FDA WARNING_LETTER - Shenzhen Airis Electronic Co. Ltd. - January 23, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to the manufacturer of Airis Vape products, identified through their website https://www.airisvape.com, for marketing unauthorized electronic nicotine delivery system (ENDS) products in the United States. The FDA determined that products like the Airis Lux P5000 Disposable Vape, Tropical Fruit, and Airis Titan Disposable Vape 10k Puff, Strawberry Mango, are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

These products are considered tobacco products under section 201(rr) of the FD&C Act, which now includes products containing nicotine from any source. They are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because they lack the required premarket authorization order or exemption. The FDA has not received any marketing authorization applications for these products.

The letter requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the unauthorized products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and products may be detained or refused admission into the U.S.