FDA Commissioner Gottlieb has been changing his tone on vaping in the past year citing the need to "narrow the off ramp" of smoking for adults. But what does he mean?

What actions could the FDA take against vaping (and JUUL)?



Could FDA Disintegrate Vaping?

In the closing days of October 2018, FDA Commissioner Scott Gottlieb issued a statement announcing that the powerful federal agency would announce a new action plan, supplanting the action plan issued in the summer of 2017.

Last month, I issued a call to action – to the FDA and to the e-cigarette industry – to stem the alarming increase in youth use of e-cigarettes. For the FDA, that has included an escalating series of steps that utilize the full range of our regulatory authorities, including increased enforcement of age- and identification-verification requirements, as well as re-examining aspects of our comprehensive plan on tobacco and nicotine regulation in order to strengthen our Youth Tobacco Prevention Plan. We’re committed to announcing a new action plan by mid-November that will set forth a series of new, forceful steps to firmly confront and reverse the youth addiction trends that are at epidemic levels. [emphasis added]

FDA Commissioner Gottlieb

While we won't be covering how the focus shifted from regulating cigarettes on to e-cigarettes in this article, we will discuss what we think is going to happen moving forward.

The rhetoric coming from all corners, except from actual vapers and harm reduction advocates, has been focused almost exclusively on how flavors are the main attractant to leading "children", "kids", "teens", and "youth" starting to vape and then begin an illustrious career as a professional cigarette smoker.

Altria has recently taken the initiative on their own to stop selling flavor pods that aren't tobacco or mint. This move will effect 20% of their sales but they wouldn't have taken this step if they didn't think a flavor ban was not already happening. Perhaps Altria believed this independant move to halt sales of certain flavors will increase pressure on JUUL. 

JUUL replaced Altria's MarkTen system as the pod market's top seller in 2017 and is currently crushing the rest of the market competition, which is comprised of other Big Tobacco firms such as Reynolds American, Imperial Tobacco and Japan Tobacco.

For the e-cigarette industry, my message was simple: Step up. Even as the FDA builds a framework to mandate additional restrictions and actions to address these trends, we welcome voluntary steps by companies to address these concerns. I asked five manufacturers whose products, collectively, represent more than 97 percent of the current market for closed-system e-cigarettes to meet with me personally to discuss this vital public health challenge, as well as to submit written plans outlining the steps they intend to take to confront the rising trends in youth use. Each of these companies market products that recently had been sold illegally to minors, either through brick-and-mortar stores or online retailers. Everyone involved in this market has a shared responsibility to address this public health crisis. [emphasis added]

Gottlieb Statement cont'd

"Your products have been sold to minors by retailers or by the minor's friends. Both of whom you have no control over. What do you plan on doing about that?"

"Submit a list of ideas I can add to my list of actions to take."

The five manufacturers, mentioned above, who control 97% of the cartridge or pod system market are:

  • Atria Group - owns MarkTen among other companies like Philip Morris, a big investor in IQOS and owns the Marlboro brand
  • JUUL Labs 
  • Reynolds American - owns the Vuse brand and cigarette brands such as Newport, Camel (merged British American and R.J. Reynolds tobacco companies)
  • Fontem Ventures -  owns the Blu E-cigs brand and a subsidiary of Imperial Tobacco (big in Europe)
  • Japan Tobacco - owns the Ploom brand and best known for Winston brand cigarettes

What is going to happen? (Some Predictions)


There are a number of things that could happen to vaping in the coming weeks and months, some not entirely predictable. 

We have come up with a list of the most likely actions the FDA will take based on what has been said over the past year by the Commissioner in this most recent statement among others as well as the general political atmosphere surrounding the industry.

The companies acknowledged the serious public health consequences associated with youth use of tobacco products. They presented thoughtful proposals, consisting not only of what steps they would take themselves to restrict youth access to and appeal of these products, but also steps that they think the FDA and other policy-makers can take to reverse the trends in youth use of e-cigarettes. Some stated explicitly that preventing youth use must be a priority, and that any potential benefits of e-cigarettes for adult smokers cannot justify significant increases in youth use and addiction.

The companies acknowledged the role that flavored e-cigarette products play in appealing to kids, as well as the role that flavored e-cigarettes can also play in helping adult smokers quit. On this point, their proposals at the meetings reflected a range of ideas: for instance, that the FDA restrict distribution of certain flavored products to channels with enhanced age verification processes. Or that the agency require certain products that are more appealing to kids to come off the market until these products receive premarket authorization from the agency.

