« ForrigeFortsett »
FOOD, DRUGS, AND COSMETICS
the United States, without delay, for the enforcement of the ponalties as In such case herein provided.
8722. 1840. 6. That the term "drug", as uscd in this Act, shall include all medicines and preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use, and any substance or mixture of substances intended to be used for the curo, initigation, or prevention of diacado of either man or other animals. Tho term "food As used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, inixed, or compound.)
SEC. B. The term "food" includes all substances and preparalions used for, or ontering into the composition of food, drink, confectionery, or condiment for man or other animals. The term “drug" includc8 (i) all substances and preparations recognized in the Uniled Slates Pharmacopæia 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 (S) all subalances and preparations, other than food, and all devices, intended to affect the slr uclure or any function of the body of man or other animals. The term "cosmelic incliules all substances and preparalions intended for cleansing, or allering the appear. ance of, or promoting the attractiveness of, the person.
8723. Sec. 7. That for the purposes of this Act an article shall be deemed to be adulterated:
In casc of druga:
First. If, when a drig is sold under or by a name recognized in the United States Pharmacopoia or National Formulary, or supplements therelo, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopeia or National Formulary official at the time of investigation: Providerl, That no drug defined in the United States Phar. macoperin or National Formulnry shall be decined to be adulterated under this provision if the standard of strength, quality, or purity loc plainly stated upon tho bottle, box, or other container thercos, although the standard inay differ from that letermined by the test laid down in the United States Pharincoporia or National Formury, anot provided further, Thul no idrig defined in the United Stalco Pharmacopria or National Formulary or supplemeniš thercio, shall be deemed lo be adulteraled under this provision if it complies with the standard of strength, quality, and purily as determined by the text laid down in the Uniled States Pharmacopeia or National Formulnry or supplements therelo, notwithslanding that it may have been made by a modification of the official formula or directions made necessary to meet manufacturing requirements.
Second. If its strength or purity fall below the prosessed standard or quality under which it is sold.
In the case of confectionery:
If it contain terra alba, barytcr, talc, chroinc yellow, or other mineral substance or poisonous color or favor, or other ingredient delctcrious or detrimental to henlth, or any vinous, malt, or spirituous liquor or compound or narcotic drug.
In the care of food:
First. If any substance has been mixed nud packed with it so as to reduce or lower or injuriously affect its quality or strength.
Second. If any substance has been substituted wholly or in part for the article.
Third. If any valuable constituent of the article has been wholly or in part abstracted.
Fourth. If it be mixed, colored, powdered, couter, or stained in a mannor whereby damage or inferiority in concoaled.
Fifth. If it contain any added poisonoun or other addor deletorious ingredient which may render auch article injurious to health: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the prcorrentive is necessarily removed mechanically, or by macreation in water, or otherwise, and directions for the removal of said prescrvative shall be printed on the covering or the package, the provisions of this act shall be construcd as applying only when said products are ready for consumption.
Sixth. If it consist in whole or in part of a filthy, decomposed. or putrid animal or vegetable substance, or any portion of an animal unfit for foodi, wlicther manufacturer or not, or if it in the product of a diacneed animal, or one that has diod otherwisc than hy slaughter.
In the case of cosmetics:
If it contains poisonous or deleterious ingredients in such quantities as likely lo be imminently dangerous to the user under the conditions of use prescribed in the labeling thereof, or when used under such conditions of use as are customary or usual.
FOOD, DRUGS, AND COSMETICS
8724. Sec. 8. That the term "misbranded", as used herein, shall apply to all drugs, or cosmetics, or articles of food, or articles which enter into the composition of food, the package, (or) label of which shall bear any statement, design, or dovice regarding auch article, or the ingredients or substances contained theroin which shall be falso or misleading in any particular, and to any food, (or) drug or cormelic (product) which is falsoly branded as to the Stato, l'erritory, or country in which it is manufactured or produced.
The term "package" or "original unbroken package" as used herein means the immediate container of the article which is intended to be delivered for consumption by the public. The lerm "label" includes ail wrillen, printed, and graphic malter in any form whalsoever accompanying any food, drug, or cosmelic.
That for the purposes of this Act an article shall also be deemed to he misbranded:
In case of drugs:
l'irst. If it be an imitation of or offered for sale under the name of another articlo.
Sucund. If the contents of the package as originally put up shull have been removed, in whole or in part, and other contents aliull huve been placed in such package, or if the package fail to bear a statement on the label of the quantity or proportion of any (alcohol) inorphine, opium, cocaine, heruin, alplia or beta eucaine, chloroforın, camabis, chlorul hydr:ste, (or) acetanilid, or barbituric acid, or any derivative or preparation of any such substances contained therein.
Third. If its package or lubel shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of tho ingredients or substunces contained therein, which is false and fraudulent.
