FDA WARNING_LETTER - Dieselbycg-Hometown Vape Lounge - March 12, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Chris Grezeszak of Diesel by CG after reviewing their website, https://www.dieselbycg.com. The review determined that e-liquid products, specifically "Diesel by CG Caribbean Snow" and "Diesel by CG Strazzle Freeze," are manufactured and offered for sale or distribution in the United States.

These e-liquid products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction. The FDA found that these 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 new tobacco 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, as the required notice or information under section 905(j) was not provided.

The letter emphasizes the firm's responsibility, as a registered manufacturer with over 1,300 listed products, to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions, including