The Fog House LLC – FDA Warning Letter, Aug 26, 2021

The FDA Center for Tobacco Products issued a Warning Letter to The Fog House LLC, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that The Fog House LLC manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation cited is the marketing of a "new tobacco product," specifically "The Fog House Black Flag 3MG 60ML e-liquid product," without the required premarket authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The letter emphasizes that such actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The Fog House LLC, a registered manufacturer with over 300 listed products, is responsible for ensuring compliance for all its tobacco products. 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