Food, Drugs, and Cosmetics

FOOD ADULTERATION, MISBRANDING, AND FALSE ADVERTISING

SEC. 3. The term "food", as used in this Act, includes (1) all articles used for food, drink, or condiment by man or animal; and (2) all articles used for confectionery or chewing gum by man; and (3) any substance or preparation intended for use as an ingredient in the composition of ay such article.

SEC. 4. A food shall be deemed to be adulterated, within the meaning of this Act

(a) If it is dangerous to public health.

(b) (1) If it bears or contains any added poisonous or any added deleterious substance which renders such food injurious to health; or (2) if its container bears or is composed of any poisonous or deleterious substance which by contamination renders such food injurious to health; or (3) in the case of an ingredient, if its use in the composition of a food, as defined in section 3(1) and (2) of this Act, renders such food injurious to health.

(c) (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2) if it is the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (3) if it has been prepared, packed, or held under insanitary conditions whereby it has become contaminated with filth and is unfit for consumption; or (4) in the case of an ingredient, if its use in the composition of a food, as defined in section 3(1) and (2) of this Act, renders such food unfit for consumption.

(d) (1) If any valuable constituent has been abstracted in whole or in part from it, whereby such food is injurious to health or deceptive; or (2) if any substance has been substituted in whole or in part for it, whereby such food is injurious to health or deceptive; or (3) if any substance has been added to it or mixed or packed with it so as to reduce its quality or strength, whereby such food is injurious to health or deceptive; or (4) if any substance has been added to it or mixed or packed with it so as to increase its bulk or weight, whereby such food is deceptive; or (5) if any substance has been added to it or mixed or packed with it in any way so as to create a deceptive appearance; or (6) if damage or inferiority has been concealed in any manner. 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) If it contains a coal-tar color other than one from a batch certified by the Secretary under this Act.

(f) If it is confectionary and it bears or contains any alcohol, resinous glaze, or nonnutritive substance, except coloring and flavoring: Provided, That this paragraph shall not be construed or applied to prevent the use of masticatory substances in chewing gum.

SEC. 5. A food 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 food 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.

(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 food 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 food.

(d) If it is an imitation of another food and its principal label does not plainly and correctly state either its true identity or that it is an imitaton. In the later case the word "imitation "shall be in juxtaposition with and in type of the same size and prominence as the name of the food 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 food 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) (1) If it is a food for which the Secretary has prescribed a minimum standard of identity, quality, and/or fill, under this subdivision, and it falls below such standard, unless its principal label plainly indicates that fact. The Secretary is hereby authorized to prescribe one minimum standard of identity, quality, and/or fill for each generic class of food, which is reasonable in character and necessary for the purposes of this Act, as and to the extent hereinafter defined: Provided, That nothing in this subdivision shall be construed or applied to prevent or restrict commerce in any proprietary food sold in compliance with the other provisions of this Act: Provided further, That in prescribing such standard the Secretary shall follow good commercial practice, if and to the extent he can do so consistently with the public interest.

(2) Whenever the Secretary shall determine upon such a minimum standard he shall first submit it to the advisory committee hereinafter described, for review. If a majority of such committee approves the standard, in its original or in a revised form, the Secretary shall give notice of a public hearing upon it, held not less than thirty days after the date of such notice. If, after such 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 promulgation. 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 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 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 Pharmacopœia, Homeopathic Pharmacopoeia of the United Staets, or National Formulary. or in any effective supplement thereto, and intended for use as or in medicine for man or animal; and (2) all substances and preparations, intended to be used for the cure, mitigation, treatment, or prevention of disease in man or animal; and (3) all substances and preparations, other than food, intended for use to remedially 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 to injuriously or deceptively 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.

(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.

(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, sulphonmethane, 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 alcohol, 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 plain 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 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.

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 "cosmetic' 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.

SEO. 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; and (2) the shipment of any such article in such commerce or the delivery of any such article for shipment in such commerce; and · (3), the receipt of any such article in such commerce or from shipment in such commerce; and (4) the delivery or proffered delivery of any such article

received in such commerce or from shipment in such commerce, in the original unbroken package of 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 good, 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

SEC. 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 cosmetic 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 juris- diction 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 per-formance 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

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Food, Drugs, and Cosmetics: Hearings Before the Committee on Commerce ...