1938 Cosmetic Act, Food, and Drugs

September 28, 2021

1938 Cosmetic Act, Food, and Drugs

The Federal Food, Drug, and Cosmetic Act of 1938 (APA) is Federal Law passed in 1938. The law established quality standards for food, drug, medical device, and cosmetics manufactured and sold in the United States. The law also provided for federal oversight and enforcement of these standards.

Law: Administrative Procedure Act.
Term: Adjudication (Administrative state)
Cases: Abbott Laboratories
Reporting: Change to the Federal Register

The 1938 law only prohibited the sale of cosmetic with any "poisonous or deleterious substance," or any "filthy,putrid,or decomposed substance, " so the Food and Drug Administration has so far only banned nine cosmetic ingredients for safety reasons.

FDR signed the Food, Drug, and Cosmetic Act on 25 June 1938. The new law brought cosmetic and medical devices under control, and it required that drugs be label with adequate directions for safe use.

The Federal Food,Drug, and Cosmetic Act of 1938

Spurred by public outcry from the Elixir Sulfanilamide disaster (in which 100 people were killed because under the 1906 law, "premarketing toxicity testing was not required"),congress rushed to enact a new bill

During September and October 1937 this drug was responsible for the deaths of more than 100 people in 15 states, as far east as Virginia and as far west as California. The drug and the deaths led to the passage of the 1938 Food, Drug, and Cosmetic Act, which increased FDA's authority to regulate drugs

Jo Anne Cramer. The six-year-old daughter of truck driver Chester and housewife Lesta (nee Taylor) from the farming township of Copley, died on October 17th at a children's hospital in Akron. The "entire details" of this care were provided in a list of nationwide elixir-related death compiled by the FDA on November -as least as early October 22nd. In addition, the Akron Beacon Journal showcased the details of this fatality in a length article, "Roundup of fatal Remedy is too late to save Child," which was printed on October 26th