TITAN SARMS LLC
FDA issued a warning letter to Titan SARMs LLC of Denver, CO in December 2025 after reviewing their website and finding they were selling unapproved new drugs — specifically SARMs including LGD-4033 (Ligandrol), RAD-140 (Testolone), S-4 (Andarine), and YK-11 — marketed with claims about muscle growth, strength, fat loss, and recovery intended for human use. Despite labeling the products as 'research-only,' FDA determined the website copy established clear intended human drug use, violating sections 301(d) and 505(a) of the FD&C Act. The agency demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure and injunction.
Flagged claims (11)
BODY COMPOSITION: o S-4 is often studied for its ability to reduce fat mass while preserving or increasing lean muscle.
STRENGTH GAINS: o Participants in research trials have demonstrated measurable improvements in lifting strength and muscular endurance.
MUSCLE HYPERTROPHY: o Clinical studies have shown Ligandrol to significantly increase lean muscle mass in healthy adults within just weeks of administration.
PERFORMANCE ENHANCEMENT: o Its anabolic effects contribute to improvements in maximal strength and explosive power.
MYOSTATIN INHIBITION: o YK-11's ability to down regulate myostatin expression may allow for greater muscle hypertrophy than SARMs without this effect.
RECOVERY SUPPORT: o By promoting anabolic signaling, Ligandrol can aid in tissue repair following injury or intense training.
ACCELERATED STRENGTH: o Research models indicate faster increases in muscular strength compared to baseline.
Lean Muscle Retention o RAD-140 (Testolone) has been observed to induce robust gains in lean muscle mass, even at low research dosages.
RESEARCH-ONLY PURPOSE
BONE HEALTH: o Research shows positive effects on bone strength and mineral density.
Research-grade compound[s]
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.
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