Federal Food, Drug, and Cosmetic Act of 1938 (2024)

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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]

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

• Adjudication
• Administrative law judge
• Final rule
• Proposed rule
• Rulemaking
  • Informal rulemaking
  • Formal rulemaking
  • Hybrid rulemaking

External links

• Federal Food, Drug, and Cosmetic Act (21 U.S. Code Chapter 9)
• Search Google News for this topic

Footnotes

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Bibliography	"Administrative Law - The 20th Century Bequeaths an 'Illegitimate Exotic' in Full and Terrifying Flower" by Stephen P. Dresch (2000) "Confronting the Administrative Threat" by Philip Hamburger and Tony Mills (2017) "Constitutionalism after the New Deal" by Cass R. Sunstein (1987) Federalist No. 23 by Alexander Hamilton (1787) "From Administrative State to Constitutional Government" by Joseph Postell (2012) "Interring the Nondelegation Doctrine" by Eric A. Posner and Adrian Vermeule (2002) "Rulemaking as Legislating" by Kathryn Watts (2015) "The Checks & Balances of the Regulatory State" by Paul R. Verkuil (2016) "The Myth of the Nondelegation Doctrine" by Keith E. Whittington and Jason Iuliano (2017) "The Progressive Origins of the Administrative State: Wilson, Goodnow, and Landis" by Ronald J. Pestritto (2007) "The Rise and Rise of the Administrative State" by Gary Lawson (1994) "The Study of Administration" by Woodrow Wilson (1887) "The Threat to Liberty" by Steven F. Hayward (2017) "Why the Modern Administrative State Is Inconsistent with the Rule of Law" by Richard A. Epstein (2008)
Agencies	Administrative Conference of the United States • United States Civil Service Commission • U.S. Government Accountability Office • U.S. Office of Information and Regulatory Affairs • U.S. Office of Management and Budget