FDA WARNING_LETTER - Highbrow Vapor - August 24, 2021

The FDA issued a Warning Letter to Brian Peck of Highbrow Vapor on August 13, 2021, following a review of their website, highbrowvapor.com. The FDA determined that e-liquid products manufactured and sold by Highbrow Vapor are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products Highbrow Vapor Amaretto Amore and Highbrow Vapor Peach Thymbra were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Highbrow Vapor, a registered manufacturer with over 1,600 listed products, is responsible for ensuring compliance across all sales and advertising platforms. Failure to address these violations may result in regulatory actions including civil money penalties, no-tobacco-sale orders, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance.