FDA WARNING_LETTER - Downtown Vapes LLC - April 19, 2022

The FDA Center for Tobacco Products reviewed dtvapes.com and determined that e-liquid products, specifically "Smurfberry Cupcake" and "D-OHM Nuts," are manufactured and offered for sale in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The FDA found that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no required notice or information was provided under section 905(j).

The letter emphasizes that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The firm has over 175 products listed with the FDA. The FDA prioritizes enforcement against products without pending applications, including those with Marketing Denial Orders or no submitted applications.

The company must submit a written response within 15 working days detailing actions taken to address