The Vape Spot – FDA Warning Letter, Nov 9, 2023

On November 8, 2023, the FDA issued a Warning Letter to Dave Durley of The Vape Spot, located at 2828 Broadway Ave, Suite 1, Monroeville, PA 15146. The letter states that the Center for Tobacco Products reviewed the website https://thevapespot2018.com and found that Electronic Nicotine Delivery System (ENDS) products are offered for sale or distribution to customers in the United States.

The FDA determined that these ENDS products are "tobacco products" under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) and are subject to FDA jurisdiction. The letter highlights that as of March 15, 2022, the definition of "tobacco product" expanded to include products containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)). Specifically, the website offers "EB Design BC5000 Disposable – Miami Mint" and "EB Design BC5000 Disposable – Lemon Mint" ENDS products, which were not commercially marketed in the U.S. as of February 15,