Vegas Vapor Emporium – FDA Warning Letter, Oct 20, 2023

The FDA issued a Warning Letter to Vegas Vapor Emporium, LLC, on October 19, 2023, following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are considered tobacco products under the FD&C Act, specifically due to containing nicotine from any source, as amended by the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Vegas Vapor Emporium Wise Guy 6mg 60ml" was cited as a new tobacco product that 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. The failure to provide a required report under section 905(j) is also a prohibited act.

The FDA requires Vegas Vapor Emporium 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/or injunction.