FDA WARNING_LETTER - NFV, LLC d/b/a NFDVapes and Nic Fix Doctor - December 13, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Zachary John Nikopoulos regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on nfdvapes.com. The FDA determined that ENDS products listed on the website are offered for sale or distribution in the United States.

Under section 201(rr) of the FD&C Act, these products are considered tobacco products. The FDA's jurisdiction over tobacco products, including ENDS, was expanded on March 15, 2022, to include products containing nicotine from any source. Generally, "new tobacco products" require a premarket authorization order to be legally marketed in the U.S., defined as products not commercially marketed as of February 15, 2007, or modified products marketed after this date.

The review of nfdvapes.com revealed the sale of Elf Bar BC5000 Disposable – Strawberry Watermelon and Kang Vape TC8000 Rechargeable Device – Rainbow Paradise. These products are identified as new tobacco products lacking FDA marketing authorization. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales and a plan for future compliance. Failure to comply may result in