FDA WARNING_LETTER - Boomtown Vapor LLC - April 05, 2022

On January 14, 2022, the FDA issued a Warning Letter to Linda and Andrew Johnson of Boomtown Express, following a review of their website, boomtownexpress.com. The FDA determined that e-liquid products, specifically "Candy Rancher" and "Watermelon," were being 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-liquids were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter notes that the firm is a registered manufacturer with over 2,600 products listed with FDA. A Premarket Tobacco Product Application (PMTA), STN PM0002953, submitted on September 4, 2020, received a Marketing Denial Order on September 8, 2021, covering 2,33