FDA WARNING_LETTER - Vape Crusades - November 08, 2022

The FDA Center for Tobacco Products issued a Warning Letter to the operator of vapecrusades.com on October 28, 2022, after reviewing their website. The FDA determined that e-liquid products, specifically "Banana Cream" and "Blueberry Custard," are manufactured and offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket 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 because required notice or information was not provided under section 905(j).

The letter mandates the company to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in regulatory actions including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing viol