J Vapes LLC – FDA Warning Letter, Sep 13, 2022

On August 19, 2022, the FDA Center for Tobacco Products issued a Warning Letter to Jourdan Michael Wheeler and John Fisher, concerning e-liquid products manufactured and sold via jvapes.com. The FDA determined that products like "High Roller" and "Raspberry" e-liquids are "new tobacco products" under the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded jurisdiction to products containing nicotine from any source.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the FDA found these products to be adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required marketing authorization or substantial equivalence reports.

The letter demands a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of non-compliant products, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.