FDA WARNING_LETTER - TITAN SARMS LLC - November 30, 2025

The FDA issued a Warning Letter to TITAN SARMS LLC on December 12, 2025, after a website review in November 2025. The agency found the company offers Selective Androgen Receptor Modulators (SARMs) such as “LGD-4033” (Ligandrol), “RAD-140” (Testolone), “S-4” (Andarine), and “YK-11” (Myostatin Inhibitor) for sale, classifying them as unapproved new drugs.

Despite claims of "Research-grade" and "RESEARCH-ONLY PURPOSE," product labeling and the company"s website contain evidence of intended human use, with advertised benefits including increased muscle mass, enhanced strength, improved recovery, and neuroprotective effects. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically sections 201(g)(1) and 201(p), these claims designate the products as drugs intended to affect the body"s structure or function, and as "new drugs" not generally recognized as safe and effective. Their introduction into interstate commerce without FDA approval violates sections 301(d) and 505(a) of the FD&C Act.

FDA highlighted significant safety concerns associated with SARMs, including life-threatening liver toxicity and an increased risk of heart attack and stroke. TITAN SARMS LLC is required to respond in writing within fifteen working days, detailing the specific steps taken to correct the violations and prevent their recurrence. Failure to comply may result in further regulatory or legal action.