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poses of coloring only are harmless and suitable for use

in drugs for purposes of coloring only.

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703, for the certification of coal-tar colors which for pur

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CHAPTER V

ADULTERATED COSMETICS

SECTION 501. 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 health users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual.

(b) If it consists in whole or in part of any filthy,

14 putrid, or decomposed substance.

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(c) If it has been prepared, packed, or held under in

16 sanitary conditions whereby it may have become contami17 nated with filth, or whereby it may have been rendered in18 jurious to health.

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(d) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render it injurious to health.

(e) 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 503 section 504, 701, and 703.

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SEC. 502. A cosmetic shall be deemed to be

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(a) If its labeling is false or misleading in any par

5 ticular, or if it is injurious to health under the conditions

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of use prescribed in the labeling or advertising thereof.

(b) If in package form it fails to bear unless it bears a label containing (1) the name and place of business of the manufacturer, and of the 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 14 packages shall be established, by regulations prescribed by the Secretary.

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(c) If any word, statement, or other information 17 required on the label under any provision of this Act is

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not prominently placed thereon in such a manner as to be 19 easily seen and in such terms as to be readily understood 20 by the purchasers and users of such articles under customary 21 conditions of purchase and use, due consideration being 22 given to the size of the package.

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REGULATIONS MAKING EXEMPTIONS

(SEC. 503. The Secretary is hereby authorized

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1 labeling requirement of this Act cosmetics which are, in 2 accordance with the practice of the trade, to be processed, 3 labeled, or repacked in substantial quantities at establish4 ments other than those where originally processed or packed,

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on condition that such cosmetics are in eonformity with

not adulterated or misbranded under the provisions of this 7 Act upon removal from such processing, labeling, or repack8 ing establishment.

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CERTIFICATION OF COAL-TAR COLORS FOR COSMETICS

SEC. 503 504. The Secretary is hereby authorized

to promulgate regulations, as provided by sections 701 and 12 703, for the certification of coal-tar colors which are harm

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less and suitable for use in cosmetics.

CHAPTER VI

FALSE ADVERTISEMENT

SECTION 601. (a) An advertisement of a food, drug, 17 device, or cosmetic shall be deemed to be false if it is 18 false or misleading in any particular relevant to the purposes of this Act regarding such food, drug, device, or cosmetic.

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Any representation concerning any effect of a drug or device 21 shall be deemed to be false under this paragraph if such representation is not supported by demonstrable scientific facts or substantial and reliable medical or scientific opinion. (b) For the purposes of this Act the The adver25 tisement of a drug or device representing it to have any

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1 therapeutic effect in the treatment of Bright's discase, cancer, 2 tuberculosis, poliomyelitis (infantile paralysis), venereal dis3 eases, heart and or vascular diseases shall be deemed to 4 be false; except that no advertisement not in violation of 5 paragraph (a) of this section shall be deemed to be false 6 under this paragraph if it is disseminated only to members of the medical and pharmaceutical professions or appears 8 only in the scientific periodicals of these professions, or is disseminated only for the purpose of public health education 10 by persons not commercially interested, directly or indi11 reetly, in the sale of such drugs or devices.

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(c) Notwithstanding any provision of this section, no advertisement of a drug shall be deemed to be false or mis14 leading under this section if it is disseminated only to 15 members of the medical profession and/or appears only in the scientific periodicals of that profession.

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CHAPTER VII

GENERAL ADMINISTRATIVE PROVISIONS

PROVISIONS AS TO REGULATIONS

SECTION 701. (a) The authority to promulgate regula

tions for the efficient enforcement of this Act, except as 22 otherwise provided in this section, is hereby vested in the

23 Secretary.

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(b) The Secretary of the Treasury and the Secretary of Agriculture shall jointly prescribe regulations for the effi

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1 cient enforcement of the provisions of section 714 712, ex2 cept as otherwise provided therein. Such regulations shall be promulgated in such manner and take effect at such time, 4 after due notice, as the Secretary of Agriculture shall 5 determine.

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(c) Hearings authorized or required by this Act shall

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(d) The definitions and standards of identity pro10 mulgated in accordance with the provisions of this Act shall be effective for the purposes of the enforcement of this 12 Act, notwithstanding such definitions and standards as may

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be contained in other laws of the United States and regula14 tions promulgated thereunder.

15 COURT REVIEW OF REGULATIONS AND ADM

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ACTIONS

SEC. 702. The district courts of the United States are

18 hereby rested with jurisdiction, on petition by any interested 19 person, ( to restrain by injunction, temporary or per 20 mmment, the enforcement by any officer, representative, or 21 employee of the Department of any regulation promulgated 22 as provided in sections 701 and 703 if it is shown that the 23 regulation is unrensomble, arbitrary, or capricious, or not 24 in accordance with the facts or law, and that the peti

25 tioner may suffer substantial damage by reason of its en

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