Nubilus Vapor, LLC – FDA Warning Letter, Aug 15, 2023

The FDA issued a Warning Letter to Nubilus Vapor, LLC on August 15, 2023, following a review of submissions and inspection records, determining the company distributes e-liquid products in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, products like Bae Dragon Pom 6mg 100ml, Nubilus Alto Apple 3mg 60ml, Nüage Vapor Citrine Salt 4.0% 30ml, and Nubilus Alto Apple Salt 4.0% 30ml were found to be commercially marketed after February 15, 2007, without FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports under section 905(j) is a prohibited act under section 301(p).

Nubilus Vapor, LLC is required to submit a written response within 15 working days