FDA WARNING_LETTER - Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes - November 03, 2022

The FDA issued a Warning Letter to Cloud X Vapes Forest Lake LLC d/b/a CloudXVapes on November 3, 2022, based on a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically an "Apple e-liquid product," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation is that the "Apple e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is 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. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires Cloud X Vapes to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/