FDA WARNING_LETTER - XL VAPE, LLC - September 09, 2020

The FDA issued a Warning Letter to Waleed Aloteibi regarding the website https://stigpods.com, which manufactures and sells Electronic Nicotine Delivery System (ENDS) products in the U.S. These products are deemed tobacco products under the FD&C Act. The FDA determined that products like STIG Disposable VGOD Iced Mango Bomb, STIG Disposable VGOD Lush Ice, and STIG Disposable Tropical Mango are "new tobacco products" that were not commercially marketed before February 15, 2007, and lack the required premarket marketing authorization.

Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA expressed particular concern about the rising youth appeal and use of ENDS products, noting a significant increase in disposable ENDS product use among middle and high school students in 2020. The letter requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for compliance. Failure to comply may result in civil money penalties, seizure, and/or injunction.