bulldog vapor llc – FDA Warning Letter, Feb 22, 2022

The FDA issued a Warning Letter to Supriya Karki of Bully's Vapor, LLC, on February 18, 2022, following a review of their website, https://www.bullysvapor.com. The FDA determined that e-liquid products, specifically "Bully’s Vapor Cats Meow" and "Bully’s Vapor Bunny Tails," were manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as "new tobacco products" under section 201(rr) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The letter emphasizes that all new tobacco products on the market without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The firm is a registered manufacturer with over 7,800 listed products. Bully's Vapor