Massive Vapor – FDA Warning Letter, Sep 15, 2022

The FDA issued a Warning Letter to Massive Vapor on September 15, 2022, following a review of submissions and inspection records. The FDA determined that Massive Vapor manufactures and distributes e-liquid products, specifically "Massive Vapor NEKTAR BERRY 6mg 60ml e-liquid product," which are considered tobacco products under the FD&C Act, including recent amendments expanding jurisdiction to products with nicotine from any source.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Massive Vapor NEKTAR BERRY 6mg 60ml e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product 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 information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Massive Vapor is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and distribution, and outlining a plan for future compliance. Failure to comply may result in regulatory actions