FDA WARNING_LETTER - Cheap MistHub - February 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to 100 Phelps Way, Meeteetse, WY, on January 31, 2024, after reviewing the website https://www.sourpromo.com. The review determined that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the U.S. without required marketing authorization.

Specifically, the products "Elf Bar BC5000 LE Disposable Vape, Honeydew Pineapple Orange" and "Elf Bar BC5000 LE Disposable Vape, Passionfruit Orange Guava" were identified. These are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for not having the required premarket authorization or notice. The letter emphasizes 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 firm must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales/distribution and a plan for future