FDA WARNING_LETTER - bellavapor.com - April 15, 2025

On April 9, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding products sold on bellavapor.com. The FDA determined that nicotine pouch products, specifically NYKD Nicotine Pouches - Citrus Ice and NYKD Nicotine Pouches - Peppermint, are offered for sale or distribution in the U.S. These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include products containing nicotine from any source.

The primary violation is that these nicotine pouch products are "new tobacco products" as 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 because the necessary notice or information under section 905(j) was not provided.

The FDA requires prompt action to address these violations, including discontinuing the sale and distribution of the non-compliant products. A written response is required within 15 working days