FDA WARNING_LETTER - Route 66 Vapor - August 31, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Route 66 Vapor on August 31, 2023, following a review of inspection records. The letter states that Route 66 Vapor manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Wet Dream" e-liquid is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided per section 905(j).

The letter emphasizes that the failure to provide a required report under section 905(j) is a prohibited act under section 301(p). Route 66 Vapor 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 violative products and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties