FDA WARNING_LETTER - Ace Moist Snuff Inc. d/b/a Outlaw Dip - September 06, 2022

On August 26, 2022, the FDA's Center for Tobacco Products issued a Warning Letter to Jared Boyce regarding nicotine pouch products sold on outlawdip.com. The FDA determined that products like Outlaw Georgia Peach Fat Cut, Outlaw Backwoods Blueberry Fat Cut, and Outlaw Wintergreen Fat Cut are 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.

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 marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.