Powder City LLC – FDA Warning Letter, Jun 1, 2017

On April 24, 2015, the FDA issued a Warning Letter to Powder City LLC regarding their product AMP Citrate, also known as 1,3 Dimethylbutylamine (DMBA). The letter states that AMP Citrate is labeled and offered for sale as a dietary supplement, with DMBA declared as a dietary ingredient.

The FDA asserts that DMBA is a "new dietary ingredient" and requires a notification 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. To the FDA's knowledge, there is no information demonstrating DMBA was lawfully marketed as a dietary ingredient before October 15, 1994, or present in the food supply in an unchemically altered form. Since the required notification was not submitted, the product is deemed 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 evidence establishing DMBA's safety when used as a dietary ingredient, leading to adulteration under the same sections due to inadequate information to assure safety. The introduction