FDA WARNING_LETTER - Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas - July 07, 2022

On July 7, 2022, the FDA issued a Warning Letter to Drive Thru Vapors, LLC, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "Strawberry Yogurt e-liquid," which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Strawberry Yogurt e-liquid" product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also cited as a prohibited act under section 301(p).

The letter emphasizes that all new tobacco products on the market without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Drive Thru Vapors, LLC, a registered manufacturer with over 2,100 listed products, is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the viol