, and containingthe name and address of, the manufacturer, of thecoal-tar color, to the effect that such color was froma batch certified in accordance with the applicableregulations promulgated by the Secretary under thischapter. (June 25, 1938, c. 675, § 303, 52 Stat. 1043.)


§ 334. Seizure-(a) Grounds and jurisdiction. Anyarticle of food, drug, device, or cosmetic that is adul-terated or misbranded when introduced into or while

in interstate commerce, or which may not, under theprovisions of section 344 or 355, be introduced intointerstate commerce, shall be liable to be proceededagainst while in interstate commerce, or at any timethereafter, on libel of information and condemnedin any district court of the United States within thejurisdiction of which the article is found: Provided,however, That no libel for condemnation shall be in-stituted under this chapter, for any alleged misbrand-ing if there is pending in any court a libel for con-demnation proceeding under this chapter based uponthe same alleged misbranding, and not more than onesuch proceeding shall be instituted if no such proceed-ing is so pending, except that such limitations shallnot apply (1) when such misbranding has been thebasis of a prior judgment in favor of the UnitedStates, in a criminal, injunction, or libel for con-demnation proceeding under this chapter, or (2) whenthe Secretary has probable cause to believe from factsfound, without hearing, by him or any officer or em-ployee of the Department that the misbranded articleis dangerous to health, or that the labeling of themisbranded article is fraudulent, or would be in a ma-terial respect misleading to the injury or damage ofthe purchaser or consumer. In any case where thenumber of libel for condemnation proceedings is limitedas above provided the proceeding pending or insti-tuted shall, on application of the claimant, seasonablymade, be removed for trial to any district agreedupon by stipulation between the parties, or, in caseof failure to so stipulate within a reasonable time, theclaimant may apply to the court of the district inwhich the seizure has been made, and such court(after giving the United States attorney for such dis-trict reasonable notice and opportunity to be heard)shall by order, unless good cause to the contrary isshown, specify a district of reasonable proximity tothe claimant's principal place of business, to whichthe case shall be removed for trial.

(b) Procedure; multiplicity of pending proceedings.The article shall be liable to seizure by process pur-suant to the libel, and the procedure in cases underthis section shall conform, as nearly as may be, tothe procedure in admiralty; except that on demand ofeither party any issue of fact joined in any suchcase shall be tried by jury. When libel for condemna-tion proceedings under this section, involving the sameclaimant and the same issues of adulteration or mis-branding, are pending in two or more jurisdictions,such pending proceedings, upon application of theclaimant seasonably made to the court of one suchjurisdiction, shall be consolidated for trial by orderof such court, and tried in (1) any district selectedby the claimant where one of such proceedings ispending; or (2) a district agreed upon by stipulationbetween the parties. If no order for consolidation isso made within a reasonable time, the claimant mayapply to the court of one such jurisdiction, and suchcourt (after giving the United States attorney forsuch district reasonable notice and opportunity to beheard) shall by order, unless good cause to the con-trary is shown, specify a district of reasonable prox-imity to the claimant's principal place of business, inwhich all such pending proceedings shall be consoli-dated for trial and tried. Such order of consolidationshall not apply so as to require the removal of anycase the date for trial of which has been fixed. Thecourt granting such order shall give prompt notifica-tion thereof to the other courts having jurisdiction ofthe cases covered thereby.

(c) Availability of samples of seized goods prior totrial. The court at any time after seizure up to areasonable time before trial shall by order allow anyparty to a condemnation proceeding, his attorney oragent, to obtain a representative sample of the articleseized, and as regards fresh fruits or fresh vegetables,a true copy of the analysis on which the proceeding isbased and the identifying marks or numbers, if any,of the packages from which the samples analyzed wereobtained.

(d) Disposition of goods after decree of condemna-tion. Any food, drug, device, or cosmetic condemnedunder this section shall, after entry of the decree, be

§ 332 Page 512


disposed of by destruction or sale as the court may, inaccordance with the provisions of this section, directand the proceeds thereof, if sold, less the legal costsand charges, shall be paid into the Treasury of theUnited States; but such article shall not be sold undersuch decree contrary to the provisions of this chapteror the laws of the jurisdiction in which sold: Provided,That after entry of the decree and upon the paymentof the costs of such proceedings and the execution of agood and sufficient bond conditioned that such articleshall not be sold or disposed of contrary to the provi-sions of this chapter or the laws of any State or Terri-tory in which sold, the court may by order direct thatsuch article be delivered to the owner thereof to bedestroyed or brought into compliance with the provi-sions of this chapter under the supervision of an officeror employee duly designated by the Secretary, and theexpenses of such supervision shall be paid by the per-son obtaining release of the article under bond. Anyarticle condemned by reason of its being an articlewhich may not, under section 344 or 355, be introducedinto interstate commerce, shall be disposed of bydestruction.

(e) Costs. When a decree of condemnation is en-tered against the article, court costs and fees, andstorage and other proper expenses, shall be awardedagainst the person, if any, intervening, as claimant ofthe article.

(f) Removal of case for trial. In the case of re-moval for trial of any case as provided by subsection(a) or (b)-

(1) The clerk of the court from which removal ismade shall promptly transmit to the court in whichthe case is to be tried all records in the case necessaryin order that such court may exercise jurisdiction.

(2) The court to which such case was removed shallhave the powers and be subject to the duties, for pur-poses of such case, which the court from which removalwas made would have had, or to which such courtwould have been subject, if such case had not beenremoved. (June 25, 1938, c. 675, § 304, 52 Stat. 1044.)


§ 335. Hearing before report of criminal violation.Before any violation of this chapter is reported by theSecretary to any United States attorney for institutionof a criminal proceeding, the person against whom suchproceeding is contemplated shall be given appropriatenotice and an opportunity to present his views, eitherorally or in writing, with regard to such contemplatedproceeding. (June 25, 1938, c. 675, § 305, 52 Stat. 1045.)


§ 336. Report of minor violations. Nothing in thischapter shall be construed as requiring the Secretaryto report for prosecution, or for the institution oflibel or injunction proceedings, minor violations ofthis chapter whenever he believes that the publicinterest will be adequately served by a suitable writtennotice or warning. (June 25, 1938, c. 675, § 306,52 Stat. 1045.)


§ 337. Proceedings in name of United States; pro-vision as to subpenas. All such proceedings for theenforcement, or to restrain violations, of this chaptershall be by and in the name of the United States.Notwithstanding the provisions of section 654 of Title28, subpenas for witnesses who are required to attenda court of the United States, in any district, may runinto any other district in any such proceeding. (June25, 1938, c. 675, § 307, 52 Stat. 1046.)

Effective twelve months aftex date of enactment, by section392 (a), post.

