FDA WARNING_LETTER - General Vape - February 01, 2024

On January 31, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to General Vape after reviewing their website, generalvape.com. The review found that the company offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. that are considered "new tobacco products" and lack the required premarket authorization.

The FDA cited five specific ENDS products: Funky Lands (Republic) Ti7000 by Elf Bar Disposable Vape – California Cherry, Lost Mary BM5000 Vape Disposable – Pineapple Coconut Ice, Cali Bars V2 6000 Disposable Vape – Frozen Fuji Apple, Kangvape Onee Max Vape – Pear Cotton Candy, and EBDesign BC5000 Disposable Vape – Peach Berry. These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization.

Consequently, these products are 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.