After over eight months of anxiously waiting to hear back after submitting our PMTA applications, we finally received a letter from the FDA letting us know that our applications have been officially accepted and that we will be moving on to the review phase!
The PMTA review and approval process is broken up into three stages:
Receiving our acceptance letter from the FDA indicates that we have successfully made it through stage one, administrative review. Each stage gets progressively more challenging and detailed and we have been working with toxicologists, labs and consultants to prepare for the next phase.
Stage Two will involve a significantly more detailed review of our application, looking to see that, not only did we cover all of the required areas, we addressed them sufficiently and in enough detail to enable the FDA to fully evaluate our products against the Appropriate for the Protection of the Public Health standard.
If we successfully navigate this review, we will receive a filing letter and will move on to the substantive review phase. During this phase, our application will be broken up into sections and reviewed by toxicologists, scientists and other experts who will review it in detail.
It is likely that the FDA will ask us questions, request additional documents or test results, or ask us to perform additional analysis or evaluations of our products and the documentation we have submitted so far.
If we successfully navigate the substantive review phase, we would then receive a marketing order, which is the end goal of the PMTA application process.
Maybe it's because we're nerdy perfectionists, but we really are actually enjoying a lot about the PMTA process. The PMTA has given us a framework to take a deep dive into the products we manufacture, reassessing everything we do from a regulatory and, with the release of FDA's full harmful and potentially harmful constituent list for e-liquid, a detailed toxicology perspective and we are learning so much! The more we learn the better we become as a company so it is actually a very exciting and rewarding process!
A big thank you to all of our wonderful customers for your support during this time! We have received so many lovely notes from you and we read every single one of them. They mean so much to us, especially during this time when we are working our butts off to continue to rise to the regulatory challenges our industry is facing. Often it is reading your sweet notes that keeps us going when the days are long and the days off are few and far between. Thank you so much!