Vapor Salon – FDA Warning Letter, Jun 29, 2023

The FDA issued a Warning Letter to Vapor Salon on June 29, 2023, following a review of submissions and inspection records. The FDA determined that Vapor Salon manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of a "new tobacco product," specifically "VS Premium Eliquid Cloud Walker 0.6%," without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA states that the failure to provide the required report under section 905(j) is a prohibited act under section 301(p). The letter mandates Vapor Salon to submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.