Fourth. !! it fail to bear the true name and address of the man ufuclurer, packer, seller, or distributor thereof.
In the case of food:
First. If it be an inuitation of or offered for sale under the distinctive naine ol another article.
Second. If it be labeled (or), branded so as to deceive or mislead the purchaser, or purport to be a foreign product when not so, or if the contents of the package to originally put up shall have been removed in whole or in part and other contents shall have been placed in such packuge, or if it fail to bear a statement on the label of the quantity or proportion of any morphine, opium, cocaine, heroin, alpha or beta cucaite, chloroforni, cannabis, chloral hydrate, or barbituric acid or any dcrivutive or proparation of any such substances contained therein.
Third. If in puckage form, the quantity of the contents bo not plainly and conspicuously marked on the outside of the package in terms of weight, ineasure, or numerical count: Provided, however, That reasonable variations shall be permitted, and tolerances and also exemptions as to small packages shall be established by rules and regulations made in accordance with the provisions of section threo of this Act.
Fourth. If the package containing it or its labol shall bear any stuteinent, douign, or device regarding the ingredients or substances contained therein, which statement, design, or device skull be falso ur misleading in any particular: Pro vided, That an article of food which dous not contain
any added poisonous or deleterious ingredients shall not be deemed to be adulterated or misbranded in the following cases:
First. In the case of mixtures or coinpounds which may be now or from time to time hereafter known as articles of food, under their own distinctive nanıcs, and not an imitation of or offered for sale under the distinctive name of another article, if the name be accompanied on the same label or brand with a statement of lbo place whero suid article has been vanuluctured or produced.
Second. In the case of articles labeled, branded, or tagged 80 as to plainly indi. cate that they are compounds, imitations, or blends, and the word "compound, "lwitation", or "blend", as the case may be, is plainly stated on the package in which it is otsured for sale: Provided, That the term "blend" as Used lieroin shall be construed to mean a mixture of liko substances, not excluding harmless coloring or flavoring ingredients used for the purpose of coloring and llavoring only: And provided further, That nothing in this act shall be construed as requiring or conpolling proprietors ur manufacturers of proprietary foods which contuin no unwholesome added ingredient to disclose their trade formulas, except insofar as the provisions of this act may require to secure freedoin from adulteration or misliranding
Fifth. If it be canned food and falls below the standard of quality, condition, and/or fill of container, promulgated by the Secretary of Agriculture fur sucb 118
FOOD, DRUGS, AND COSMETICS
canned food and its package or label does not bear a plain and conspicuous statement prescribed by the Secretary of Agriculture indicuting that such canned food falls below such standard. For the purposes of this paragraph the words "canned food" mean all food which is in hermetically sealed containers and is sterilized by heat, except meat and meat food products, which are silbject to the provisions of the meat inspection act of March 4, 1907, as amended, and except canned milk; the word "class" means and is limited to a generic product for which a standard is to be established and doca not mean a grade, variety, or species of a generic product. The Secretary of Agriculture is authorized to determine, establish, and promulgate from time to tiine, a reasonable standard of quality, condition, and/or fill of container for each class of canned food as will, in his judginent, promote honesty and fair dealing in the interest of the consumer; and he is authorized to alter or modify such standard from time to time As, in his judgment, honesty, and fair dealing in the interest of the consumer may require. The Secretary of Agriculture is further anthorized to prescribe and promulgate from time to time the forın of statement which must appcar in a plain and conspicuous manner on cach package or label of canned foort which falls below the standard promulgated by him, and which will indicate that such canned food falls below such standard, and he is authorized to alter or modify such form of statement from time to time, as in his judgment may be necessary. In promulgating such standards and forms of stateinents and any alteration or modification thereof, the Secretary of Agriculture shall specify the dato or dates when such standards shall become cfloctive, or after which wiich statoments shall be used, and shall give public notice not less than ninety days in advance of the dato or dates on which such standards shall become effective or such statements shall be used. Nothing in this paragraph shall be construed to authorize the manufacture, sale, shipment, or transportation of adulterated or misbranded foods.
8725. Sec. 9. That no dealer shall be proxecuted under the provisions of this act when he can establish a guarantee signed by the wholesaler, jobber, manufacturer, or other party residing in the United States, from whom he purchases such articles, or who caused said articles to be introduced in interstate commerce, to the effect that the same is not adulterated or misbranded within the meaning of this act, designating it. Suid guaranty, to afford protection, shall contain the panic and address of the party or partics making the sale of such articles to Buch dealer, and in such case vaid party or parties shall be amendable to the prosecutions, fines, and other penulties which would attach, in due course, to the dealer under the provisions of this Act.
