FDA WARNING_LETTER - Vapes Xpress LLC - December 13, 2023

On December 12, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to Adrian Gonzalez regarding the website https://vapesxpress.com. The FDA determined that the website offers for sale or distribution in the United States electronic nicotine delivery system (ENDS) products that are "new tobacco products" without the required premarket authorization.

Specifically, the products "Lost Mary MO5000 Disposable Vape 5000 Puffs - Energize" and "Funky Republic Ti7000 Disposable Vape - California Cherry" were identified as lacking FDA marketing authorization orders. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and do not have an FDA marketing authorization order or exemption.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) due to the lack of required notice or information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing