FDA WARNING_LETTER - Mr-Joy Group Holding B.V. d/b/a Mr. Joy - June 22, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Bob Josephus Ten Herkel of Mr-Joy.nl on June 16, 2023, for offering unauthorized electronic nicotine delivery system (ENDS) products for sale in the United States. The FDA determined that products listed on https://www.mr-joy.nl, specifically Elf Bar 600 Disposable Device Blueberry, Elf Bar 600 Disposable Device Grape, and Elf Bar 600 Disposable Device Watermelon, are tobacco products under section 201(rr) of the FD&C Act.

These ENDS products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 absence of required marketing authorization or notification.

The FDA requires the firm to address these violations and bring all tobacco products offered in the U.S. into compliance with the FD&C Act. Failure to comply may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within