The Federal Food, Drug, and Cosmetic Act of 1938 (APA) was enacted in 1938. Quality requirements for food, pharmaceuticals, medical devices, and cosmetics manufactured and sold in the United States were established by the law. The legislation also included provisions for government oversight and enforcement of these criteria. The Pure Food and Drug Act of 1906, which was the first law to provide for federal control of the food and pharmaceutical sectors, was repealed by the Federal Food, Drug, and Cosmetic Act of 1938.
President Theodore Roosevelt (R) signed the Pure Food and Drug Act, often known as the Wiley Act, into law on June 30, 1906. This law, along with the Meat Inspection Act of 1906, divided federal food regulation into two agencies: the Bureau of Chemistry (which would become the Food and Drug Administration) was primarily responsible for Pure Food and Drug Act enforcement, and the Bureau of Animal Industry (a division of the United States Department of Agriculture) was responsible for meat inspections.
The Pure Food and Drug Act directed federal authorities to “prevent the manufacture, sale, or transportation of adulterated or misbranded or toxic or deleterious foods, medications, medicines, and liquors.” The provisions of the legislation apply to interstate commerce in foods, pharmaceuticals, and liquors.
In September and October 1937, the medicine Elixir Sulfanilamide killed over 100 persons in 15 states. According to the Food and Drug Administration, this incident “accelerated the final enactment in 1938 of the Federal Food, Drug, and Cosmetic Act,” which President Franklin D. Roosevelt (D) signed into law on June 25, 1938.
Penalties and prohibited acts
The Federal Food, Drug, and Cosmetic Act of 1938 outlined a number of forbidden acts and provided penalties for law violators. The following is a partial list of behaviors that are prohibited by law:
- “the introduction or delivery for introduction into interstate commerce of any adulterated or misbranded food, medication, device, cigarette product, or cosmetic.”
- “in interstate commerce, the adulteration or misbranding of any food, medication, gadget, tobacco product, or cosmetic”
- “the reception in interstate commerce of any adulterated or misbranded food, medication, gadget, tobacco product, or cosmetic, and the delivery or suggested delivery thereof for pay or otherwise.”
- As required by law, “the refusal to give access to or copying of any record”
- As required by law, “the refusal to permit access or inspection.”
Food safety requirements
The law established the Secretary of Health and Human Services’ (at the time of the law’s enactment, the Secretary of Agriculture’s) jurisdiction to define and establish food quality standards:
Whenever the Secretary believes that doing so will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing a reasonable definition and standard of identity, a reasonable standard of quality, or a reasonable standard of fill of container for any food, under its common or usual name, as far as practicable.
On June 25, 1938, FDR signed the Food, Drug, and Cosmetic Act.
Strict Products Liability (1941);
The Hot Coffee Case (1994).
The Law Book: From Hammurabi to the International Criminal Court, 250 Milestones in the History of Law (Sterling Milestones) Hardcover – Illustrated, 22 Oct. 2015, English edition by Michael H. Roffer (Autor)