FDA WARNING_LETTER - Vape Junkie EJuice - April 26, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Jessica Forit and Michelle Lynn Allen regarding e-liquid products sold on vapejunkieejuice.com. The FDA determined these e-liquids are "tobacco products" under the FD&C Act, specifically ENDS products, and are subject to FDA regulation.

The primary violation is the sale of "new tobacco products" without required premarket authorization. Products like Granny Smith Apple, Cucumber, and Milk e-liquids were identified as new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes that unlawfully marketed products are subject to enforcement actions, including civil money penalties, seizure, and injunction. The recipients must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for compliance. Failure to comply may lead to further regulatory action.