Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistPrime Sports Nutrition was warned for marketing unapproved new drugs, specifically selective androgen receptor modulators (SARMs) including LGD-4033, RAD-140, MK-677, and S-23, in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. Despite labeling these products as "research compounds" and "not for human consumption," the FDA determined they were intended for human use based on website marketing claims, making them unapproved drugs requiring premarket approval. The FDA identified significant safety concerns with SARMs, including documented cases of life-threatening liver toxicity and potential increased risk of heart attack and stroke in users.