SUBCHAPTER IV.-FOOD

§ 341. Definitions and standards for food. When-ever in the judgment of the Secretary such actionwill promote honesty and fair dealing in the interestof consumers, he shall promulgate regulations fixingand establishing for any food, under its common or

usual name so far as practicable, a reasonable defini-tion and standard of identity, a reasonable standardof quality, and/or reasonable standards of fill of con-tainer: Provided, That no definition and standard ofidentity and no standard of quality shall be estab-lished for fresh or dried fruits, fresh or dried vege-tables, or butter, except that definitions and standardsof identity may be established for avocadoes, canta-loupes, citrus fruits, and melons. In prescribing anystandard of fill of container, the Secretary shall givedue consideration to the natural shrinkage in storageand in transit of fresh natural food and to need forthe necessary packing and protective material. Inthe prescribing of any standard of quality for anycanned fruit or canned vegetable, consideration shallbe given and due allowance made for the differingcharacteristics of the several varieties of such fruit orvegetable. In prescribing a definition and standard ofidentity for any food or class of food in which optionalingredients are permitted, the Secretary shall, for thepurpose of promoting honesty and fair dealing in theinterest of consumers, designate the optional ingredi-ents which shall be named on the label. Any defini-tion and standard of identity prescribed by the Secre-tary for avocadoes, cantaloupes, citrus fruits, or mel-ons shall relate only to maturity and to the effectsof freezing. (June 25, 1938, c. 675, § 401, 52 Stat.1046.)


§ 342. Adulterated food. A food shall be deemedto be adulterated-

(a) Poisonous, insanitary, etc., ingredients. (1) Ifit bears or contains any poisonous or deleterious sub-stance which may render it injurious to health; but incase the substance is not an added substance such foodshall not be considered adulterated under this clauseif the quantity of such substance in such food does notordinarily render it injurious to health; or (2) if itbears or contains any added poisonous or added dele-terious substance which is unsafe within the meaningof section 346; or (3) if it consists in whole or in partof any filthy, putrid, or decomposed substance, or if itis otherwise unfit for food; or (4) if it has been pre-pared, packed, or held under insanitary conditionswhereby it may have become contaminated with filth,or whereby it may have been rendered injurious tohealth ; or (5) if it Is, in whole or in part, the productof a diseased animal or of an animal which has diedotherwise than by slaughter; or (6) if its container iscomposed, in whole or in part, of any poisonous ordeleterious substance which may render the contentsinjurious to health.

(b) Absence, substitution, or addition of constitu-ents. (1) If any valuable constituent has been inwhole or in part omitted or abstracted therefrom; or(2) if any substance has been substituted wholly or inpart therefor; or (3) if damage or inferiority has beenconcealed in any manner; or (4) if any substance hasbeen added thereto or mixed or packed therewith soas to increase its bulk or weight, or reduce its qualityor strength, or make it appear better 'or of greatervalue than it is.

(c) Uncertified coal tar coloring. If it bears orcontains a coal-tar color other than one from a batchthat has been certified in accordance with regulationsas provided by section 346: Provided, That this para-graph shall not apply to citrus fruit bearing or con-taining a coal-tar color if application for listing ofsuch color has been made under this chapter and suchapplication has not been acted on by the Secretary, ifsuch color was commonly used prior to the enactmentof this chapter for the purpose of coloring citrus fruit.

(d) Confectionery containing alcohol or nonnutri-tive substance. If it is confectionery, and it bears orcontains any alcohol or nonnutritive article or sub-stance except harmless coloring, harmless flavoring,harmless resinous glaze not in excess of four-tenths of1 per centum, natural gum, and pectin: Provided, Thatthis paragraph shall not apply to any confectioneryby reason of its containing less than one-half of 1 percentum by volume of alcohol derived solely from the

13 § 342


use of flavoring extracts, or to any chewing gum byreason of its containing harmless nonnutritive masti-catory substances. (June 25, 1938, c. 675, § 402, 52Stat. 1046.)

Effective twelve months after (late of enactment, by section392 a), post.

Effective date of certain provisions postponed, see noteunder section 392, post.

§ 343. Misbranded food. A food shall be deemed tobe misbranded-

(a) False or misleading label. If its labeling isfalse or misleading in any particular.

(b) Offer for sale under another name. If it isoffered for sale under the name of another food.

(c) Imitation of another food. If it is an imitationof another food, unless its label bears, in type of uni-form size and prominence, the word "imitation" and,immediately thereafter, the name of the food imitated.

(d) Misleading container. If its container is somade, formed, or filled as to be misleading.

(e) Package form. If in package form unless itbears a label containing (1) the name and place of busi-ness of the manufacturer, packer, or distributor; and(2) an accurate statement of the quantity of the con-tents in terms of weight, measure, or numerical count:Provided, That under clause (2) of this paragraphreasonable variations shall be permitted, and exemp-tions as to small packages shall be established, byregulations prescribed by the Secretary.

(f) Prominence of information on label. If anyword, statement, or other information required by orunder authority of this chapter to appear on the labelor labeling is not prominently placed thereon withsuch conspicuousness (as compared with other words,statements, designs, or devices, in the labeling) andin such terms as to render it likely to be read andunderstood by the ordinary individual under customaryconditions of purchase and use.

(g) Representation as to definition and standardof identity. If it purports to be or is represented as afood for which a definition and tandard of identityhas been prescribed by regulations as provided by sec-tion 341, unless (1) it conforms to such definition andstandard, and (2) its label bears the name of the foodspecified in the definition and standard, and, insofaras may be required by such regulations, the commonnames of optional ingredients (other than spices,flavoring, and colcring) present in such food.

(h) Representation as to standards of quality andfill of container. If it purports to be or is repre-sented as-

(1) a food for which a standard of quality has beenprescribed by regulations as provided by section 341,and its quality falls below such standard, unless itslabel bears, in such manner and form as such regula-tions specify, a statement that it falls below suchstandard; or

(2) a food for which a standard or standards offill of container have been prescribed by regulationsas provided by section 341, and it falls below the stand-ard of fill of container applicable thereto, unless itslabel bears, In such manner and form as such regula-tions specify, a statement that it falls below suchstandard.

(i) Label where no representation as to definitionand standard of identity. If it is not subject to theprovisions of paragraph (g) of this section unless itslabel bears (1) the common or usual name of thefood, If any there be, and (2) in case it is fabricatedfrom two or more ingredients, the common or usualname of each such ingredient; except that spices, fla-vorings, and colorings, other than those sold as such,may be designated as spices, flavorings, and coloringswithout naming each: Provided, That, to the extentthat compliance with the requirements of clause (2)of this paragraph is impracticable, or results in decep-tion or unfair competition, exemptions shall be estab-lished by regulations promulgated by the Secretary.

(j) Representation for special dietary use. If itpurports to be or is represented for special dietaryuses, unless its label bears such information concerning

its vitamin, mineral, and other dietary properties asthe Secretary determines to be, and by regulationsprescribes as, necessary in order fully to inform pur-chasers as to its value for such uses.

(k) Artificial flavoring, etc.; exception of articlesfrom (g), (i), and (k). If it bears or contains anyartificial flavoring, artificial coloring, or chemicalpreservative, unless it bears labeling stating that fact:Provided, That to the extent that compliance with therequirements of this paragraph is impracticable,exemptions shall be established by regulations pro-mulgated by the Secretary. The provisions of thisparagraph and paragraphs (g) and (i) with respectto artificial coloring shall not apply in the case ofbutter, cheese, or ice cream. (June 25, 1938, c. 675,§ 403, 52 Stat. 1047.)

