Assault Labs – FDA Warning Letter, May 9, 2022

The FDA issued a Warning Letter to a firm regarding its product, Wild Thing Tropical Tornado flavor, labeled as a dietary supplement. The product is deemed an adulterated dietary supplement due to the inclusion of unsafe food additives.

The label declares hordenine HCl and higenamine HCl as dietary ingredients, but the FDA states neither qualifies as a dietary ingredient under section 201(ff)(1) of the FD&C Act. Since these substances are not generally recognized as safe (GRAS) for their intended use in food and do not qualify for other exemptions from the food additive definition, they are considered unapproved food additives.

Under section 402(a)(2)(C)(i) of the FD&C Act, any food additive not approved for its intended use causes the food to be adulterated. The introduction or delivery of adulterated food into interstate commerce is a prohibited act under section 301(a) of the FD&C Act.

The firm is responsible for investigating and correcting these violations and preventing recurrence. They must respond in writing within fifteen working days, detailing specific corrective actions, an explanation of steps taken to prevent recurrence, and supporting documentation. Failure to adequately address the matter may result in legal action, including seizure and injunction.