Why was the federal food, drug, and cosmetic act of 1938 created

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The Food, Drug, and Cosmetic Act (FDCA) was signed into law by President Franklin Roosevelt on June 25, 1938. Its goal was to improve public safety and its major provisions regulated cosmetics and medical devices; required that safety directions be included with medicine; required that new medicines be approved by the Food and Drug Administration (FDA); outlawed false therapeutic claims; enhanced food safety standards (e.g., packaging); and authorized inspections and enforcement [1].

By the time of the New Deal, there was a long-standing feeling that the pioneering legislation that created the FDA—the famous 1906 Food and Drugs Act—had become inadequate. Several dramatic product failures and poisonings had occurred over the years, such as the tragic 1937 case of “Elixir Sulfanilamide” (billed as a cure-all, but chemically similar to anti-freeze) killing about 100 people.

The new bill was sponsored by U.S. Senator Royal Copeland (D-NY), who wrote it with the assistance of prominent New Dealer Rexford Tugwell and two university professors, Milton Handler and David Cavers [2]. At the time the FDCA became law, Secretary of Agriculture Henry Wallace observed in a radio address:

“This is a law of far-reaching importance to every person in the United States… Within two decades after the old food and drugs act went into effect the conditions of American life had changed profoundly. New machinery, new roads, new transportation, new knowledge in chemistry and physics had worked together to transfer much food preparation from the home kitchen to the factory… New ways of living in small homes with automatic heating and electric power to do the household chores set a large group of American women free from the sun-to-sun household work…” [3].

Wallace noted that more leisure time for women had resulted in more time devoted to physical appearance, which in turn created “Very quickly, an almost wholly new cosmetic industry… [which] was not subject to any control under the old act” [4]. One of the first enforcement actions under the FDCA was the seizure of “Lash Lure” and “Magic-di-Stick,” eyelash products that “contained a preparation which might cause serious eye injury or even blindness” [5]. Indeed, the FDA had created an influential travelling exhibit in 1933 called the “American Chamber of Horrors,” which included photographs of a woman blinded by Lash Lure that reportedly brought Eleanor Roosevelt to tears [6].

For fiscal year 1941, the FDA reported 2,016 shipment seizures and 325 criminal prosecutions for various FDCA violations. Out of 1,376 applications for new medicines, the FDA approved 807 [7]. By the 1960s, about half of the American food supply was required to meet standards set up under the FDCA [8]. The New Deal’s FDCA has protected America’s food supply and medicines for decades, and it “still looms large in guiding the FDA’s mission” [9].

Through the 1930s, the FDA was under the purview of the US Department of Agriculture but was moved to the Federal Security Agency in the 1939 federal reorganization and later transferred to the Department of Health and Human Services in the 1960s.

Sources: (1) “Part II: 1938, Food, Drug, Cosmetic Act,” U.S. Food and Drug Administration (accessed October 20, 2020).  (2) See, e.g., “Food, Drug, and Cosmetic Act of 1938,” in James S. Olson, ed., Historical Dictionary of the New Deal: From Inauguration to Preparation for War, Westport, CT: Greenwood Press, 1985, p. 200.  (3) “Secretary Wallace Talks on New Food and Drug Act,” The Morning Call (Paterson, New Jersey) June 30, 1938, p. 10.  (4) Ibid.  (5) “Beauty Czar Will Not Try Cosmetics On Himself,” The Times Dispatch (Richmond, Virginia), August 7, 1938, p. 27.  (6) “80 Years of the Federal Food, Drug, and Cosmetic Act,” U.S. Food and Drug Administration (accessed October 20, 2020); “Three Horrifying Pre-FDA Cosmetics: From mercury-loaded face cream to mascara that left you blind,” Smithsonian Magazine, June 26, 2017; “Food and Drug Law Reform Bill Comes Up For Hearing This Week; Powerful Lobby Is Fighting It,” St. Louis Post-Dispatch, December 5, 1933, p. 13; “Lash Lure and Paraphenylenediamine: Toxic Beauty Past and Present,” American Academy of Ophthalmology, November 2, 2017. (7) Second Annual Report, Federal Security Agency, 1941, pp. 29-30 (available on Hathitrust, accessed October 20, 2020).  (8) “Part III: Drugs and Foods Under the 1938 Act and Its Amendments,” U.S. Food and Drug Administration (accessed October 20, 2020). (9) See note 6, U.S. Food and Drug Administration.