FDA WARNING_LETTER - Cali Steam, LLC - November 15, 2022

On November 10, 2022, the FDA issued a Warning Letter to Michael DiNapoli regarding e-liquid products sold on calisteam.com. The FDA determined these products, including Blu Razz, Carnival, and Toucan, are tobacco products under the FD&C Act and require premarket authorization.

The e-liquids are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007, and lack the required FDA marketing authorization order. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although a Premarket Tobacco Product Application (PMTA) (STN PM0001175) was submitted on September 7, 2020, it received a Refuse to File determination on August 9, 2021, covering 33 products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may lead to further regulatory action.