Big Chief Vapor Products LLC – FDA Warning Letter, Jan 29, 2021

On January 29, 2021, the FDA issued a Warning Letter to Tanner Adams of Chief Vapor, following a review of their website, chiefvapor.com. The FDA determined that Chief Vapor manufactures and sells e-liquid products, specifically CV Serial Killa and CV Spaceboy, which are considered tobacco products under the FD&C Act.

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

Chief Vapor, a registered manufacturer with over 17,700 products listed with the FDA, is responsible for ensuring compliance with all applicable provisions of the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products, and outlining a plan for