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Wisconsin Canners Association sales report for period Dec. 2 to Dec. 9, 1933, 26

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STATEMENT WITH REFERENCE TO REVISED BILL, S. 2000 As a result of the hearings early in December on the proposed revision of the Food and Drugs Act, Senator Copeland introduced a new bill embodying sweeping changes in the measure. These changes have not detracted from the

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consumer protection the original bill sought to afford, but they remove the causes for apprehension so generally felt by reputable manufacturers whose products would be regulated by the law.

One of the principal points of difference between the old and new bills is the extent to which authority is lodged in the hands of administrative officers. In Senator Copeland's draft the delegation of regulation-making power is confined to those few instances where the problems are so complex and so changing with scientific progress that adequate protection of the public cannot otherwise be offered. Even in these instances the administrative officers cannot act independently, but are subject to the check of nonpartisan committees of scientists whose members are affiliated with neither the enforcing agency nor the regulated industries. Moreover, definite provision is made for court review of regulations.

Senator Copeland's revision omits references to “inference and ambiguity" in defining offenses, which aroused great opposition to the old bill, but in clarifying these and other provisions there has been no weakneing of the measure. It also omits the sweeping provision requiring full formula disclosure on all proprietary drugs, the advantage of which to consumers has been questioned with good reason, and substitutes for it requirements for label declaration of certain potent ingredients, coupled with label warnings against unsafe methods of administration.

Instead of prohibiting therapeutic claims for a drug if they are contrary to the general agreement of medical opinion, such claims are declared as misbranding if they are not supported by substantial medical opinion or by demonstrable scientific facts. The requirement that a palliative be labeled as not a cure has been changed to compel labeling to show how the palliation is effected.

In these and all other possible ways the bill has been made clearer and more definite, without the sacrifice of any provision essential to public welfare. The section on voluntary inspection service has been deleted, as well as that authorizing investigations through the medium of the Federal Trade Commission Act, since these sections had caused great apprehension, and protection of consumers has been accomplished through other provisions in the bill.

An important addition to the measure authorizes the enforcing agency to accept plans of representative advertising associations for the self-regulation of advertising practices. But this does not relieve the enforcing agency from any of its responsibilities.

“The bill as it now stands”, Senator Copeland says, "should receive the support of all consumers. It should likewise receive the endorsement of that great majority of the industries affected which is doing a reputable business. It is fair to all concerned."

The new bill, S. 2000, follows:

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(S. 2000, Seventy-third Congress, second session) A BILL To prevent the manufacture, shipment, and sale of adulterated or misbranded food, drink, drugs,

and cosmetics, and to regulate traffic therein; to prevent the false advertisement of food, drink, 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.

DEFINITION OF TERMS

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, Homeopathic Pharmacopoeia 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 and preparations, other than food, and all devices intended to affect the structure or any function of the body.

(c) The term "cosmetic” includes all substances and preparations intended for cleansing, or altering 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.

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(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 or manufacture within the District of Columbia or within any other 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 immediate 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.

ADULTERATED FOOD

SEC. 3. A food 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 bears or contains any added poisonous or added deleterious substance prohibited, or in excess of the limits of tolerance prescribed, by regulations as provided by sections 10 and 22; 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 product 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 added thereto or mixed or packed therewith so as to increase its bulk or weight in a deceptive manner, 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 masticatory substances in chewing gum, coloring, and flavoring.

(d) If it contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by sections 10 and 22.

ADULTERATED DRUGS

SEC. 4. A drug shall be deemed to be adulterated(a) If it is 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 Pharmacopæia, Homeopathic Pharmacopæia of the United States, or National Formulary, or in any supplement thereto, official at the time the drug is introduced into interstate commerce, or if it purports to be such a drug, and it (1) fails to meet the definition, formula, and description set forth therein, or (2) differs from the standard of strength, quality, or purity 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 insufficient, the Secretary is hereby authorized to prescribe by regulations, as provided by section 22, tests or methods of assay for determining whether or not such drug complies with such standard. No drug shall be deemed to be adulterated under subdivision (2) of this paragraph if its label bears, in juxtaposition with the name of the drug, a statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in the United States Pharmacopæia, Homeopathic Pharmacopæia of the United States, or National Formulary, as the case may be, 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. Whenever a drug is recognized in both the United States Pharmacopæia and the Homeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopæia unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopæia of the United States and not to those of the United States Pharmacopoeia.

(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 its purports or is represented to pos

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

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ADULTERATED COSMETICS

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

(a) If it bears or contains any poisonous or deleterious substance which may render it 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 provided by sections 10 and 22.

