hearing, the Secretary shall conclude that the standard should be prescribed by him under this subdivision he shall promulgate the standard accordingly, in a form approved by a majority of such committee. The minimum standard so promulgated shall become effective on a date fixed by the Secretary, which date shall not be prior to ninety days after the date of proulgation. Any such promulgated standard may be amended or repealed, by the same procedure.

(3) The President shall annually appoint an expert Committee on Food advisory to the Secretary, and such Committee is hereby vested with the necessary jurisdiction, for the purposes of paragraph (2) of this subdivision. The Committee shall consist of nine members proportionately representative of the Department, the food-manufacturing or -processing industry, and the public at large, respectively. Each member of the Committee shall hold office for a term of one year. The President may remove any member of the Committee for cause. The President shall fill any vacancy in the Committee when it occurs. The President shall make and promulgate regulations prescribing the procedure of the Committee. A majority vote shall prevail upon any motion before or upon any decision by the Committee.

(g) If it is for a special dietary or nutritional use and its principal label does not contain a plain and correct informative statement accordingly, which is adequate in the circumstances.

SEC. 6. An advertisement of a food shall be deemed to be false, within the meaning of this Act, (1) if it false in any particular; or (2) if, while not false, it is actually and injuriously misleading to the purchasing public in any particular. But no advertisement of a food shall be deemed to be false under this paragraph because of any representation regarding its value or effect if such representation is supported by substantial scientific opinion or by demonstrable scientific facts, as the case may be.

DRUGS ADULTERATION, MISBRANDING, AND FALSE ADVERTISING

SEC. 7. The term "drug" as used in this Act includes (1) all substances and preparations recognized in the latest edition of the United States Pharmacopoeia, Homeopathic Pharmacopoeia of the United States, or National Formulary, or in any effective supplement thereto, and intended for use as or in medicine for man or animal; (2) all substances and preparations intended to be used for the cure, mitigation, treatment, or prevention of disease in man or animal; (3) all substances and preparations, other than food, intended for use remedially to affect the structure or any function of the body of man; and (4) all devices offered for sale for therapeutic use or for use to remedially affect the structure or any function of the body of man.

SEC. 8. A drug shall be deemed to be adulterated within the meaning of this Act

(a) If it is injurious to health, when it is used as a medicine or remedy as directed upon its principal label.

(b) If it is offered for sale under a name recognized in the latest edition of the United States Pharmacopoeia or National Formulary or in any supplement thereto, effective when the drug enters commerce; or if it is offered for sale as a homeopathic drug and under a name recognized in the latest edition of the Homeopathic Pharmacopoeia of the United States or in any supplement thereto, effective when the drug enters commerce; and it differs from the standard of strength, quality, or purity for it therein, as determined by the tests or methods of assay prescribed therein; except that whenever tests or methods of assay are not prescribed therein for determining whether or not the drug complies with such standard and they are required for the purposes of this Act; and if such tests and methods are not prescribed therein within a reasonable time after notice accordingly by the Secretary; then the Secretary may prescribe and promulgate such tests or methods, reasonable in character, by regulations. Such regulations shall be made upon public hearing held not less than thirty days after the notice of such hearing and shall be effective on a date fixed by the Secretary and not prior to ninety days after the date of promulgation. But a drug subject to this paragraph shall not be deemed to be adulterated hereunder, notwithstanding it differs from such standard therefor, if its principal label plainly and correctly indicates wherein its actual standard differs from such aforesaid standard, when such standards are determined by the tests or methods of assay applicable under this paragraph.

(c) If it is not subject to paragraph (b) of this section and its identity or strength differs from, or its purity or quality falls below, that professed

for it. In construing and applying this paragraph, reasonable variations and tolerances shall be permitted, which allow for discrepancies due to a natural or other cause beyond reasonable control in good commercial practice.

(d) If any substance has been (1) mixed or packed with it so as injuriously or deceptively to reduce its quality or strength, or (2) injuriously or deceptively substituted in whole or in part for it. If and to the extent an adulteration defined in this paragraph is subject to a label correction, consistent with the purposes of this Act, such correction may be made accordingly.

(e) In the case of a device, if it is injurious to health, when it is used as directed by the seller.

SEC. 9. A drug shall be deemed to be misbranded within the meaning of this Act

(a) (1) If its label is false in any particular; or (2) if its label, while not false, is actually and injuriously misleading to the purchasing public, in any particular. But no drug shall be deemed to be misbranded under this paragraph because of any representation regarding its value or effect, if such representation is supported by substantial medical opinion or by demonstrable scientific facts, as the case may be.

