Great Vapes – FDA Warning Letter, Oct 20, 2023

The FDA issued a Warning Letter to Great Vapes II LLC d/b/a Great Vapes on October 19, 2023, following a review of inspection records. The letter states that Great Vapes II LLC manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid product "Berry Crunch" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. 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 Great Vapes II LLC to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.