FDA WARNING_LETTER - EC Supply, Inc. - July 27, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to EC Supply, Inc. after reviewing inspection records, determining the company distributes Electronic Nicotine Delivery Systems (ENDS) products for commercial 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, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the products "EB Design BC5000 Disposable Pod Device Blue Razz Ice 50 mg/ml" and "Pastel Cartel Esco Bars Mesh Watermelon Ice 5% 50mg/ml 2500 puffs" were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization.

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 marketing authorization or notice. The introduction of adulterated or misbranded tobacco products into interstate commerce, or the failure to provide required reports, constitutes prohibited acts under sections 301(a) and 301(p) of the FD&C Act.

EC Supply, Inc.