Dispo Mode – FDA Warning Letter, Nov 16, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Dispomode.com on November 16, 2023, after reviewing their website and determining they offer unauthorized electronic nicotine delivery system (ENDS) products for sale in the U.S. These products, including "Lemon Mint Snowwolf Ease – 8000 Puffs," "Icy Mint Snowwolf Ease – 8000 Puffs," and "Blueberry Kiwi Lemon Snowwolf Ease – 8000 Puffs," are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA expressed particular concern that the product labeling and advertising for the Snowwolf Ease products imitate beverage containers and their design helps conceal their nature as tobacco products, potentially promoting youth use.

Dispomode.com must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.