FDA WARNING_LETTER - Nic Nac Naturals, LLC - November 07, 2023

On November 7, 2023, the FDA issued a Warning Letter to Niccolo Magnotto regarding nicotine mints sold on nicnac.com. The FDA determined that "nicotine mints" (Blood Orange Nic Nac and Wintergreen Nic Nac) are tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter states that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance.