Regulatory record

Regulatory recordSupporting passage inspected

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.

2026-09-08 · Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

2026-09-09 · 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.

2026-09-09 · 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.

Safety findings

Case reportAbstract inspected

A separate published case describes severe cholestatic liver injury, complicated by pancreatitis and acute kidney injury and requiring plasmapheresis and intensive care, in a man who used a single supplement product containing both RAD-140 and Andarine (S4) together. Because the product combined two SARMs, this report cannot attribute the injury to either compound alone; it is a product coexposure case, not pure-compound evidence for RAD-140 or Andarine individually.^[3]

A combined-product coexposure case cannot isolate which compound, or their combination, caused the injury.
Only the indexed abstract was inspected; the article is not open access and the full case discussion was not reviewed.

Inspection history

Clinical review: not reviewed by a qualified clinician.

2026-09-09 · New finding added per this batch's instruction to keep product-labelled coexposure cases separate from pure-compound evidence; attached to both rad-140 and andarine because the product named in the report contained both compounds.

Clinical & experimental findings

Animal / laboratoryAbstract inspected

The inspected primary andarine (S-4) study treated castrated male rats for 8 weeks and reported restoration of muscle mass and strength, a larger increase in bone mineral density than with dihydrotestosterone, and dose-dependent suppression of LH and FSH, while prostate and seminal vesicle weights reached only 16 to 17 percent of intact-animal levels versus more than 200 percent with dihydrotestosterone. It does not establish clinical benefit, human pharmacokinetics or the incidence and reversibility of reported visual symptoms.^[2]

The compound-specific human visual-risk claims in the inherited text remain unverified by this source.
This is an 8-week rat study; no human exposure, duration or dose is reported here.

Inspection history

Clinical review: not reviewed by a qualified clinician.

2026-09-08 · Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

2026-09-09 · Reopened the abstract and added the exact study duration (8 weeks), the bone-density comparison with dihydrotestosterone, and the specific prostate/seminal-vesicle percentages that demonstrate tissue selectivity.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Published the actual rat model and limited inference; withheld uncorroborated visual-event frequency or recovery claims.

Human visual-risk incidence, reversibility, pharmacokinetics and endocrine recovery need direct sources.
Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

Explore the interaction evidence for this compound →

References

FDA warns of selective androgen receptor modulators marketed to teens and young adults
FDA web page. The footer states "Content current as of: 04/26/2023" (26 April 2023); confirmed unchanged against a Wayback Machine snapshot dated 2026-05-18, inspected 2026-09-09. 2023-04-26. Regulatory document.
Inspected location: Full consumer-update text: SARM approval status, listed adverse-event categories (including liver injury and acute liver failure), dietary-supplement/drug status and MedWatch reporting guidance
Study context and inspection record
Selective androgen receptor modulator treatment improves muscle strength and body composition and prevents bone loss in orchidectomized rats.
2005-08-11. PMID:16099859 · DOI:10.1210/en.2005-0572 Abstract only.
Inspected location: Abstract: methods and results
Study context and inspection record
Unregulated gains: a case of RAD-140-induced liver injury.
2026-07-08. PMID:42417499 · DOI:10.1080/08998280.2026.2691619 Abstract only.
Inspected location: Abstract: case presentation and outcome (the product combined two SARMs; the abstract itself calls this the most severe RAD-140-associated case reported to date)
Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts

peptide-fda-sarms: Sections explaining lack of FDA approval and reported adverse effects
peptide-pmid-16099859: Abstract: methods and results

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Related records in this class

Grouped under SARMs for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.