Pure Food and Drug Act (1906) (Major Acts of Congress)
Daniel P. Carpenter
Excerpt from the Pure Food and Drug 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.
That the introduction into any State or Territory or the District of Columbia ... of any article of food or drugs which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited?. [Section 2]
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.... [Section 4]
It would not stretch matters to say that the Pure Food and Drug Act of 1906 (P.L. 59-384, 34 Stat. 768), also known as the Wiley Act, stands as the most consequential regulatory statute in the history of the United States. The act not only gave unprecedented new regulatory powers to the federal government, it also empowered a bureau that evolved into today's Food and Drug Administration (FDA). The legacy of the 1906 act includes federal regulatory authority over one-quarter of gross domestic product, and includes market gatekeeping power over human and animal drugs, foods and preservatives, medical devices, biologics and vaccines. Other statutes (such as the Interstate Commerce Act of 1887, the Sherman and Clayton antitrust laws, and the Federal Trade Commission Act of 1914) have received more study, but the Pure Food and Drug Act has had the longest-lasting and most widespread economic, political, and institutional impact.
The passage of regulatory legislation came only after two decades of wrangling and congressional opposition to federal regulation of food and drugs. Three political forces converged to force food and drug regulation onto the congressional agenda. First, consumer movements dominated by highly organized women activists put pressure on legislators to satisfy public wishes. The decades-long struggle for a law was actively supported by the General Federation of Women's Clubs (especially Alice Lakey) and the Women's Christian Temperance Union.
A second force was the rise of journalism. In 1905 Upton Sinclair's The Jungle, which exposed practices in the Chicago meat-packing industry, sold 1 million copies in its first year after publication. Nearly as important were the articles of Samuel Collins Adams in Collier's magazine on patent medicines and advertising fraud. These and other articles served to highlight the widespread adulteration of ethical drugs as well as of food.
The most important force behind the act was a single individual, Harvey Washington Wiley, and the agency he led, the Bureau of Chemistry in the U.S. Department of Agriculture (USDA). Wiley assumed leadership of this division of the USDA in 1883 and soon acquired legal and administrative power over the food, patent medicine, and pharmaceutical industries. Wiley experimented with small-scale programs in food regulation, built a multifaceted coalition behind food and drug regulation, and even helped Adams write his Collier's articles. Congress largely followed Wiley's lead, with opponents gradually giving way to Wiley's political machine. The 1906 act stands as one of the most daring demonstrations of bureaucratic autonomy in the history of the United States.
RELATIONSHIP WITH OTHER LAWS
The Pure Food and Drug Act was passed on the same day as the Meat Inspection Act of 1906. This act mandated examination of livestock before slaughter as well as analysis of carcasses, and required ongoing USDA
At the time, the Pure Food and Drug Act of 1906 was the most daunting intrusion by federal authorities into interstate commerce. Although other federal agencies could regulate prices and occupational safety, the USDA was now engaged in the regulation of the very manufacture and sale of products, in addition to advertising. Two subsequent laws, the Food, Drug, and Cosmetic Act of 1938 and the 1962 Kefauver-Harris Amendments, strengthened the 1906 act's legacy of empowering the FDA. Today the FDA regulates one-quarter of gross domestic product, and not a week goes by without an FDA action making news headlines. The economic legacy of the act includes strong consumer safeguards, controls on pharmaceutical and medical device markets, regulatory intervention in the process of pharmaceutical development and advertising, and government oversight of food production and marketing.
See also: FEDERAL FOOD, DRUG, AND COSMETIC ACT; FOOD QUALITY PROTECTION ACT.
Anderson, Oscar E. The Health of a Nation: Harvey W. Wiley and the Fight for Pure Food. Chicago: University of Chicago Press, 1958.
Bailey, Thomas A. "Congressional Opposition to Pure Food Legislation, 1879906." American Journal of Sociology 36 (July 1930): 524.
Carpenter, Daniel P. The Forging of Bureaucratic Autonomy: Reputations, Networks and Policy Innovation in Executive Agencies, 1862928. Princeton, NJ: Princeton University Press, 2001.
Young, James Harvey. Pure Food: Securing the Pure Food and Drug Act of 1906. Princeton, NJ: Princeton University Press, 1989.