FDA WARNING_LETTER - Atomix LLC - November 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Atomix LLC on December 12, 2025, following a review of the company"s website and social media in November 2025. The FDA identified that Atomix LLC is illegally marketing and distributing products containing selective androgen receptor modulators (SARMs), specifically "MK-2866" (Ostarine/Enobosarm) and "RAD-140" (Testolone). Despite claims of "RESEARCH USE ONLY," evidence from product labeling and online content clearly indicates these products are intended for human use, promoting effects like muscle growth, strength enhancement, and bone health, classifying them as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

These SARM products are considered unapproved new drugs under sections 505(a), 201(g)(1), and 201(p) of the FD&C Act, as they lack FDA approval and are not generally recognized as safe and effective for their intended uses. The FDA highlighted significant safety concerns associated with SARMs, including potential liver toxicity, increased risk of heart attack, and stroke. Introducing these unapproved drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. Atomix LLC is required to respond within fifteen working days, detailing corrective actions taken, measures to prevent recurrence, and supporting documentation. Failure to comply may result in further regulatory action.