From reading this blog, you probably know that the FDA is requiring vape companies to submit a Premarket Tobacco Product Application (PMTA) by September 9th of this year or go out of business. The applications are crushingly expensive, extremely complicated and time consuming making it extraordinarily difficult for anyone but a very large corporation to successfully comply.
Many of you have written us asking, where does that leave Kai's Virgin Vapor? We've held off on answering that question, wanting to make sure we had a definitive answer.
Today, we can finally give you a reply:
WE ARE GOING FOR IT!!!
That's right, Kai's Virgin Vapor has officially thrown its hat into the PMTA ring!
Will we be successful? There's no way to know. But we are putting every cent we have and working 18 hour days and through the weekends between now and when the application is due on September 9th to give it our all.
We have already been working on this project for many months but we are finally far enough along that we feel confident we will be able deliver a fully completed, good faith PMTA to the FDA by the deadline. Whether the FDA accepts it or not, we can but hope and pray!
The task we face is daunting. The PMTA requires that we hire experts to review every scientific paper ever published on the subject of vaping. It requests a massive document dump showing all of our standard operating procedures, quality control policies, marketing plans and company organization. It asks that we present detailed arguments as to why our products are "appropriate for the protection of the public health" -- and, no, it's not enough to just say "because they are not cigarettes!" We must draw on every published study pertaining to vaping that has every been done in order to present our argument to the FDA on why we should be allowed to live.
Most of all, the PMTA demands extensive and crushingly expensive laboratory testing. For example, as many of you know, we already test our products regularly with an independent lab for potential ingredients of concern. However, the FDA requires that we replicate those tests dozens of times. For a single flavor, the FDA asks that we treat each nicotine level as if it were a completely separate product. Each nicotine level must be tested 21 times, repeating the same lab test on three separate batches with the lab replicating each of those tests seven separate times--presumably to prove the first twenty tests weren't a fluke? Every one of those replications comes with a hefty price tag. Then the FDA wants us to test again at multiple points in time over a period of a year as the product ages. In all, our Operations Director worked out that for a single vape juice flavor, we would have to perform over 800 separate tests and retests--all looking for the same compounds!
The bad news is, there is no way we can afford to keep all of our wonderful flavors. Many of your favorites will, sadly, no longer be available come September. We faced a moment of personal heartbreak as we realized that many of the flavors we have offered for 10 years will soon be resigned to the dustbin of history.
Our company will hardly be alone in losing many well loved flavors. Many vapers don't quite realize just how devastating the impact of the PMTA will be. Almost certainly, at least 95% of the vape juices currently on the market will no longer be available following the application deadline.
The good news is, we are putting everything we have into trying to get 10 of our best selling flavors through the PMTA process so that you can continue to enjoy them for years to come. The decision process was difficult, as it often felt like choosing between our children. We have narrowed the list down to 20 candidates. All 20 are currently out for their first round of testing with our lab. After this Phase 1 testing is complete, we will pair the list down to the final 10 flavors that we will take through to a fully completed PMTA.
We know customers are anxious to know, so here is the list of the 20 candidates. Please keep in mind that this list will be cut in half once our first round of lab testing is complete. And please understand that we share your sorrow if your favorite flavor is not on this list! We wish we could save all of our wonderful flavors but, sadly, this is far beyond our means and we simply cannot afford it!
The 20 candidates are:
We will post the final list in a couple of weeks but expect to see half of these flavors drop out as we narrow it down to the final 10. If your favorite flavor is not on the list, we are sad to say that it will no longer be available starting on September 9th of this year.
We know this news is bitter sweet and it is with heavy hearts that we let you know the reality that we all face. However, we are hopeful that we will be successful in our PMTA bid.
