Federal Food, Drug, and Cosmetic Act of 1938
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The Federal Food, Drug, and Cosmetic Act of 1938 (APA) is a federal law passed in 1938. The law established quality standards for food, drugs, medical devices, and cosmetics manufactured and sold in the United States. The law also provided for federal oversight and enforcement of these standards. The Federal Food, Drug, and Cosmetic Act of 1938 replaced the Pure Food and Drug Act of 1906, which was the first law to provide for federal regulation of the food and pharmaceutical industries.[1]
Background
On June 30, 1906, President Theodore Roosevelt (R) signed into law the Pure Food and Drug Act, also known as the Wiley Act. This law, together with the Meat Inspection Act of 1906, split federal food regulation between two agencies: the Bureau of Chemistry (which would become the Food and Drug Administration) was primarily responsible for enforcement of the Pure Food and Drug Act, and the Bureau of Animal Industry (a division of the U.S. Department of Agriculture) was responsible for meat inspections. The Pure Food and Drug Act provided for federal agencies to involve themselves in "preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods drugs, medicines, and liquors." The act's provisions applied to foods, drugs, and liquors involved in interstate commerce.[2][3]
In September and October 1937, the drug Elixir Sulfanilamide caused the deaths of more than 100 people across 15 states. According to the Food and Drug Administration, this incident "hastened the final enactment in 1938 of the Federal Food, Drug, and Cosmetic Act," which was signed into law by President Franklin Roosevelt (D) on June 25, 1938.[4]
Provisions
Prohibited acts and penalties
The Federal Food, Drug, and Cosmetic Act of 1938 defined a series of prohibited acts under the law and established penalties for violations of the law. The following is a partial list of acts prohibited under the law:[5]
- "the introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded"
- "the adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce"
- "the receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise"
- "the refusal to permit access to or copying of any record" as required by the law
- "the refusal to permit entry or inspection" as required by the law
Food regulations
The law established the authority of the Secretary of Health and Human Services (at the time of the law's enactment, the Secretary of Agriculture) to define and establish quality standards for food:[6]
| “ | Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container.[7] | ” |
Drug, medical device, and cosmetics regulation
The law defined adulterated drugs and medical devices, misbranded drugs and medical devices, adulterated cosmetics, and misbranded cosmetics.[8][9]
Regulatory authority
The law established the authority of the Secretary of Health and Human Services (at the time of the law's enactment, the Secretary of Agriculture) to "promulgate regulations for the efficient enforcement" of the law.[10]
Amending statutes
Below is a partial list of subsequent laws that amended provisions of the Federal Food, Drug, and Cosmetic Act of 1938:[11]
- Food, Drug, and Cosmetics Act Amendments (1951): These amendments established definitions for over-the-counter and prescription medications, the former of which can be purchased without a prescription and the latter of which must be taken under a doctor's supervision.[12]
- Food, Drug, and Cosmetics Act Amendments (1962): These amendments required drug manufacturers to provide proof of a medicine's effectiveness and safety before receiving federal government approval. These amendments also required drug manufacturers to provide information about side effects in advertising.[13]
- Food Quality Protection Act (1996): These amendments provided for health-based standards to govern the use of pesticides in food cultivation.[14]
See also
External links
Footnotes
- ↑ U.S. Food and Drug Administration, "Promoting Safe and Effective Drugs for 100 Years," accessed January 24, 2018
- ↑ Encyclopedia.com, "Pure Food and Drug Act (1906)," accessed January 24, 2018
- ↑ U.S. Food and Drug Administration, "Federal Food and Drugs Act of 1906," accessed January 24, 2018
- ↑ U.S. Food and Drug Administration, "Sulfanilamide Disaster," June 1981
- ↑ Legal Information Institute, "21 U.S. Code § 331 - Prohibited Acts," accessed January 24, 2018
- ↑ Legal Information Institute, "21 U.S. Code § 341 - Definitions and standards for food," accessed January 24, 2018
- ↑ Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
- ↑ Legal Information Institute, "21 U.S. Code Part A - Drugs and Devices," accessed January 24, 2018
- ↑ Legal Information Institute, "21 U.S. Code Subchapter VI - Cosmetics," accessed January 24, 2018
- ↑ Legal Information Institute, "21 U.S. Code § 371 - Regulations and hearings," accessed January 24, 2018
- ↑ Mercatus Center – George Mason University, "The Food and Drug Administration and the Federal Food, Drug, and Cosmetic Act," August 26, 2015
- ↑ Government Publishing Office, "Public Law 215: Chapter 578," accessed January 24, 2018
- ↑ Government Publishing Office, "Public Law 87-781," accessed January 24, 2018
- ↑ Government Publishing Office, "Public Law 104-170," accessed January 24, 2018
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