FDA WARNING_LETTER - nykdpouches.com - April 29, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to the recipient at 2834 Hamner Ave #315, Norco, CA 92860, on April 10, 2025. The letter states that a review of the website https://nykdpouches.com revealed nicotine pouch products 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 determined that the following nicotine pouch products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization: NYKD – Berry Lemon Ice Nicotine Pouches, NYKD – Strawberry Watermelon Ice Nicotine Pouches, and NYKD – Tropical Ice Nicotine Pouches.

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 absence of required marketing authorization orders or exemptions. The letter mandates a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales and distribution, and a plan for future compliance