FDA WARNING_LETTER - iSatori Global Technologies, LLC

The FDA issued a Warning Letter to iSatori Global Technologies, LLC, regarding its dietary supplement product, PWR, which contains 1,3-dimethylpentylamine HCL, also known as dimethylamylamine (DMAA). The FDA determined that DMAA is a new dietary ingredient (NDI) for which no notification was submitted, rendering PWR adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a). Furthermore, the FDA found no evidence establishing DMAA's safety, noting its potential to narrow blood vessels, increase blood pressure, and precipitate cardiovascular events, thus making PWR adulterated due to inadequate safety assurance. The letter also states that if synthetically produced, DMAA is not a dietary ingredient as defined by section 201(ff)(1) of the Act. iSatori is required to take prompt action to correct these violations, cease distribution of PWR and any other DMAA-containing products, and respond in writing within 15 days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply could result in enforcement actions like product seizure and injunctions.