Food and Drug Administration (FDA)

The Food and Drug Administration is a regulatory agency of the Department of Health and Human Services, with authority descending from the 1906 Pure Food and Drugs Act and the 1938 Federal Food, Drug, and Cosmetic Act that followed the sulfanilamide elixir deaths. Human drugs are reviewed by the Center for Drug Evaluation and Research, biologics by the Center for Biologics Evaluation and Research, and devices by the device centre, with separate centres for food, veterinary medicine and tobacco.

Its method is documentary. FDA does not run its own trials and does not, as a rule, test products before approval; it reviews the sponsor's data, sometimes reanalysing it from the raw datasets, and inspects manufacturing sites. Review timelines are set by user fee agreements, broadly ten months from filing for a standard application and six for a priority one, and a large fraction of the human drug review budget is funded by industry user fees, a structural feature that both critics and defenders take seriously.

The scope of authority is uneven, and knowing where a product sits tells you how much scrutiny it actually received. Drugs and biologics require pre-market approval. Most devices require only clearance. Dietary supplements and cosmetics require neither, and the agency acts mainly after harm appears. A peptide sold as a research chemical sits outside the approval system altogether rather than at the bottom of it.

The recurring abuse of the name is registration. Facilities register and products are listed, and neither act is an approval, so FDA-registered, FDA-listed or FDA-inspected on a website says nothing about a product's quality. The agency's enforcement record of warning letters, import alerts and recalls is public and searchable, and is a far better guide to how a firm behaves than any badge on its homepage.