FDA WARNING_LETTER - Easy Wholesale, LLC - July 27, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to Easy Wholesale, LLC, based on inspection records, determining the company distributes Electronic Nicotine Delivery System (ENDS) products, specifically citing the "Elf Bar BC5000 Ultra Disposable Pod Device - Blue Razz Ice US 5% Nicotine 5000 Puffs." These products are classified as 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 primary violation is the marketing of a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. The cited Elf Bar product was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j).

Introducing or delivering adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a) and failure to provide required reports is prohibited under section 301(p). The FDA requires Easy Wholesale,