U.S. FDA Sends 3 Enforcement Letters for Illegal Sales

On the same day premarket tobacco applications (PMTAs) were due, the U.S. Food and Drug Administration (FDA) issued warning letters notifying three companies who sell or distribute unauthorized electronic nicotine delivery system (ENDS) products to remove those products from the market.

The FDA issued a warning letter to XL Vape LLC (doing business as Stig Inc.) warning the company to remove their disposable e-cigarettes from the market because they do not have the required premarket authorization. Additional warning letters were issued to Flavour Warehouse LTD (doing business as Vampire Vape) and Pretty Women UK LTD (T/A Coil2oil and Mad Kingdom Liquids) for illegally marketing unauthorized menthol-flavored e-liquids.

The labeling and/or advertising of these products also features cartoon images, such as vampires and kings, that are commonly marketed and/or appeal to youth.

The FDA stated in a release that it will be prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a PMTA. “The warning letters issued today underscore our concern with the rise in youth use of disposable e-cigarettes and the notable use of menthol-flavored e-cigarettes,” thr release states. “As we have said many times, the FDA will take action against any ENDS product—regardless of whether it is cartridge-based, disposable, flavored, or otherwise—if it is targeted to kids, if its marketing is likely to promote use by minors, or if the manufacturer fails to take adequate measures to prevent youth access.”