FDA WARNING_LETTER - PWJ Mart Corp d/b/a Puff Joy - May 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Guyue Fang of PuffJoy on April 30, 2024, following a review of the website https://www.puffjoy.com. The review determined that electronic nicotine delivery system (ENDS) products were offered for sale or distribution in the United States without required marketing authorization.

The identified violations involve "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders. Specifically, the products cited are "Elf Bar BC5000 Disposable Vape, Tropical Rainbow Blast" and "Lost Mary OS5000 Disposable – 13ML Cranberry Soda." These products are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because required premarket authorization or notification was not provided.

The letter emphasizes that all tobacco products containing nicotine from any source are subject to FDA jurisdiction and must comply with the FD&C Act. The company is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing