FDA WARNING_LETTER - everythingvapes.com - May 13, 2025

On May 2, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom it May Concern" regarding electronic nicotine delivery system (ENDS) products offered for sale on https://everythingvapes.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The letter states that "new tobacco products" require premarket authorization. The FDA identified two specific ENDS products, Funky Republic Ti7000 Disposable Vape Device – Tropical Island and Lost Mary MO5000 Disposable Vape Device – Lemon Sparkling Wine, as new tobacco products lacking the required marketing authorization. These products were not commercially marketed in the U.S. as of February 15, 2007, and do not have 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 because required information was not provided under section 905(j). The FDA emphasizes that marketing new tobacco products without premarket authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

The recipient must submit a written response within 15 working days detailing actions taken to