FDA WARNING_LETTER - Tooters Vape Shop - March 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Jeremy Anderson after reviewing https://tootersvapeshop.com/, identifying e-liquid products manufactured and offered for sale in the United States. The FDA determined that products such as Banana Nut Bread, Berry Crunch, and Cherry Bomb e-liquids are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation. The primary violations stem from these e-liquids being "new tobacco products" that were not commercially marketed as of February 15, 2007, and are being sold without the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. As a result, 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 failure to provide required notices or information under section 905(j). The firm, a registered manufacturer, is responsible for ensuring all its tobacco products comply with the FD&C Act. The FDA requires a written response within 15 working days detailing corrective actions, including the dates of discontinuation for violative activities and a plan for maintaining compliance. Failure to address these violations could lead to civil money penalties, product seizure, injunction, and refusal of admission for imported products.