FDA WARNING_LETTER - Vapeify - November 16, 2023

On November 16, 2023, the FDA issued a Warning Letter to Vapeify.us after reviewing their website and determining they offer unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are considered tobacco products under the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The identified violations include marketing "new tobacco products" without required premarket authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. Specific products cited are Snowwolf Ease Disposable Vape 8000 Puffs, Blitz Bot-It Disposable Vape 10,000 Puffs, and Glamee Dice Disposable Vape 6000 Puffs. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization.

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

Vapeify.us must submit 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, or injunction.