The Food and Drug Administration FDA

Upton Sinclair's descriptions of Chicago meatpacking plants and Harvey Wiley's experiments feeding preservatives to volunteers pushed Congress to pass the Pure Food and Drug Act on June 30, 1906, the first federal law against adulterated and misbranded products. Wiley's Bureau of Chemistry in the Agriculture Department enforced it and took the name Food and Drug Administration in 1930. Each expansion of the agency's power followed a disaster: the 1938 act requiring proof of safety after a poisoned elixir killed more than a hundred people, the 1962 amendments requiring proof of effectiveness after thalidomide, and the device law of 1976 after the Dalkon Shield.

No new drug, vaccine, or high-risk medical device can be sold in the United States until the FDA approves it, and the agency's review of a company's clinical trials, typically running six to ten months under deadlines set by user-fee law, is the gate through which the pharmaceutical industry passes. Its authority extends to the safety and labeling of most of the food supply other than meat and poultry, to tobacco products since 2009, to cosmetics, dietary supplements, animal drugs, and blood. The agency inspects manufacturing plants at home and abroad, orders recalls, and polices advertising claims. Its scientific centers for drugs, biologics, devices, food, tobacco, and veterinary medicine each run as near-separate institutions.

About 18,000 people work for the FDA, most at the White Oak campus in Silver Spring, Maryland, on a budget near 7 billion dollars, nearly half of it paid by the companies it regulates through user fees that Congress first authorized in 1992 to speed approvals. The Commissioner is appointed by the President and confirmed by the Senate. The agency's decisions carry economic weight few regulators match: an approval can create a hundred-billion-dollar product and a rejection can end a company.

The FDA is attacked from both sides. Patient groups and free-market critics say it is too slow and too cautious, denying dying people drugs that might help them. Consumer advocates say user fees and accelerated approval pathways have made it too close to industry and too willing to approve drugs on thin evidence. Vaccine policy became the sharpest fight after 2020, and in 2025 new leadership restricted approvals of updated COVID vaccines and narrowed recommendations, overriding the agency's advisory committees and drawing objections from much of the medical establishment. The agency also lost thousands of staff that year.