FDA WARNING_LETTER - Prime Nutrition

On April 24, 2015, the FDA issued a Warning Letter to Prime Nutrition regarding their product PWO/STIM, labeled as a dietary supplement. The product's Supplement Facts panel declares AMP Citrate, also known as DMBA, as a dietary ingredient.

The FDA determined that DMBA is a "new dietary ingredient" under section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6, requiring a notification. No such notification was submitted, rendering the product adulterated under sections 402(f)(1)(B) and 413(a) of the Act. Furthermore, the FDA stated there is no evidence establishing DMBA's safety for use as a dietary ingredient, making the product adulterated due to inadequate safety assurance.

The letter also highlights that synthetically produced DMBA is not a "dietary ingredient" as defined in section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)), as it is not a vitamin, mineral, amino acid, herb, botanical, or a derivative thereof, nor is it commonly used as human food.

Prime Nutrition was requested to promptly correct these violations for PWO/STIM and any other products containing DMBA. Failure to