March 17, 2022 4 min read
Like most times in our industry, we face eradication. And through that consistent attempt aimed at getting rid of us and our products, we adapt. We play by the rules and we prove time and again that we're not out to make a quick buck, but rather, to legitimately improve the lives of our users.
President Biden signed the 2022 Omnibus Package which included a clause to pull Tobacco-Free Nicotine products under the jurisdiction of the FDA. Under the new jurisdiction, all Tobacco-Free Nicotine products must undergo another round of Premarket Tobacco Applications due 60 days from the signing of the bill - so May 14, 2022. BLVK is proud to announce that we are taking the necessary steps not only to resubmit our entire product collection, now using Tobacco-Free Nicotine, but to improve our submission given all the data and lessons we've learned since our initial submission.
THE NITTY, GRITTY DETAILS
We are aware of the incredibly short timelines presented to us. To give you an idea of the timelines we are referring to, brands are required to take all Tobacco-Free Nicotine products to market within thirty (30) days, and to submit a PMTA in sixty (60) days. Upon submission, the FDA has 90 days to review the thousands of incoming PMTAs and make a decision.
These three deadlines alone are daunting. To that extent, your typical e-liquid brand generally has at least ten product collections that may have existed pre-TFN transition, that now need to not only switch the nicotine present in the formulations, but also significantly change the product name and recipe to be considered a "new tobacco product" in the eyes of the FDA. On top of that, the brand would then have to launch those products into the market.
Then, going into the PMTA process, mind you, submitting a complete PMTA for any company of any size requires MONTHS of physically doing the work. Yet here we are giving ourselves two months to get it done, and to get it done well. We are fortunate to be a Gold Member of the American Vapor Manufacturers who are helping us to round up the requirements to submit this on-time.
Here's where the waters get a little more murky. Back in 2021, the FDA blanket-denied nearly all vapor companies that submitted a PMTA. Whether a company spent tens of thousands, hundreds of thousands, or even millions to create the application, almost all of them were wiped from the market without a single thought behind why. Seeing that the PMTAs are due mid-May, and are only given 90 days to review and make a decision, it's fair to say that most companies do not hold faith in the FDA to make a decision that would protect the interests of public health.
HOW THIS PMTA IS DIFFERENT
Technically speaking, this 2022 submission of the PMTA would be our second official submission, and a third pass at doing the act. Our original submission contained 104 different products - every single one of our flavors across all sizes and nicotine strengths at the time. This 2022 submission now contains 136 different products across all sizes and nicotine strains. All of which, contain Tobacco-Free Nicotine, adjusted recipes, and entirely new names.
Upon submission of the original PMTA, we inherently knew that given the sheer amount of data we included in the application, that the FDA would hopefully appreciate that and pass us through to the later stages of review. We also know that we were lacking in certain aspects, hence why we sought out additional assistance from other regulatory compliance agencies such as Interscientific and Arcus Compliance, both based in the UK. We did this for a few reasons: 1) we know that our application was lacking in literature reviews, so we asked Interscientific for more resources on where to find and explain those reviews in a way that the FDA can understand. And 2) we know that our application lacked more in-depth GMP Standard Operating Procedures, so we asked the AVM to supply us with an app that will take our unique situation and generate the documents for us.
By taking these two, fundamental weaknesses, and asking for help, or at the very least, knowledge on how to strengthen the PMTA sections, not only are we providing a more complete application, but we are setting ourselves up for further scalability. The ability to scale the operation to now only service the United States, but rather, to service the entirety of the world for our clients is just as important as providing a truly premium vaping experience for the individual smokers we cater to.
RESUBMITTING THE PMTA GUARANTEES OUR FUTURE
Let's be real, we understand that submitting the PMTA has a ripple effect. We are a company that's been in the industry since it started and we don't plan on leaving it or circumventing regulations to continue existing under the radar. That's not what we're about.
On top of that, as we mentioned at the very beginning of this article, this is not the first time our industry has faced eradication - and this will certainly not be the last. BLVK consistently adapts to new situations that arise that aren't always in our control. Nevertheless, we as a brand will continue to thrive not just for our own sake, but for the thousands of customers both within the United States and outside of it, to deliver a truly premium vaping experience. And all of this starts, by maintaining compliance to the agencies that regulate us.
All-in-all, the FDA decided to throw another PMTA at us and we'll be taking that smashing it home.