FDA WARNING_LETTER - Getsmoke - February 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Dmitrii Kniazev on January 31, 2024, following a review of the website https://getsmoke.com. The review determined that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the United States without required premarket authorization.

The identified violations include the marketing of "new tobacco products" that lack an FDA marketing authorization order, making them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act. Specifically, the products cited are Grape Energy – EB Design BC5000 Disposable Vape, Tropical Rainbow Blast – EB Design BC5000 Disposable Vape, and Cherry Peach Lemonade – Lost Mary OS5000 Disposable Vape. These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and do not have the necessary marketing authorization or exemptions.

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement action. The firm is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result