FDA WARNING_LETTER - lostmary.com - May 20, 2025

On May 9, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Lost Mary, identifying that electronic nicotine delivery system (ENDS) products were offered for sale or distribution to U.S. customers via lostmary.com. These products are classified as tobacco products under section 201(rr) of the FD&C Act, including those with nicotine from any source, and are subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, the Lost Mary MT15000 Turbo Disposable – Raspberry Watermelon and Lost Mary MT15000 Turbo Disposable – Sour Strawberry Peach were identified as new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires prompt action to address these violations and bring the products into compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken, including discontinuation of violative sales and a plan for maintaining compliance.