FDA WARNING_LETTER - Prestige 22, Inc. d/b/a The Vapers World - November 16, 2023

The FDA issued a Warning Letter to Arlene Sharon of The Vapers World (thevapersworld.com) on November 16, 2023, for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA's Center for Tobacco Products reviewed the website and determined that products listed, specifically "Snowwolf Ease Vape Disposable 8000 Puffs" in Blue Cotton Candy, Strawberry Ice Cream, and Triple Berry Ice flavors, are "new tobacco products" lacking required premarket authorization.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they were not commercially marketed as of February 15, 2007, and do not have an FDA marketing authorization order or exemption. The FDA also expressed concern that the product labeling and/or advertising for the Snowwolf Ease products imitate beverage containers and their design helps conceal their nature as tobacco products, potentially promoting youth use.

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 or legal actions such as civil money penalties, seizure, and/or injunction.