
Our Mandatory Response to the FDA Warning Letter
December 5, 2022 Dear Ann Simoneau, J.D.: Please see Cali Steam LLC’s response to the warning letter received on November 10, 2022. The referenced warning letter stated the following: “FDA received your Premarket Tobacco Product Application (PMTA) assigned STN PM0001175 on September 7, 2020. However, FDA issued a negative action for PMTA STN PM0001175 in the form of a Refuse to File determination on August 9, 2021, which covers 33 products.” We have no receipt of this determination. We weren’t aware that we didn’t meet the threshold determination of whether the application contains sufficient information to permit a substantive...