Effective twelve months after date of enactment, by sec-tion 392 (a), post.


§ 344. Emergency permit control-(a) Conditionson manufacturing, processing, etc., as health measure.Whenever the Secretary finds after investigation thatthe distribution in interstate commerce of any classof food may, by reason of contamination with micro-organisms during the manufacture, processing, orpacking thereof in any locality, be injurious to health,and that such injurious nature cannot be adequatelydetermined after such articles have entered interstatecommerce, he then, and in such case only, shall pro-mulgate regulations providing for the Issuance, tomanufacturers, processors, or packers of such classof food in such locality, of permits to which shall beattached such conditions governing the manufacture,processing, or packing of such class of food, for suchtemporary period of time, as may be necessary to pro-tect the public health; and after the effective dateof such regulations, and during such temporary period,no person shall introduce or deliver for introductioninto interstate commerce any such food manufac-tured, processed, or packed by any such manufacturer,processor, or packer unless such manufacturer, proc-essor, or packer holds a permit issued by the Secre-tary as provided by such regulations.

(b) Violation of permit; suspension and reinstate-ment. The Secretary is authorized to suspend imme-diately upon notice any permit issued under authorityof this section if it is found that any of the conditionsof the permit have been violated. The holder of apermit so suspended shall be privileged at any time toapply for the reinstatement of such permit, and theSecretary shall, immediately after prompt hearingand an inspection of the establishment, reinstate suchpermit if it is found that adequate measures havebeen taken to comply with and maintain the condi-tions of the permit, as originally issued or as amended.

(c) Inspection of permit-holding establishments.Any officer or employee duly designated by the Secre-tary shall have access to any factory or establish-ment, the operator of which holds a permit from theSecretary, for the purpose of ascertaining whether ornot the conditions of the permit are being compliedwith, and denial of access for such inspection shallbe ground for suspension of the permit until suchaccess is freely given by the operator. (June 25, 1938,c. 675, § 404, 52 Stat. 1048.)

Effective twelve months after date of enactment, by sec-tion 392 (a), post.

§ 345. Regulations making exemptions. The Sec-retary shall promulgate regulations exempting fromany labeling requirement of this chapter (1) smallopen containers of fresh fruits and fresh vegetablesand (2) food which is, in accordance with the practiceof the trade, to be processed, labeled, or repacked insubstantial quantities at establishments other thanthose where originally processed or packed, on condi-tion that such food is not adulterated or misbrandedunder the provisions of this chapter upon removalfrom such processing, labeling, or repacking establish-ment. (June 25, 1938, c. 675, § 405, 52 Stat. 1049.)


Page 514§. 343


§ 346. Tolerances for poisonous ingredients in foodand certification of coal-tar colors for food-(a) Reg-ulations for tolerating unavoidable poisonous ingre-dients. Any poisonous or deleterious substance addedto any food, except where such substance is requiredin the production thereof or cannot be avoided by goodmanufacturing practice shall be deemed to be unsafefor purposes of the application of clause (2) of sec-tion 342 (a) ; but when such substance is so requiredor cannot be so avoided, the Secretary shall promulgateregulations limiting the quantity therein or thereon tosuch extent as he finds necessary for the protectionof public health, and any quantity exceeding the limitsso fixed shall also be deemed to be unsafe for purposesof the application of clause (2) of section 342 (a).While such a regulation is in effect limiting the quan-tity of any such substance in the case of any food,such food shall not, by reason of bearing or containingany added amount of such substance, be considered tobe adulterated within the meaning of clause (1) ofsection 342 (a). In determining the quantity of suchadded substance to be tolerated in or on different arti-cles of food the Secretary shall take into account theextent to which the use of such substance is requiredor cannot be avoided in the production of each sucharticle, and the other ways in which the consumer maybe affected by the same or other poisonous or deleteri-ous substances.

(b) Regulations for coal tar colors. The Secretaryshall promulgate regulations providing for the listingof coal-tar colors which are harmless and suitable foruse in food and for the certification of batches of suchcolors, with or without harmless diluents. (June 25,1938, c. 675, § 406, 52 Stat. 1049.)


SUBCHAPTER V.-DRUGS AND DEVICES

§ 351. Adulterated drugs and devices. A drug ordevice shall be deemed to be adulterated-

(a) Poisonous, insanitary, etc., ingredients. (1) Ifit consists in whole or in part of any filthy, putrid, ordecomposed substance; or (2) if it has been prepared,packed, or held under insanitary conditions whereby itmay have been contaminated with filth, or whereby itmay have been rendered injurious to health; or (3) ifit is a drug and its container is composed, in whole orin part, of any poisonous or deleterious substance whichmay render the contents injurious to health; or (4) ifit is a drug and it bears or contains, for purposes ofcoloring only, a coal-tar color other than one from abatch that has been certified in accordance with regu-lations as provided by section 354.

(b) Strength, quality, or purity differing from offi-cial compendium. If it purports to be or is representedas a drug the name of which is recognized in an officialcompendium, and its strength differs from, or its qual-ity or purity falls below, the standard set forth in suchcompendium. Such determination as to strength, qual-ity, or purity shall be made in accordance with thetests or methods of assay set forth in such compendium,except that whenever tests or methods of assay havenot been prescribed in such compendium, or such testsor methods of assay as are prescribed are, in the judg-ment of the Secretary, insufficient for the making ofsuch determination, the Secretary shall bring such factto the attention of the appropriate body charged withthe revision of such compendium, and if such body failswithin a reasonable time to prescribe tests or methodsof assay which, in the judgment of the Secretary, aresufficient for purposes of this paragraph, then the Sec-retary shall promulgate regulations prescribing appro-priate tests or methods of assay in accordance withwhich such determination as to strength, quality, orpurity shall be made. No drug defined in an officialcompendium shall be deemed to be adulterated underthis paragraph because it differs from the standard ofstrength, quality, or purity therefor set forth in suchcompendium, if its difference in strength, quality, orpurity from such standard is plainly stated on its label.Whenever a drug is recognized in boththeUnited States

Pharmacopeia and the Homoeopathic Pharmacopoeia ofthe United States it shall be subject to the requirementsof the United States Pharmacopoeia unless it is labeledand offered for sale as a hommeopathic drug, in whichcase it shall be subject to the provisions of the Homceo-pathic Pharmacopoeia of the United States and not tothose of the United States Pharmacopoeia.

(c) Misrepresentation of strength, etc., where drugis unrecognized in compendium. If it is not subjectto the provisions of paragraph (b) of this section andits strength differs from, or its purity or quality fallsbelow, that which it purports or is represented topossess.

(d) Mixture with or substitution of another sub-stance. If it is a drug and any substance has been(1) mixed or packed therewith so as to reduce itsquality or strength or (2) substituted wholly or in parttherefor. (June 25, 1938, c. 675, § 501, 52 Stat. 1049.)



§ 352. Misbranded drugs and devices. A drug ordevice shall be deemed to be misbranded-

(a) False or misleading label. If its labeling isfalse or misleading in any particular.

(b) Package form; contents of label. If in packageform unless it bears a label containing (1) the nameand place of business of the manufacturer, packer, ordistributor; and (2) an accurate statement of thequantity of the contents In terms of weight, measure,or numerical count: Provided, That under clause (2)of this paragraph reasonable variations shall be per-mitted, and exemptions as to small packages shall beestablished, by regulations prescribed by the Secretary.

(c) Prominence of information on label. If anyword, statement, or other information required by orunder authority of this chapter to appear on the labelor labeling is not prominently placed thereon withsuch conspicuousness (as compared with other words,statements, designs, or devices, in the labeling) andin such terms as to render it likely to be read andunderstood by the ordinary individual under custom-ary conditions of purchase and use.

(d) Habit forming substances. If it is for use byman and contains any quantity of the narcotic orhypnotic substance alpha eucaine, barbituric acid,betaeucaine, bromal, cannabis, carbromal, chloral,coca, cocaine, codeine, heroin, marihuana, morphine,opium, paraldehyde, peyote, or sulphonmethane; orany chemical derivative of such substance, whichderivative has been by the Secretary, after investiga-tion, found to be, and by regulations designated as,habit forming; unless its label bears the name andquantity or proportion of such substance or derivativeand in juxtaposition therewith the statement "Warn-ing-May be habit forming." (As amended June 23,1939, c. 242, § 3, 53 Stat. 854.)

(e) Designation of drug by name not in compen-dium. If it is a drug and is not designated solely by aname recognized in an official compendium unless itslabel bears (1) the common or usual name of thedrug, if such there be; and (2), in case it is fabri-cated from two or more ingredients, the common orusual name of each active ingredient, including thequantity, kind, and proportion of any alcohol, andalso including, whether active or not, the name andquantity or proportion of any bromides, ether, chloro-form, acetanilid, acetphenetidin, amidopyrine, antipy-rine, atropine, hyoscine, hyoscyamine, arsenic, digi-talis, digitalis glucosides, mercury, ouabain, strophan-thin, strychnine, thyroid, or any derivative or prepara-tion of any such substances, contained therein: Pro-vided, That to the extent that compliance with therequirements of clause (2) of this paragraph is im-practicable, exemptions shall be established by regu-lations promulgated by the Secretary.

(f) Directions for use and warnings on label.Unless its labeling bears (1) adequate directions foruse; and (2) such adequate warnings against use inthose pathological conditions or by children where its

Page 515 § 352


use may be dangerous to health, or against unsafedosage or methods or duration of administration orapplication, in such manner and form, as are neces-sary for thb protection of users: Provided, That whereany requirement of clause (1) of this paragraph, asapplied to any drug or device, is not necessary forthe protection of the public health, the Secretary shallpromulgate regulations exempting such drug or de-vice from such requirement.

(g) Representation as recognized drug; packingand labeling. If it purports to be a drug the nameof which is recognized in an official compendium, unlessit is packaged and labeled as prescribed therein:Provided, That the method of packing may be modi-fied with the consent of the Secretary. Whenever adrug is recognized in both the United States Phar-macopceia and the Homoeopathic Pharmacopoeia of theUnited States, it shall be subject to the requirementsof the United States Pharmacopoeia with respect topackaging and labeling unless it is labeled and offeredfor sale as a homeopathic drug, in which case it shallbe subject to the provisions of the HomcebpathicPharmacopiia of the United States, and not to thoseof the United States Pharmacopeia.

(h) Deteriorative drugs; packing and labeling.If it has been found by the Secretary to be a drugliable to deterioration, unless it is packaged in suchform and manner, and its label bears a statement ofsuch precautions, as the Secretary shall by regula-tions require as necessary for the protection of thepublic health. No such regulation shall be establishedfor any drug recognized in an official compendiumuntil the Secretary shall have informed the appro-priate body charged with the revision of such com-pendium of the need for such packaging or labeling re-quirements and such body shall have failed within areasonable time to prescribe such requirements.

(i) Drug; misleading container; imitation; offer forsale under another name. (1) If it is a drug and itscontainer is so made, formed, or filled as to be mis-leading; or (2) if it is an imitation of another drug;or (3) if it is offered for sale under the name ofanother drug.

(j) Health-endangering when used as prescribed.If it is dangerous to health when used in the dosage,or with the frequency or duration prescribed, recom-mended, or suggested in the labeling thereof. (June25, 1938, c. 675, § 502, 52 Stat. 1050, as amended June23, 1939, c. 242, § 3, 53 Stat. 854.)

Effective twelve months after date of enactment, exceptsubsection (j), which is effective on date of enactment. Seasection 392 (a), post.


§ 353. Exemptions in case of drugs and devices-(a) Regulations for goods to be processed, labeled,or repacked elsewhere. The Secretary is hereby di-rected to promulgate regulations exempting from anylabeling or packaging requirement of this chapter drugsand devices which are, in accordance with the prac-tice of the trade, to be processed, labeled, or repackedin substantial quantities at establishments other thanthose where originally processed or packed, on conditionthat such drugs and devices are not adulterated or mis-branded under the provisions of this chapter upon re-moval from such processing, labeling, or repackingestablishment.

(b) Prescription by physician, etc. A drug dis-pensed on a written prescription signed by a physician,dentist, or veterinarian (except a drug dispensed inthe course of the conduct of a business of dispensingdrugs pursuant to diagnosis by mail), shall if-

(1) such physician, dentist, or veterinarian islicensed by law to administer such drug, and

(2) such drug bears a label containing the name andplace of business of the dispenser, the serial numberand date of such prescription, and the name of suchphysician, dentist, or veterinarian,

be exempt from the requirements of section 352 (b)and (e), and (in case such prescription is marked bythe writer thereof as not refillable or its refilling is

prohibited by law) of section 352 (d). (June 25, 1938,c. 675, § 503, 52 Stat. 1061.)


§ 354. Certification of coal-tar colors for drugs.The Secretary shall promulgate regulations providingfor the listing of coal-tar colors which are harmlessand suitable for use in drugs for purposes of coloringonly and for the certification of batches of such colors,with or without harmless diluents. (June 25, 1938,c. 675, § 504, 52 Stat. 1052.)


§ 355. New drugs-(a) Necessity effective applica-tion. No person shall introduce or deliver for intro-duction into interstate commerce any new drug, unlessan application filed pursuant to subsection (b) iseffective with respect to such drug.

(b) Filing application; contents. Any person mayfile with the Secretary an application with respect toany drug subject to the provisions of subsection (a).Such person shall submit to the Secretary as a partof the application (1) full reports of investigationswhich have been made to show whether or not suchdrug is safe for use; (2) a full list of the articles usedas components of such drug; (3) a full statement ofthe composition of such drug; (4) a full description ofthe methods used in, and the facilities and controlsused for, the manufacture, processing, and packing ofsuch drug; (5) such samples of such drug and of thearticles used as components thereof as the Secretarymay require; and (6) specimens of the labeling pro-posed to be used for such drug.

