By: Harvey W. Wiley
Source: Wiley, Harvey W. Pure Food and Drug Act. Matrix. Available online at http://coursesa.matrix.msu.edu/~hst203/documents/pure.html; website home page: http://coursesa.matrix.msu.edu (accessed March 15, 2003).
About the Author: Harvey W. Wiley (1844–1930) received his doctorate in chemistry from Harvard University in 1873. He was a professor of chemistry at Purdue University between 1874 and 1883 and chief of the Bureau of Chemistry in the U.S. Department of Agriculture between 1883 and 1912. He was also the author of the Pure Food and Drug Act of 1906.
The safety and wholesomeness of food and drugs suffered a crisis of confidence at the beginning of the twentieth century. Two movements exposed contaminated and impure foods and ineffective and dangerous drugs.
The first movement was in 1900, when Theodore Roosevelt testified before Congress that he and his troops became ill eating the canned meat the U.S. Army served as rations during the Spanish-American War (1898). Following this congressional investigation, newspapers began to report on the quality of beef and pork.
In 1905, Upton Sinclair was hired by the Appeal to Reason, a socialist newspaper, to investigate the meat-packers. He eventually published his observations in The Jungle (1906), which revealed the filth that contaminated U.S. meat and caused a public uproar. The second movement was sparked by writer Samuel Hopkins Adams, who in 1905 published a series of magazine articles that attacked the drug industry as a fraud. Many drugs had no medicinal value, wrote Adams. Instead, they filled patients with alcohol and opium. Some drugs were nothing more than diuretics, eliminating fluids from a person at the very time he or she needed to be hydrated to fight infection. Such drugs worsened rather than improved health. He stated that drug manufacturers cared nothing for the truth and advertised medicinal benefits they knew their drugs lacked.
The crisis peaked in 1906 when an outraged public demanded action. Roosevelt, by now president (served 1901–1909), saw an opportunity to enhance his reputation as a crusader for the public. Opposing Roosevelt and the public were the meatpackers and drug manufacturers. They pointed to the American tradition in which business regulated itself without governmental oversight, and they lobbied Congress to do nothing. But public uproar and Roosevelt's steady pressure forced Congress to act.
On June 30, 1906, Congress passed the Meat Inspection Act, which empowered the U.S. Department of Agriculture to ensure the safety and wholesomeness of U.S. meat. Had Congress gone no further, business might have been able to declare victory. True, the act put meat-packers under Department of Agriculture oversight, but other food manufacturers and all drug manufacturers could continue business as usual.
That day, however, Roosevelt also signed the Pure Food and Drug Act. The act empowered the Departments of the Treasury, Agriculture, and Commerce to inspect any "specimen" of food and drug for purity and truth in safety and labeling. Should the departments find manufacturers selling impure food and drugs or falsely advertising them, the act empowered federal courts to fine violators $500 and imprison them for a year.
Like the Meat Inspection Act, the Pure Food and Drug Act put public health above the right of business to maximize profit. The act reinforced the role of the federal government as protector of public health. It also demonstrated that a president backed by public support could compel business to guarantee the safety and wholesomeness of its products.
Primary Source: Pure Food and Drug Act [excerpt]
SYNOPSIS: The Pure Food and Drug Act empowered the Departments of the Treasury, Agriculture, and Commerce to inspect food and drugs for safety and labeling and for purity and truth. If the manufacturers were found to be selling impure food and drugs or falsely advertising them, the act empowered federal courts to fine and imprison violators.
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.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That it shall be unlawful for any person to manufacture within any territory or the District of Columbia any article of food or drug which is adulterated or misbranded, within the meaning of this Act; and any person who shall violate any of the provisions of this section shall be guilty of a misdemeanor, and for each offense shall, upon conviction thereof, be fined not to exceed five hundred dollars or shall be sentenced to one year's imprisonment, or both such fine and imprisonment, in the discretion of the court, and for each subsequent offense and conviction thereof shall be fined not less than one thousand dollars or sentenced to one year's imprisonment, or both such fine and imprisonment, in the discretion of the court.
