How Chemists Pushed for Consumer Protection: The Food and Drugs Act of 1906

Just as the milieu of progressivism had prepared the way for passage of the long-sought food and drug law, so the coming of Franklin Roosevelt to the White House along with the New Deal introduced an ear receptive to proposed remedies for the shortcomings of the 1906 act. To help get its point across to a variety of audiences, including Congress, the White House, the press, radio listeners, and even visitors to the 1933 World’s Fair in Chicago, the FDA assembled a collection of sometimes gruesome examples of products that were on the market legally. Among them were Banbar, a remedy for diabetes consisting of an extract of horsetail weed, introduced by a shirt salesman—after the discovery of insulin—as an injection-free cure for this disease. Although the FDA established in court that diabetics were dying on this nostrum even though insulin was available, the government lost its case because it could not meet the standard of establishing fraud.

Another star in this collection of consumer minefields that a press observer aptly christened the “Chamber of Horrors” was Lash Lure, an aniline eyelash and eyebrow dye that seriously injured and even blinded several women in the early 1930s; a picture of one victim, her disfigurement exposed in a poster, was one of the more shocking entries in the chamber. So were X-rays showing children who had ingested trinkets enclosed in food, the prize outlined in the esophagus for all to see. Yet another example of outlandish and dangerous medical technology was the Diana Ideal Womb Supporter, which could puncture the uterus if inserted the wrong way. No federal statute stood between a dangerous drug and its sale directly to the public, as evidenced by the popularity of the diet preparation dinitrophenol in the 1930s. Dinitrophenol so accelerated metabolism, creating grave side effects, including cataracts, that most clinicians skilled in the evaluation of such products had abandoned it. Yet about two dozen brands, heavily promoted in newspapers, magazines, and radio, remained on the market for any lay user interested in losing weight. Another dangerous drug, which came on the market in October 1937, was not part of the Chamber of Horrors exhibit but was more influential than any exhibited product in demonstrating that the 1906 law needed to be improved. The S. E.Massengill Company of Tennessee introduced a liquid form of the new wonder drug sulfanilamide as an alternative to the large tablets of the original formulation. The chemical chosen to effect this route of administration, diethylene glycol, was never examined for safety, neither in the laboratory nor even in the medical literature. Recourse to either would have revealed that Elixir Sulfanilamide, the name Massengill chose for its preparation, was deadly.

Over 100 people died, including many children, and the FDA staff around the country launched a massive search for any Elixir Sulfanilamide that might remain in warehouses, pharmacies, physician offices, and medicine cabinets of those to whom the drug had been prescribed. The government charged Massengill with the only violation it had committed under the law, selling a misbranded drug in interstate commerce: technically, elixirs had to contain alcohol as a drug vehicle, and Elixir Sulfanilamide had none.

Congress had introduced bills to replace the Food and Drugs Act since 1933, but none had earned enough support until the time of Elixir Sulfanilamide. That therapeutic disaster and the public outrage it engendered pressured Congress to step up efforts to pass a comprehensive law, and on 30 June 1938 President Franklin Roosevelt signed the Food, Drug, and Cosmetic Act. Besides the provision that the FDA approve new drugs before they were marketed, the law brought medical devices and cosmetics under regulation; it required that standards of identity and packaging for foods be implemented; it mandated factory inspections; it instituted tolerances for certain poisonous substances; and it created the framework within which the FDA could require good manufacturing processes. Further, drugs had to carry adequate directions for safe use—though advertising of drugs would fall under the Federal Trade Commission—and fraud no longer had to be established to prove misbranding. The 1938 act has since been amended many times, and the regulation of several products, including medicines of biological origin and radiation-emitting devices, has been added to the FDA’s responsibilities. But the Food, Drug, and Cosmetic Act remains today the essential law overseen by the FDA.

Almost 100 years ago, America decided it had had enough of a marketplace where the only rule was caveat emptor. People deserved better than to be treated thoughtlessly by unscrupulous, deceitful, and avaricious peddlers of goods to which no one should be exposed. It did not happen overnight: efforts were constantly thwarted by those who stood to benefit by a marketplace of this nature and by those who were philosophically opposed to the sort of government intervention that these bills required. But the steadfast devotion to change by many, especially Harvey Wiley, won in the end. The Bureau of Chemistry, predecessor of the FDA, enforced its provisions tirelessly and innovatively, drawing upon experts from its own ranks and sometimes from outside to inform its policies and buttress its arguments. Sometimes problems were attacked collaboratively with industry. The law was far from perfect, but it nevertheless represents a revolutionary landmark in the history of consumer protection in America. Its centennial is cause for every citizen to celebrate and to remember.

For Further Reading

Anderson, Oscar E., Jr. The Health of a Nation:Harvey W. Wiley and the Fight for Pure Food. Chicago: University of Chicago Press, 1958.

Hilts, Phil. Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred A. Knopf, 2003.

Junod, Suzanne White. “U.S. Federal Food Standards: The Case of the Peanut Butter and Jelly Sandwich.” In Food, Science, Policy, and Regulation in the Twentieth Century: International and Comparative Perspectives, ed. David F. Smith and Jim Phillips (London: Routledge Press, 2000), pp. 167–188.

Kay, Gwen. “Healthy Public Relations: The FDA’s 1930s Legislative Campaign.” Bulletin of the History of Medicine 75 (2001), 446–487.

Swann, John P. “Pharmaceutical Regulation Before and After the Food, Drug, and Cosmetic Act.” In The Pharmaceutical Regulatory Process, ed. Ira R. Berry (Drugs and the Pharmaceutical Sciences, 144) (New York: Marcel Dekker, 2005), pp. 1–46.

Wiley, Harvey W. An Autobiography. Indianapolis: Bobbs-Merrill, 1930.

———. The History of a Crime against the Food Law. Washington, DC, 1929.

Young, James Harvey. Pure Food: Securing the Federal Food and Drugs Act of 1906. Princeton: Princeton University Press, 1989. See especially the summary of literature on Wiley and the Food and Drugs Act.

———.“Drugs and the 1906 Law.” In Safeguarding the Public: Historical Aspects of Medicinal Drug Control, ed. John B. Blake (Baltimore: Johns Hopkins Press, 1970), pp. 147–157.

“Selected Sources on the History of FDA.” www.fda.gov/opacom/morechoices/sources.html.