Food, Drugs, and Cosmetics

The subcommittee met, pursuant to call, in room 335 Senate Office Building, at 10:30 a.m., Senator Royal S. Copeland, presiding. Present: Senators Copeland, McNary, and Caraway.

Senator COPELAND. The hearing will come to order, please. We have a crowded room. I am sorry we have not chairs enough for everybody. Perhaps we can secure enough after awhile to fill the room. We had to go from a room which we had arranged into this larger one, and even this seems to be crowded. So you will help us a lot if you will be as quiet as possible.

This is a hearing of the subcommittee of the Committee on Commerce to consider Senate Bill 1944, and the record at this point will show a copy of the bill.

(S. 1944 is as follows:) In the Senate of the United States, June 6 (calendar day, June 12), 1933.

Mr. Copeland introduced the following bill; which was read twice and referred to the Committee on Commerce.

A BILL to prevent the manufacture, shipment, and sale of adulterated or misbranded food, drugs, and cosmetics, and to regulate traffic therein; to prevent the false advertisement of food, drugs, and cosmetics, and for other purposes

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may be cited as the "Federal Food and Drugs Act."

DEFINITIONS

SEC. 2. As used in this Act, unless the context otherwise indicates:

(a) The term "food" includes all substances and preparations used for, or entering into the composition of, food, drink, confectionery, or condiment for man or other animals.

(b) The term "drug" includes (1) all substances and preparations recognized in the United States Pharmacopoeia or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food, and all devices, intended to affect the structure or any function of the body of man or other animals. (c) The term "cosmetic" includes all substances and preparations intended for cleansing, or altering the appearance of, or promoting the attractiveness of the person. Except as indicated in paragraph (b) (3) of this section, the definitions of food, drug, and cosmetic shall not be construed as mutually exclusive. (d) The term "territory" means any territory or possession of the United States.

(e) The term "interstate commerce" means (1) commerce between any State or Territory and any place outside thereof, or between points within the same State or Territory but through any place outside thereof, and (2) commerce and manufacture within the District of Columbia or the Canal Zone or within any territory not organized with a legislative body.

(f) The term "person" includes individual, partnership, corporation, and association.

(g) The term "Secretary" means the Secretary of Agriculture.

(h) The term "label" means the principal label or labels (1) upon the i àmediate container of any food, drug, or cosmetic, and (2) upon the outside container or wrapper, if any there be, of the retail package of any food, drug, or cosmetic.

(i) The term "labeling" includes all labels and other written, printed, and graphic matter, in any form whatsoever, accompanying any food, drug, or cosmetic.

(j) The term "advertisement" includes all representations of fact or opinion disseminated in any manner or by any means other than by the labeling. (k) The term "in package form" includes wrapped meats enclosed in paper or other materials as prepared by the manufacturers thereof for sale.

ADULTERATION OF FOOD

SEC. 3. A food shall be deemed to be adulterated:

(a) (1) If it is or may be dangerous to health; or (2) if it bears or contains any added poisonous or added deleterious substance prohibited, or in excess of the limits of tolerance prescribed, by regulations as hereinafter provided; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth; or (5) if it is the produce of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed of any poisonous or deleterious substance which may by contamination render the contents injurious to health.

(b) (1) If any valuable constituent has been in whole or in part abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or create a deceptive appearance.

(c) If it is confectionery and bears or contains any alcohol, resinous glaze, or nonnutritive substance except coloring and flavoring.

(d) If it contains a coal-tar color other than one from a batch that has been certified by the Secretary in accordance with regulations as hereinafter provided

ADULTERATION OF DRUGS

SEC. 4. A drug shall be deemed to be adulterated:

(a) If it is or may be dangerous to health under the conditions of use prescribed in the labeling thereof.

