# FDA WARNING_LETTER - SNI LLC - April 24, 2012

Source: https://www.keypedia.com/records/warning_letter/sni-llc/1cedd3b9-b0d8-4276-93fb-cf89d8565e52

> FDA WARNING_LETTER for SNI LLC on April 24, 2012. Product: Food. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: SNI LLC
- Inspection Date: 2012-04-24
- Product Type: Food
- Office Name: Department of Health and Human Services
- Summary: 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.

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/michael-w-roosevelt/136906d6-8e93-4080-acf9-5d48d4509a80)

Company: https://www.keypedia.com/companies/sni-llc/69fbddb7-900a-4541-8d8b-9dd5cce89e57

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861