FDA WARNING_LETTER - Rappa Fire Inc. - May 30, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Rosario Perez regarding tobacco leaf products sold on rappa.com. The FDA determined that products like "Rappa Fire – All-Natural Tobacco Blunt Wrap Cones" and flavored variants (Minterberry, Russian Creme, Tropical) are tobacco products under the FD&C Act, subject to FDA jurisdiction.

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 are being sold without the required premarket marketing authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The FDA also noted that imported products appearing adulterated or misbranded may be detained.