The PMTA deadline has arrived and, so far, we're still here!
We filed our PMTA with the FDA on September 8th. We worked up until the last possible minute and we weren't taking any chances on our application getting lost in the mail so we had our PMTA's hand delivered. Here's our stamped letter showing our PMTA's were received on time by the FDA:
As you can see, we found a way to submit applications for 19 flavors, including Romancing the Strawberry, which squeaked by at the last minute! We wanted to celebrate, but, honestly, we were too exhausted!
So, what happens next?
Delivering a PMTA is really just the beginning. Each application will go through several phases of FDA review before a final decision is made. Here's what to expect:
Phase 1: Administrative Review. The FDA will look over the application doing an initial pass to make sure all required elements are included. For example, we had to submit an Environmental Assessment not only for each flavor but for every separate bottle size and nicotine level, reviewing the environmental impact of continuing to offer each product for sale. If an application is submitted that doesn't have this or any other required element, the applicant will receive a "refuse to accept" letter from the FDA and it's game over. If all the required elements are there, we should get an acceptance letter which means the FDA has accepted the application and it will move on to the next phase.
Timeline: The FDA received a lot of PMTA's in the last few weeks so we don't know exactly how long it will be until we hear from them. It could be any day or it could take them a month or even longer to get to our applications.
Phase 2: Filing. The next phase is a slightly more detailed review of our application. The FDA will examine the application more closely, looking to see that, not only are all the elements there, but that they are substantive and cover the important areas such as a full description of the product, health risk data, harmful and potentially harmful constituent testing (HPHC's), a description of manufacturing controls and standard operating procedures, and much more. If the application passes muster, we'll get a letter from the FDA letting us know they have accepted the application for filing. If not, it's a "refuse to file" letter and again, it would be game over.
Timeline: The timeline for a filing acceptance is difficult to gauge but we expect it could take up to a couple months after acceptance for filing given how many PMTA's the FDA is likely to be working through.
Phase 3: Substantive Review. The final phase of the PMTA review is the full on, fine tooth comb, read all the footnotes and cross reference the data review. The FDA will evaluate the scientific data presented and will likely initiate a dialogue with us, asking us to provide additional information or fix any elements that are lacking. This process is expected to take a full year. If the FDA finds our products, marketing and manufacturing to be "appropriate for the protection of the public health," they will issue us a marketing order. A marketing order means that we may continue to market and sell our products in the United States as long as we continue to abide by all FDA requirements.
Timeline: A year or more.
Phase 4: Post Market Surveillance Program. A marketing order is the goal of the entire PMTA process, but it doesn't mean we'll never hear from the FDA again. Marketing orders come with a plan in place for the FDA to continue to monitor a company to ensure that we stay on track. The FDA may want to review our marketing materials or get updates on how we prevent sale of our products to minors. They may ask for follow up studies or other reports on various aspects of our operation. We'll have to keep FDA up to date on an ongoing basis so that they can be assured we continue to operate in a manner that remains consistent with protecting the public health.
So, to recap (and to remind you what to include in your prayers!), we are hoping to receive an acceptance letter from the FDA in the next few weeks or so. After that, we'll look for a letter accepting the applications for filing. We'll then have about a year of back and forth while the application goes through a thorough review process. If all goes well, we would then receive the coveted marketing order from the FDA. The FDA will keep an eye on us after that with a post market surveillance program--but we'll make sure we keep our ducks in a row so we don't blow it after all of that hard work!
We know our customers are anxious to know how likely it is that we'll make it through the rest of this process. PMTA's are extremely complex, detailed and, frankly, ginormous! We turned in thousands and thousands of pages to the FDA and they covered a lot of ground. Having never been through a process like this before, it's difficult to say exactly what our chances of success are.
As part of our PMTA preparation process, we read PMTA's that had previously been accepted by the FDA--namely those submitted by Big Tobacco such as the PMTA for the IQOS heated tobacco product submitted by Philip Morris. There's no way we can produce a PMTA that can compete with one produced by a company worth 126.5 billion dollars, but, given our capabilities we feel cautiously optimistic.
We had a lawyer who reviewed many other PMTA's take a look at our application before submission. We were told our application was "more thorough," "more robust," and "one of the more comprehensive ones" they had seen. In particular, they were impressed with our manufacturing and operations section as well as our marketing and sales data supporting that our product is appropriate for the protection of the public health. We'll admit, there were some tears of joy and relief when we read that e-mail!
We will keep you updated as our PMTA's work their way through this ongoing process.
We offer our wonderful customers our deepest thanks! Thank you for your prayers, your letters of support and your patience during this time. We had slower than normal customer service response times and some shipping delays, especially in the final hectic weeks, and we deeply appreciate your understanding. We wouldn't still be here without you and we will continue to work our butts off to do everything we can to make sure we will be here to serve you into the future!