FDA WARNING_LETTER - SEI Pharmaceuticals, Inc.

This FDA Warning Letter to SEI Pharmaceuticals, Inc. concerns their dietary supplement product, MethylHex 4,2, which contains 4-methylhexan-2-amine HCL (dimethylamylamine or DMAA). The FDA states that dimethylamylamine is a "new dietary ingredient" for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6.

The product is deemed adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a) because the required notification was not submitted. Furthermore, the FDA states there is no evidence establishing that dimethylamylamine is reasonably expected to be safe, citing its effect of narrowing blood vessels, increasing cardiovascular resistance, and potentially leading to elevated blood pressure and cardiovascular events.

Additionally, the FDA asserts that synthetically produced dimethylamylamine is not a "dietary ingredient" as defined in 21 U.S.C. 321(ff)(1), as it is not a vitamin, mineral, amino acid, herb, botanical, or a substance commonly used as human food or drink, nor a concentrate, metabolite, constituent, extract, or combination of a dietary ingredient.

SEI Pharmaceuticals, Inc. is requested to take prompt action to correct these violations for MethylHex 4,2 and any other