FDA WARNING_LETTER - Infantry Labs LLC

The FDA issued a Warning Letter to Infantry Labs, LLC and 1 Nation Nutrition, specifically addressing John Fogarty and Steve Ludwig, regarding the distribution of "The Officer (MK-2866)" and "Lieutenant (LGD-4033)." The FDA has safety concerns about these products, marketed as dietary supplements, because they contain Selective Androgen Receptor Modulators (SARMs), which have been linked to life-threatening reactions including liver toxicity, heart attack, and stroke.

The products are deemed to violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) on multiple grounds. Firstly, they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act [21 U.S.C. § 321(ff)], as Ostarine (MK-2866) and LGD-4033 were authorized for investigation as new drugs and were not marketed as dietary supplements or food prior to this authorization.

Secondly, the products are considered unapproved new drugs. Claims on the firm's website and product labels, such as "Great for strength," "Great for lean mass gains," and "increases in lean body mass and decrease in body fat," indicate an intended use to affect the body's structure or function, classifying them as drugs under section 201(g)(1)(C) [21 U.S.C.