FDA WARNING_LETTER - Goldstar Distribution - April 30, 2019

On April 10, 2019, the FDA issued a Warning Letter to Goldstar Performance Products regarding their product, Triple X Pre-Workout Stimulator. The product's Supplement Facts panel declares 2-amino-6-methylheptane HCl (DMHA) as a dietary ingredient.

The FDA states that DMHA is a "new dietary ingredient" as it was not marketed in the U.S. before October 15, 1994, and there's no evidence it was present in the food supply in an unchemically altered form. Therefore, the product is adulterated under sections 402(f) and 413(a) of the Act because a new dietary ingredient notification was not submitted, or if submitted, there's no evidence establishing its safety. The FDA also questions if DMHA is a dietary ingredient at all; if not, it would be an unsafe food additive, rendering the product adulterated under section 402(a)(2)(C)(i).

Goldstar Performance Products must promptly correct these violations, including ceasing distribution of Triple X Pre-Workout Stimulator and any other products containing DMHA. Failure to comply could result in enforcement actions like product seizure and injunctions. The company must respond within fifteen working days, detailing corrective actions and prevention measures, or provide reasoning and supporting information if they believe no violation occurred.