FDA WARNING_LETTER - Dominant Vapor, LLC - October 07, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Christopher Wanner of Dominant Vapor after reviewing their website, dominantvapor.com. The FDA determined that Dominant Vapor manufactures and sells e-liquid products, including "Dominant Vapor - Boom Pop Strong Flavor" and "Dominant Vapor - Cereal Killer Charmed Insane Flavor," which are deemed tobacco products under section 201(rr) of the FD&C Act.

These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Dominant Vapor is a registered manufacturer with over 35,000 products listed with the FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0003625) submitted on September 9, 2020, covering 12,680 products, received a Marketing Denial Order on September 2, 2021.

The FDA requires a written response within 15 working