The U.S. Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services responsible for protecting public health by regulating a broad range of products: human and veterinary drugs, biologics and vaccines, medical devices, the nation’s food supply, dietary supplements, cosmetics, radiation‑emitting products, and tobacco. Key centers include CDER (drugs), CBER (biologics), CDRH (devices and radiological health), CFSAN (food and cosmetics), and CTP (tobacco).
For the chemical industry, the FDA sets and enforces standards that shape product development, manufacturing, and market access. The agency reviews New Drug Applications and Abbreviated New Drug Applications, assesses active pharmaceutical ingredients and excipients, oversees current Good Manufacturing Practices (cGMP), and evaluates impurities, stability, and quality systems. It regulates food and color additives, food‑contact substances, and labeling, and oversees cosmetics safety under evolving authorities. The FDA issues guidance, conducts facility inspections, manages recalls and import alerts, and monitors post‑market safety. It collaborates with international bodies and aligns with global quality and safety frameworks to support consistent, science‑based regulation across the supply chain.
