Exclusive Supplements, Inc. – FDA Warning Letter, Apr 24, 2012

This Warning Letter from the FDA to Exclusive Supplements, Inc. addresses their product Biorhythm SSIN Juice, which contains 1,3-dimethylamylamine (DMAA). The FDA states that DMAA is a "new dietary ingredient" for which a notification is required under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. No such notification was submitted, rendering the product adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

Furthermore, the FDA asserts there is no evidence establishing DMAA's safety as a dietary ingredient. It notes that DMAA narrows blood vessels, increasing cardiovascular resistance and potentially leading to elevated blood pressure, which could precipitate cardiovascular events. Therefore, the product is adulterated under 21 U.S.C. 342(f) due to inadequate safety information.

The letter also highlights that synthetically produced DMAA is not considered a "dietary ingredient" under 21 U.S.C. § 321(ff)(1), as it is not a vitamin, mineral, amino acid, herb, botanical, or a dietary substance commonly used as human food.

Exclusive Supplements, Inc. is requested to take prompt action to correct these violations for Biorhythm SSIN Juice and any other products containing DMA