FDA WARNING_LETTER - Kai’s Virgin Vapor - November 30, 2021

The FDA issued a Warning Letter to Tod Stebbins and Shawnee Jones regarding e-liquid products sold on kaisvirginvapor.com. The FDA determined these e-liquids are tobacco products subject to regulation under the FD&C Act, requiring premarket authorization for "new tobacco products" not commercially marketed before February 15, 2007. The firm was found to be manufacturing and offering e-liquid products, including "Coconut Conniption" and "Bed of Roses," without the required FDA marketing authorization order. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Although the firm is a registered manufacturer and submitted a Premarket Tobacco Product Application (PMTA) for 272 products, it received a Marketing Denial Order on September 15, 2021. The FDA considers products without authorization, especially those with Marketing Denial Orders, as high enforcement priorities. The firm must submit a written response within 15 working days detailing actions 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, or injunction, and imported products may be detained.