Update Regarding Theoreon PMTA Application
As you may know, the FDA required all manufacturers of Electronic Nicotine Delivery Systems to submit a Pre-Market Tobacco Application by September 9, 2020 in order to remain on the market.
We are happy to report that Theoreon has submitted its PMTA in advance of the September 9th deadline and our submission is currently pending FDA review. We take our regulatory obligations seriously and the safety of our consumers is of utmost importance. As part of this process, we have undertaken rigorous scientific testing of all of our products at accredited laboratories. We wanted to thank our team of scientists and regulatory advisers, who have worked tirelessly over the past year to make this submission possible.
The FDA submission is simply a first critical step in an on-going regulatory process. We look forward to working with the FDA to obtain a formal marketing order for our products. We will keep you apprised of developments throughout this process.