TRT

Dynamic Health Group dba SARMS AMERICA

FDA issued a warning letter to Dynamic Health Group dba SARMS AMERICA (Cheyenne, WY) in December 2025 for marketing unapproved new drugs — specifically SARMs including Ostarine MK-2866, MK-677 Ibutamoren, Cardarine GW501516, and LGD-4033 Ligandrol — via their website sarmsamerica.co. Despite labeling the products 'for research use only,' the website's health and body-composition claims established intended human drug use, violating FD&C Act sections 301(d) and 505(a). FDA cited safety concerns including liver toxicity, increased risk of heart attack, and stroke. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Prime Sports Nutrition

FDA issued a warning letter to Prime Sports Nutrition (Fernando Arias, Bakersfield, CA) in December 2025 after reviewing the company's website and finding it was selling unapproved new drugs marketed as SARMs — specifically LGD-4033, RAD-140, MK-677, and S-23 — with claims about muscle building, fat loss, testosterone boosting, and treatment of conditions like Alzheimer's disease and androgenic deficiencies. Despite labeling some products as 'research compounds not for human consumption,' FDA determined the marketing copy established clear intent for human drug use. The firm was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Atomix LLC

FDA issued a warning letter to Atomix LLC (Sheridan, WY) in December 2025 after reviewing the company's website, Instagram, and Facebook accounts and finding that it was selling unapproved new drugs marketed as selective androgen receptor modulators (SARMs), specifically MK-2866 (Ostarine/Enobosarm) and RAD-140 (Testolone). Despite 'research use only' disclaimers, FDA determined the products were intended for human use based on marketing claims about muscle growth, bone health, and treatment of conditions like sarcopenia, cachexia, and osteoporosis. The products lack FDA-approved applications under section 505 of the FD&C Act, making their interstate sale a violation of sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure and injunction.

Empower Clinic Services, LLC dba Empower Pharma

Empower Clinic Services, LLC dba Empower Pharma, a 503B outsourcing facility in Houston, TX, received an FDA Warning Letter citing adulterated and misbranded sterile drug products — including Testosterone Cypionate, Glutathione, Pyridoxine HCl, and Lipo-B injections — due to serious CGMP deficiencies in aseptic processing, inadequate environmental monitoring, and failure to meet 503B labeling conditions. The facility released batches despite positive microbial contamination findings, failed to conduct adequate smoke studies, and had repeat violations previously discussed at a May 2023 regulatory meeting. Because the compounded products did not meet all 503B conditions, they are subject to unapproved new drug and misbranding violations under the FDCA. FDA warned that failure to adequately address violations may result in seizure and injunction.

Elite Supplement Center LLC and Elite Training Facility LLC

FDA issued a warning letter to Elite Supplement Center LLC and Elite Training Facility LLC (Wayne/Pompton Lakes, NJ) in July 2022 after reviewing their website and finding they were selling five SARM products — Ostarine MK-2866, Ligandrol LGD-4033, Ibutamoren MK-677, Testolone RAD140, and Cardarine GW501516 — with marketing claims establishing intended human use despite 'Research Only / Not for Human Consumption' labels. FDA determined these products are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, citing safety concerns including liver toxicity, heart attack, and stroke risk. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.