FDA WARNING_LETTER - F & N Trading 1 Inc. d/b/a/ Puffholic - June 22, 2023

On June 15, 2023, the FDA issued a Warning Letter to Fahed AL Hassan and Nabeel Mansour, owners of puffholic.com, for offering for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products without required marketing authorization. The FDA's review of puffholic.com identified ENDS products, specifically Elf Bar TE5000 Grape and Elf Bar TE5000 Blueberry Ice, as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of an FDA marketing authorization order or exemption. The letter emphasizes that the definition of "tobacco product" now includes products containing nicotine from any source, not just tobacco-derived nicotine, as per the Consolidated Appropriations Act, 2022. The firm is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.