FDA WARNING_LETTER - North Disposable - October 30, 2024

The FDA's Center for Tobacco Products issued a Warning Letter on October 29, 2024, to the entity operating northdisposable.com, following a review of their website. The letter states that electronic nicotine delivery system (ENDS) products offered for sale on the website are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products V-Touch 30K Disposable - Jolly Rancher, Halo Vapor Synix 30K Bluetooth Vape - Black Cherry, and South Connect 35K Disposable - Grape Blow Pop are cited as new tobacco products that were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA also expressed concern that the labeling and advertising for these products, particularly their imitation of smartphones and smart technology (e.g., Bluetooth connectivity, call functionality, AI chat, built-in games), are attractive to youth and may help conceal their nature as tobacco products.

The letter requires