FDA WARNING_LETTER - Vapor Invasion LLC - August 30, 2022

The FDA Center for Tobacco Products issued a Warning Letter to James Mitchell and Jeff Morrison of Vapor Invasion on August 19, 2022, following a review of their website, https://vaporinvasion.com. The FDA determined that the firm is manufacturing and offering e-liquid products, such as Raspberry Lemonade (TFN) e-liquid, for sale in the U.S. without the required marketing authorization. These products are considered 'new tobacco products' under section 910(a) of the FD&C Act, especially given the recent amendment expanding FDA's jurisdiction to products containing nicotine from any source (section 201(rr)). 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 premarket authorization and notice under section 905(j). The FDA has not received an application for marketing authorization for the listed product. The firm is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or import detention.