FDA WARNING_LETTER - Driven Sports Inc.

The FDA issued a Warning Letter to Driven Sports Inc. regarding its dietary supplement, CRAZE, which lists "Dendrobex" (Dendrobium Extract) as an ingredient. The letter states that CRAZE is adulterated under sections 402(f)(1)(B) and 413(a) of the Federal Food, Drug, and Cosmetic Act because Dendrobex is a new dietary ingredient (NDI) for which the required notification (21 U.S.C. 350b(a)(2), 21 CFR 190.6) was not submitted. Additionally, CRAZE is adulterated due to a lack of safety evidence for Dendrobex, meaning there is inadequate information to reasonably assure it does not pose a significant risk of illness or injury. The FDA also highlighted that a recent study indicated CRAZE might contain N,?-diethylphenylethylamine, an undeclared ingredient that would also be an NDI requiring notification, leading to further adulteration if present. The letter questioned the firm's declaration of phenethylamine-type alkaloids (PEAs) as part of Dendrobex. Driven Sports Inc. had ceased CRAZE distribution and was destroying inventory but had not initiated a recall or provided written assurances of corrective actions. The FDA requested prompt corrective actions, a written response within 15 days detailing steps taken and recurrence prevention, and documentation of CRAZE destruction. A meeting was also requested to discuss future products. Non-compliance could lead to enforcement actions, including product seizure and injunction, and further distribution of products containing Dendrobex is prohibited.