FDA
Meaning of FDA: Its remit is wide but not total, since meat and poultry, most supplements and much product advertising sit partly or wholly with other agencies.
Definition of FDA
The FDA, the Food and Drug Administration, is the agency of the United States government responsible for the safety of most of the food supply and for the safety and effectiveness of drugs, biological products, medical devices, cosmetics, tobacco products and veterinary medicines. It reviews evidence from manufacturers before many products may be sold, and continues to monitor them afterward.
What does it regulate?
| Area | What oversight involves |
|---|---|
| Human drugs | Review of evidence for safety and effectiveness before marketing, then monitoring of reports afterward |
| Biological products | Vaccines, blood for transfusion, tissue for transplant, and cell and gene therapies |
| Medical devices | Graded by risk, from bandages through to implanted devices |
| Food | Most of the food supply, including labeling, additives and contamination |
| Cosmetics | Safety and labeling, with far less review before sale than drugs receive |
| Tobacco products | Ingredients, labeling and marketing |
| Veterinary products | Animal medicines and animal feed |
| Radiation emitting products | Equipment ranging from x-ray machines to microwave ovens |
Approved, cleared or neither?
These words are not interchangeable, and advertising blurs them constantly. A drug is approved once the agency has reviewed trial evidence that it works and that its risks are acceptable for a stated use. Most medical devices are cleared instead, by a route in which the maker shows the device is substantially equivalent to one already on the market, a lower bar that does not always require new clinical trials; only the highest risk devices go through full approval. A nutritional supplement is a third case again. Supplements are treated as food rather than as medicines, so they need no approval before sale, and the agency acts mainly after a problem emerges. A supplement label reading FDA approved therefore describes something that does not exist.
What sits outside its remit?
Meat, poultry and processed egg products are overseen by the Department of Agriculture. Advertising for products sold over the counter, for supplements and for cosmetics falls to the Federal Trade Commission, while the FDA handles the promotion of prescription drugs. Alcohol sits largely with a separate bureau and drinking water with the Environmental Protection Agency. The practice of medicine is not regulated by the agency at all, which is why a clinician may lawfully prescribe an approved drug for a purpose it was never approved for. Its authority is also national, so other countries run their own regulators and an approval in one does not carry to another. Research funding and much of the research itself sit elsewhere again, chiefly with the National Institutes of Health.
Also known as
Used in a sentence
The new medical device received clearance from the FDA before becoming available for clinical use.
Good to know
FDA approval of a drug records a judgment that its benefits outweigh its risks for a stated use rather than that it is free of risk, and most medical devices reach the market through clearance, which is a different and lower standard than approval.