FDA WARNING_LETTER - Blackstone Labs LLC

On April 24, 2015, the FDA issued a Warning Letter to Blackstone Labs, LLC, regarding their dietary supplement product, Angel Dust. The letter states that Angel Dust is adulterated because it contains AMP Citrate (DMBA), which is considered a "new dietary ingredient" under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6.

The FDA asserts that there is no evidence DMBA was lawfully marketed as a dietary ingredient before October 15, 1994, nor has it been present in the food supply as an unchemically altered food. Therefore, a new dietary ingredient notification was required but not submitted, rendering the product adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).

Furthermore, the FDA states there is no history of use or other safety evidence establishing that DMBA is reasonably expected to be safe, making Angel Dust adulterated due to inadequate safety information. The letter also notes that synthetically produced DMBA is not a "dietary ingredient" as defined in section 201(