(c) Effective date of application. An applicationprovided for in subsection (b) shall become effectiveon the sixtieth day after the filing thereof unless priorto such day the Secretary by notice to the applicantin writing postpones the effective date of the applica-tion to such time (not more than one hundred andeighty days after the filing thereof) as the Secretarydeems necessary to enable him to study and investigatethe application.

(d) Grounds for refusing application to becomeeffective. If the Secretary finds, after due notice tothe applicant and giving him an opportunity for a hear-ing, that (1) the investigations, reports of which arerequired to be submitted to the Secretary pursuant tosubsection (b), do not include adequate tests by allmethods reasonably applicable to show whether or notsuch drug is safe for use under the conditions pre-scribed, recommended, or suggested in the proposedlabeling thereof; (2) the results of such tests showthat such drug is unsafe for use under such conditionsor do not show that such drug is safe for use undersuch conditions; (3) the methods used in, and thefacilities and controls used for, the manufacture, proc-essing, and packing of such drug are inadequate topreserve its identity, strength, quality, and purity; or(4) upon the basis of the information submitted tohim as part of the application, or upon the basis ofany other information before him with respect to suchdrug, he has insufficient information to determinewhether such drug is safe for use under such conditions,he shall, prior to the effective date of the application,issue an order refusing to permit the application tobecome effective.

(e) Suspension of effectiveness of application. Theeffectiveness of an application with respect to any drugshall, after due notice and opportunity for hearing tothe applicant, by order of the Secretary be suspendedif the Secretary finds (1) that clinical experience,tests by new methods, or tests by methods not deemedreasonably applicable when such application becameeffective show that such drug Is unsafe for use underthe conditions of use upon the basis of which the appli-cation became effective, or (2) that the applicationepntains any untrue statement of a material fact. Theorder shall state the findings upon which it is based.

(f) Revocation of order refusing effectiveness. Anorder refusing to permit an application with respect

§ 353 Page 516


to any drug to become effective shall be revoked when-ever the Secretary finds that the facts so require.

(g) Service of orders. Orders of the Secretaryissued under this section shall be served (1) in personby any officer or employee of the department designatedby the Secretary or (2) by mailing the order by reg-istered mail addressed to the applicant or respondent athis last-known address in the records of the Secretary.

(h) Appeal from order. An appeal may be takenby the applicant from an order of the Secretary refus-ing to permit the application to become effective, orsuspending the effectiveness of the application. Suchappeal shall be taken by filing in the district court ofthe United States within any district wherein suchapplicant resides or has his principal place of business,or in the District Court of the United States for theDistrict of Columbia, within sixty days after the entryof such order, a written petition praying that the orderof the Secretary be set aside. A copy of such petitionshall be forthwith served upon the Secretary, or uponany officer designated by him for that purpose, andthereupon the Secretary shall certify and file in thecourt a transcript of the record upon which the ordercomplained of was entered. Upon the filing of suchtranscript such court shall have exclusive jurisdictionto affirm or set aside such order. No objection to theorder of the Secretary shall be considered by the courtunless such objection shall have been urged before theSecretary or unless there were reasonable grounds forfailure so to do. The finding of the Secretary as tothe facts, if supported by substantial evidence, shallbe conclusive. If any person shall apply to the courtfor leave to adduce additional evidence, and shall showto the satisfaction of the court that such additionalevidence is material and that there were reasonablegrounds for failure to adduce such evidence in theproceeding before the Secretary, the court may ordersuch additional evidence to be taken before the Secre-tary and to be adduced upon the hearing in such man-ner and upon such terms and conditions as to thecourt may seem proper. The Secretary may modifyhis findings as to the facts by reason of the additionalevidence so taken, and he shall file with the courtsuch modified findings which, if supported by substan-tial evidence, shall be conclusive, and his recommenda-tion, if any, for the setting aside of the original order.The judgment and decree of the court affirming orsetting aside any such order of the Secretary shall befinal, subject to review as provided in sections 225,346, and 347 of Title 28, as amended, and in section 7,as amended, of the Act entitled "An Act to establisha Court of Appeals for the District of Columbia ",approved February 9, 1893 [c. 74, 27 Stat. 435] (D. C.Code, title 18, sec. 26). The commencement of pro-ceedings under this subsection shall not, unless specifi-cally ordered by the court to the contrary, operate asa stay of the Secretary's order.

(i) Exemption of drugs for research. The Secre-tary shall promulgate regulations for exempting fromthe operation of this section drugs intended solely forinvestigational use by experts qualified by scientifictraining and experience to investigate the safety ofdrugs. (June 25, 1938, c. 675, § 505, 52 Stat. 1052.)

Effective on date of enactment, by section 392 (a). post.

SUBCHAPTER VI.-COSMETICS

§ 361. Adulterated cosmetics. A cosmetic shall bedeemed to be adulterated-

(a) If it bears or contains any poisonous or deleteri-ous substance which may render it injurious to usersunder the conditions of use prescribed in the labelingthereof, or under such conditions of use as are custom-ary or usual: Provided, That this provision shall notapply to coal-tar hair dye, the label of which bears thefollowing legend conspicuously displayed thereon:"Caution-This product contains ingredients whichmay cause skin irritation on certain individuals and apreliminary test according to accompanying directionsshould first be made. This product must not be usedfor dyeing the eyelashes or eyebrows; to do so maycause blindness.", and the labeling of which bears

adequate directions for such preliminary testing. Forthe purposes of this paragraph and paragraph (e) theterm "hair dye" shall not include eyelash dyes oreyebrow dyes.

(b) If it consists in whole or in part of any filthy,putrid, or decomposed substance.

(c) If it has been prepared, packed, or held underinsanitary conditions whereby it may have becomecontaminated with filth, or whereby it may have beenrendered injurious to health.

(d) If its container is composed, in whole or inpart, of any poisonous or deleterious substance whichmay render the contents injurious to health.

(e) If it is not a hair dye and it bears or containsa coal-tar color other than one from a batch that hasbeen certified in accordance with regulations as pro-vided by section 364. (June 25, 1938, c. 675, § 601,52 Stat. 1054.)

Effective twelve months after date of enactment, exceptsubsection (a), which with certain exceptions, is effective ondate of enactment. §ee section 392 (a), post.


§ 362. Misbranded cosmetics. A cosmetic shall bedeemed to be misbranded-

(a) If its labeling is false or misleading in anyparticular.

(b) If in package form unless It bears a label con-taining (1) the name and place of business of themanufacturer, packer, or distributor; and (2) anaccurate statement of the quantity of the contents Interms of weight, measure, or numerical count: Pro-vided, That under clause (2) of this paragraph reason-able variations shall be permitted, and exemptions asto small packages shall be established, by regulationsprescribed by the Secretary.

(c) If any word, statement, or other informationrequired by or under authority of this chapter toappear on the label or labeling Is not .prominentlyplaced thereon with such conspicuousness (as com-pared with other words, statements, designs, or de-vices, in the labeling) and in such terms as to renderit likely to be read and understood by the ordinaryindividual under customary conditions of purchaseand use.

(d) If its container is so made, formed, or filledas to be misleading. (June 25, 1938, c. 675, § 60252 Stat. 1054.)



