FDA WARNING_LETTER - The Clean Vape - March 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Raffy Tasmajian, operating TheCleanVape.com, after determining that e-liquid products listed on the website are manufactured and offered for sale or distribution in the U.S. These e-liquids, including "Loops," "Dragonberry Kiwi," and "Gramberry," are considered "new tobacco products" under section 201(rr) of the FD&C Act and are subject to FDA regulation. The firm failed to obtain the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering these products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the required notice or information under section 905(j) was not provided. Despite being a registered manufacturer with over 800 listed products, the firm did not comply with these critical regulatory requirements. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative activities and a plan for future compliance. Failure to address these violations may result in civil money penalties, product seizure, injunction, and refusal of admission for imported products.