FDA WARNING_LETTER - G&FIRE INC - July 17, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to G&FIRE INC on July 15, 2024, following a review of inspection records. The letter states that G&FIRE INC sells and/or distributes e-liquid products in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "DAZE reds APPLE ORIGINAL ICED 3mg/mL 100mL" is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information under section 905(j) was not provided.

G&FIRE INC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale/distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties,