TRT

Indiangoods.shop

FDA issued a warning letter to Indiangoods.shop, an India-based online retailer, for selling three unapproved new drugs — 'Moon Herbal Josh Awar Khas,' 'Kapiva Him Foods Testo Capsules,' and 'Patanjali Youvan Gold Plus Capsule' — into U.S. interstate commerce without FDA-approved applications. The products were marketed with claims related to testosterone boosting, sexual performance, stamina, and libido, qualifying them as drugs under the FD&C Act. FDA cited violations of sections 301(d) and 505(a) of the FD&C Act and warned that failure to correct could result in seizure or injunction. The recipient was required to respond within 15 business days with corrective steps.

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.

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.

ECI Pharmaceuticals, LLC

FDA issued a warning letter to ECI Pharmaceuticals, LLC (Fort Lauderdale, FL) regarding drug registration and listing violations for two esterified estrogens and methyltestosterone products (NDC 51293-639 and NDC 51293-640). The firm submitted electronic listing files identifying 'conjugated estrogens' as the active ingredient, which does not match the 'esterified estrogens' stated on the product labeling — two distinct, non-equivalent ingredients. This constitutes a violation of FD&C Act sections 510(j) and 301(p), and renders the products misbranded under section 502(o). FDA previously notified the firm of these deficiencies in October and December 2021, resulting in removal from the Online NDC Directory, and now requires written corrective action within 15 working days.

ECI Pharmaceuticals, LLC

FDA issued a warning letter to ECI Pharmaceuticals, LLC (Fort Lauderdale, FL) regarding drug registration and listing violations for two esterified estrogens and methyltestosterone products (NDC 51293-639 and NDC 51293-640). The firm submitted electronic listing files naming 'conjugated estrogens' as the active ingredient, which does not match the 'esterified estrogens' stated on the product labeling — two distinct, non-equivalent ingredients. This constitutes a violation of FD&C Act sections 510(j) and 301(p), and renders the products misbranded under section 502(o). FDA previously notified the firm of these deficiencies in October and December 2021, resulting in removal from the Online NDC Directory, and now requires written corrective action within 15 working days.

AbbVie Inc., et al.

The FTC filed a federal complaint against AbbVie Inc. and Besins Healthcare Inc. in 2014, alleging they illegally blocked generic competition to the testosterone replacement drug AndroGel through sham patent infringement litigation. A district court found liability and ordered $448 million in consumer relief, though the Third Circuit and subsequent Supreme Court precedent (AMG Capital Management v. FTC) reversed the monetary judgment. AbbVie and Teva were subjected to Commission orders barring certain reverse-payment settlements, and on July 30, 2021, the FTC withdrew its remaining reverse-payment claim, ending the litigation.

Umbrella

FDA issued this warning letter to Brendan Mullins of Umbrella (Tucson, AZ) covering multiple product lines sold across several websites, including SARMs, kratom powders, tianeptine, and Alpha Male Plus, a product laboratory-confirmed to contain undeclared tadalafil (the active ingredient in Cialis) while labeled as a dietary supplement. The NACET Powder Nootropic was marketed with explicit claims that it would mitigate and protect against COVID-19, constituting promotion of an unapproved treatment for a serious disease. All cited products were deemed unapproved new drugs under FD&C Act sections 505(a) and 301(d), and misbranded drugs under sections 502 and 301(a), due to therapeutic and disease-treatment claims made on product pages, labels, and social media. The presence of a hidden pharmaceutical ingredient, COVID-19 treatment claims, and the breadth of unapproved drug categories across multiple storefronts compound the severity of the violations.

Watson Pharmaceuticals, Inc., et al. (FTC v. Actavis)

The FTC filed a federal complaint against Solvay Pharmaceuticals and generic manufacturers Watson Pharmaceuticals and Par Pharmaceuticals, alleging an anticompetitive 'reverse payment' settlement in which Solvay paid the generics to delay market entry of competing testosterone-replacement drugs (AndroGel equivalents) for nine years. The district court and Eleventh Circuit initially dismissed the complaint, but the U.S. Supreme Court reversed in 2013, rejecting the 'scope of the patent' test and allowing antitrust review of reverse payment agreements. The case involved no direct marketing-claim violations but centered on pay-for-delay tactics that suppressed generic competition for a testosterone-replacement therapy. Three related administrative proceedings were also initiated against Watson Pharmaceuticals and affiliated entities.

Perrigo Company and Paddock Laboratories, Inc.

The FTC required generic drug manufacturers Perrigo Company and Paddock Laboratories, Inc. to divest six generic drugs as a condition of resolving charges that Perrigo's $540 million acquisition of Paddock would be anticompetitive. The settlement included specific provisions to preserve future competition in the market for generic testosterone gel. A modified final order issued on June 26, 2012 directed the companies to sell the six generic drugs to Watson Pharmaceuticals, Inc.