FDA WARNING_LETTER - United Zone Store - June 22, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to United Zone Store after reviewing their website, https://unitedzonestore.com, and identifying electronic nicotine delivery system (ENDS) products offered for sale in the U.S. These products, including ELF Bar BC5000 Disposable Vapes, are classified as "new tobacco products" under section 201(rr) of the FD&C Act, subject to FDA jurisdiction. The firm is in violation for marketing these new tobacco products without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) because the necessary information under section 905(j) was not provided. The FDA requires the company to submit a written response within 15 working days detailing actions to discontinue violative sales and a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions, including civil money penalties, seizure, or injunction, and products may be detained or refused admission.