FDA WARNING_LETTER - Vapor Sense LLC d/b/a Vapor Sense E-Cigs & Supplies - July 21, 2023

The FDA issued a Warning Letter to Vapor Sense LLC d/b/a Vapor Sense E-CIGS & SUPPLIES on July 20, 2023, following a review of submissions and inspection records. The FDA determined that Vapor Sense manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Vapor Sense Pimango Berry 3mg" was found to be a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

This renders the product 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 failure to provide such a report is a prohibited act under section 301(p).

Vapor Sense LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.