Shenzhen IJOY Technology Co., LTD. – FDA Warning Letter, Nov 28, 2023

The FDA Center for Tobacco Products issued a Warning Letter to the manufacturer of IJOY electronic nicotine delivery system (ENDS) products, based on a review of their website, https://www.ijoycig.com. The FDA determined that products listed, specifically "IJOY Bar IC8000 Disposable, Apple Juice" and "IJOY Bar SD10000, Blue Razz Ice," are manufactured and offered for sale or distribution in the United States.

These ENDS products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended to include products containing nicotine from any source. As "new tobacco products" not commercially marketed in the U.S. as of February 15, 2007, they require a premarket authorization order from the FDA under section 910(a) of the FD&C Act. The FDA has not received such an application for the listed products.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required marketing authorization and failure to provide necessary information under section 905(j). The letter requires a written response within 15 working days detailing actions to address violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may