FDA WARNING_LETTER - Distribution Inc - December 19, 2024

The FDA's Center for Tobacco Products issued a Warning Letter on December 18, 2024, to an entity associated with the website https://vaporush.com, which offers electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA determined that the products are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded jurisdiction to products containing nicotine from any source.

The identified violations concern "new tobacco products" lacking required premarket authorization. Specifically, the products "Death Row DR15000 15,000 Puff Disposable Vape – 5% Nicotine - Apple Peach" and "Nicky Jam X Fume - 10,000 Puff Disposable Vape – 5% Nicotine - 69 Bananas" were found to be new tobacco products not commercially marketed as of February 15, 2007, and without FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required premarket authorization or notice under section 905(j). The letter states that unlawful marketing of new tobacco products without authorization is subject to enforcement actions, including civil money