FDA WARNING_LETTER - Cloudberry Vapors, LLC - July 05, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Sharon Seiter regarding e-liquid products, Cloudberry Vapors Cereal Crunch and Cloudberry Vapors Vanilla Creme Cookie, offered for sale on https://cloudberryvapors.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction. The products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack 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 absence of required notice or information under section 905(j). The firm, a registered manufacturer with over 700 listed products, is marketing these e-liquids unlawfully. The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates and a compliance plan, or justification if the firm believes no violation exists. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.