FDA WARNING_LETTER - nikkdripsretail.com - April 29, 2025

On April 2, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding nicotine pouch products offered for sale on https://nikkdripsretail.com. The FDA determined these products, including "Wyn Nicotine Pouches - Banana Chill" and "Wyn Nicotine Pouches - Mango," are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded jurisdiction to products containing nicotine from any source.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after that date. The identified products lack FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided under section 905(j).

The FDA requires prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. Failure to comply may