FDA WARNING_LETTER - Great Vapes - August 31, 2023

The FDA issued a Warning Letter to Great Vapes on August 31, 2023, following a review of inspection records. The letter states that Great Vapes manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. Specifically, the product "Great Vapes E-juice Cinnamon Crunch 6 Nicotine 60ml" was found to be a new tobacco product, as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or 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 cited as a prohibited act under section 301(p).

Great Vapes is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuation of violative sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.