MISBRANDED FOOD, DRUGS, AND COSMETICS-GENERAL
Sec. 6. A food, drug, or cosmetic shall be deemed to be misbranded-

(a) If its labeling is false or misleading in any particular: Provided, That no drug shall be deemed to be misbranded under this paragraph because of any representation concerning any effect of such drug if that representation is supported by substantial medical opinion or by demonstrable scientific facts.

(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 terms of weight, measure, or numerical count: Provided, That under subdivision (2) of this paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(c) The Secretary is hereby authorized to promulgate regulations exempting from any labeling or packaging requirement of this Act food, drugs, and cosmetics, which are, in accordance with the practice of the trade, processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such articles are in conformity with the provisions of this Act upon removal from such processing, labeling, or repacking establishment.

(d) If any word, statement, or other information required on the label to avoid adulteration or misbranding under any provision 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.

MISBRANDED FOOD

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

(a) (1) If its container is so made, formed, or filled as to mislead the purchaser, or (2) if its contents fall below the standard of fill prescribed by regulations as provided by sections 11 and 22.

(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 prominence as the name of the food imitated.

(d) If it purports to be or is represented as a food for which a definition and minimum standard of identity have been prescribed by regulations as provided by sections 11 and 22, and (i) its label fails to bear the name of the food prescribed in the definition and minimum standard, or (2) it fails to conform to such definition and minimum standard.

(e) If it purports to be or is represented as a food for which standards of quality have been prescribed by regulations as provided by sections 11 and 22, and (1) its label fails to bear, if so required by the regulations, a standard of quality in such terms as the regulations specify, or (2) it falls below such standard.

(f) If it purports to be or is represented as a food for which no definition and minimum standard of identity has been prescribed by regulations as provided by

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sections 11 and 22, 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 such food bears or contains in order of predominance by weight; except that spices, flavors, and colorings, other than those sold as such, may be designated as spices, flavors, and colorings without naming each: Provided, That, to the extent that a statement on the label of each ingredient in order of predominance by weight is impracticable because of normal variations in ingredients or their quantities, usual to manufacturing or packing processes, reasonable variations from such order shall be permitted, and exemptions as to packages of assorted food shall be established, by regulations promulgated by the Secretary.

(g) If it is for special dietary uses, such as by infants or invalids or for other special nutritional requirements, and its label fails to bear, if so required by regulations as provided by section 22, statements concerning its vitamin, mineral, and other dietary properties which fully inform the purchaser as to its nutritional value.

MISBRANDED DRUGS Sec. 8. A drug shall be deemed to be misbranded

(a) 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 a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is affected.

(b) If it is for internal use by man and contains any quantity of any of the following narcotic or hypnotic substances: Alpha eucaine, 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 quantity or proportion of. such substance or derivative in juxtaposition with the statement Warning—May be habit forming.”. The Secretary is hereby authorized to designate by regulations, as provided by section 22, other substances possessing habit-forming narcotic or hypnotic properties, which substances shall thereafter be subject to the provisions of this paragraph.

(c) If it contains any quantity of the stimulant-depressant substances ethyl alcohol, ethyl ether, chloroforın, or isopropyl alcohol; or the sedative substances acetanilid, acetphenetidin, amidopyrin, antipyrin, bromides, or hyascyamus; or the cumulative substances arsenic, atropine, digitalis, mercury, or strychnine; and its label fails to bear a statement of the name and quantity or proportion of such substance. The Secretary is hereby authorized to designate by regulations, as provided by section 22, other substances possessing stimulant-depressant, sedative, or cumulative properties, which substances shall thereafter be subject to the provisions of this paragraph.

(d) If its labeling fails to bear, plainly and conspicuously, complete and explicit directions for use: Provided, That where any requirement of this paragraph, as applied to any drug, is not necessary for the protection of the public health, the Secretary shall promulgate regulations, as provided by section 22, exempting such drug from such requirement.

(e) If its label fails to bear (1) such warnings as may be prescribed by regulations, as provided by section 22, against use in such pathological conditions or by children where its use is contraindicated and may be dangerous to health, or against unsafe dosage or methods of administration or application; and (2) the common or usual name of the drug, if any there be: Provided, That subdivision (2) of this paragraph shall not apply to drugs subject to paragraph (b) of section 4,

(f) If its name is the same as, or simulates, a name recognized in the United States Pharmacopæia, Homeopathic Pharmacopæia of the United States, 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. Whenever a drug is recognized in both the United States Pharmacopæia and the Homeopathic Pharmacopæia of the United States it shall be subject to the requirements of the United States Pharmacopæia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to such provisions of the Homeopathic Pharmacopæia of the United States and not those of the United States Pharmacopeia.

(g) If it has been designated by regulations, as provided by section 22, as a drug liable to deterioration, and is not packaged in such form or manner, or its label fails to bear a statement of such precautions, as such regulations require for the protection of public health.

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