FDA WARNING_LETTER - chiefcottonmouth.com - April 01, 2025

On March 21, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to "To Whom It May Concern" regarding electronic nicotine delivery system (ENDS) products offered for sale on https://www.chiefcottonmouth.com. The FDA determined that products listed, specifically Elfbar Tropical Rainbow Blast 5000 puffs, Lost Mary Berry Crush Ice 5000 puffs, and Lost Mary OS5000 Forest Mint, are 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.

These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these products lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. 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 notices or information under section 905(j).

The letter states that all new tobacco products marketed without statutory premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure,