FDA WARNING_LETTER - Apollo Future Technology, Inc. - August 27, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Lawrence Robert Ciardella concerning electronic nicotine delivery system (ENDS) products sold on apolloecigs.com. The FDA determined that specific ENDS products, namely FLUM Gio 3000 puff Disposable Vape - Power Bull and Brez Pods 4-Pack Breeze, are being offered for sale or distribution in the U.S. without the required premarket authorization. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and lack an FDA marketing authorization order. Consequently, these products are considered adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification. The letter stresses the firm's responsibility to ensure all tobacco products comply with the FD&C Act and its regulations. Failure to address these violations may lead to regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including the discontinuation of violative sales, and a plan for maintaining future compliance.