FDA WARNING_LETTER - Dieselbycg-Hometown Vape Lounge - November 09, 2023

On November 9, 2023, the FDA issued a Warning Letter to DieselbyCG--Hometown Vape Lounge following a review of inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically "DIESEL by CG Cake Batter 3MG 60ML," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The product "DIESEL by CG Cake Batter 3MG 60ML" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order, a substantial equivalence order, or an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p).

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/