FDA WARNING_LETTER - Cloudride Vapor - June 28, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Scott Thompson regarding e-liquid products sold on cloudridevapor.com. An FDA review determined that the "Cloudride – Perfect Pina" e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007. This product is being offered for sale without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. As a result, the product is 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 under section 905(j). The FDA states that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement action. The company must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the violative product, and outlining a plan for maintaining compliance with the FD&C Act. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, and/or injunction.