Federal Food, Drug, and Cosmetic Act (FD&C Act)
Federal Food, Drug, and Cosmetic Act (FD&C Act) is the 1938 US law, amended many times since, that gives FDA authority over the safety, labeling and marketing of food, drugs, medical devices, cosmetics and tobacco.
What it requires
It prohibits introducing adulterated or misbranded food, drugs, devices or cosmetics into interstate commerce, and adulteration includes holding products under insanitary conditions. Drugs and many devices need FDA approval or clearance before marketing. FDA can inspect facilities, refuse imports, seize products and seek injunctions, and violations can bring civil and criminal penalties. Later amendments, including FSMA, DSCSA and MoCRA, added the registration, traceability and safety rules that now govern these products.
Why it matters
The FD&C Act is why warehouses holding food, supplements, cosmetics or medical devices are subject to FDA inspection and can be liable for how they store goods. Its prohibition on holding products under insanitary conditions applies to storage, so pest activity or temperature abuse in a fulfillment center can make inventory adulterated. For example, an FDA investigator who finds rodent evidence near stored supplements at a 3PL can treat that inventory as adulterated, leading to destruction and a warning letter.
Related laws
- Food Safety Modernization Act (FSMA)2011 · 2011 law shifting FDA food safety to prevention
- Modernization of Cosmetics Regulation Act (MoCRA)2022 · 2022 law adding FDA registration rules for cosmetics
- Drug Supply Chain Security Act (DSCSA)2013, enhanced requirements 2023 · US law on serialized, interoperable drug tracing
Sources
- FDA: Federal Food, Drug, and Cosmetic Act fda.gov
- 21 U.S.C. Chapter 9 (Cornell LII) law.cornell.edu
Not legal advice.