FDA WARNING_LETTER - Vapor Nuvola - December 09, 2021

The FDA issued a Warning Letter to Vapor Nuvola on December 9, 2021, following a review of submissions and inspection records. The FDA determined Vapor Nuvola manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of the "Vapor Nuvola Green Goblin 3mg e-liquid product" without the required premarket authorization. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of 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, as no required notice or information was provided.

The letter states that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Vapor Nuvola, a registered manufacturer with over 100 listed products, is responsible for ensuring all products comply with the FD&C Act and FDA regulations.

Vapor Nuvola must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales/distribution, and a plan for maintaining compliance. Failure to comply may