FDA WARNING_LETTER - MUUV Holdings Inc. - September 06, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Michael T. Banta on August 26, 2022, following a review of the website https://muuvpouches.com. The FDA determined that nicotine pouch products, specifically Wintergreen, Mint, and Citrus flavors, are manufactured and offered for sale or distribution in the United States.

These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include products containing nicotine from any source. The FDA asserts that these nicotine pouch products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products are marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, the 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 information submission under section 905(j).

The letter demands a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of these products, and a plan for future compliance. Failure to