FDA WARNING_LETTER - Wild Vapers LLC - March 01, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Eddy Bowman (Wild Vapers) on February 18, 2022, following a review of their website, https://www.wildvapers.com. The FDA determined that e-liquid products, such as Gorilla Mist and Dragon’s Dew, are tobacco products under section 201(rr) of the FD&C Act and are being manufactured and offered for sale without the required premarket authorization order. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary marketing authorization under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j). The firm, a registered manufacturer, is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and providing a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.