FDA WARNING_LETTER - Aladdin Smoke Shop LLC d/b/a Aladdin Glass & Vape - September 14, 2023

The FDA's Center for Tobacco Products reviewed the website https://www.aladdingv.com and determined that Aladdin Glass & Vape is offering electronic nicotine delivery system (ENDS) products for sale or distribution in the United States without the required marketing authorization. These products, including Lava Vape Lava 2 Pod’s Gummy Bear, Lava Vape Lava 2 Pod’s Strawberry Banana, and EB Design TE6000 Elf Bar Juicy Peach, are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack an FDA marketing 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 notice under section 905(j). The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained.