FDA WARNING_LETTER - Sublime Liquids - March 03, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Saad Mansour regarding e-liquid products advertised and sold on sublimeliquids.com. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction. The primary violation identified is that several e-liquid products, including Sublime Liquids Apple Jack, Cowboy, and FOB, are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). This misbranding stems from the website advertising's failure to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). The letter requires immediate corrective actions to bring all tobacco products and related advertising into compliance with the FD&C Act and FDA regulations. A written response detailing corrective actions, dates of discontinuance of violative advertising, and a compliance plan must be submitted within 15 working days. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction, and refusal of admission for imported products.