Vertigo Vapor Inc. d/b/a Baton Vapor – FDA Warning Letter, Oct 26, 2021

On October 19, 2021, the FDA issued a Warning Letter to Thomas Vo and Gabriel Laurant of Baton Vapor, following a review of their website, batonvapor.com. The FDA determined that Baton Vapor manufactures and sells e-liquid products, which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA regulation.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Specifically, the products Baton Nic-Salts Iced Watermelon Limeade, Baton Nic-Salts Vanilla Wafer, and Baton Nic-Salts Fruit Confit were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although Baton Vapor is a registered manufacturer with over 14,000 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0000975, submitted September 4, 2020, received a Marketing Denial Order on September 8, 2021, covering 50 products. The FDA emphasizes that products with