Mad Buck Vapes Inc d/b/a Detroit Rock Candy – FDA Warning Letter, Sep 13, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Jennifer Lubinski of Heydenreich Road, Clinton Township, MI, on August 11, 2022. The letter states that a review of the website https://www.detroitrockcandy.com revealed the manufacture and sale of e-liquid products, specifically Mad Buck Vapes Apple Scrape and Mad Buck Vapes Sylvia’s Secret, to U.S. customers.

These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source and being intended for human consumption. The FDA asserts that these e-liquid products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these products are being marketed without the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor are they exempt. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA has not received an application for marketing authorization for these products. The letter warns that failure to address these violations may lead to regulatory