PBDragon LLC – FDA Warning Letter, Feb 22, 2022

On February 11, 2022, the FDA issued a Warning Letter to Jeremy M. Harris regarding e-liquid products sold on pbdragon.com/store. The FDA determined that products like PBCookie and Snickerdoodle e-liquids are "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction since August 8, 2016.

These products were found to be marketed without the required premarket authorization order, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

The firm is a registered manufacturer with over 6,900 listed products. The FDA prioritizes enforcement against new tobacco products lacking statutory premarket authorization. The letter emphasizes the firm's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in regulatory actions, including civil money penalties, seizure, and/or injunction.

A written response is required within 15 working days, detailing actions taken to address violations, including discontinuation of violative activities and