Posted by Cloudy Shaman on 17th Jun 2022
FDA Decimating the Vaping Industry
The Vapocalyse is upon us.
Over the past couple of Years, the FDA has issued marketing denial orders (MDO's) to nearly every company that submitted a PMTA, to keep their products on the market. The few companies that have escaped will almost surely receive their death warrants soon. Now that the FDA has the right to regulate synthetic nicotine, they have signaled that they will not approve any product with tobacco-free derived nicotine.
The MDOs amount to a de facto flavor ban. The FDA claims the rejections are because the applications lacked "sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth."
However, this was not a standard that was issued prior to the PMTA submission deadline or ever once uttered since. The FDA is essentially applying a retroactive requirement and is using the fact that no companies fulfilled this tacked-on standard to justify decimating an entire industry.
Moreover, the FDA has spent the past 5 years telling vape companies that we cannot advertise or sell our products as smoking cessation devices. Now all of a sudden, they are turning around and demanding that we prove that they are?
All flavored vape products are being rapidly forced off the market except for tobacco flavors, as the FDA rubber stamps rejection letters to every vape company in the United States with nearly identical form letters.
The MDOs (Market Denial Orders) are not being reserved for small companies or PMTA applications of low quality. Several very large vape companies that spent between 10 and 20 million dollars on their PMTA applications have also received the exact same MDO letters for all their flavored products. We expect the MDO will force most to all products off the market apart from Tobacco flavored e-juice and the few FDA-favored hardware items.
The PMTA process is very costly and many small businesses like us at Vapor E-cigarette, could not afford this process. We have tried everything we can to stay compliant. We will continue to sell ALL our products, but we will have to change a few things to stay open under the new FDA’s draconian overreach of the vape market. Based on what we have seen, only Tobacco flavors are being approved by the FDA with the all-out ban on all other flavors. This includes cities and states passing their own flavor bans. This has forced many into the DIY world. FDA has already, through a lawsuit admitted it could not regulate the DIY Vaping Community, which we at Vapor E-cigarette will have to adapt. We already offered for many years DIY supplies, so we will have to make that our focal point going forward. We are being forced to stop offering an in-house completed tobacco product to our customers.
Like most vape companies, we will almost certainly be forced to adapt. Moreover, given the outrageous actions on the part of the FDA, We at Vapor E-Cigarette LLC believe it is worth continuing to adapt and overcome.
The FDA has shown a blatant disregard for the rights of small business owners. They have not only kept us in regulatory limbo for over a few years, they actively encouraged us to continue to invest in our DIY in anticipation of receiving deficiency letters and an opportunity to keep doing business.
In the end, none of it mattered. We have fought it with documentation, studies, test results, working with national groups, and much more to get the FDA to recognize the importance of vaping. The FDA never even looked at any of it and dismissed most of it except a few small notes buried on their website. We received the same form letter they delivered to every other vape company in the United States.
Meanwhile, the FDA has punted on making a decision as to whether it will continue to allow Juul and other Big Tobacco vape products to remain on the market. The FDA as of this writing has only approved 3 vape products.
The FDA's recent actions have shown us that the PMTA process was a sham. The FDA never intended to give a fair review to any in the vape community. They are destroying hundreds of small businesses and handing the market to Big Tobacco.
It is Vapor E-Cigarette LLC intention to let our customers know the changes we will have to make to keep offering vape products to you, our customers for years to come and to keep FDA out.
However, we have already told you through our blog, ‘Don’t Panic’. If you are not subscribed to our newsletter, please go to our website and enter your email at the bottom of the page. Plus, you can access our blog here. Also follow us on Facebook, Instagram, & YouTube. We will keep you up to date on the changes that are coming. Please be aware that our newsletter and blog are the best ways to stay informed because there are also limitations set on vaping on social media outlets we must tread lightly on those platforms.
We are not going to approach these changes as a negative and you shouldn’t either but as an opportunity to show the powers that be, that we as vapors are resilient. That no government agency is going to stop us. We will do whatever it takes to stay away from smoking and help others discover the wonder of Vaping, Kratom, and Hemp Products.
To prove these changes are not negative, We at Vapor E-cigarette, are doing a giveaway of 3 gift certificates to help get the word out about the changes. Plus, we will be having a ‘BURNED by the FDA’ event and sale to celebrate the changes we will be doing to stay in business to keep you supplied with the vape products, Kratom, and Hemp items. This includes introducing our new DYI Juice kit called ‘Juice Barrel’. We will also be opening our website for ordering with in-store pickup only. You can check out our new re-vaped website now, just can’t order yet because the changes are still happing. We will also be adding QR codes to our products, that way if you, friends, or family wonder about a product you got from us, you can scan the QR code, and it will guide you to the product section on our website.
To qualify for the first of three gift certificates worth $150, (1) you must like the Facebook post, (2) share it on your page, and (3) comment. ‘Liked, Shared, & #BURNEDbytheFDA’. We will do a random pick out of the qualifying posts. The winner will have to show proof of following all 3 before the gift certificate will be awarded. They will be awarded on the day of the event & sale. The Gift Certificates will be good for any item in-store and in stock, with no special orders. The Gift Certificates will be good for 90 days. Each of the 3 posts will run for 1 week. Any like, share, or comment after 1 week will not qualify for the random pick for the gift certificates.
Get ready for the ‘BURNED by the FDA’ event and sale. Stay tuned for more information on the event & sale in the coming weeks.
If you would like more information about the changes, make sure to sign up for our newsletter and keep checking our blog for updates on the event & sale and the other 2 gift certificates. Thanks for sharing and liking our posts!