(b) If its container is so made, formed, or filled as to mislead the purchasing public. In construing and applying this paragraph, as to the fill of a container, reasonable variations and tolerances shall be permitted, which allow for subsequent shrinkage or expansion of the drug and for discrepancies due to a natural or other cause beyond reasonable control in good commercial practice. (c) If it is offered for sale under the name of another drug.

(d) If it is an imitation of another drug and its principal label does not plainly and correctly state either its true identity or that it is an imitation. In the latter case the word "imitation" shall be in juxtaposition with and in type of the same size and prominence as the name of the drug imitated.

(e) If its principal label does not plainly and correctly state (1) the name and address of a manufacturer, packer, distributor, or seller; and (2) the quantity of the contents in terms of weight, measure, or numerical count. In construing and applying subdivision (2) of this paragraph reasonable variations and tolerances shall be permitted, which allow for discrepancies due to a natural or other cause beyond reasonable control in good commercial practice; and reasonable exemption of small packages shall be made. A drug put up at one establishment and labeled at another shall be exempt from the labeling requirements of this Act while in transit from the former to the latter establishment.

(f) If it is for use as a medicine or remedy and put up in a package for retail sale and the principal label thereof does not plainly and correctly state directions for such use, which are adequate in the circumstances, and any warning, which is necessary in the circumstances. In construing and applying this paragraph reasonable allowance and exemption shall be made in the case of small packages and drugs dispensed by or under the direction of a physician, dentist, or veterinarian. And the Secretary may by regulations exempt from this paragraph any drug for which such a label statement is not required to safeguard the public health.

(g) If it is for internal use by man and it contains any of the following narcotic or hypnotic substances, to wit: alpha eucaine, barbital, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana morphine, opium, paraldehyde, peyote, sulphon-methane, or any habit-forming narcotic or hypnotic substance chemically derived therefrom; and its principal label does not plainly and correctly state the name and the quantity or proportion of such substance. But this paragraph shall not be construed or applied to permit the use of any substance as or in a drug, if and to the extent such use is prohibited by or under any other Federal statute now effective or hereafter enacted.

(h) If it contains ethyl aucohol, ethyl ether, chloroform, isopropyl alcohol, acetanilid, or acetphenetidin, and its principal label does not plainly and correctly state the name and the quantity or proportion of such substance.

(i) If it is liable to substantial deterioration which injuriously affects its therapeutic value or remedial effect, and its principal label does not contain a plan and correct precautionary statement.

(j) In the case of a device, if it is offered for sale in pursuance of any representation regarding the device or its use, value, or effect, (1) which is false in any particular; or (2) which, while not false, is actually and injuriously misleading to the purchasing public, in any particular. But no device shall be deemed to be misbranded under this paragraph because of any representa

tion regarding its value or effect if such representation is supported by substantial medical opiniou or by demonstrable scientific facts, as the case may be.

SEC. 10. An advertisement of a drug shall be deemed to be false, within the meaning of this Act (1) if it is false in any particular; or (2) if, while not false, it is actually and injuriously misleading to the purchasing public, in any particular. But no advertisement of a drug shall be deemed to be false under this section because of any representation regarding its value or effect if such representation is supported by substantial medical opinion or by demonstrable scientific facts, as the case may be.

COSMETICS ADULTERATION, MISBRANDING, AND FALSE ADVERTISING

SEC. 11. The term "cosmetics", as used in this Act, includes all substances and preparations intended for use to clean, or to alter or improve the appearance of, the human body or any part thereof.

SEC. 12. A cosmetic shall be deemed to be adulterated, within the meaning of this Act, if it bears or contains any poisonous or deleterious substance which renders such cosmetic injurious to health when it is used as directed or customary.

SEC. 13. A cosmetic shall be deemed to be misbranded within the meaning of this Act (1) if its label is false in any particular, or (2) if its label, while not false, is actually and injuriously misleading to the purchasing public in any particular. But no cosmetic shall be deemed to be misbranded under this paragraph because of any representation regarding its value or effect if such representation is supported by substantial scientific opinion or by demonstrable scientific facts, as the case may be.

SEC. 14. An advertisement of a cosmetic shall be deemed to be false within the meaning of this Act (1) if it is false in any particular, or (2) if, while not false, it is actually and injuriously misleading to the purchasing public in any particular. But no advertisement of a cosmetic shall be deemed to be false under this paragraph because of any representation regarding its value or effect if such representation is supported by substantial scientific opinion or by demonstrable scientific facts, as the case may be.