§ 363. Regulations making exemptions. The Sec-retary shall promulgate regulations exempting fromany labeling requirement of this chapter cosmeticswhich are, in accordance with the practice of thetrade, to be processed, labeled, or repacked In sub-stantial quantities at establishments other than thosewhere originally processed or packed, on conditionthat such cosmetics are not adulterated or misbrandedunder the provisions of this chapter upon removalfrom such processing, labeling, or repacking estab-lishment. (June 25, 1938, c. 675, § 603, 52 Stat. 1054.)


§ 364. Certification of coal-tar colors for cos-metics. The Secretary shall promulgate regulationsproviding for the listing of coal-tar colors which areharmless and suitable for use in cosmetics and for thecertification of batches of such colors, with or withoutharmless diluents. (June 25, 1938, c. 675, § 604, 52Stat. 1055.)


SUBCHAPTER VII.-GENERAL ADMINISTRATIVEPROVISIONS

§ 371. Regulations and hearings-(a) Authority topromulgate regulations. The authority to promul-gate regulations for the efficient enforcement of thischapter, except as otherwise provided in this section,is hereby vested in the Secretary.

§ 371Page 517


(b) Regulations for imports and exports. TheSecretary of the Treasury and the Secretary of Agri-culture shall jointly prescribe regulations for the effi-cient enforcement of the provisions of section 381,except as otherwise provided therein. Such regula-tions shall be promulgated in such manner and takeeffect at such time, after due notice, as the Secretaryof Agriculture shall determine.

(c) Conduct of hearings. Hearings authorized orrequired by this chapter shall be conducted by theSecretary or such officer or employee as he may desig-nate for the purpose.

(d) Effectiveness of definitions and standards ofidentity. The definitions and standards of identitypromulgated In accordance with the provisions of thischapter shall be effective for the purposes of the en-forcement of this chapter, notwithstanding such defini-tions and standards as may be contained in other lawsof the United States and regulations promulgatedthereunder.

(e) Hearings of proposed changes in regulations;orders. The Secretary, on his own initiative or uponan application of any interested industry or substantialportion thereof stating reasonable grounds therefor,shall hold a public hearing upon a proposal to issue,amend, or repeal any regulation contemplated by anyof the following sections of this chapter: 341, 343 (j),344 (a), 346 (a) and (b), 351 (b), 352 (d), 352 (h),354, and 364. The Secretary shall give appropriatenotice of the hearing, and the notice shall set forth theproposal in general terms and specify the time andplace for a public hearing to be held thereon not lessthan thirty days after the date of the notice, except thatthe public hearing on regulations under section 344 (a)may be held within a reasonable time, to be fixed bythe Secretary, after notice thereof. At the hearingany interested person may be heard in person or by hisrepresentative. As soon as practicable after comple-tion of the tearing, the Secretary shall by order makepublic his action in issuing, amending, or repealing theregulation or determining not to take such action. TheSecretary shall base his order only on substantial evi-dence of record at the hearing and shall set forth aspart of the order detailed findings of fact on which theorder is based. No such order shall take effect prior tothe ninetieth day after it is issued, except that if theSecretary finds that emergency conditions exist neces-sitating an earlier effective date, then the Secretaryshall specify In the order his findings as to such condi-tions and the order shall take effect at such earlier dateas the Secretary shall specify therein to meet theemergency.

(f) Review of order. (1) In a case of actual con-troversy as to the validity of any order under subsec-tion (e), any person who will be adversely affected bysuch order if placed in effect may at any time prior tothe ninetieth day after such order is issued file a peti-tion with the Circuit Court of Appeals of the UnitedStates for the circuit wherein such person resides orhas his principal place of business, for a judicial reviewof such order. The summons and petition may beserved at any place in the United States. The Secre-tary, promptly upon service of the summons and peti-tion, shall certify and file in the court the transcript ofthe proceedings and the record on which the Secretarybased his order.

(2) If the petitioner applies to the court for leave toadduce additional evidence, and shows to the satisfac-tion of the court that such additional evidence is mate-rial and that there were reasonable grounds for thefailure to adduce such evidence in the proceeding beforethe Secretary, the court may order such additional evi-dence (and evidence in rebuttal thereof) to be takenbefore the Secretary, and to be adduced upon the hear-ing, In such manner and upon such terms and condi-tions as to the court may seem proper. The Secretarymay modify his findings as to the facts, or make newfindings, by reason of the additional evidence so taken,and he shall file such modified or new findings, and hisrecommendation, If any, for the modification or settingaside of his original order, with the return of suchadditional evidence.

(3) The court shall have jurisdiction to affirm theorder, or to set it aside in whole or in part, temporarilyor permanently. If the order of the Secretary refusesto issue, amend, or repeal a regulation and such orderis not in accordance with law the court shall by Itsjudgment order the Secretary to take action, withrespect to such regulation, in accordance with law.The findings of the Secretary as to the facts, if sup-ported by substantial evidence, shall be conclusive.

(4) The judgment of the court affirming or settingaside, in whole or in part, any such order of the Sec-retary shall be final, subject to review by the SupremeCourt of the United States upon certiorari or certifica-tion as provided in sections 346 and 347 of Title 28, asamended.

(5) Any action instituted under this subsection shallsurvive notwithstanding any change in the person oc-cupying the office of Secretary or any vacancy in suchoffice.

(6) The remedies provided for in this subsectionshall be in addition to and not in substitution for anyother remedies provided by law.

(g) Copies of records of hearings. A certified copyof the transcript of the record and proceedings undersubsection (e) shall be furnished by the Secretary toany interested party at his request, and payment of thecosts thereof, and shall be admissible in any criminal,libel for condemnation, exclusion of imports, or otherproceeding arising under or in respect to this chapter,irrespective of whether proceedings with respect to theorder have previously been instituted or become finalunder subsection (f). (June 25, 1938, c. 675, § 701,52 Stat. 1055.)

Effective on enactment, by section 392 (a), post.§ 372. Examinations and investigations-(a) Au.

thority to conduct. The Secretary Is authorized toconduct examinations and investigations for the pur-poses of this chapter through officers and employees ofthe Department or through any health, food, or drugofficer or employee of any State, Territory, or politicalsubdivision thereof, duly commissioned by the Secre-tary as an officer of the Department. In the case offood packed in a Territory the Secretary shall attemptto make inspection of such food at the first point ofentry within the United States when, in his opinionand with due regard to the enforcement of all theprovisions of this chapter, the facilities at his disposalwill permit of such inspection. For the purposes ofthis subsection the term "United States " means theStates and the District of Columbia.

(b) Availability to owner of part of analysis sam-ples. Where a sample of a food, drug, or cosmetic iscollected for analysis under this chapter the Secretaryshall, upon request, provide a part of such official sain-pIe for examination or analysis by any person namedon the label of the article, or the owner thereof, orhis attorney or agent; except that the Secretary isauthorized, by regulations, to make such reasonableexceptions from, and impose such reasonable termsand conditions relating to, the operation of this sub-section as he finds necessary for the proper adminis-tration of the provisions of this chapter.

