FDA WARNING_LETTER - Black Dog Reserve LLC - February 26, 2021

The FDA issued a Warning Letter to Corey Tunnell, operating Black Dog Reserve, after reviewing their website, blackdogreserve.com. The FDA determined that e-liquid products listed on the website are manufactured and offered for sale or distribution in the United States. These e-liquids are considered tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction and compliance requirements.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, Black Dog Reserve Banana Split, Black Dog Reserve Strawberry Milk, Black Dog Reserve Banana Taffy, and Black Dog Reserve Rice Crunchies e-liquids were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,700 products listed with FDA, to ensure compliance with the FD&C Act and FDA regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to address these violations may result in regulatory actions including civil money