FDA WARNING_LETTER - Breeze Smoke, LLC - May 25, 2023

On May 25, 2023, the FDA issued a Warning Letter to Mark Faraj and Steven Haddad of Breeze Smoke, LLC, following a review of their website, https://www.breezesmoke.com. The FDA determined that the company is receiving and offering for sale or distribution in the United States electronic nicotine delivery system (ENDS) products that are considered "new tobacco products" and lack the required premarket authorization.

Specifically, the products identified as violative are "Breeze Pro Disposable Vape – Candy Cane" and "Breeze Pro Disposable Vape - Candy Hearts." These products are deemed new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007, and do not have an FDA marketing authorization order or exemption. Consequently, these products are adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) for not providing required information under section 905(j).

The FDA mandates that Breeze Smoke, LLC promptly address these violations and bring all tobacco products into compliance with the FD&C Act and its implementing regulations. Failure to do so may result in regulatory or legal actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the