Pure Food and Drugs Act of 1906
Although the Pure Food and Drugs Act of 1906 influenced the labeling of
Conditions in the
In the same era, thousands of so called 'patent' medicines such as 'Kick-a-poo Indian Sagwa' and 'Warner's Safe Cure for Diabetes' reflected both the limited medical capability of the period and public acceptance of the doctrine that the buyer could and should look out for himself. Medicines containing such drugs as opium, morphine, heroin, and cocaine were sold without restriction. Labeling gave no hint of their presence. Otherwise harmless preparations were labeled for the cure of every disease and symptom. Labels did not list ingredients and warnings against misuse were unheard of. What information the public received came frequently from bitter experience…
In 1903, Wiley (Dr. Harvey Wiley, first head of the FDA) captured the attention of the country by establishing a volunteer "poison squad" of young men who agreed to eat only foods treated with measured amounts of chemical preservatives, with the object of demonstrating whether these ingredients were injurious to health…
Strenuous opposition to Wiley's campaign for a Federal food and drug law came from whiskey distillers and the patent medicine firms, who were then the largest advertisers in the country. Many of these men thought they would be put out of business by Federal regulation. In any case, it was argued, the Federal Government had no business policing what people ate, drank, or used for medicine. On the other side were strong agricultural organizations, many food packers, State food and drug officials, and the health professions. But the tide was turned, according to historians and Dr. Wiley himself, when the voteless but militant club women of the country rallied to the pure food cause.
The following sections are cited from the Pure Food and Drugs Act of 1906: United States Statutes at Large (59th Cong., Sess. I, Chp. 3915, p. 768-772). Full text of the Act can be found at http://www.ncbi.nlm.nih.gov/books/bookres.fcgi/history/pdf_purefood.pdf.
An Act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes…
Sec. 4. That the examinations of specimens of foods and drugs shall be made in the Bureau of Chemistry of the Department of Agriculture, or under the direction and supervision of such Bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this Act…
Sec. 6. That the term 'drug,' as used 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 cure, mitigation, or prevention of disease of either man or other animals. The term 'food,' as used herein, shall include all articles used for food, drink, confectionery, or condiment by man or other animals, whether simple, mixed, or compound.
Sec. 7. That for the purposes of this Act an article shall be deemed to be adulterated…In the case of food:
First. If any substance has been mixed and 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, coated, or stained in a manner whereby damage or inferiority is concealed.
Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health…
Sec. 8. That the term, 'misbranded,' as used herein, shall apply to all drugs, 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 device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactured or produced.
That for the purposes of this Act an article shall also be deemed to be misbranded…In the case of food:
First. If it be an imitation of or offered for sale under the distinctive name of 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 as originally put up shall have been removed in whole or in part and other contents shall have been placed in such package, 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 eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein.
Third. If in package form, and the contents are stated in terms of weight or measure, they are not plainly and correctly stated on the outside of the package.
Fourth. If the package containing it or its label shall bear any statement, design, or device regarding the ingredients or the substances contained therein, which statement, design, or device shall be false or misleading in any particular…
Sec. 13. That this Act shall be in force and effect from and after the first day of January, nineteen hundred and seven.
Approved, June 30, 1906.
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