FDA WARNING_LETTER - Red Rock Vapor, LLC d/b/a Red Rock Vapor - September 08, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Joseph White regarding products sold on redrockvapor.com. The FDA determined that Electronic Nicotine Delivery System (ENDS) products, specifically "Nic Pods – Grape" and "Nic Pods – Pineapple," are offered for sale or distribution in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act.

These ENDS products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. The primary violation is the sale of these new tobacco products without the required premarket authorization, such as a marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, or an exemption.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information or notice under section 905(j) was not provided. The letter emphasizes the responsibility to ensure compliance with the FD&C Act and FDA regulations for all tobacco products, labeling, and advertising across all platforms.

The company is required to submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for ongoing compliance. Failure to comply may result