(b) If its name is the same as or simulates a name recognized in the United States Pharmacopoeia or National Formulary or in any supplement thereto, cfficial at the time the drug is introduced into the interstate commerce, or if it purports to be such a drug, and it fails to meet the definition, formula, and description set forth therein, or differs from the standard of strength, quality, or purity as as determined by the tests or methods of assay set forth therein; except that whenever tests or methods of assay have not been prescribed therein or such tests or methods of assay as are prescribed are found by the Secretary to be insufficient, he is hereby authorized to prescribe by regulations, tests, or methods of assay for determining whether or not such drug complies with such standards. No drug shall be deemed to be adulterated under this paragraph if its label bears, in the manner and form prescribed by regulations of the Secretary, a statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in the United States Pharmacopoeia or National Formulary or in any supplement thereto, official at the time the drug is introduced into interstate commerce, as determined by the tests or methods of assay applicable under this paragraph.

(c) If it is not subject to the provisions of paragraph (b) of this section and its identity or strength differs from or its purity or quality falls below, that which it purports or is represented to possess.

(d) (1) If any substance has been mixed or packed therewith so as to reduce its quality or strength; or (2) if any substance has been substituted wholly or in part therefor.

ADULTERATION OF COSMETICS

SEC. 5. A cosmetic shall be deemed to be adulterated:

(a) If it is or may be injurious to the user under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.

(b) If it bears or contains any poisonous or deleterious ingredient prohibited, or in excess of the limits of tolerance prescribed, by regulations as hereinafter provided.

MISBRANDING GENERAL

SEC. 6. A food, drug, or cosmetic shall be deemed to be misbranded:

(a) If its labeling is in any particular false, or by ambiguity or inference creates a misleading impression regarding any food, drug, or cosmetic.

(b) If in package form it fails to bear a label containing: (1) the name and place of business of the manufacturer, packer, seller, or distributor; and (2) an accurate statement of the quantity of the contents in such terms of weight, measure, or numerical count as may be prescribed by regulations of the Secretary: Provided, That under subdivision (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages of foods and cosmetics shall be established, by regulations prescribed by the Secretary: And provided further, That such classes of canned foods as the Secretary finds, after notice and hearing, are, in accordance with the practice of the trade, labeled in substantial quantities at establishments other than the establishments where processed or packed, shall be exempted by regulations from the requirements of this paragraph during transportation from the establishment where processed or packed to an establishment for labeling, if such articles are labeled in conformity with the provisions of this Act prior to removal from such labeling establishment.

(c) If any word, statement, or other information required on the label to avoid adulteration or misbranding under any provisions of this Act is not prominently placed thereon in such a manner as to be easily seen and in such terms as to be readily intelligible to the purchasers and users of such articles under customary conditions of purchase and use.

MISBRANDING OF FOOD

SEC. 7. A food shall be deemed to be misbranded:

(a) If (1) its container is so made, formed, or filled as to mislead the purchaser, or (2) its contents fall below the standard of fill prescribed by regulations as hereinafter provided.

(b) If it is offered for sale under the name of another food.

(c) If it is an imitation of another food, except that no imitation shall be deemed to be misbranded under this paragraph if its label bears the word "imitation" in juxtaposition with and in type of the same size and prominent as the name of the food imitated.

(d) If it purports to be or is represented as a food for which a definition of identity has been prescribed by regulations as hereinafter provided, and (1) fails to bear on its label the name of the food defined in such terms as the regulations specify, or (2) fails to conform to the definition.

(e) If it purports to be or is represented as a food for which standards of quality have been prescribed by regulations as hereinafter provided, and (1) fails to state on its label, if so required by the regulations, a standard of quality in such terms as the regulations specify, or (2) falls below the standard stated on the label.

(f) If it purports to be or is represented as a food for which no definition of identity has been prescribed by regulations as hereinafter provided, and its label fails to bear (1) the common or usual name of the food, if any there be, and (2) the common or usual name of each ingredient thereof in order of predominance by weight; except that spices, flavors, and artificial colors may be designated as such without naming each spice, flavor, or artificial color. The Secretary is hereby authorized to prescribe by regulations requirements for such further information on the label thereof as he may deem necessary to protect the public from deception.

