FDA WARNING_LETTER - HighFi Vape - May 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Highfivape.com on April 30, 2024, after reviewing their website and determining they offer electronic nicotine delivery system (ENDS) products for sale in the U.S. These products are classified as tobacco products under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the Funky Republic Ti7000 Disposable 1 ct, Peach Pie, and Kangvape Onee Stick Disposable Kit 3000 Puffs 1600mAh 1 ct, Blueberry Bubblegum, were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices.

The letter mandates a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter also notes that imported products appearing adulterated or misbranded may be detained.