FDA WARNING_LETTER - Elite Supplement Center LLC and Elite Training Facility LLC - July 12, 2022

On July 6, 2022, the FDA issued a Warning Letter to Elite Training Facility LLC (CMS# 627498) following a June 2022 review of their website, https://www.elitesupplementcenter.com/. The FDA observed that the company sells "Ostarine MK-2866," "Ligandrol LGD 4033," "Ibutamoren MK-677," "Testolone Rad140," and "Cardarine GW501516," marketed as selective androgen receptor modulators (SARMs).

The FDA determined these SARMs products are unapproved new drugs, sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 301(d). Despite labels stating "RESEARCH ONLY" and "Not for Human Consumption," website claims indicated intended human use. The FDA cited safety concerns, including potential for liver toxicity, heart attack, and stroke associated with SARMs.

As these products are not generally recognized as safe and effective, they are considered "new drugs" under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). No