SNI LLC – FDA Warning Letter, Apr 24, 2012

This FDA Warning Letter, dated April 24, 2012, addresses SNI LLC regarding their dietary supplement product, Nitric Blast, which contains "geranium extract," also known as dimethylamylamine (DMAA).

The FDA identifies several violations. Firstly, DMAA is considered a "new dietary ingredient" under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. SNI LLC failed to submit the required pre-market notification for this new dietary ingredient, rendering Nitric Blast adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a). The FDA states there is no evidence DMAA was lawfully marketed as a dietary ingredient before October 15, 1994, or present in the food supply in an unaltered form.

Secondly, even if a notification had been submitted, the FDA states there is no history of use or other safety evidence establishing that DMAA is reasonably expected to be safe. The letter highlights that DMAA narrows blood vessels, increasing cardiovascular resistance and potentially leading to elevated blood pressure and cardiovascular events, including heart attacks. Therefore, Nitric Blast is adulterated under 21 U.S.C. 342(f) due to inadequate safety information, and its introduction into interstate commerce is prohibited under 21 U.