FDA WARNING_LETTER - RPM Nutrition, LLC

This FDA Warning Letter, dated April 24, 2015, addresses RPM Nutrition, LLC regarding their dietary supplement product, Red Rum SS. The product's label declares 2-amino-4-methylpentane (AMP) citrate, also known as DMBA, as a dietary ingredient.

The FDA asserts that DMBA is a "new dietary ingredient" for which a notification is required under section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 190.6. To the FDA's knowledge, there is no information demonstrating DMBA was lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, nor that it has been present in the food supply in an unchemically altered form.

Consequently, Red Rum SS is deemed adulterated under sections 402(f)(1)(B) and 413(a) of the Act because the required notification was not submitted. Furthermore, the FDA states there is no evidence establishing DMBA's safety for use as a dietary ingredient, rendering the product adulterated due to inadequate safety assurance.

The letter also highlights that synthetically produced DMBA is not considered a "dietary ingredient" under section 201(ff)(1) of the Act, as it is not a vitamin, mineral, amino acid,