As covered in this blog, the FDA has begun issuing Marketing Denial Orders (MDO's) to vape manufacturers. The receipt of an MDO signals the end of the road for companies attempting to navigate the FDA's PMTA process and mandates the immediate removal of all vape products from the market.
Over the Labor Day weekend, the vape industry reeled from the news that the FDA intends to issue MDO's to all companies that did not include "sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth." Such evidence "would likely be in the form of a randomized controlled trial or longitudinal cohort study," FDA noted.
Randomized controlled trials and longitudinal cohort studies cost millions of dollars and take a year or more to complete putting them firmly out of reach of any small or even medium sized vape company. Moreover, the vast majority of PMTA applications submitted to the FDA last September did not contain such studies leaving most if not all vape companies vulnerable to imminent FDA action.
On Tuesday the 7th of September, Kai's Virgin Vapor attended a teleconference update to the industry from one of the top vape lawyers in the country. The mood was somber and attendees were told that every single company on the call should expect to receive an MDO within the next few weeks. Only tobacco and menthol flavors were likely to be safe.
The move by the FDA is a sudden and swift departure from all public statements the FDA has been making to the industry over the past year.
We have been told to expect and prepare for a thorough scientific review that would weigh the totality of all available evidence, rather than just a cursory glance to see if one particular checkbox had been ticked. We were told that we would receive deficiency letters, giving us a chance to cure any gaps in our original PMTA applications. Many companies, including Kai's Virgin Vapor, have spent hundreds of thousands of dollars to prepare on the presumption that the FDA would act in good faith and give us our day in front of their scientific review board.
Now it appears that the FDA is preparing to unleash a tsunami of MDO's that threatens to wipe out the entire vape industry in one fell swoop.
If the FDA follows through, the shockwaves will be devastating. Few if any companies will be able to survive on only one or two flavors (tobacco or menthol). Vape shops across the country will shutter as vape stores, likewise, will not be able to keep their doors open when available vape flavors dwindle to nothing.
And what will be left? All of Big Tobacco's mass market disposable vape products which are available at every corner store across America. With the competition wiped out, the choice between vaping and smoking will soon be putting money into the same pockets--that of the very industry the vape market sought to revolutionize.
All roads, it seem in the end, will lead to Big Tobacco.