FDA WARNING_LETTER - 8OHM1 d/b/a Digital Smoke - November 02, 2023

The FDA Center for Tobacco Products issued a Warning Letter to 8OHM1 d/b/a Digital Smoke for manufacturing and distributing e-liquid products, specifically "Melon Mint Gum," without the required premarket authorization. These products are classified as "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction, particularly after the 2022 amendment extending oversight to nicotine from any source. The firm's e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification under section 905(j). The letter highlights that marketing adulterated or misbranded tobacco products (section 301(k)) and failing to provide required reports (section 301(p)) are prohibited acts. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a compliance plan. Non-compliance may result in civil money penalties, seizure, injunction, or detention of imports.