FDA WARNING_LETTER - Dukhan Store - April 27, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to dukhanstore.com after reviewing its website and identifying e-liquid products offered for sale or distribution to U.S. customers. These e-liquids, including "Cartoon Vapor - Sponge Tart," "Mega Grape," and "Sour Puff Kiwi Lime," are classified as tobacco products under the FD&C Act and are subject to FDA regulation. The inspection revealed that these products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and are being sold without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the firm failed to provide necessary information or reports as required by section 905(j). This failure also constitutes a prohibited act under section 301(p). The FDA also expressed significant concern that these products feature graphic images imitating cartoons appealing to children, potentially promoting unlawful sales and increasing youth use of ENDS products. The firm is required to promptly correct these violations, cease all violative sales and distribution, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Non-compliance may result in civil money penalties, product seizure, injunctions, or refusal of admission for imported products.