FDA WARNING_LETTER - Dynamic Health Group dba SARMS AMERICA - November 30, 2025

On December 12, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Dynamic Health Group dba SARMS AMERICA, following a November 2025 review of their website. The FDA found the company unlawfully marketing and distributing selective androgen receptor modulators (SARMs), including "Ostarine MK-2866," "MK-677 Ibutamoren," "Cardarine GW501516," and "LGD-4033 Ligandrol," as unapproved new drugs for sale in the United States. Despite claims of "research use only," the FDA determined that the products" labeling and website content clearly promote them for human use, intending to affect the body"s structure or function, or for disease treatment. This classifies them as "new drugs" under sections 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are not generally recognized as safe and effective. The introduction of such unapproved drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, as no FDA approvals exist. The FDA emphasized significant safety concerns associated with SARMs, including life-threatening liver toxicity, heart attack, and stroke risk. Dynamic Health Group is therefore required to cease marketing and distributing these unapproved drug products.