FDA WARNING_LETTER - JJDS E Cigarettes LLC d/b/a TKO Vapor Overstock Ecigs & More - October 15, 2021

The FDA issued a Warning Letter to JJDS E Cigarettes LLC d/b/a TKO Vapor Overstock Ecigs & More for manufacturing and distributing e-liquid products without required marketing authorization. The company's "VF Watermelon Strawberry 2oz e-liquid product" is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This product is therefore adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided. Prohibited acts include holding for sale adulterated/misbranded products (section 301(k)) and failing to provide required reports (section 301(p)).

The company is a registered manufacturer with over 5,500 listed products. Its Premarket Tobacco Product Application (PMTA), STN PM0003750, submitted September 9, 2020, received a Marketing Denial Order on September 1, 2021, covering 3,600 products. Products without premarket authorization, especially those with Marketing Denial Orders, are high enforcement priorities.

JJDS E Cigarettes LLC must respond within 15 working days