FDA WARNING_LETTER - Bulldog Vapor, LLC - February 26, 2021

The FDA issued a Warning Letter to Wesley Swanson of Bulldog Vapor on February 26, 2021, following a review of their website, https://www.bulldog-vapor.com. The FDA determined that e-liquid products, specifically "Bulldog Vapor Rainwater" and "Bulldog Vapor Strawberry (Strawberry Fields)," are manufactured and offered for sale 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 required premarket authorization orders, as mandated by section 910(a) of the FD&C Act. Since these e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Bulldog Vapor, a registered manufacturer with over 1,100 products listed with FDA, is responsible for ensuring compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to address these violations may result in regulatory actions