What does FDA approval actually mean?

For prescription drugs, FDA approval means the agency reviewed clinical trial evidence and concluded the drug is effective for a specific indication and that its benefits outweigh its risks for that use. It is a comparative judgment rather than a declaration of safety, which is why approved drugs carry extensive warnings and why some are later withdrawn when rare harms surface in populations far larger than any trial. Approval is also indication-specific, and physicians may prescribe off-label for other uses, which is legal and common though not backed by the same review.

Coverage is much narrower than the public assumes. Dietary supplements are not approved by the FDA at all: under the 1994 DSHEA law, manufacturers are responsible for their own safety substantiation, and the agency generally acts only after a product is on the market and problems appear. That is why supplement contents frequently do not match labels in independent testing. Cosmetics receive limited premarket oversight. Most medical devices reach the market through the 510(k) clearance pathway by demonstrating substantial equivalence to an existing device rather than through the more rigorous premarket approval used for high-risk devices, and cleared is a meaningfully weaker claim than approved.

Two further distinctions worth carrying. Accelerated approval permits marketing based on a surrogate endpoint likely to predict clinical benefit, with confirmatory trials required afterward, a pathway that has drawn criticism when those trials are delayed or fail. And emergency use authorization is not approval, but a temporary authorization during a declared emergency based on a lower evidentiary standard. When evaluating any health product claim, the useful question is which pathway it went through, since approved, cleared, authorized, and unregulated describe very different levels of scrutiny while sounding similar in marketing copy.