FDA WARNING_LETTER - Viper Vapor LLC d/b/a Viper Vapor Kelso LLC - August 23, 2023

The FDA issued a Warning Letter to Viper Vapor LLC d/b/a Viper Vapor Kelso LLC on August 23, 2023, for manufacturing and distributing unapproved new tobacco products. The FDA determined that the company's e-liquid products, specifically BURST VAPE BLUE RAZZ 6MG 60 ML and Drippy Drops POMEGRANATE RASPBERRY 3MG 60ML, are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act, rendering them 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 letter emphasizes that products containing nicotine from any source are now subject to FDA jurisdiction.

Viper Vapor LLC must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.