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COMMITTEE ON COMMERCE

ROYAL S. COPELAND, New York, Chairman DUNCAN U. FLETCHER, Florida

CHARLES L. McNARY, Oregon MORRIS SEEPPARD, Texas

HIRAM W. JOHNSON, California JOSIAL WILLIAM BAILEY, North Carolina GERALD P. NYE, North Dakota BATTIE W. CARAWAY, Arkansas

ARTHUR H. VANDENBERG, Michigan BESNETT CHAMP CLARK, Missouri WALLACE H. WHITE, JR., Maido LOUIS MURPHY, Iows

ERNEST W. GIBSON, Vermont
JOHN H. OVERTON, Louisiana
NATHAN L. BACHMAN, Tennessee
THEODORE G. BILBO, Mississippi
VIC DONAHEY, Oblo
JOSEPH F. QUFFEY, Pennsylvania
FRANCIS T. MALONEY, Connecticut
GEORGE L. RADCLIFFE, Maryland

GRACE MCELDOWNEY, Clerk
M. C. PARBONS, Jr., Assistant Clark

SUBCOMMITTEE ON 6.5

BENNETT CHAMP CLARK, Chairman HATTIE W. CARAWAY

ERNEST W. GIBBON

II

FOODS, DRUGS, AND COSMETICS

SATURDAY, MARCH 2, 1996

UNITED STATES SENATE,
SUBCOMMITTEE OF THE COMMITTEE ON COMMERCE,

Washington, D.C. The subcommittee met, pursuant to call, in the caucus room, Senate Office Building, at 10 a. m., to consider S. 5, Senator Clark presiding.

Present: Senators Clark (chairman), Copeland, Gibson.
Senator CLARK. The committee will come to order.

(The subcommittee have under consideration S. 5, with proposed amendments, which is here printed in full as follows:)

(Committee Print No. 3, Pob. 14, 1935)

(8.-3, 74th Cong., Ist Sess.) (Omit the part struck througb and insert the part printed in Italic) A BILL To prevent the mapulacture, shipment, and sale of adulterated or misbranded lood, drink, drugh and cosmetics, and to regulate

traffic therein;

to prevent the false advertisement of food, drink, drugs, and cosmetics; and for otber purposes.

Be it enacted by the Senate and House of Representatives of the United Stales of America in Congress assembled,

CRAPTER I SECTION 1. That this Act may be cited as the “Federal Food, Drugs, and Cosmetic Act."

CHAPTER II

DEFINITION OF TERMS

Sae. Section 201. 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, chewing gum, or condiment for man or other animals.

(b) The term “drug”, for the purposes of this Act and not for the regulation of the legalized practice of the healing art, includes (1) all substances and preparations recognized in the United States Pharmacopæia, Homeopathic Pharmacopæia of the United States, 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, preparations, and devices, other than food, intended to affect the structure or any function of the body.

(c) The term "cosmetic" includes all substances and preparations intended for cleansing, or altcring the appearance of, or promoting the attractiveness of, the person.

(d) The term “Territory” means any Territory or possession of the United States, including the District of Columbia.

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

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FOODS, DRUGS, AND COSMETICS

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

(8) The term “Secretary" means the Secretary of Agriculture.

(h) The term "label” means the principal display or displays of written, printed, or graphic matter (1) upon any food, drug, or cosmetic, or the immediate container thereof, and (2) upon the outside container or wrapper, if any there be, of the retail package of any food, drug, or cosmetic.

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

() The term "advertisement” includes all representations of fact or opinion disseminated to the public in any manner or by any means other than by the labeling.

(k) The term "medical profession” ineans the legalized professions of the healing art; and the term “medical opinion" means the opinion, within their respective fields, of the practitioners of any branch of the healing art medical profession, the practice of which is licensed by law in the jurisdiction where such opinion is placed in issue in any proceeding under this Act.

(1) The term "official compendiuin” incans the United States Pharmacopæia, Homaopathic Pharmacopæia of the United States, National Formulary, or any suppleinent thereto, official at the time any drug to which the provisions thereof relate is introduced into interstate commerce.

(m) The term Department" means the Department of Agriculture of the United Stales.

(n) The term Administration" means the Food and Drug Administration of the Department.

CHAPTER III

ADULTERATED FOOD

Sectiox 301. I loud shall be deemed to be adulterated

(a) (1) If it bears or contains any poisonous or deleterious substance which may render it dangerous to health; or (2) if it bcars or contains any added poisonulls or added deleterious substance prohibited by section 304, or in excess of the limits of tolerance prescribed by regulations as provided by sections 304, 701, and 703; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed sulistance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held mder insanitary conditions whereby it may have become containinated with silth, or whereby it may harc leou rendered injurious lo health; or (5) if it is the product of a diseased animal or of an animal which has died otherwise than hy slaughter; or (0) 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 dainage or inferiority has been concealed in any inansicr; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or create a deceptive appearance.

fecht (c) it contains a coal-tar color other than one from a batch that has been certificd in accordance with regulaiions as provided by sections 301, 701, and 703.

fet (d) If it is confectionery or ice creain and it shall also be deemed to be adulteraled if it bears or contains any alcohol, resinous glaze, or nonnutritive substance except harinless coloring, favo:ing, natural gum, and pectin: Provided, That this paragr:ph shall not apply to any confectionery or ice cream by reason of its containing less than one-half of 1 per centum by volume of alcohol derived solely froni the use of flavoring extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances.

MISBRANDED FOOD

Sec. 302. A food shall be deemed to be misbranded

(a) If its labeling is false or misleading in any particular. tatt (b) If it is offered for sale under the naine of another food.

Hot (c) If it is an imitation of another food, and its label fails to bcar, in type of uniform size and prominence, the word "imitation" and, immediately thereaster, the name of the food imitated.

toy (d) ** If its container is so made, formed, or filled as to mislead the purchaser; or 42% if it contents fort below the standard of th preseribed by Pegulations to provided by sections 30%, Fot, and 703.

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