Orphaned by an Evidentiary Standard: How Efficacy Review Emptied the Anabolic-Androgenic Steroid Market, and What Doping Control Inherited.

The anabolic-androgenic steroids have largely left clinical medicine while remaining in wide non-medical use. This review documents how that happened from the supply side, using the US Federal Register from 1970 to 2026, approval and patent records, statutes, treaty texts, and the peer-reviewed analytical literature. Three European firms created the class in 1935, their research contracted to university laboratories, and seven firms in five countries built it out by 1962, into a market where branded androgen preparations were already sold. The FDA's Drug Efficacy Study Implementation 7630 then condemned the tissue-building claims in 1970, retained an osteoporosis claim only while no alternative existed, and closed in 1985 after no sponsor completed the studies. A parallel proceeding on the estrogen-androgen combinations, opened in 1972, was resolved only in 2026. No safety finding drove any of it. Only one product in the class, oxandrolone, was ever determined withdrawn for reasons of safety or effectiveness, and 21 CFR 216.24 contains no anabolic-androgenic steroid. Most applications lapsed. The two jurisdictions then diverged. The US moved these substances into narcotics law in 1990 while European states did not make that move, with consequences for the public health work possible in each. Three of the first designer steroids identified in sport had never been sold as medicines, and for two of them the laboratories had to synthesize reference material before any assay existed. Section S0 of the WADA Prohibited List now names discontinued drugs. The pattern has since repeated with the selective androgen receptor modulators.