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Food, Drug, and Cosmetic Act

The United States Federal Food, Drug, and Cosmetic Act (FFDCA, FDCA, or FD&C) is a set of laws passed by Congress that give the Food and Drug Administration (FDA) authority to oversee the safety of food, drugs, medical devices, and cosmetics. The FDCA is located in the United States Code, beginning at 21 U.S.C. §301.

In New York, as in all states, the Federal Food, Drug, and Cosmetic Act (FDCA) provides the framework for the regulation of food, drugs, medical devices, and cosmetics. This federal law, which is found in Title 21 of the United States Code starting at Section 301, grants the Food and Drug Administration (FDA) the authority to ensure that these products are safe for public use and accurately labeled. The FDA's regulations are nationally applicable, including in New York, and the state's own laws and regulations must be consistent with federal standards. The FDCA prohibits the interstate commerce of products that are adulterated or misbranded, and it outlines the processes for product approvals, inspections, and enforcement actions. New York entities involved in the manufacture, distribution, or sale of these products must comply with both FDCA requirements and any additional state-specific regulations that may apply to their operations.

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Food, Drug, and Cosmetic Act

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Food, Drug, and Cosmetic Act

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