FDA WARNING_LETTER - lulu’s mini market llc - May 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Murat Khalifa and Yousef Abdelhamid on April 30, 2024, following a review of the website https://rubiismokeshop.com. The review determined that Electronic Nicotine Delivery System (ENDS) products were offered for sale or distribution in the United States.

The identified violations concern the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Lost Mary BC5000 Disposable Vape Cranberry Soda" and "Elf Bar BC5000 Ultra Disposable Vape Raspberry Watermelon" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. This renders them adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the absence of required notice or information under section 905(j).

The letter emphasizes that ENDS products, including those containing nicotine from any source, are subject to FDA jurisdiction and must comply with the FD&C Act and its regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm is required to submit a written response within 15 working days detailing corrective actions, including discontinuation of violative