FDA WARNING_LETTER - Turning Point Brands d/b/a Directvapor.com - June 22, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Direct Vapor (directvapor.com) on June 7, 2023, 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 by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The FDA identified specific violations: Direct Vapor is offering "new tobacco products" without the required premarket authorization. Examples cited are "Elf Bar Ultra BC5000 Disposable Vape Kiwi Passion Fruit Guava" and "Esco Bar 2500 Puff Disposable Vape Pen Mango Ice." These products are deemed "new tobacco products" 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 adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Direct Vapor must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also states that imported products appearing