Huff and Puffers, LLC – FDA Warning Letter, May 31, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Bonimit Pang and Phong Nguyen (Huff and Puffers, LLC) after reviewing their website, https://www.huffandpuffers.com, and identifying the sale of unauthorized electronic nicotine delivery system (ENDS) products. Specifically, "Puff Xtra Limited Disposable Vape – Gummy Bear" and "Puff Xtra Limited Disposable Vape – Peach Gummy" were offered for sale without the required premarket authorization order. These products are considered "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization. Consequently, these ENDS products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice under section 905(j). The letter emphasizes that all new tobacco products require premarket authorization to be legally marketed. The firm is required to submit a written response within 15 working days detailing actions taken to address these 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.