MISBRANDING OF DRUGS

SEC. 8. A drug shall be deemed to be misbranded:

(a) (1) If its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative, and fails to bear in juxtaposition with such name and in letters of the same size and prominence a statement that the drug is not a

cure for such disease; or (2) if its labeling bears any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion.

(b) If it is for internal use by man and contains any quantity of any of the following narcotic or hypnotic substances: Alpha cucaine, barbital, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, morphine, opium, paraldehyde, peyote, sulphonmethane, or any narcotic or hypnotic derivative therefrom by actual or theoretical chemical reaction, and its label fails to bear the name and a statement, in the manner and form prescribed by regulations promulgated by the Secretary, of the quantity or proportion of such substance or derivative in juxtaposition with the statement Warning-May be habit forming." The Secretary is hereby authorized, by regulations prescribed after notice and hearing, to designate as narcotics or hypnotics within the meaning of this pargaraph such other substances as he may find to possess narcotic or hypnotic properties.

(c) If it contains any quantity of ethyl alcohol, ethyl ether, or chloroform, and its label fails to bear a statement, in the manner and form prescribed by regulations of the Secretary, of the quantity or proportion of such substance.

(d) If it is not subject to the provisions of paragraph (i) of this section, and its labeling fails to bear complete and explicit directions for use: Provided, That the Secretary may by regulation exempt any drug from any requirement of this paragraph if he deems such requirement unnecessary for the protection of public health.

(e) If it is not subject to the provisions of paragraph (b) of section 4 and its label fails to bear (1) the common name of the drug, if any there be, and (2) the name and quantity or proportion of each medicinal or physiologically active ingredient thereof. The Secretary is hereby authorized to prescribe by regulations requirements for such further information on the label of such drug as he may deem necessary to protect the public health.

(f) If its name is the same as, or simulates, a name recognized in the United States Pharmacopoeia or National Formulary or any supplement thereto official at the time such drug is introduced into interstate commerce, and it is not packaged and labeled as prescribed therein.

(g) If it is a drug liable to deterioration, and is not packaged in such form or manner, or if its label fails to bear a statement of such precautions, as the Secretary may prescribe by regulations, after notice and hearing, for the protection of public health. The Secretary is hereby authorized to designate by regulations, prescribed after notice and hearing, as drugs liable to deterioration within the meaning of this paragraph, such drugs as he may find to be liable to deterioration. (h) (1) If its container is so made, formed, or filled as to mislead the purchaser; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.

(i) If it purports to be or is represented as a germicide, bactericide, disinfectant, or antiseptic for any use on or within the human or animal body and its labeling fails to bear a statement of each such use and, plainly and conspicuously and in juxtaposition therewith, the method and duration of application necessary to kill all micro-organisms in the vegetative or other active form with which it comes in contact when so used; except that no drug shall be deemed to be misbranded under this paragraph if its label bears a statement that it is a germicide, bactericide, disinfectant, or antiseptic for specific kinds of micro-organisms only, and its labeling bears a statement of each purported or represented use and, plainly and conspicuously and in juxtaposition therewith, the conditions, including duration of application, under which the drug kills all such specific kinds of micro-organisms in the vegetative or other active form with which it comes in contact when so used.

FALSE ADVERTISEMENT

SEC. 9. (a) An advertisement of a food, drug, or cosmetic shall be deemed to be false if in any particular it is untrue, or by ambiguity or inference creates a misleading impression regarding such food, drug, or cosmetic.

(b) An advertisement of a drug shall also be deemed to be false if it includes (1) the name of any disease for which the drug is not a specific cure but is a palliative, and fails to state with equal prominence and in immediate connection with such name that the drug is not a cure for such disease; or (2) any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion.

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Food, Drugs, and Cosmetics: Hearings Before a Subcommittee of the Committee ...