FDA WARNING_LETTER - Smokin Fire Vapor - April 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Smokin’ Fire Vapor, LLC, on April 23, 2021, after reviewing their website, https://smokinfirevapor.com. The FDA determined that the company manufactures and offers e-liquid products, specifically Smokin’ Fire Vapor Captain Custard and Smokin’ Fire Vapor Wrecking Ball, for sale or distribution in the U.S. These e-liquids are classified as "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction under section 901(b) and 21 C.F.R. § 1100.1. The core violation is the marketing of these new tobacco products without the required premarket authorization order 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 failure to provide required notice or information under section 905(j). The FDA requires a written response within 15 working days detailing actions to address violations, discontinue violative activities, and outline a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.