THE PROHIBITION

SEC. 15. The following Acts are hereby declared unlawful and prohibited: (a) (1) The adulteration or misbranding of any food, drug, or cosmetic, within the meaning of this Act, in commerce; and (2) the false advertising of any such article, within the meaning of this Act, in commerce.

(b) (1) The introduction into commerce, as defined in section 2 (d) (1) of this Act, of any food, drug, or cosmetic that is adulterated or misbranded within the meaning of this Act; (2) the shipment of any such article in such commerce or the delivery of any such article for shipment in such commerce; (3) the receipt of any such article in such commerce or from shipment in such commerce; (4) the delivery or proffered delivery of any such article received in such commere or from shipment in such commerce, in the original unbroken package or shipment in such commerce, for pay or otherwise; and (5) the manufacture or sale of, or the offer to sell, any such article within the District of Columbia or within any Territory not organized with a legislative body.

(c) (1) The use of any advertisement of a food, drug, or cosmetic which is false within the meaning of this Act, in commerce, or for the purpose or with the effect of directly or indirectly inducing commerce in any such article; and (2) the dissemination of any such false advertisement in commerce, through the United States mails, or by radio broadcast, or for the purpose or with the effect of directly or indirectly inducing commerce in any such article.

EXCEPTIONS-COMMON CARRIERS AND EXPORTS

SEO. 16. But this Act shall not apply

(a) To any regularly established common carrier in the ordinary conduct of its business, in good faith, as a common carrier; nor

(b) To any food, drug, or cosmtic shipped or delivered for shipment for export to a foreign country, in a form complying with the laws of such country and acceptable to the foreign consignee: Provided, That if such article is diverted for domestic use and remains in commerce it shall become subject to this Act.

ADMINISTRATION

SEC. 17. (a) Except as and to the extent provided in section 25 of this Act, the Secretary is hereby empowered and directed to administer this Act as and by the procedure prescribed by this Act.

(b) Except as and to the extent provided in section 25 of this Act, the Secretary is authorized to make and promulgate reasonable regulations necessary for the efficient and effective administration of this Act. Such regulations shall be promulgated upon public hearing held not less than thirty days after the notice of such hearing and shall be effective on a date fixed by the Secretary: Provided, That such date shall not be prior to ninety days after the date of promulgation, with respect of regulations prescribing commercial practice under this Act, except in cases of public emergency.

(c) The regulations authorized by section 8 (b) of this Act shall be made subject to approval by the committee hereinafter described. The President shall create and maintain an expert committee advisory to the Secretary and such committee is hereby vested with the necessary jurisdiction, for the purposes of such approval. The committee shall consist of five members appointed by the President for terms and subject to regulations prescribed by him. The President may remove any member of the committee for cause. A majority vote shall prevail upon any motion before or upon any decision by the committee.

(d) The District Courts of the United States are hereby vested with jurisdiction to restrain by injunction, temporary or permanent, any announced or effective administrative action under this Act shown to be invalid and prejudicial to the petitioner or to any defendant, claimant, or respondent in any court or administrative proceeding under this Act.

(e) In construing and applying this Act a reasonable allowance, consistent with the purposes of this Act, shall be made for (1) an abnormal individual reaction by a consumer; and (2) "trade puffing" in an advertisement, recognized by and under the common law.

(f) Any person who uses to his own advantage or reveals, other than to the Secretary or his officers or employees or to the courts when relevant in the trial of any case under this Act, any information secured by him in the performance of his official duties under this Act concerning any secret formula or any secret process of manufacture, shall be guilty of a felony, and shall upon conviction thereof, be subject to imprisonment for not more than two years or a fine of not more than $5,000, or both such imprisonment and fine.

ADMINISTRATIVE INVESTIGATION

SEC. 18. (a) The Secretary is authorized—

(1) To cause the collection and examination of representative samples of food, drugs, and cosmetics in commerce, in order to determine whether they are adulterated or misbranded within the meaning of this Act. A reasonable payment shall be made for each such sample, upon request by the person from whom it is taken. If practicable, a sufficient sample shall be taken in each instance to permit a representative part to be delivered to the person affected and such part shall be delivered to such person, upon his request therefor.

(2) To cause the collection and examination of advertisements subject to this Act, in order to determine whether they are false within the meaning of this Act.

