eflow Nutrition LLC – FDA Warning Letter, Apr 16, 2019

This FDA Warning Letter, dated April 10, 2019, addresses eflow Nutrition LLC regarding their dietary supplement product, Enrage Extreme. The primary concern is the inclusion of 2-Aminoisoheptane (DMHA) as a declared dietary ingredient.

The FDA states that DMHA is a "new dietary ingredient" under section 413(d) of the Act, as there is no information demonstrating its lawful marketing as a dietary ingredient in the U.S. before October 15, 1994, nor its presence in the food supply in an unchemically altered form. Consequently, Enrage Extreme is deemed adulterated under sections 402(f) and 413(a) of the Act because a required new dietary ingredient notification (NDIN) was not submitted. Even if an NDIN had been submitted, the FDA knows of no evidence establishing DMHA's safety for use as a new dietary ingredient, rendering products containing it adulterated due to inadequate safety assurance.

Furthermore, the FDA questions whether DMHA is, in fact, a dietary ingredient. If not, it would be considered an unsafe food additive, causing the product to be adulterated under section 402(a)(2)(C)(i) of the Act, as DMHA is not generally recognized as safe (GRAS) for its intended use.

eflow Nutrition LLC is required to take prompt action to