FDA WARNING_LETTER - The Hand Media, Inc. d/b/a Vapor Shark - June 22, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Brandon Leidel of Vapor Shark on June 16, 2023, following a review of their website, vaporshark.com. The review determined that the company offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the United States without the required premarket authorization.

Under section 201(rr) of the FD&C Act, ENDS products are classified as tobacco products, subject to FDA jurisdiction and compliance requirements. The letter highlights that the definition of "tobacco product" was expanded on March 15, 2022, to include products containing nicotine from any source.

The specific violations identified include the sale of "Esco Bar Watermelon Ice," "Elf Bar Ultra BC5000 Disposable – 1 Pack," and "EB Design BC5000 Disposable - 1 Pack." These products are considered "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Vapor Shark is required to