FDA WARNING_LETTER - Hot Grabba LLC d/b/a Buttas Hot Grabba - April 27, 2023

On April 27, 2023, the FDA issued a Warning Letter to Hot Grabba LLC d/b/a Buttas Hot Grabba for manufacturing and distributing "Buttas HOT GRABBA CHIPZ" roll-your-own tobacco product without required premarket authorization.

The FDA determined that "Buttas HOT GRABBA CHIPZ" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. Under sections 910(a) and 910(c)(1)(A)(i) of the FD&C Act, new tobacco products require a marketing authorization order or an exemption, which this product lacks.

Consequently, the product is deemed 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 of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports is prohibited under section 301(p).

The FDA requires Hot Grabba LLC to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation of sales/distribution and a plan for future compliance. Failure to