Gaspari Nutrition, Inc. – FDA Warning Letter

This FDA Warning Letter, dated April 24, 2012, was issued to SEI Pharmaceuticals concerning their product MethylHex 4,2, which contains 4-methylhexan-2-amine HCL (dimethylamylamine or DMAA). The FDA determined that DMAA is a "new dietary ingredient" (NDI) for which the required notification under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6 was not submitted, rendering the product adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a). Furthermore, the FDA found no evidence establishing DMAA's safety when used as recommended, leading to further adulteration due to inadequate information to assure safety and an unreasonable risk of illness or injury, including cardiovascular events like elevated blood pressure and potential heart attack. The FDA also stated that synthetically produced DMAA does not meet the definition of a "dietary ingredient" under 21 U.S.C. 321(ff)(1). SEI Pharmaceuticals was requested to promptly cease distribution of MethylHex 4,2 and any other DMAA-containing products. A written response within 15 days detailing corrective actions, including steps taken for products in the marketplace and measures to prevent recurrence, was required. Failure to comply could result in enforcement actions such as product seizure and injunctions.