FDA WARNING_LETTER - ejuiceconnect.com - April 29, 2025

On April 18, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Ejuiceconnect.com after reviewing their website and finding nicotine pouch products offered for sale in the U.S. These products, including "NYKD Nicotine Pouches - Tropical Ice" and "NYKD Nicotine Pouches - Peppermint," are considered 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 FDA determined these 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 order under section 910(c)(1)(A)(i) of the FD&C Act. 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 notice or information under section 905(j).

The letter mandates prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates and a compliance plan,