(c) Records of other departments and agencies.For purposes of enforcement of this chapter, recordsof any department or independent establishment inthe executive branch of the Government shall be opento inspection by any official of the Department ofAgriculture duly authorized by the Secretary to makesuch inspection. (June 25, 1938, c. 675, § 702, 52Stat. 1056.)


§ 372a. Examination of sea food on request ofpacker; marking food with results; fees; penalties.The Secretary of Agriculture, upon application of anypacker of any sea food for shipment or sale withinthe jurisdiction of this Act,1 may, at his discretion,designate inspectors to examine and Inspect such foodand the production, packing, and labeling thereof. Ifon such examination and inspection compliance isfound with the provisions of this Act' and regulations

§ 372 Page 518


promulgated thereunder, the applicant shall be author-ized or required to mark the food as provided by regu-lation to show such compliance. Services under thissection shall be rendered only upon payment by theapplicant of fees fixed by regulation in such amountsas may be necessary to provide, equip, and maintainan adequate and efficient inspection service. Receiptsfrom such fees shall be covered into the Treasury andshall be available to the Secretary of Agriculture forexpenditures incurred in carrying out the purposes ofthis section, including expenditures for salaries ofadditional inspectors when necessary to supplementthe number of inspectors for whose salaries Congresshas appropriated. The Secretary is hereby authorizedto promulgate regulations governing the sanitary andother conditions under which the service herein pro-vided shall be granted and maintained, and for other-wise carrying out the purposes of this section. Anyperson who forges, counterfeits, simulates, or falselyrepresents, or without proper authority uses any mark,stamp, tag, label, or other identification devices author-ized or required by the provisions of this section orregulations thereunder, shall be guilty of a misde-meanor, and shall on conviction thereof be subject toimprisonment for not more than one year or a fine ofnot less than $1,000 nor more than $5,000, or both suchimprisonment and fine. (June 30, 1906, c. 3915, § 1OA;June 22, 1934, c. 712, 48 Stat. 1204; Aug. 27, 1935, c.739, 49 Stat. 871; June 25, 1938, c. 675, § 902 (a),52 Stat. 1059.)

1 See sections 1-5 and 7-15, ante, and note to this section.This section. which is not a provision of the Federal Food,

Drug, and Cosmetic Act, was formerly section 14a of thistitle. Act June 25, 1938, cited to the text, provided that thesection should remain in force and effect and be applicableto the provisions of this chapter. See section 392 (a), post.

§ 373. Records of interstate shipment. For thepurpose of enforcing the provisions of this chapter,carriers engaged in interstate commerce, and personsreceiving food, drugs, devices, or cosmetics in interstatecommerce or holding such articles so received, shall,upon the request of an officer or employee duly desig-nated by the Secretary, permit such officer or employee,at reasonable times, to have access to and to copy allrecords showing the movement in interstate commerceof any food, drug, device, or cosmetic, or the holdingthereof during or after such movement, and the quan-tity, shipper, and consignee thereof; and it shall beunlawful for any such carrier or person to fail topermit such access to and copying of any such recordso requested when such request is accompanied by astatement in writing specifying the nature or kind offood, drug, device, or cosmetic to which such requestrelates: Provided, That evidence obtained under thissection shall not be used in a criminal prosecution ofthe person from whom obtained: Provided further,That carriers shall not be subject to the other provi-sions of this chapter by reason of their receipt, car-riage, holding, or delivery of food, drugs, devices, orcosmetics in the usual course of business as carriers.(June 25, 1938, c. 675, § 703, 52 Stat. 1057.)


§ 374. Factory inspection. For purposes of enforce-ment of this chapter, officers or employees duly desig-nated by the Secretary, after first making request andobtaining permission of the owner, operator, or custo-dian thereof, are authorized (1) to enter, at reasonabletimes, any factory, warehouse, or establishment inwhich food, drugs, devices, or cosmetics are manu-factured, processed, packed, or held, for introductioninto interstate commerce or are held after such intro-duction, or to enter any vehicle being used to transportor hold such food, drugs, devices, or cosmetics in inter-state commerce; and (2) to inspect, at reasonabletimes, such factory, warehouse, establishment, or ve-hicle and all pertinent equipment, finished and un-finished materials, containers, and labeling therein.(June 25, 1938, c. 675, § 704, 52 Stat. 1057.)


§ 375. Publicity-(a) Reports. The Secretary shallcause to be published from time to time reports sum-marizing all judgments, decrees, and court orderswhich have been rendered under this chapter, includingthe nature of the charge and the disposition thereof.

(b) Information regarding certain goods. TheSecretary may also cause to be disseminated informa-tion regarding food, drugs, devices, or cosmetics insituations involving, in the opinion of the Secretary,imminent danger to health or gross deception of theconsumer. Nothing in this section shall be construedto prohibit the Secretary from collecting, reporting, andillustrating the results of the investigations of theDepartment. (June 25, 1988, c. 675, § 705, 52 Stat.1057.)


§ 376. Cost of certification of coal-tar colors. Theadmitting to listing and certification of coal-tar colors,in accordance with regulations prescribed under thischapter, shall be performed only upon payment ofsuch fees, which shall be specified in such regulations,as may be necessary to provide, maintain, and equipan adequate service for such purposes. (June 25, 1938,c. 675, § 706, 52 Stat. 1058.)


Section made "immediately effective" by Act May 2, 1939,c. 107, § 1, Title I, 53 Stat. 631. It was originally effectivetwelve months after date of enactment, by section 392 (a),post.

SUBCHAPTER VIII.-IMPORTS AND EXPORTS

§ 381. Imports and exports-(a) Imports; exam-ination and refusal of admission. The Secretary ofthe Treasury shall deliver to the Secretary of Agricul-ture, upon his request, samples of food, drugs, devices,and cosmetics which are being imported or offered forimport into the United States, giving notice thereof tothe owner or consignee, who may appear before theSecretary of Agriculture and have the right to intro-duce testimony. If it appears from the examinationof such samples or otherwise that (1) such article hasbeen manufactured, processed, or packed under In-sanitary conditions, or (2) such article is forbidden orrestricted in sale in the country in which it was pro-duced or from which it was exported, or (3) sucharticle Is adulterated, misbranded, or In violation ofsection 355, then such article shall be refused admis-sion. This paragraph shall not be construed to pro-hibit the admission of narcotic drugs the importationof which is permitted under section 2 of the Act ofMay 26, 1922, as amended (U. S. C., 1934 edition,Title 21, sec. 173).'

1 So in original. Section 2 of cited Act comprises sections180 and 182 of this title.

(b) Same; disposition of refused articles. TheSecretary of the Treasury shall refuse delivery to theconsignee and shall cause the destruction of any sucharticle refused admission, unless such article is ex-ported by the consignee within three months from thedate of notice of such refusal, under such regulations asthe Secretary of the Treasury may prescribe: Provided,That the Secretary of the Treasury may deliver to theconsignee any such article pending examination anddecision in the matter on execution of a bond as liqui-dated damages for the amount of the full invoice valuethereof together with the duty thereon and on refusingfor any cause to return such article or any part thereofto the custody of the Secretary of the Treasury whendemanded for the purpose of excluding it from thecountry or for any other purpose, such consignee shallforfeit the full amount of the bond as liquidateddamages.

