Central Vapors and Central Vapors LLC – FDA Warning Letter, Oct 22, 2024

On October 9, 2024, the FDA issued a Warning Letter to Cameron Wesley Harris regarding electronic nicotine delivery system (ENDS) products sold on centralvapors.com. The FDA determined that "Puff Bar Plus Disposable – Long Island Iced Tea" and "Puff Bar Plus Disposable – Cheese Cake" are new tobacco products offered for sale or distribution in the U.S. without the required premarket authorization.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j).

The FDA mandates that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The recipient must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance.