FDA WARNING_LETTER - iq formulations, llc / - April 16, 2019

On April 10, 2019, the FDA issued a Warning Letter to IQ Formulations, LLC / DBA Metabolic Nutrition Inc. concerning their dietary supplement products, Synedrex and E.S.P. Extreme. The letter states that both products declare 2-aminoisoheptane (DMHA) as a dietary ingredient.

The FDA asserts that DMHA is a "new dietary ingredient" (NDI) as it was not marketed in the U.S. before October 15, 1994, and there is no information demonstrating its prior presence in the food supply in an unaltered form. Therefore, products containing DMHA are deemed adulterated under sections 402(f) and 413(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 342(f) and 350b(a)] because a required NDI notification was not submitted.

Furthermore, the FDA states there is no evidence establishing that DMHA is reasonably expected to be safe for use as a dietary ingredient. Consequently, dietary supplements containing DMHA are adulterated under sections 402(f) and 413(a) of the Act due to inadequate safety assurance. The letter also questions whether DMHA is, in fact, a dietary ingredient. If not, it would be considered an unsafe food additive, rendering the