FDA WARNING_LETTER - Funny Vapes - October 30, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to funnyvapes.com after reviewing its website and identifying electronic nicotine delivery system (ENDS) products offered for sale in the U.S. The products, specifically "We Fume 30000 Puffs – Dragon Fruit" and "We Fume 30000 Puffs – Lychee Soda," are classified as tobacco products under the FD&C Act, including the expanded definition covering nicotine from any source. These ENDS products are considered "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required notices. FDA expressed particular concern regarding the products' youth appeal, noting their design imitates smartphones with features like "Touch Screen, Voice Function, Smart Connection," which could conceal their nature as tobacco products. The firm is required to submit a written response within 15 working days detailing actions to address violations, discontinue sales, and ensure future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.