FDA WARNING_LETTER - Muscle Warfare Inc - April 24, 2012

The FDA issued a Warning Letter to Muscle Warfare, Inc. regarding its product Napalm, a dietary supplement containing 1,3-dimethylamylamine HCL (dimethylamylamine or DMAA). The FDA identified several violations of the Federal Food, Drug, and Cosmetic Act. Firstly, assuming DMAA is a dietary ingredient, it is considered a "new dietary ingredient" (NDI) requiring notification under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. Since no notification was submitted, Napalm is deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a). Secondly, even if a notification had been submitted, there is no evidence establishing the safety of DMAA when used as recommended, leading to Napalm being adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) due to inadequate safety information and potential risks like elevated blood pressure and cardiovascular events. The introduction of such an adulterated product into interstate commerce is prohibited under 21 U.S.C. 331(a) and (v). Finally, the FDA stated that synthetically produced DMAA does not meet the definition of a "dietary ingredient" under 21 U.S.C. 321(ff)(1). Muscle Warfare, Inc. is required to take prompt action to correct these violations, immediately cease distribution of Napalm and any other products containing DMAA, and provide a written response within 15 days detailing corrective steps, measures to prevent recurrence, and supporting documentation. Failure to comply could result in enforcement actions, including product seizure and injunctions.