FDA WARNING_LETTER - Rogue Vapers, LLC - November 03, 2022

On November 3, 2022, the FDA issued a Warning Letter to Rogue Vapers LLC for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that Rogue Vapers LLC's "ROGUE Cornucopia 18MG 30ml e-liquid product" is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product lacks an FDA marketing authorization order, making it 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 under section 301(p). Rogue Vapers LLC's Premarket Tobacco Product Application (STN PM0003584), covering 341 products, received a Refuse To Accept determination on May 28, 2021.

The FDA requires Rogue Vapers LLC to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales/distribution of violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.