thesmokeplug.com – FDA Warning Letter, Jun 3, 2025

The FDA Center for Tobacco Products issued a Warning Letter to The Smoke Plug (thesmokeplug.com) on May 30, 2025, for offering electronic nicotine delivery system (ENDS) products for sale in the U.S. without required marketing authorization. The FDA determined that specific products, "Raz DC25000 Disposable Vape Device 25000 Puffs – Mango Loco" and "Raz DC25000 Disposable Vape Device 25000 Puffs – Razzle Dazzle," are new tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source, and lack the necessary premarket authorization order under section 910(a). Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failing to provide required notice or information under section 905(j). The firm is required to take prompt action to address these violations, including discontinuing the violative sale and distribution of these products. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, injunction, and potential detention of imported products. The letter emphasizes the firm's responsibility to ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations.