FDA WARNING_LETTER - JJDS E Cigarettes LLC d/b/a TKO Vapor Roswell - August 08, 2022

The FDA issued a Warning Letter to JJDS E Cigarettes LLC d/b/a TKO Vapor Roswell on August 8, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products, including "CARAMEL APPLE" and "CINNAMON CHURRO ICE CREAM," are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack FDA marketing authorization orders 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). The failure to provide required reports under section 905(j) is also a prohibited act. The company's Premarket Tobacco Product Application (PMTA), STN PM0003750, received a Marketing Denial Order on September 1, 2021, covering 3,600 products.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of 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.