FDA WARNING_LETTER - Forbiddenlabz - April 16, 2019

On April 10, 2019, the FDA issued a Warning Letter to Kristoffer Spencer, Owner of Forbidden Labz, regarding their product "Chaos Unleashed," marketed as a dietary supplement. The letter identifies the ingredient 2-aminoisoheptane (DMHA) on the Supplement Facts Panel.

The FDA states that DMHA is a "new dietary ingredient" (NDI) as it was not marketed in the U.S. before October 15, 1994, and there's no evidence of its presence in the food supply in an unchemically altered form. Therefore, "Chaos Unleashed" is 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 DMHA's safety as a dietary ingredient, making products containing it adulterated under sections 402(f) and 413(a) of the Act due to inadequate safety assurance. The FDA also questions if DMHA is a dietary ingredient at all; if not, it would be an unsafe food additive, rendering the product adulterated under section 402(a)(2)(C