FDA WARNING_LETTER - Elk River Vapor Shop - June 28, 2022

The FDA issued a Warning Letter to Elk River Vapor Shop on June 28, 2022, following a review of submissions and inspection records. The FDA determined that Elk River Vapor Shop manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "Crack The Whip 6mg 60 mil" and "Peach Wht. Grape 3mg 60 mil" were found to be new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption.

This renders the products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

Elk River Vapor Shop has over 1,100 products listed with the FDA. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and/or injunction.

The company is required to submit a written