FDA WARNING_LETTER - Sweet TSV 1 d/b/a Sweet Vape Shop - September 13, 2024

On September 12, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Christopher Dalou regarding the sale of electronic nicotine delivery system (ENDS) products on sweetvapeshop.com. The FDA determined that certain ENDS products offered for sale are "new tobacco products" lacking the required premarket authorization.

Specifically, the products cited as violations are: Mood Bar - Air Disposable 6000 Puffs (Blood Orange, Blue Magic, and Passion Fruit Guava Citrus). These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the absence of required premarket notification.

The letter emphasizes that all tobacco products containing nicotine from any source are subject to FDA jurisdiction and must comply with the FD&C Act. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The recipient