FDA WARNING_LETTER - Vapejoose, Inc. - May 24, 2022

The FDA issued a Warning Letter to Stephen Knight regarding e-liquid products sold on shopjoose.com. The FDA determined these e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. Effective August 8, 2016, e-liquids were deemed subject to regulation.

The violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, Vapejoose Arctic Blast, Vapejoose Superberry Crunch, and Vapejoose Moon Fruit e-liquid products were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 4,000 products listed. While a Premarket Tobacco Product Application (PMTA) PM0000939 was submitted on July 15, 2020, FDA issued a Marketing Denial Order for products covered by this PMTA on October 8, 2021.

The letter emphasizes the firm's responsibility to ensure all tobacco products and related labeling/advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in regulatory actions including civil