FDA WARNING_LETTER - Ballistic Vape - August 10, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Rudy Distaso regarding e-liquid products sold on https://balisticvape.myshopify.com. The FDA determined that products like "Ballistic Vape - The Tsunami" and "Ballistic Vape - Praline Dream" are tobacco products subject to FDA regulation. These e-liquids are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization and notice. The firm, a registered manufacturer, is responsible for ensuring all its tobacco products comply with the FD&C Act. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance.