FDA WARNING_LETTER - Vape Mania - December 19, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to vapemania.com after reviewing its website and determining that electronic nicotine delivery system (ENDS) products were offered for sale or distribution to U.S. customers. These products are classified as tobacco products under section 201(rr) of the FD&C Act, encompassing nicotine from any source following a March 2022 amendment. The FDA found that specific ENDS products, including Chris Brown CB15K Disposable Vape – Pineapple Lemonade, Tyson 2.0 Heavyweight 7000 Disposable Vape – Lush Lime, and Hulkamania Hogan 8000 Disposable Vape – Dragon Fruit Lemonade, are "new tobacco products" that lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided. The firm is required to submit a written response within 15 working days detailing actions taken to discontinue the violative sale and distribution of these products and outlining a plan for future compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.