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  1. Changes in Science, Law and Regulatory Authorities

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))

The U S. Food and Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 20 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 15,000 employees and a budget of $4.4 billion in 2014, 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 non-regulatory 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.An Act against selling unwholesome Provisions.

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.

10 men standing outside

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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