...

To inform our approach, we’re looking at a variety of factors, including how different types of electronic nicotine delivery systems (ENDS) products are used by kids; the popularity of various products, such as cartridge-based e-cigarettes; the popularity of non-tobacco flavors; and the strength of various distribution methods in ensuring robust age verification.

...

Achieving the right balance requires a strong regulatory process that protects our nation’s youth. [emphasis added]

Gottlieb cont'd

We get it: no one cares about adult smokers anymore. The priority is focusing on the already illegal use of vaping products by goofy high schoolers who apparently don't know there is nicotine in vape juice or that nicotine is addictive. 

Note to journalists: Make sure to refer to high schoolers as "children" or "kids" to shift personal responsibility of their actions away from the individual and their parents to the specter of Big Vape! If the discussed demographic is over 18 refer to them as "youth" or "young people".

The FDA along with their market partners, Big Tobacco and to a lesser degree JUUL, are playing along in focusing on a flavor ban and restricting the benefits to adult smokers but to what end? 

Most of the companies at the meeting, besides JUUL, have been losing a significant amount of formerly dependable customers (smokers) to e-cigarettes but not to their e-cigarette products exclusively.  Mega corporations love a monopoly or as close to one as possible.

Several of the big tobacco companies have indicated that cigarettes are on their way out and that their focus is on alternative technology such as e-cigarettes or heat-not-burn.

Each of the big tobacco companies also has some form of heat not burn or IQOS style device either waiting for approval or in the works. 

Big tobacco will continue on regardless but what about everyone else?

Nicotine Restriction


Nicotine levels in cigarettes are already expected to be reduced to levels that FDA Commissioner Gottlieb believes smokers will find "unsatisfactory", meaning smoking a cigarette will no longer satisfy nicotine cravings. 

In Europe, juice sales are restricted to a limited volume (small bottle size) and contain restricted nicotine levels to 20 milligrams per milliliter (mg/ml).

One of the huge problems with JUUL, a mouth to lung vape, comes down the fact that they use nicotine salts in their juice pods. Juice that uses nicotine salts are pretty good taste wise but usually are far stronger than the typical 3mg/ml concentration that direct lung vapers enjoy.

Typical nicotine levels in cartridge style vapes is around 24mg/ml, but the JUUL uses levels as high as 59mg/ml in the popular 5% pod. 

The high levels of nicotine in their pods lead to the company's product being banned in Israel and also lead the company to introduce a lower nicotine content version, 3% or 35mg/ml. Markten's rival pod system has a 1.8% nicotine by volume level and some of their other cartridge offerings go as high as 4%.

However, nicotine levels in cartridges or in vape juice in the wider market has not had much discussion by the FDA in a public capacity, which leads one to believe that action on this front is unlikely.

The only thing anyone wants to talk about is flavors, which means the main action will probably target flavors directly.

The Flavor Ban Scenario


Prediction: Some style of flavor ban.

A flavor ban would be quite destructive to the vaping industry as it is a prime motivator to keep people from smoking cigarettes in addition to the reduced risk profile vaping provides.

Not all flavor bans are equal however. In Canada, the vape juice market is still able to provide a wide variety of flavors but aren't able to market or describe the flavors in a way that would be appealing to a youth market, but this method does cause confusion for adult vapers. 

Best case scenario: flavor ban restricted to cartridge or pod based e-cigarette systems.

Since Commissioner Gottlieb only met with the makers who control the market on this style of devices, we can hope that the flavor restrictions to tobacco flavors only hits these manufacturers and leaves the rest of the market untouched.

Or that the agency require certain products that are more appealing to kids to come off the market until these products receive premarket authorization from the agency.
Commissioner Gottlieb

Good luck on getting approval after your product gets pulled off the market. Good luck staying in business. 

What product is most appealing to kids? JUUL has been meme'd into being the face of nicotine addiction among "the youth" by essentially everyone from the politicians, journalists, nicotine prohibitionists, weirdo activists, wall street, Big Tobacco, and even the FDA themselves.

Could JUUL be in danger of getting pulled off the market until they receive premarket authorization or was that line targeting the entire vape industry? 

Worst case scenario: flavor ban covering all vape juice manufacturers.

This will have really wide spread reverberations. 

Even though the flavored vape juice has been acknowledged by the FDA in this statement as an important component to attracting smokers, flavor has been thoroughly demonized and not just cucumber JUUL pods. Also "we have to narrow the off ramp for adults" to "narrow the on ramp" for kids.

