PURE FOOD AND DRUG ACT (1906)
P URE F OOD
AND
D RUG A CT (1906)
Daniel P. Carpenter
Excerpt from the Pure Food and Drug Act
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.
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]
I
t 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.
gross domestic product: the total market
value of goods and services produced within a
nation in a given time period (usually one
year)
The act not only gave unprecedented new
BACKGROUND
The passage of regulatory legislation came only after two regulatory powers to the federal government, it
decades of wrangling and congressional opposition to federal
regulation of food and drugs. Three political forces converged also empowered a bureau that evolved into today’s
to force food and drug regulation onto the congressional Food and Drug Administration (FDA).
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
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PURE FOOD AND DRUG ACT (1906)
The 1906 act stands as one of the most daring
demonstrations of bureaucratic autonomy in the
history of the United States.
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
A food research laboratory in early-twentieth-century New York. (©CORBIS)
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inspection of slaughterhouses and processing plants. The Pure
Food and Drug Act and the Meat Inspection Act divided
administration of food regulation into two bureaus. The
Bureau of Chemistry, headed by Wiley, administered most
provisions of the Pure Food and Drug Act. The Bureau of Animal Industry, led by Daniel Salmon, carried out federal meat
inspections. This division of administrative oversight persists
to this day. The USDA still inspects beef and poultry, whereas
the FDA inspects most other foods.
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.
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.
BIBLIOGRAPHY
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, 1879–1906.”
American Journal of Sociology 36 (July 1930): 52–64.
Carpenter, Daniel P. The Forging of Bureaucratic Autonomy: Reputations, Networks
and Policy Innovation in Executive Agencies, 1862–1928. 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.
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