The Vapocalyse is upon us.
Over the past couple of weeks, the FDA has issued marketing denial orders (MDO's) to nearly every company that submitted a PMTA to keep their products on the market by the September 9th deadline last year. The few companies that have escaped will almost surely receive their death warrants in the next week or two.
The MDO's 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 as the FDA rubber stamps rejection letters to every vape company in the United States with nearly identical form letters.
The MDO's 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.
Kai's Virgin Vapor has received an MDO, however, the FDA has not actually given us a list of which of our products the MDO applies to. We will continue to sell all products until the actual product list is delivered. Based on what we have seen, we expect the MDO will force all of our products off the market with the exception of Best Damn Tobacco and Menthol Moon Drops.
Like most vape companies, we cannot remain financially viable with only two products and we will almost certainly be forced to close our business after 11 years. Moreover, given the outrageous actions on the part of the FDA, we do not believe it is worth continuing to fight.
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 year, they actively encouraged us to continue to invest in our PMTA's in anticipation of receiving deficiency letters and an opportunity to cure any gaps in our original submissions. Kai's Virgin Vapor, like many vape companies, has invested hundreds of thousands of dollars in good faith on the basis of FDA's public representations.
In the end, none of it mattered. We submitted 50,000 pages of documentation, studies, test results, and much more to the FDA. The FDA never even looked at it. 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's recent actions have shown us that the PMTA process was a sham. The FDA never intended to give a fair review to any of us. They are destroying hundreds of small businesses and handing the market to Big Tobacco.
It is with heavy hearts that we let our customers know this terrible news.
Put in your orders as quickly as possible for any flavors you want to stock up on. These products could disappear any day so don't delay as they will never be available again.
Orders may take significantly longer than normal to ship due to order backlog. We may be forced to cancel some orders if we run out of stock so place any final orders as quickly as possible to ensure you get the flavors you want.
All sales are final.
Use the following discount codes, discount applies to all e-liquid flavors:
GOODBYE20 for 20% off all orders up to $250.
GOODBYE25 for 25% off all orders from $250 to $499.
GOODBYE30 for 30% off all orders above $500.
We will continue to blog and keep our customers informed as this situation develops.