The Federal Food, Drug, and Cosmetic Act gives the United States Food and Drug Administration authority to oversee the safety of food, drugs, medical devices and cosmetics. President Franklin D. Roosevelt signed it into law on June 25, 1938, replacing the earlier Pure Food and Drug Act of 1906; Senator Royal S. Copeland was its principal author. Congress acted after the Elixir Sulfanilamide disaster of 1937, in which the toxic solvent diethylene glycol was used to dissolve a drug into liquid form with no prior animal testing, killing more than one hundred patients. The Act is codified at Title 21 of the United States Code, Chapter 9, beginning at Section 301, and has been amended many times since, most significantly by the 1962 Kefauver-Harris Amendment requiring proof of efficacy as well as safety. This description is adapted from Wikipedia contributors under CC BY-SA 4.0; changes were made. https://creativecommons.org/licenses/by-sa/4.0/
Facts
EraUnited States, enacted June 25, 1938; amended repeatedly since, most significantly in 1962 1 Promulgated ByThe 75th United States Congress, principally authored by Senator Royal S. Copeland, signed by President Franklin D. Roosevelt; administered and enforced by the United States Food and Drug Administration 1 Jurisdiction ScopeUnited States federal regulation of food, drugs, medical devices and cosmetics 1 Regulatory DomainFood, drug, medical device and cosmetic safety 1 Classification
Legal Status Legal Status Jurisdiction Scope
Jurisdiction Scope (category) Era
Era (category)20th Century (1900-1999) 1 Connections
Associated With
Both are federal product safety statutes covering consumer goods.
The Federal Food, Drug, and Cosmetic Act is federal legislation within United States law.
The FDCA (1938) replaced the earlier Pure Food and Drug Act of 1906.
The FDCA is codified at Title 21 of the United States Code, Chapter 9, beginning at Section 301.
In Legal System
Source Federal Food, Drug, and Cosmetic Act (Wikipedia)
Sources
1. Federal Food, Drug, and Cosmetic Act (Wikipedia)
Wikipedia, Federal Food, Drug, and Cosmetic Act, lede and History sections
the toxic solvent diethylene glycol was used to dissolve the drug and make a liquid form
Lead paragraph
The Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
- In Legal System: Common Law
In Group: Health, Drug and Product Safety Statutes, Introduction, sentence 1
The Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
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