FDA WARNING_LETTER - 21 Century Smoking, Inc. - November 02, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Brent Duke of 21st Century Smoking on October 29, 2021, following a review of their website, 21centurysmoking.com. The FDA determined that e-liquid products, specifically Blueberry and Juicy Peach, were manufactured and offered for sale or distribution in the U.S. These products are classified as 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 the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 200 products listed with FDA. A Premarket Tobacco Product Application (PMTA) (STN PM0002136) submitted on September 9, 2020, covering 120 products, received a Marketing Denial Order on September 7, 2021.