FDA WARNING_LETTER - Vape Wholesale USA - November 16, 2023

On November 16, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to vapewholesaleusa.com after reviewing their website and identifying electronic nicotine delivery system (ENDS) products offered for sale in the U.S. These products are considered tobacco products under the FD&C Act, as amended to include nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the VapMod MV12000 Disposable, Strawberry Ice Cream, and Vpro Jelly Juice 8000 Puffs Disposable, Cranberry Grape, were identified as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed particular concern that the labeling and advertising for these products imitate toy phones and beverage containers, potentially promoting youth use and concealing their nature as tobacco products.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.