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By John P. Swann, Ph.D.
FDA History Office
(adapted from George Kurian, ed., A Historical Guide to
the U.S. Government
(New York: Oxford University Press, 1998))
Origins
The U S. Food and Drug Administration is a scientific, regulatory,
and public health agency that oversees items accounting for
25 cents of every dollar spent by consumers. Its jurisdiction
encompasses most food products (other than meat and poultry),
human and animal drugs, therapeutic agents of biological origin,
medical devices, radiation-emitting products for consumer, medical,
and occupational use, cosmetics, and animal feed. The agency
grew from a single chemist in the U.S. Department of Agriculture
in 1862 to a staff of approximately 9,100 employees and a budget
of $1.294 billion in 2001, comprising chemists, pharmacologists,
physicians, microbiologists, veterinarians, pharmacists, lawyers,
and many others. About one-third of the agency's employees are
stationed outside of the Washington, D. C. area, staffing over
150 field offices and laboratories, including five regional
offices and 20 district offices. Agency scientists evaluate
applications for new human drugs and biologics, complex medical
devices, food and color additives, infant formulas, and animal
drugs. Also, the FDA monitors the manufacture, import, transport,
storage, and sale of about $1 trillion worth of products annually
at a cost to taxpayers of about $3 per person. Investigators
and inspectors visit more than 16,000 facilities a year, and
arrange with state governments to help increase the number of
facilities checked.
Beginning as the Division of Chemistry and then (after July
1901) the Bureau of Chemistry, the modern era of the FDA dates
to 1906 with the passage of the Federal Food and Drugs Act;
this added regulatory functions to the agency's scientific mission.
The Bureau of Chemistry's name changed to the Food, Drug, and
Insecticide Administration in July 1927, when the nonregulatory
research functions of the bureau were transferred elsewhere
in the department. In July 1930 the name was shortened to the
present version. FDA remained under the Department of Agriculture
until June 1940, when the agency was moved to the new Federal
Security Agency. In April 1953 the agency again was transferred,
to the Department of Health, Education, and Welfare (HEW). Fifteen
years later FDA became part of the Public Health Service within
HEW, and in May 1980 the education function was removed from
HEW to create the Department of Health and Human Services, FDA's
current home. To understand the development of this agency is
to understand the laws it regulates, how the FDA has administered
these laws, how the courts have interpreted the legislation,
and how major events have driven all three.
States
exercised the principal control over domestically produced and
distributed foods and drugs in the 19th century, control that
was markedly inconsistent from state to state. The illustration
at right shows an act passed by Massachusetts, which led the
way in state-sponsored food and drug laws. The Vaccine Act of
1813, though short-lived, was the first federal law dealing
with consumer protection and therapeutic substances. Federal
authority was limited mostly to imported foods and drugs. Adulteration
and misbranding of foods and drugs had long been a fixture in
the American cultural landscape, though the egregiousness of
the problems seemed to have increased by the late 19th century
(or at least they became more identifiable). By this time science
had advanced significantly in its ability to detect this sort
of fraud. Also, legitimate manufacturers were becoming more
concerned that their trade would be undermined by purveyors
of deceitful goods. Quinine-containing cinchona bark powder
could be made less therapeutically effective--and much more
profitable--by cutting it with just about anything, alum and
clay masked poor wheat flour and thus netted a heftier return
for the unethical company, and sufferers of any number of serious
or self-limited diseases were relieved only of their finances
by vendors of worthless nostrums. Even the so-called ethical
drug firms were guilty of this practice.
The Division of Chemistry began investigating the adulteration
of agricultural commodities as early as 1867. When Harvey Washington
Wiley arrived as chief chemist in 1883, the government's handling
of the adulteration and misbranding of food and drugs took a
decidedly different course, which eventually helped spur public
indignation at the problem. Wiley expanded the division's research
in this area, exemplified by Foods and Food Adulterants,
a ten-part study published from 1887 to 1902. He demonstrated
his concern about chemical preservatives as adulterants in the
highly publicized "poison squad" experiments, in which able-bodied
volunteers consumed varying amounts of questionable food additives
to determine their impact on health. And Wiley unified a variety
of groups behind a federal law to prohibit the adulteration
and misbranding of food and drugs, including state chemists
and food and drug inspectors, the General Federation of Women's
Clubs, and national associations of physicians and pharmacists.
Harvey Wiley, third from right, is photographed with
his staff from the Division of Chemistry, U.S. Department
of Agriculture, not long after he arrived in Washington
in 1883. |
Next: The 1906 Food and Drugs Act and
Its Enforcement
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