Federal Food, Drug, and Cosmetic Act

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Federal Food, Drug, and Cosmetic Act

United States [1938]

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Last updated

June 26, 2026

Quick Summary

The Federal Food, Drug, and Cosmetic Act of 1938 is a landmark piece of U.S. legislation that significantly expanded the government's authority to regulate food and drug products. It granted the Food and Drug Administration (FDA) the power to set safety and purity standards for foods, drugs, cosmetics, and medical devices. The act also mandated factory inspections and established legal remedies for violations.

This law was a crucial update to earlier legislation, particularly concerning the safety of food coloring additives, which were assigned specific numbers and required batch certification. The act's provisions are fundamental to ensuring consumer safety by preventing untested products from entering the market and allowing legal action against harmful or risky items. The FDA's authority under this act is limited to regulating products involved in interstate commerce.12

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e-cigarette
…and drug-delivery devices under the Federal Food, Drug, and Cosmetic Act (FFDCA, FDCA, or FD&C), the organization initiated action against the import of e-cigarettes. In January 2010, following a lawsuit by an e-cigarette distributor, the U.S. District Court for the District of Columbia ruled that e-cigarettes did not meet the…
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…and drug-delivery devices under the Federal Food, Drug, and Cosmetic Act (FFDCA, FDCA, or FD&C), the organization initiated action against the import of e-cigarettes. In January 2010, following a lawsuit by an e-cigarette distributor, the U.S. District Court for the District of Columbia ruled that e-cigarettes did not meet the…
Read More

Food and Drug Administration
…power from four laws: the Federal Food, Drug, and Cosmetic Act, which established safety and purity standards and provided for factory inspection and for legal remedy; the Fair Packaging and Labeling Act, which required honest, informative, and standardized labeling of products; the Radiation Control for Health and Safety Act, which…
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…power from four laws: the Federal Food, Drug, and Cosmetic Act, which established safety and purity standards and provided for factory inspection and for legal remedy; the Fair Packaging and Labeling Act, which required honest, informative, and standardized labeling of products; the Radiation Control for Health and Safety Act, which…
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food coloring
In 1938 the Federal Food, Drug, and Cosmetic Act was passed, giving food coloring additives numbers (e.g., Amaranth was renamed FD&C Red No. 2) and requiring certification of each batch of coloring. Dyes again became the focus of controversy in the 1950s because the excessive use of certain…
Read More
In 1938 the Federal Food, Drug, and Cosmetic Act was passed, giving food coloring additives numbers (e.g., Amaranth was renamed FD&C Red No. 2) and requiring certification of each batch of coloring. Dyes again became the focus of controversy in the 1950s because the excessive use of certain…
Read More

quackery
Legislation to curb quackery
The Federal Food, Drug, and Cosmetic Act of 1938 and the Wheeler-Lea Act (also 1938) provided a certain amount of governmental control over claims made in advertising, in newspapers and magazines, over radio and television, in circulars, and on labels. Such controls are exercised only on…
Read More
The Federal Food, Drug, and Cosmetic Act of 1938 and the Wheeler-Lea Act (also 1938) provided a certain amount of governmental control over claims made in advertising, in newspapers and magazines, over radio and television, in circulars, and on labels. Such controls are exercised only on…
Read More