FDA states that SARMs are not FDA approved. Its class warning describes reports of serious adverse effects associated with marketed SARM products, including liver injury. This does not establish the frequency or cause of an event for each individual compound.[1]
- Jurisdiction
- United States
- Product
- Products marketed as selective androgen receptor modulators
- Indication
- No FDA-approved SARM therapeutic indication in the cited agency communication
- Record date
- 2026-09-08
- Class-level regulatory advice must not be mistaken for a study of every individual SARM or combination.
Inspection history
Clinical review: not reviewed by a qualified clinician.
· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.
· Independently reopened the FDA page directly; the live URL returned an automated bot-detection response on this attempt, so the Internet Archive Wayback Machine snapshot dated 2026-05-18 was read as a lawful alternative. Confirmed the full page text verbatim, that it names no individual SARM, and its footer statement Content current as of 04/26/2023. This claim's own regulatory.asOf field still carried the evidence-cutoff placeholder (2026-09-08) rather than the source's actual date even though the source record itself was already corrected to 2023-04-26 by an earlier batch; corrected regulatory.asOf to 2023-04-26 here. The claim text required no change. Independent editorial review pending.
· Independent editorial review: the 2026-09-09 change of regulatory.asOf from 2026-09-08 to 2023-04-26 is rejected and reverted. Every other regulatory claim in the published model (17 of 18, by direct count) and two prior coordinator corrections in this same pass (aas-coordinator-edits.json, ancillary-coordinator-edits.json) establish that regulatory.asOf records the date through which this pass confirms the described status is still current, capped at the evidence cutoff -- not the cited document's own date, which is already fully recorded on the source record's own publicationDate and availableBy fields. regulatory.asOf is restored to 2026-09-08. No other change to this claim's text, sources or limitations was required; independently reconfirmed the FDA page's class-only, no-molecule-named framing, its exact adverse-event list including liver injury and acute liver failure, and its footer date. No qualified clinical review has occurred.