The FDA is primarily concerned with two things. First, the FDA is looking to eliminate companies that are selling or marketing their products to minors. This is an area where Kai's Virgin Vapor shines. For years we have made decisions that limited the appeal of our products to people who are underage, opting for simple product design with adult appealing names. How many kids do you know who like flavors named after a Greek myth (Hunger of Persephone) or enjoy vaping something named in Latin (Temus Fugit)? While many companies have candy colored product lines that are designed to mimic the taste of kid's cereal, our flavors appeal to more sophisticated palates. Our website focuses on intelligent, well thought out content and in depth news reporting.
These efforts to eliminate appeal to underage individuals have been successful. The average age of Kai's Virgin Vapor customers is 45 and 90% of our customers are 30 years old or older! We definitely aren't going after the younger crowd. Our company appeals to and caters to mature adult vapers and that fact should be a huge help in the PMTA process.
Second, the FDA wants to see lab testing and other information showing that our products are "appropriate for the protection of the public health." Again, Kai's Virgin Vapor has placed a huge emphasis on lab testing over the years, spending hundreds of thousands of dollars on lab analysis, hiring a Ph.D. chemist to help us establish testing protocols, and on purchasing our own in-house GCMS machine. While the FDA testing list expands on the compounds we have already tested for, we are already way ahead of the game as we took steps years ago to reduce or eliminate certain compounds and ingredients in our vape juices that we felt could be of concern. In addition, we won't have to argue with the FDA about why we should be allowed to include artificial colors or artificial sweeteners in our formulas because we don't use them. We already have USP grade certifications for our ingredients and our USDA organic certification will likely help as well.
Third, the FDA requires that we have a robust quality control system in place with proper documentation and systems to ensure that we produce a consistent product every time and that we have standard operating procedures in place to investigate any deviations from expected performance results.
Again, this is an area where Kai's Virgin Vapor is already way ahead of the game. While lots of other companies have spent their money on catchy advertising or slick websites, we've invested in our product itself, purchasing and upgrading sophisticated lab equipment and software that eliminates the possibility of human error when we make our product. Our batches are exact, down to the gram, and we have proved that again and again by sending samples to an independent lab on a regular basis for testing. Likewise, for years we have had complete ingredient traceability, required by our USDA organic certification, which tracks every lot of every e-juice ingredient and ties it to each particular batch so we know exactly where every component in every bottle originated from.
In order to make sure we have crossed every "t" and dotted every "i," we have also applied for ISO 9001 certification, a process whereby an external agency will audit our systems to ensure we have fully established procedures in every area, properly follow those procedures, and document every step along the way.
There's no way to know if our PMTA will be successful. The guidance the FDA has offered is very far from clear and it is undoubtedly a major gamble. However, we strongly feel that, if any smaller companies will be allowed to survive, we should be one of them! We've worked hard to do the right and responsible thing since day one, working to make the cleanest, highest quality product possible while preventing sales to minors, and isn't that, after all, what the FDA is really looking to see?
Despite the fact that we have always run our business in a way that is in line with upcoming regulations, the PMTA process is daunting. We ask for our customer's prayers as it is going to take everything we have to succeed! We encourage you to stock up on the flavors that you love that we won't be able to continue to carry, both so you can enjoy them once they are forced into retirement, and to help us raise money to cover the hundreds of thousands of dollars in lab testing we are struggling to afford.
We also ask for your patience and understanding as we will be making many changes, both seen and behind the scenes, as we take the necessary steps to be fully compliant with the upcoming regulatory environment. These will include changes to our labels, alterations to our website, changing of product photos and many other things. Please bear with us! The PMTA may require us to operate like a big company but we will never lose our small business ethics. We will always treat our customers like family and be only a phone call away if you need help!
We thank you for 10 amazing years and we sincerely hope we will continue to be around to keep the love going! We are facing a new world but we are determined to do so with our PMTA in hand and a smile on our faces!
Lots of love to our Vape Family! We are fighting hard to stay alive, fighting for our own jobs, fighting for the future of our business, and fighting for you so that you can continue to enjoy the flavors that you love! We couldn't do it without you! Thank you!
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