8726. Src. 10. That any article of food, rug, cosmclic, or liquor that is adulterstood or misbranded within the meaning of this Act, and is being transported from one State, Territory, District, or insular possession to another for sale, or, having been transportel, renisins umlouded, insold, or in original unbrokeri packages, or if it be sold or offered for sale in the District of Columbia or the Territorios, or insular porOSBÍONN of the United States, or if it be imported from & forcign country for sale, or if it is intended for export to a foreign country, shall be linble to be proceeded against in any district court of the United Statcs within the district where the same in fournil, and scized for continention by a process of libel for condemnation. And is much article in condemmed leing adulterated or misbranded, or of a poisonoun or deleterious character, within the meaning of this Act, the name klinll be disposed of by destruction or sale, as the said court may direct, and the proceeds thereof, is vold, less the legal CONts and charges, shall be paid into the Treilelry of the I'nited States, but such good shall not be sold in any jurisdiction contrary to the provisions of this Act or the laws of that jurisdiction: l'rovided, however Thnt upon the payment of the costs of much libel proceedings And Ilir esecution and delivery of a good and wuflicient bond to the effect that such articles shall not lop sold or otherwise dispored of contrary to the provisions of this Act, or the laws of any Slate, Territory, District, or insular posseksioni, the court my by order direct that such articles be delivered to tlic owner thereor. The proceedings of suchi libel CARCH sha]] conform, ils near us may be, to the proceedings in animirally, except, that either party may demand trial by jury of niny issue of fact joined in any such Case, and all such proceedings shall be at the suit of and in the rane of the United States.
SEC102. Notwithsluning the provisions of spalio 4 the Serratury of Igriculture shall, before rerlifying any riolation of paragraphe thiril, “In the roar as druge", in rection 8 of this ill, 10 any l'ailed States listrict allorney. lo punor criminal proceedings to be comienced and progreutoid or to cause any seizure for confiscalion by process of libel for condemnation, cause notice to be given in the person primarily
FOOD, DRUGS, AND COSMETICS
responsible for the representations alleged to be in violation of said paragraph third, ani a day to be fixed upon which said person mny be heard. No criminal proceedings shall be commenced nor shull any article of drug be proceeded againsl or seized for condemnation on the grounds that the label or package of said article of drug bears or contains any statement, cl«sign, or device regarding ihe curative of therapeutic ffect of such article or any of the ingredients or Niobstances conluined therein which is Julse and fraudulent, unles8 anul until the Secretary of Agriculture shall hure yiven The notice and usorilerl the opportunity for hearing as provided in this section.
At such hearing the party of parlies interested may furnish evidence, either by himself or his representative, to justify the representations of therapeutic or curative value mailc in or upon such lubel, or package.
In the event such person shull refuse or is unable to juslify such representations to the satisfaction of the person designated by the Secretary of Agriculture to hold such hearing, the secretary shall fi:r a reasonable time for such party to discontinue such representations or to make changes in or upon the label or package in the manner indicated by the Secretary. After such hearing the Secretary shall furnish such person a statemeni of his ruling and sel forth his reasons therefor.
If such person al such hearing shall by proper evidence justify such representations or shall niake changes indicated by the Secretury, the Secretary shall 'then furnish such person with a cerlificule that his rulings have been complied with.
In the event of the refusul or suilure of such person to consorin to directions of the Secrelary or his designate within the time so fired to discontinue representations or make changes in the package or label, the Secretary shall at once cerlify the facts as provided in section 4 of this Act.
Not more than one uctiun bused upon alleged false and fraudulent representations of Therapeutic value shall be pending in the courts of the United States ut one time until after there has been an adjudication that said article is misbranded within the mouning of said puragraph "thiril" herein mentioned.
After nolice and upon good cause being shown by the district attorney that an emergency exists, the judge of the court in which said action has been commenced inay enjoin the repelilious introduction in interstale commerce of arlicles similar lo the article seized, until such time (18 the pending cause may be tried.
In the event, after the trial of said single action, there shall have been a final decreo or judgment entered in favor of the Government, then further proceedings in libel for confisculion inay be cominenced against the urticle of drugs compluined of and the label or packnge bear or conluin similar statements, designs or devices and which have been shipped in interstule commerce.
The district allorney may apply to the district court in any jurisdiction where un article or drugs may be found, ihe label anı package of which bears or contains any slalement, design or device, concerning the theripeulic value of such arlicle or of the ingredients contained therein which is false and fraudulent, upon a showing that an emergency exists and trustic action in the interests of public health is necessary, and oblain an order directing the United Stales marshal to impound such article pending further order of the court.
Appeals and other proceedings under this section may be had in accordance with tille 12c, section 1121 (Judiciury Code No. 129).
