FDA WARNING_LETTER - denverelectroniccigarettes.com - June 03, 2025

On May 16, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Denver Electronic Cigarettes after reviewing their website, denverelectroniccigarettes.com. The FDA determined the company offers for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products that are considered "tobacco products" under section 201(rr) of the FD&C Act, including those containing nicotine from any source, as amended on March 15, 2022.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the products "Geek Bar Pulse Disposable 5% Mintz Edition – Creamy Mintz" and "Raz DC25000 Disposable 5% – Mango Loco" were found to be new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided.

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products, and