Next Steps on the Sept. 9 Premarket Submissions

Now that the PMTA deadline has passed in the United States what happens now?

The Sept. 9 premarket submission deadline for certain deemed new tobacco products marked a major milestone for ensuring new tobacco products, including many already on the market, undergo a robust scientific evaluation by FDA.

Now that the deadline has passed, and the submissions are with FDA, many may be wondering about the upcoming steps for both submitters and the Agency. As Mitch Zeller, CTP Director, stated in a recent perspective piece, FDA strives to be as transparent as possible with regards to the status of these submissions and plans to provide regular updates to the public over the course of the next year. Accordingly, FDA wants to be sure that the public and, specifically industry—most of whom are experiencing FDA’s premarket review process for the first time—have a general understanding of FDA’s review process and reasons FDA might contact a submitter. For those that made premarket submissions, it is important to respond promptly to correspondence from FDA as failure to do so may have an impact on the status of the products contained in the submission.

We at Cali Steam have submitted our products for review. Once we are notified of any updates from the FDA we will notify YOU, our loyal customers. We thank you for the years of support and enjoyment of our high quality vape products.