FDA WARNING_LETTER - Virtue Vape, LLC

The FDA Center for Tobacco Products issued a Warning Letter to Catalina Jimenez after reviewing the website http://www.virtuevapewholesale.com, which sells e-liquid products deemed tobacco products under section 201(rr) of the FD&C Act. The primary violation identified is that the firm's Unicorn Cakes e-liquid is misbranded under section 903(a)(1) and/or 903(a)(7)(A) of the FD&C Act. This misbranding stems from its labeling and/or advertising being false or misleading, specifically by imitating food products, such as pancakes and strawberry beverages, and using cartoon imagery (e.g., unicorns eating pancakes) that is marketed toward, and appealing to, children. This creates a significant risk of accidental ingestion by children, leading to potential acute nicotine toxicity, including severe harms like cardiac arrest, seizure, coma, and respiratory arrest. The FDA requires immediate correction of this violation, discontinuation of all violative labeling, advertising, sale, and distribution of these tobacco products, and a plan for maintaining compliance with the FD&C Act. A written response detailing corrective actions and compliance plans must be submitted within 15 working days. Failure to comply may result in further FDA actions, including civil money penalties, criminal prosecution, seizure, and injunction.