FDA WARNING_LETTER - Prime Nutrition - November 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Prime Sports Nutrition on December 12, 2025, following a website review in November 2025. The company, through its owner Fernando Arias, was cited for illegally marketing unapproved new drugs, specifically Selective Androgen Receptor Modulators (SARMs) such as LGD-4033, RAD-140, MK-677, and S-23, on its website. Despite labeling some products as "RESEARCH COMPOUND" and "NOT FOR HUMAN CONSUMPTION," the FDA found extensive evidence from product descriptions and claims that these products are intended for human use, with advertised benefits including muscle growth, fat loss, and improved physical performance. These claims classify the SARMs as "drugs" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that lack required FDA approval. The agency highlighted significant safety concerns associated with SARMs, including potential liver toxicity and increased risk of heart attack and stroke. Prime Sports Nutrition is required to respond within fifteen working days, detailing specific corrective actions taken to address the violations and prevent their recurrence. Failure to comply may result in further regulatory and legal action.