(3) To prescribe reasonable methods of examination of such samples and advertisements, for the purposes of this Act, if and to the extent such methods are not prescribed by this Act. The Secretary shall publish the methods so prescribed by him for the information of all concerned.

(4) To conduct the collection of such samples and advertisements through officers and employees of the Department or through any health, food, or drug officer or employee of any State or Territory, or any political subdivision thereof, duly commissioned by the Secretary for the purpose.

(5) To conduct the examination of such samples and advertisements through competent officers and employees of the Department, or through experts duly commissioned by the Secretary for the purpose.

(6) To encourage, assist, approve, and use any legitimate and responsible plan of organized industrial self-regulation purposed and effective to secure due compliance with this Act without resort to its enforcement: Provided, That nothing in this paragraph shall be construed to qualify the duty or to limit the outhority of the Secretary to administer this Act as herein prescribed.

(b) If it cannot be determined by an examination of a food, drug, or cosmetic, after it has entered commerce, whether it is adulterated or misbranded within the meaning of this Act, and if an officer or employee of the Department duly designated by the Secretary for the purpose is refused permission to inspect the manufacture, processing, or packing of such article to the extent deemed necessary to determine whether it is adulterated or misbranded within the meaning of this Act, then the Secretary is authorized to apply to the District Court of the United States, in the district wherein such manufacture, processing, or packing is done, for an order effective to secure such inspection. Said court is hereby vested with jurisdiction over such application and shall grant it, if and to the extent the order is adjudged necessary in the circumstances. Each such order shall duly provide against an unwarranted disclosure of a secret process or private formula.

(c) Any carrier transporting a food, drug, or cosmetic in commerce, and any person receiving a food, drug, or cosmetic in commerce or from shipment in commerce, which article is subject to investigation under this Act, shall inform the Secretary, or his representative duly designated for the purpose, of the record of such transportation or receipt, upon his written request for such information. It shall be unlawful for any carrier or person to refuse or fail to give such information, upon such request therefor: Provided, That evidence obtained under this paragraph shall not be used in any criminal proceeding under this Act against the person from whom it was obtained. Any carrier or person willfully violating this paragraph shall be guilty of a misdemeanor and shall, upon conviction thereof, be subject to a fine of not more than $500 for each violation.

ADMINISTRATIVE HEARING, REVIEW, AND SETTLEMENT

SEC. 19. (1) (a) If, as a result of an investigation authorized by this Act, it appears that a person has violated section 15 of this Act, the Secretary shall cause notice of such apparent violation to be given to such person, hereinafter called the "respondent." The notice shall state such violation in sufficient detail to inform the respondent of it and shall fix a reasonable time and place of hearing upon it, before the Secretary or his representative duly designated for the purpose, hereinafter called the "presiding officer." The respondent shall have the right to appear at such hearing and to show cause why this Act should not be enforced against him or why the matter should be administratively settled as provided in subdivision (2) of this section. Upon the hearing the presiding officer shall make a written report of the investigation and hearing, containing his finding and his reasons for it. A copy of such report shall be forthwith given to the respondent.

(b) If the report contains a finding that the respondent has violated section 15 of this Act, he shall have the right of a review of such report by the Board hereinafter described, provided he makes prompt application to the Board for such review anld the Board grants his application. The decision of the Board, upon such review, that the respondent has not violated section 15 of this Act shall be binding upon the Secretary under this Act. The President shall create and maintain an administrative Board of Review, and such Board is hereby vested with the necessary jurisdiction for the purposes of this paragraph. The Board shall consist of five members appointed by the President for terms and subject to regulations prescribed by him. The President may remove any member of the Board for cause. A majority vote shall prevail upon any motion before or upon any decision by the Board.

(2) The Secretary is authorized to settle an apparent or found violation of this Act, upon the basis (a) of a suitable notice or warning to the respondent or (b) of a written agreement by the respondent to cease and desist from such violation, if the Secretary believes that such settlement satisfies the purposes of this Act. The Secretary may modify the procedure prescribed by subdivision (1) (a) of this section to permit a settlement accordingly.

CRIMINAL PROCEEDING

SEC. 20. (a) If the respondent ignores such notice apparent violation, or if the respondent disregards such notice or warning for settlement, or if the respondent fails to carry out his said agreement, or if upon such administrative hearing or review the Secretary concludes that the respondent has violated section 15 of this Act and that the public interest requires a criminal proceed