Selective Androgen Receptor Modulator (SARM) Products Marketed for Human Use
No SARMs are approved by the U.S. Food and Drug Administration (FDA) for any indication for human use as prescription or over-the-counter drugs. FDA enforcement actions and public consumer safety communications state that SARMs marketed as “dietary supplements” or “research use only” are treated as unapproved drugs. [1]; [2]
Common Commercial Formulations Described in U.S. FDA Warning Letters
Marketed SARM products in the U.S. are most commonly presented as oral dosage forms, including capsules, and sometimes as “dietary supplements” (despite regulatory findings that the products do not meet the dietary supplement definition). [2]; [3]
Example vendor-specific marketed products (selected)
- Titan SARMS LLC
- LGD-4033 (Ligandrol) marketed as “Ligandrol capsules.” [2]
- RAD-140 (Testolone) marketed as “RAD140 capsules.” [2]
- S-4 (Andarine) marketed as “S4 capsules.” [2]
-
YK-11 (Myostatin inhibitor) marketed as “YK11 capsules.” [2]
-
Infantry Labs LLC
- “The Officer (MK-2866/Ostarine)” marketed as a dietary supplement (FDA found the product to be an unapproved drug). [3]
- “The Lieutenant (LGD-4033)” marketed as a dietary supplement (FDA found the product to be an unapproved drug). [3]
Typical Dosing Regimens in Commercial Advertising
Provision of dosing regimens for SARMs is not appropriate because these substances are unapproved drugs and dosing information would materially facilitate unsafe use. [1]; [2]
Regulatory Status for Human Use (U.S.)
- FDA has stated that SARMs are unapproved drugs, including when sold as dietary supplements or “sold for research use only.” [1]
- FDA warning letters describe SARM-containing products as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act and as violating requirements for approval and adequate directions for use. [2]; [3]
- FDA warning letters also cite safety concerns from SARMs, including serious liver toxicity and potential cardiovascular risks. [2]; [3]
Regulatory Status Outside the U.S. (Selected)
- UK Anti-Doping states SARMs sold to the public are unapproved products and have not passed safety assessments required for food or supplement ingredients. UK Anti-Doping: About SARMs
Sports/Anti-Doping Legal Status (Selected)
- U.S. Anti-Doping Agency (USADA) describes SARMs as prohibited in sport and notes there is no FDA-approved medical use for these substances (i.e., they are not authorized pharmaceuticals for human use). USADA substance education: Ostarine
Practical Note on “Commercial Availability”
The presence of a product listing (capsules, “research-grade,” or “dietary supplement” labeling) does not establish legal or clinical legitimacy. FDA enforcement actions document that SARM products marketed online as “research” or “supplements” have been treated as unapproved drugs intended for human use. [2]; [3]