FDA WARNING_LETTER - Raven Route - November 21, 2023

On September 20, 2023, the FDA's Center for Tobacco Products issued a Warning Letter to RavenRoute following a review of their website, ravenroute.com. The FDA determined that the company was offering for sale or distribution in the U.S. electronic nicotine delivery system (ENDS) products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The letter identified two primary violations. First, RavenRoute was found to be marketing "new tobacco products" without the required premarket authorization. Specifically, the Bang XXL Disposable Vape – Strawnana and Elf Bar BC500 – Sakura Grape were cited as new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Second, the company was cited for modified risk tobacco product violations. The website's labeling, advertising, or claims implicitly or explicitly suggested reduced risk, reduced substance levels, or absence of substances, without an FDA order permitting such claims. This makes the products adulterated under section 902(8) of the FD&C Act.

RavenRoute is required to submit a written response within 15 working days detailing