Sec. 2. That the introduction into any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or from any foreign country, or shipment to any foreign country of any article of food or drugs which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited; and any person who shall ship or deliver for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, or to a foreign country, or who shall receive in any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or foreign country, and having so received, shall deliver, in original unbroken packages, for pay or otherwise, or offer to deliver to any other person, any such article so adulterated or misbranded within the meaning of this Act, or any person who shall sell or offer for sale in the District of Columbia or the Territories of the United States any such adulterated or misbranded foods or drugs, or export or offer to export the same to any foreign country, shall be guilty of a misdemeanor, and for such offense be fined not exceeding two hundred dollars for the first offense, and upon conviction for each subsequent offense not exceeding three hundred dollars or be imprisoned not exceeding one year, or both, in the discretion of the court: Provided, That no article shall be deemed misbranded or adulterated within the provisions of this Act when intended for except to any foreign country and prepared or packed according to the specifications or directions of the foreign purchaser when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption, then this proviso shall not exempt said article from the operation of any of the other provisions of this Act.
Sec. 3. That the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce and Labor shall make uniform rules and regulations for carrying out the provisions of this Act, including the collection and examination of specimens of foods and drugs manufactured or offered for sale in the District of Columbia, or in any Territory of the United States, or which shall be offered for sale in unbroken packages in any State other than that in which they shall have been respectively manufactured or produced, or which shall be received from any foreign country, or intended for shipment to any foreign country, or which may be submitted for examination by the chief health, food, or drug officer of any State, Territory, or the District of Columbia, or at any domestic or foreign port through which such product is offered for interstate commerce, or for export or import between the United States and any foreign port or country.
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; and if it shall appear from any such examination that any of such specimens is adulterated or misbranded within the meaning of this Act, the Secretary of Agriculture shall cause notice thereof to be given to the party from whom such sample was obtained. Any party so notified shall be given an opportunity to be heard, under such rules and regulations as may be prescribed as aforesaid, and if it appears that any of the provisions of this Act have been violated by such party, then the Secretary of Agriculture shall at once certify the facts to the proper United States district attorney, with a copy of the results of the analysis or the examination of such article duly authenticated by the analyst or officer making such examination, under the oath of such officer. After judgment of the court, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid.
Sec. 5. That is shall be the duty of each district attorney to whom the Secretary of Agriculture shall report any violation of this Act, or to whom any health or food or drug officer or agent of any State, Territory, or the District of Columbia shall present satisfactory evidence of any such violation, to cause appropriate proceedings to be commenced and prosecuted in the proper courts of the United States, without delay, for the enforcement of the penalties as in such case herein provided.
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 case of drugs:
First. If, when a drug is sold under or by a name recognized in the United States Pharmacopoeia or National Formulary, it differs from the standard of strength, quality, or purity, as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation: Provided, That no drug defined in the United States Pharmacopoeia or National Formulary shall be deemed to be adulterated under this provision if the standard of strength, quality, or purity be plainly stated upon the bottle, box, or other container thereof although the standard may differ from that determined by the test laid down in the United States Pharmacopoeia or National Formulary.
Second. If its strength or purity fall below the professed standard or quality under which it is sold.
In the case of confectionery:
If it contain terra alba, barytes, talc, chrome yellow, or other mineral substance or poisonous color or flavor, or other ingredient deleterious or detrimental to health, or any vinous, malt or spirituous liquor or compound or narcotic drug.
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: Provided, That when in the preparation of food products for shipment they are preserved by any external application applied in such manner that the preservative is necessarily removed mechanically, or by maceration in water, or otherwise, and directions for the removal of said preservative shall be printed on the covering or the package, the provisions of this Act shall be construed as applying only when said products are ready for consumption.
Sixth. If it consists in whole or in part of a filthy, decomposed, or putrid animal or vegetable substance, or any portion of an animal unfit for food, whether manufactured or not, or if it is the product of a diseased animal, or one that has died otherwise than by slaughter.
Kline, Mahlon N. Digest of National Food and Drugs Act and Regulations. Philadelphia: Smith, Kline and French, 1907.
Robertson, William. Meat and Food Inspection. Chicago: Keener, 1908.
U.S. Department of Agriculture. Decisions of Courts in Cases Under the Federal Food and Drugs Act. Washington, D.C.: U.S. Government Printing Office, 1934.
"Early Drug Laws." Congressional Quarterly Researcher, July 28, 2000, 604–607.
"Safer and Healthier Foods." Morbidity and Mortality Weekly Report, October 15, 1999, 905–913.
"Stamp Marks Early Public Health Law." FDA Consumer, March–April 1998, 4.
Weisberger, Bernard A. "Dr. Wiley and His Poison Squad." American Heritage, February–March 1996, 14–16.
"Harvey Washington Wiley." U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Available online at ; website home page: http://www.fda.gov (accessed March 15, 2003).
"The Pure Food and Drug Act." Forces International. Available online at http://www.forces.org/articles/files/whiteb/white02.htm; website home page: http://www.forces.org (accessed March 15, 2003).