Vapor Amor – FDA Warning Letter, Jul 23, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Vapor Amor LLC after determining the company manufactures and distributes e-liquid products, which are deemed tobacco products subject to FDA regulation. Specifically, the firm was found to be manufacturing, selling, and/or distributing "Iced Tahiti Twist 6mg e-liquid product" without the required premarket marketing authorization. This product is considered a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is 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). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. As a registered manufacturer with over 1,600 listed products, Vapor Amor LLC is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including the discontinuation of violative sales and a plan for future compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.