FDA WARNING_LETTER - Massive Vapor - December 17, 2021

The FDA issued a Warning Letter to Massive Vapor on December 16, 2021, following a review of submissions and inspection records. The FDA determined that Massive Vapor manufactures and distributes e-liquid products, specifically identifying "Massive Vapor Papa Smurf 3mg 30ml e-liquid," which are deemed tobacco products under the FD&C Act.

The primary violation is that this e-liquid product is a "new tobacco product" (not commercially marketed in the U.S. as of February 15, 2007) and is being sold without the required premarket marketing authorization order from the FDA, as mandated by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided.

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Massive Vapor, a registered manufacturer with over 15,200 listed products, is responsible for ensuring all its tobacco products comply with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction.