FDA WARNING_LETTER - Smokecignals LLC - April 30, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Anthony Kolesa of 8129 Oleander Street, New Orleans, LA, on April 23, 2021, following a review of the website https://smokecignals.com. The review determined that e-liquid products, specifically "Blue Puppet" and "Black Frost," are manufactured and offered for sale or distribution in the U.S. These e-liquids 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. Since these products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 100 products listed with FDA, to ensure 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 firm is required to