FDA WARNING_LETTER - Wyo Witches Brew LLC - June 29, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Holly Stone regarding e-liquid products sold on https://wyowitchesbrew.company. The FDA determined that products like Wyo Witches Brew Warlock and Wyo Witches Brew Strawberry Ice Cream are "new tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation (21 C.F.R. § 1100.1). These products were found to be marketed without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act for new tobacco products not commercially marketed before February 15, 2007. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required information under section 905(j). The firm, a registered manufacturer with over 9,700 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.