FDA WARNING_LETTER - Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas - May 18, 2023

On May 18, 2023, the FDA issued a Warning Letter to Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that their "Grape e-liquid products" are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine.

These products lack the necessary FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. Consequently, the 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 notice under section 905(j). The sale or distribution of such products constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the violative products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money