(c) Same; charges concerning refused articles.All charges for storage, cartage, and labor on anyarticle which is refused admission or delivery shall bepaid by the owner or consignee and in default of suchpayment shall constitute a lien against any futureimportations made by such owner or consignee.

§ 381Page 519


(d) Exports. A food, drug, device, or cosmetic in-tended for export shall not be deemed to be adulteratedor misbranded under this chapter if it (1) accords tothe specifications of the foreign purchaser, (2) is notin conflict with the laws of the country to which it isintended for export, and (3) is labeled on the outsideof the shipping package to show that it is intendedfor export. But if such article is sold or offered forsale in domestic commerce, this subsection shall notexempt it from any of the provisions of this chapter.(June 25, 1938, c. 675, § 801, 52 Stat. 1058.)


SUBCHAPTER IX.-MISCELLANEOUS

§ 391. Separability clause. If any provision of thischapter is declared unconstitutional, or the applica-bility thereof to any person or circumstances is heldinvalid, the constitutionality of the remainder of thechapter and the applicability thereof to other personsand circumstances shall not be affected thereby. (June25, 1938, c. 675, § 901, 52 Stat. 1059.)


§ 392. Effective date and repeals-(a) Effectivedate; repeal of 1906 Act; laws unaffected. This chap-ter shall take effect twelve months after the date ofits enactment. The Federal Food and Drugs Act ofJune 30, 1906, as amended,' shall remain in force untilsuch effective date, and, except as otherwise providedin this subsection, is hereby repealed effective uponsuch date: Provided, That the provisions of section 371shall become effective on the enactment of this chapter,and thereafter the Secretary is authorized hereby to(1) conduct hearings and to promulgate regulationswhich shall become effective on or after the effective(late of this chapter as the Secretary shall direct, and(2) designate prior to the effective date of this chapterfood-baving common or usual names and exempt suchfood from the requirements of clause (2) of section 343(i) for a reasonable time to permit the formulation,promulgation, and effective application of definitionsand standards of identity therefor as provided by sec-tion 341: Provided further, That sections 352 (j), 355,and 361 (a),:and all other provisions of this chapterto the extent that they may relate to the enforcementof such sections, shall take effect on the date of theenactment of this chapter, except that in the case of acosmetic to which the proviso of section 361 (a) relates,such c9smetic shall not, prior to the ninetieth day aftersuch date of enactment, be deemed adulterated by rea-son .of the failure of its label to bear the legend pre-scribed in such proviso: Provided further, That section321a of this title defining butter and providing a stand-.ard therefor; ,section 321b of this title, defining wrappedmeats as in package form; and section 372a of thistitle shall remain in force and effect and be applicableto the provisions of this chapter. •(b) Exemption of meats and meat food products.M6ats and -meat food products shall be exempt fromthe provisions of this chapter to the extent of the appli-.cation or the extension thereto of the Meat InspectionAct, approved March 4, 1907, as amended (U. S. C.,1934 ed., title 21, sees. 71-91; 34 Stat. 1260 et seq.).

(c) Laws unaffected. Nothing contained in thischapter shall be construed as in any way affecting,modifying, repealing, or superseding the provisions ofthe virus, serum, and toxin Act of July 1, 1902 (U. S.C., 1934 ed., title 42, chap. 4)2; the Filled Cheese Act ofJune 6, 1896 (U. S. C., 1934 ed., title 26, ch. 10),' theFilled Milk Act of March 4, 1923 (U. S. C., 1934 ed.,title 21, ch. 3, sees. 61-63) ; or the Import Milk Act ofFebruary 15, 1927 (U. S. C., 1934 ed., title 21, ch. 4,secs. 141-149).

(d) Availability of appropriations. In order tocarry out the provisions of this chapter which takeeffect prior to the iepeal of the Food and Drugs Actof June 30, 1906, as amended,' appropriations availablefor the enforcement of such Act of June 30, 1906, arealso authorized to be made available to carry out suchprovisions. (June 25, 1938, c. 675, 902, 52 Stat. 1.059.)

1 See sections 1-5, 7-15, and 372a, ante.I See section 141 et seq. of title 42, The Public Health and

Welfare.3 Now chapter 17 of Title 26, Internal Revenue.Postponement of effective date of certain provisions of the

Federal Food, Drug, and Cosmetic Act was effected by ActJune 23, 1939, c. 242, 53 Stat. 853, 854, sections 1 and 2 ofwhich provided as follows: "[Sec. 11 (a) The effective dateof the following provisions of the Federal Food, Drug, andCosmetic Act is hereby postponed until January 1. 1940:Sections 402 [342 of this title] (c) ; 403 [343 of this title](e) (1) ; 403 [343 of this title] (g), (h). (1), (J), and (k);501 [351 of this title] (a) (4) ; 502 [352 of this title] (b),(d), (e), (f), (g), and (h) ; 601 [361 of this title] (e) ; and602 [362 of this title] (b).

"(b) The Secretary of Agriculture shall promulgate regu-lations further postponing to July 1, 1940, the effective dateof the provisions of sections 403 [343 of this title] (e) (1) ;403 [343 of this title] (g), (h), (i), (j), and (k) ; 502 [352of this title] (b), (d), (e), (f), (g), and (h), and 602 [362of this title] (b) of such Act with respect to lithographedlabeling 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 compliancewith such provisions would be unduly burdensome by reasonof causing the loss of valuable stocks of such labeling or con-tainers, and where such postponement would not prevent thepublic interest being adequately served: Provided, That inno case shall such regulations apply to labeling which wouldnot have complied with the requirements of the Food andDrugs 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 caseof food: ', of the Food and Drugs Act of June 30, 1906, asamended, and regulations promulgated thereunder, and allother provisions of such Act to the extent that they mayrelate to the enforcement of such section 8 [section 10 ofthis title] and of such regulations, shall remain in force untilJanuary 1, 1940.

"(b) The provisions of such Act of June 30, 1906, asamended [sections 1-5, 7-15, and 372a of this title], to theextent that they impose, or authorize the imposition of, anyrequirement imposed by section 403 [343 of this title] (k)of the Federal Food, Drug, and Cosmetic Act, shall remainin force until January 1, 1940.

"(c) Notwithstanding the provisions of section 1 of thisAct, such section shall not apply-

"(1) to the provisions of section 502 [352 of this title] (d)and (e) of the Federal Food, Drug, and Cosmetic Act, insofaras such provisions relate to any substance named in section 8[section 10 of this titlel, paragraph second, under the heading'In the case of drugs: , of the Food and Drugs Act of June30. 1906, as amended, or a derivative of any such sub-stance ; or

"(2) to the provisions of section 502 (b), (d), (e), (f),(g), and (h) of the Federal Food, Drug, and Cosmetic Act.insofar as such provisions relate to drugs to which section 505[355 of this title] of such Act applies."

Section 376, ante, made " immediately effective " by ActMay 2, 1939, c. 107. § 1, Title 1, 53 Stat. 631.

§ 391 Page 520

509 § title 21.-food and drugs 225 · 346. tolerances for poisonous ingredients in food and...

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