HP Industries Inc. – FDA Warning Letter, Sep 6, 2022

The FDA Center for Tobacco Products issued a Warning Letter to HP Industries Inc. on September 1, 2022, following a review of submissions and inspection records. The letter states that HP Industries Inc. manufactures and distributes "Cinnamon NicotinePicks.com Nicotine Toothpicks," which are deemed tobacco products under section 201(rr) of the FD&C Act and subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The FDA determined that "Cinnamon NicotinePicks.com Nicotine Toothpicks" were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The introduction of adulterated or misbranded tobacco products into interstate commerce, and the failure to provide required reports, are prohibited acts under sections 301(a) and 301(p) of the FD&C Act, respectively. The FDA emphasizes that all new tobacco products without premarket authorization are unlawfully marketed and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.