Some percentage of adult vapers, dual users in particular, will return to smoking cigarettes in the short term, until the FDA takes the nicotine out of cigarettes. 

From there, IQOS and crippled e-cigarettes are the only survivors among a variety of approved nicotine replacement therapies and prescription drugs.

Lots of small e-juice manufacturers, along with brick and mortar and online retailers go out of business, leaving thousands of employees out of work.

Check out our in depth guide on how to make your own vape juice (DIY) to be Mad Max in the flavor ban apocalyptic future. 

Strong Verifiable Age Restriction on Sales Scenario


The companies also acknowledged the power of social sourcing of tobacco products – in other words, of-age purchasers sharing or selling products to underage friends – in contributing to youth tobacco use. To address this issue, some companies said that they would support raising the minimum age to purchase tobacco to 21 years of age. Companies also described their current actions to promote retailer compliance with age- and identification-verification requirements ... [emphasis added]

Gottlieb statement cont'd

Hmm, I thought retailer compliance was an FDA issue. Why else would the FDA have been conducting underage stings and issuing warning letters?

One of the possible outcomes of the supposed "youth epidemic" is that underage buyers and possessors of e-cigarettes get treated like what used to happen when someone would get caught with cigarettes on school property; a ticket resulting in a hefty fine and a mandatory class on the dangers of cigarette addiction.

Best case scenario: Age of purchase of any nicotine product raised to 21 years of age.

The age to purchase tobacco or e-cigarettes is already 21 in some states and municipalities around the United States, including California.  

JUUL is based in California and already enforces over 21 sales. JUUL has even stopped using models under the age of 35 in product promotions to make their product less appealing to the "youth" but marketing to the youth now seems to include anyone on the better side of middle age.

Adults currently in the gap between 18 and 21 is out of luck. Is 18 is even considered an adult anymore? It's getting hard to tell.

Worst case scenario:  online sales banned.

If online sales are banned, the age requirements will also most assuredly be raised as well.

Online retailers already do a pretty damn good job at stifling sales to minors to the point of frustrating adult consumers, but the FDA found some shady online retailers such as EBAY in their "sting operations" which could be used a pretense to take such a drastic action. 

This would be pretty crippling to the e-cigarette community, restricting e-cigarettes to the limited availability of products at the local B&M or it may force adults to purchase their gear from outside of the United States.

Industry Wide Product Guideline Scenario


Another scenario, perhaps more troubling than a flavor ban, would be that the FDA issues industry wide guidelines that determine not only what flavors are on the market but also what devices, such as vape tanks, and vape mods get manufactured and sold.

Best case scenario: access to products issued in 2015 or before stays on the market.

There have been huge improvements in the last few years as far as product quality and safety goes, not to mention the huge improvements in the features available. 

All of those advancements would be gone along with any new companies that have started since that time. 

Worst case scenario: We only get to buy products from Big Tobacco again.

Since the FDA only met with these big five manufacturers, it is possible that the FDA will use input from these groups to issue a set of rules that restrict the e-cigarettes to products similar to what these five companies are selling.

Commissioner Gottlieb could decide that only vape pens matching the current cartridge designs are available in the United States. 

"You only get low powered devices with tiny disposable only pods in either tobacco or mint flavor. Never mind, kids like mint. Tobacco only and no refills!"

Or we are all stuck with ageing vape gear.

Another scenario is we end up in a situation like Europe where we get restrictions on everything from vape juice bottle size, nicotine content, specific labeling requirements and more.

E-Cigarettes Won't Be Banned

But the Industry may be limited to big players only

I am not worried about e-cigarettes being banned but I am worried about e-cigarettes being crippled. 

There is simply too much money invested in the various brands of e-cigarette systems, on top of the FDA acknowledging their benefit to help smokers, for the devices to be out right pulled from the market.

With billions at stake, combined with the hundreds of thousands of dollars in fees required to even apply to get one product approved by the FDA will mean that only fairly large companies will be able to bring any products to market.

The FDA meeting with these companies could been seen as a way to get control of the vape market after the cat is already out of the bag. The same could be said for the government to have classified e-cigarettes as tobacco products in the first place.

The fact of the matter seems to be that no one in the government or the tobacco sector was able to see what a huge impact e-cigarettes have had on everything from cigarette sales and tax revenue to nicotine addiction treatments like prescriptions or nicotine replacement therapies.

Fairly significant action will probably happen, either in the new action plan expected later in November of 2018 or in other announcements expected in December. 

The only question is how drastic will the new regulations be.