FDA WARNING_LETTER - Dorsett Vapor - October 20, 2020

The FDA's Center for Tobacco Products reviewed the website http://www.orderejuice.com and determined that e-liquid products advertised and sold, such as Custard Creme Apple, Custard Creme Banana Butter, Custard Creme Blueberry, Strawaffle, and Apple Crack, are tobacco products under section 201(rr) of the FD&C Act. These products are misbranded under section 903(a)(7)(B) of the FD&C Act because their advertising fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 CFR 1143.3(b).

The letter specifies that it is unlawful for a tobacco product manufacturer, packager, importer, distributor, or retailer to advertise covered tobacco products without this warning statement, which must also meet the requirements of 21 CFR 1143.3(b)(2). The FDA requires immediate correction of this violation and any similar ones, ensuring all tobacco products and related advertising on all platforms comply with the FD&C Act. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including dates of discontinuance of violative advertising/sales and a plan for maintaining compliance, is required within 15 working days.