106. The lerin advertisement as used herein includes all representations of fact disseminated by the manufacturer, producer, owner, or distributor of an article of food, drug, or cosmetic, or by his authorized agent or representative in any inanner by other than label, and excludes statements which involve matters of opinion where there is no exact standard of absolule truth. Any advertisement of food, drug, or cosmetic will be deemed false if in any parlicular representations of fact are untrue. The Secrelary shall before reporting any violation of this uc by reason of any adverlisement of foods, drugs, or cosmetics for institution of criminal proceedings, afford due notice and opporlunity for a hearing to interested parties.
The examination of ailvertising shall be made in a bureau of the Department of Agriculture as may be directed by the Secretary of Agriculture, and if it appears that such advertisement is false within the meaning of this section the Secretary of Agriculture shall cause notice to be given to the person primarily responsible for the representations appearing in such adverliscient alleged to be in violation of this seclion, and the day fixed upon which said person may be heard. No criminal proceedings shall be commenced on the grounds that said advertisement is false, as dofined in this section, until the notice and hearing provided for have been given and afforded. If it appears to the Secrelary after such hearing that such advertisement is false as provided herein, then the Secretary shall direct that such party shall cease und desist front making the representations complained of, and in making such order the Secrelary shall furnish lo such person a staternent of his ruling and sel forth his
reasons therons. In the event such person shall fail to cease and desist from continuing the representations in such advertising complained of, the Secrelary shall al once certify the facts as provided in section 4 of this act.
10c. The dissemination of any false adverliscment as defined in the nest preceding section by any means for the purpose of inducing directly or indirectly the sale of foods, drugs, or cosmetica in interslale commerce is prohibiled, and any person who violater or causes to be violated any of the provisions of paragraph 1 of this section, and who shall fall or refuse to comply with the cense and desisl order as provided for herein, shall be guilly of a misdemeanor and shall, on conviction thereof be subject to a fine of not less than $100 not more than $1,000, or imprisonment for not more than 1 year, or both such fine and imprisonment, in the discretion of the court.
8727. Sec. 11. The Secretary of tho I'roasury sball deliver to the Sccrctary of Agriculture, upon his roquest from time to time, snmples of foods (and), drugs, and conmelice which are being imported into the United States or offered for import, giving notice thereof to the ownor or consignce, who may appcar before the Secrctary of Agriculture, and have the right to introduce testimony, and if it appear from the examination of such samples thint any article of food (or), cirug or cosmetic offered to be imported into the United Stntes le adulterated or misbranded within the meaning of this act, or is otherwise dangerous to the bealth of the peoplo of the United Statrs, or if of a kind forbidden outry into, or forbidden to be sold or restricted in anle in the country in which it is inode or from which it is exported or in otherwino friscly Inbeleci in any respect, the Raid article sliall be reluiscd admission, and the Secretary of the Treasury shall refuse delivery in the consignee and shall Calac the destruction of any goods refined delivery which shall not be exported by the consignee within 3 months from the date of notice of such refusal under auch regulations as the Secretary or the Treasury may prescribe: Provideid, 'That the Secretary of the Treasury nay deliver to the consignee such goods pending examination and decision in the matter on execution of a penal bond for the amount of the full invoico value of :such goodle, togсther with the duty thereon, and on rofural to return auch goods for any caulso to the custody of the Secretary of the Treasury, when demanded, for the purpose of cxcluding them from the country, or for any other purpose, anid consignee gliall forfeit the full amount of the bond: And provided further, That all charges for storage, cartngr, nurl labor on gooils which are refused admission or delivery shall be paid by the owner or consignoe, and in default of such payment shall constitute a lion against any future importation made by such owner or consignee.
8727. Soc. 12. That the term "Territory" as ured in this Act shall include the insular l'Ornegal0118 of the United States. The word "person" As und in this act shall be construed to import both tho plural and the singular, as tho cane demands, and shall include corporations, companies, sociotics, and Annociations. When construing and enforcing the provisions of this act, the act, omission, or frilure of any officer, agent, or other person acting for or employed by any corporation, compnny, society, or Association, within the scope of his employment or office, shall in every cane bo Alko doomed to ho the act, omission, or failure of such corporation, company, society, or Association as well as that of the person.
Senator COPELAND. T'ho stotomonts of James W. Baldwin of the National Association of Broadcasters, and of Dr. D). Aitchison, praaident of tho National Libertios Association, aro prosonted for the rocord.
STATEMENT OF JAMES W. BALDWIN, ON BEHALF OF THE
NATIONAL ASSOCIATION OF BROADCASTERS Mr. BALDWIN. My namo is James W. Baldwin, of Washington, D.C. I nppear on behalf of tho Notional Association of Broadcasters, the only trade orgnnization reprosenting the radio broalcasting industry of the United States. The National Associntion of Brondcastors lins nt prosent 283 monibers, and its membership doos approximately 83 porcent of tho commorcinl brondcasting business of tho country, Full dotnils regarding this association aro on file with the National Recovery Administrntion, which cortified on November 14, 1933,