bellavapor.com – FDA Warning Letter, Apr 29, 2025

On April 9, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to the entity operating bellavapor.com, following a review that identified nicotine pouch products offered for sale in the U.S. These products, including "NYKD Nicotine Pouches - Citrus Ice" and "NYKD Nicotine Pouches - Peppermint," are classified as 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 this date. Since the listed nicotine pouch products were not commercially marketed by the February 15, 2007, predicate date and lack FDA marketing authorization orders or exemptions, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires the firm to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and distribution of the non-compliant products, and a plan for maintaining future