FDA WARNING_LETTER - Vape Closeouts - December 12, 2023

On December 12, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Vapecloseouts.com after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are considered tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The FDA identified three specific ENDS products lacking required premarket authorization: Pineapple Mango Lost Mary OS5000 Disposable Vape, Malaysian Mango Funky Republic FI3000, and Peach Berry Elf Bar BC5000 EB Design. These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, they are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter mandates 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. The firm is responsible for ensuring all products, labeling, and advertising comply with the FD&C