The Vapor Technology Association (VTA) and Vapor Stockroom sued the FDA last week for what they described as an unreasonable and arbitrary Pre-Market Tobacco Application (PMTA) process. For a deep dive into this lawsuit, make sure you check out our feature: Vape Company Sues FDA.
The fallout from this lawsuit has already begun. This week, Juul announced they will be pulling out of the VTA in response to the court filing. The reasons for this withdrawal were outlined in a Juul press release:
We are not appealing the recent federal court case in the District of Maryland and similarly do not support the recent lawsuit against FDA filed by the Vapor Technology Association in the Eastern District of Kentucky.
While we have appreciated the opportunity to collaborate with the VTA, we will not renew our membership when it expires later this month as we are not aligned on too many critical policy issues. For example, we support clean Tobacco 21 legislation and an outright ban on certain flavors.
Those certain flavors would be the flavors preferred by adult vapers, but falsely painted as "kid-friendly" and the root cause of the teen vaping epidemic. These are flavors that Juul does not offer, but are available for the users of refillable vape pod kits. Juul Mint, the most popular flavor with minors, is a menthol derivative and would not be impacted by a flavor ban.
In a survey of adult vapers, Dr. Farsalino found that adult vapers prefer sweet and fruity dessert style vape juices to tobacco and menthol. Interestingly, Juul studied the use patterns of their customers and also found that flavored e-juices play a major role in smokers switching to vaping. But this does not appear to be the company line anymore.
The PMTA process has been dangling over the head of the vape industry like the Sword of Damocles for several years. And the date when the sword is scheduled to fall has been moved repeatedly. It now stands at May 2020.
Before a new tobacco product can be legally marketed, it must receive FDA approval in the form of a PMTA. To receive approval, the FDA must evaluate that product based on a “public health” standard that considers the risks and benefits of the product to the population as whole, including both users and non-users.
This is obviously a fairly serious ask of any recreational product. If similar metrics were applied on the food side of the FDA, would the obesity epidemic be taken into consideration? Would store shelves be wiped clean of processed foods? For example, most "kid friendly" granola bars are bombarding a developing child with almost half of their daily recommended intake of sugar. And what about produce and meats that take a toll on the environment? It is a slippery slope.
To make matters even more difficult for the vape industry, the FDA failed to provide basic guidelines to help vape companies successfully navigate the process until this June. This moving of goalposts prompted the lawsuit.
Juul Pulls out of VTA
The vaping industry is hardly demonstrating a unified front. Angry politicians still are pushing flavor bans, despite the fact that retro ejuice flavors mimicking 1980s breakfast cereals target nostalgic adult vapers. The whole concept of "kid-appealing" and "kid friendly" is utter bollocks when adults prefer those flavors and kids are gravitating to menthol derived mint.
On the subject of mint, Juul Mint would not be covered by the flavor ban. In other words, the flavor that most minors are vaping is not impacted and the refillable vape pod market is damaged most of their flavor options are banned.
Refillable, vape pod systems are far better price performers than their prefilled pods, and have literally thousands of flavors to choose from. Check out our Top Ten Juul Alternatives for more information. Even more vape pods have hit the market since that comparison was written. Long story short, it is worth reiterating that a flavor ban would wipe out the competition and leave Juul's core business intact.
Juul is in reasonable shape to tackle the PMTA process, which requires multiple filings for each flavor, device and nic strength. They have a rather limited lineup of flavors and a single device. It makes sense that they do not want to be party to a lawsuit which would protect small vape companies, and could block the FDA from reshaping the regulatory landscape in their favor.
It makes sense that Juul would protect their own interests but capitulating to the demands of lawmakers and regulators dead-set on a total vape ban is a dangerous game. Flavor bans are just an opening salvo. Fairly or unfairly, Juul remains public enemy number one when it comes to vaping.
The truth and technology behind Juul is actually a much more nuanced subject than the public writ large has been led to believe. They have been successfully tarred by a Stanford University’s study of e-cig marketing, which is little more than curated slideshow chock full of anti-vaping bromides. There is no reason to think anti-vaping zealots are open for negotiation. They will gladly accept a flavor ban and thousands of vape shops being put out of business. But their eyes are on the ultimate prize.
Nonsense about "kid-friendly" dessert and fruit vape juice flavors will only throw anti-vapers off the scent for so long, and possibly embolden them to make even more punitive demands of the industry. At the end of the day, they are looking to claim the biggest trophy of all. And that is not a faceless Chinese mod manufacturer, or a business with a couple dozen employees marketing cheesecake ejuice.
It seems incredibly hubristic for Juul to try to harness the anti-vaping furies, and not expect to have the tables turned on them sooner rather than later.
Although it has been easy to divert the attention of lawmakers and public health groups to the fanciful dessert flavors preferred by box mod users, banning this style of vape juice will have next to no impact on the teen vaping rate. If the teen rate does not drop, will the FDA call it a day? Or will they move to ban closed vape pod devices and limit nicotine levels?
The whole obsession with flavors sounds a bit like regulatory capture, and all the pieces are in place. The dominant vape companies have a high-stakes interest in protecting their products from an FDA crackdown. The FDA is being compelled to act by outside pressure. A generally disinterested but agitated public has bought into the idea that dessert vape juices, and not a new generation of discrete devices and potent nic salts formulas are to blame for an uptick in teen vaping.
Consider how few editorials on the subject of teen vaping will even mention nicotine salts or even nicotine! That is how ignorant of the subject matter most pundits are.
For more information on high-nic ejuices, check out our deep-dive What is Salt Nic?
The FDA in theory is acting in the public’s interest by cracking down on vaping, but the scenario that is currently shaping up will leave the makers of the devices most popular with minors in a stronger position than before. That the initial beneficiaries happen to be the largest manufacturers might seem suspect to an outside observer. Small vape companies and ejuice manufacturers will be decimated by flavor bans and a PMTA process that punishes a company for carrying a wide range of flavors.
Marlboro maker Altria bought 35 percent of Juul this winter, and the other tobacco giants in the vape business all sell a much more limited variety of flavors and devices. These giants also have the financial and legal wherewithal to negotiate the PMTA process.
Not supporting the VTA or the lawsuit against the FDA makes business sense for Juul, but the appearance of full regulatory capture is in an illusion. Unless teen vaping starts to decrease, which a ban of devices and flavors favored by adults is unlikely to accomplish, closed vape pods and high nicotine levels are next.
Without high nic levels, the appeal of the closed vape pod is greatly reduced. The lack of power, lofty price per milliliter of juice, and technological limitations in the form of a minimal juice capacity and battery life are real detriments when the nicotine level is ratcheted down.
Enter the iQOS
It is easy to envision a neutered vaping industry that can only offer tobacco flavored and low nicotine options. Entering from stage left is heat not burn technology. The iQOS has received FDA approval. Not surprisingly, Altria also supports a flavor ban. If the only vapes available are low-nic tobacco vapes, the heat not burn technology becomes a viable alternative for heavy smokers. Vapers used to the strength and variety of ejuices currently available may also choose to make the jump. Game, set, match.