FDA WARNING_LETTER - LA-ROYAL INC - February 08, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to LA-ROYAL INC on February 8, 2024, following a review of inspection records. The letter states that LA-ROYAL INC imports and distributes hookah tobacco products, which are defined as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Shisha Royal Tobacco Two Apple e250 GR" was found to be a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks 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, as no notice or information was provided as required by section 905(j).

The introduction or delivery of adulterated or misbranded tobacco products into interstate commerce, or the failure to provide required reports, constitutes prohibited acts under sections 301(a), 301(c), and 301(p) of the FD&C Act. LA-ROYAL INC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales