Title 21: Food and Drugs
FDA authority, food safety, drug approval, controlled substances scheduling, and medical device regulation.
27 chapters · 589 sections · 4 key sections available
Key Sections (4)
Federal Food, Drug, and Cosmetic Act — Short Title
The Federal Food, Drug, and Cosmetic Act is the foundational law giving the FDA authority to ensure the safety and proper labeling of food, drugs, medical devices, cosmetics, and tobacco products.
Controlled Substances Act — Schedules of Controlled Substances
The Controlled Substances Act classifies drugs into five schedules based on medical use, abuse potential, and safety. Schedule I (like heroin) has no accepted medical use; Schedule V has the lowest abuse risk.
Food Safety Modernization Act — Standards for Produce Safety
The FDA must set science-based safety standards for growing and harvesting produce, designed to prevent foodborne illness while being flexible enough for farms of different sizes.
Controlled Substances Act — Prohibited Acts — Manufacturing and Distribution
It is a federal crime to manufacture, distribute, or possess with intent to distribute controlled substances. Penalties are severe, with mandatory minimums of 10 years to life for large quantities of drugs like heroin and cocaine.