FDA WARNING_LETTER - sinzs.net

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to sinzs.net on September 26, 2025, following a review of their website. The FDA determined that sinzs.net was offering unauthorized electronic nicotine delivery system (ENDS) products for sale to U.S. customers, specifically citing "Lost Mary MO5000 5% Disposable Vape—Ginger Beer" and "Lost Mary OS5000 Puff Disposable Vape – Black Lemonade (Luster Edition)."

These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially marketed in the U.S. before February 15, 2007. The main violation is the absence of required premarket authorization orders, which makes these products adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively. The FDA highlighted that the definition of "tobacco product" now includes nicotine from any source.

sinzs.net is required to submit a written response within 15 working days from receiving the letter. This response must describe the actions taken to discontinue the violative sale and distribution of these products and outline a plan for maintaining future compliance with the FD&C Act. Failure to adequately address these violations may result in further enforcement actions, such as civil money penalties, product seizure, or injunctions.