FDA WARNING_LETTER - Iron Brothers - April 16, 2019

On April 10, 2019, the FDA issued a Warning Letter to Iron Brothers Supplements regarding their product, Pre-Workout Relentless V1, labeled as a dietary supplement. The product's Supplement Facts panel declares 2-Aminoisoheptane (DMHA) as a 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 in the U.S. before October 15, 1994, or its presence in the food supply as an unchemically altered food article. Consequently, the product is deemed adulterated under sections 402(f) and 413(a) of the Act because the required new dietary ingredient notification (NDIN) under section 413(a)(2) and 21 CFR 190.6 has not been submitted.

Furthermore, even if an NDIN had been submitted, the FDA knows of no evidence establishing that DMHA is reasonably expected to be safe for use as a dietary ingredient. Therefore, dietary supplements containing DMHA are adulterated under sections 402(f) and 413(a) of the Act due to inadequate safety assurance.

The FDA also questions whether DMHA is, in fact, a dietary ingredient. If not, it would be considered an unsafe food