FDA WARNING_LETTER - Brand New Energy, LLC

On April 24, 2015, the FDA issued a Warning Letter to Brand New Energy, LLC, concerning their dietary supplement product, Yellow Bullet AMP. The product's label declares 4-Amino-2-Methylpentane Citrate (DMBA) as a dietary ingredient.

The FDA identified several violations: 1. **Adulterated New Dietary Ingredient (NDI):** DMBA is considered a "new dietary ingredient" as there's no information it was marketed in the U.S. before October 15, 1994, or present in the food supply in an unaltered form. A required notification under Section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6 was not submitted. This renders the product adulterated under Sections 402(f)(1)(B) and 413(a) of the Act. 2. **Lack of Safety Evidence:** Even if notified, there's no evidence establishing DMBA's reasonable safety when used as a dietary ingredient, making the product adulterated under the same sections due to inadequate safety assurance. 3. **Not a Dietary Ingredient:** Synthetically produced DMBA, as suspected in the marketplace, does not fit the definition of a "dietary ingredient" under Section