Vapor Invasion LLC – FDA Warning Letter, Feb 26, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to James Mitchell and Jeff Morrison of Vapor Invasion after reviewing their website, https://vaporinvasion.com. The FDA determined that their e-liquid products, specifically "Vapor Invasion Custard Berries" and "Vapor Invasion Choco Moo," are tobacco products subject to FDA jurisdiction under section 201(rr) of the FD&C Act and 21 C.F.R. § 1100.1. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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, as no required notice or information was provided under section 905(j). The firm, a registered manufacturer with over 9,400 listed products, is responsible for ensuring compliance with all applicable FD&C Act provisions and FDA regulations. 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.