September 13, 2018

FDA Threatens to Ban Flavors and Pull Products Off the Market in 60 Days

FDA Commissioner Scott Gottlieb announced that the agency might reverse course and demand immediate premarket review for existing vapor products, rather than by 2022, as he had promised a year ago. He also threatened an immediate ban on e-liquid flavors.

The agency also sent letters to JUUL Labs and the four tobacco companies whose products together make up almost the entire convenience store/gas station vape market. The FDA suggests those companies should consider eliminating online sales and voluntarily removing flavored products from the market. They were given 60 days to respond with their plans to prevent youth use.

Gottlieb and the FDA’s multi-pronged attack on the vaping industry also included the announcement of over 1,300 warning letters and monetary penalties for retailers and online businesses selling to minors, and the promise of more to come.

The anti-vaping spectacle delighted the Campaign for Tobacco-Free Kids, who congratulated Gottlieb for recognizing the “crisis.” Billionaire anti-tobacco activist Michael Bloomberg said the agency should go further and remove vaping products from the market.

The aggressive actions and loud talk caused tobacco industry stock prices to spike upward. It’s no secret that the success of JUUL has cut into cigarette sales, and caused pain in the tobacco industry. The FDA actions will hurt the independent vapor industry and help the cigarette manufacturers in equal parts.

Gottlieb says that the vapor industry isn’t doing enough to stem the tide of youth vaping. He claims that preliminary, unpublished data suggest that teenage use of vapor products has exploded in the last year. The data, of course, are secret. You’ve got to trust the commissioner on this one.

The culprit may be flavors, he thinks. The agency is already in the process of issuing rules on e-liquid flavors, but Gottlieb seems to indicate drastic action may be called for. A flavor ban isn’t unexpected. After all, the FDA already tried to ban flavors in 2016. But asking vapor companies to choose between voluntarily shutting down sales of their most popular products or facing an FDA ban is akin to offering the choice of suicide or murder.

“One factor we’re closely evaluating is the availability of characterizing flavors,” he said in an official statement. “We know that the flavors play an important role in driving the youth appeal. And in view of the trends underway, we may take steps to curtail the marketing and selling of flavored products. We’re now actively evaluating how we’d implement such a policy.”

Gottlieb explains that he postponed the final deadline for manufacturers to submit premarket tobacco applications (PMTA’s) for existing products from 2018 to 2022 in order to create workable standards for the industry to follow. “But in view of the accelerating use among youth,” he says in his official statement, “we’re actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.”

“Thousands of small-business vape shops across America do not engage in irresponsible marketing practices and do not even sell the products being targeted by the FDA with threatening letters,” responded American Vaping Association president Gregory Conley. “Despite this, Commissioner Gottlieb is threatening to shut down all these businesses unless larger manufacturers unilaterally choose to change their marketing practices. It is absolutely absurd and a perversion of how regulatory agencies are supposed to approach their work.”

Of course, the FDA never intended to offer detailed guidance to manufacturers. If Gottlieb hadn’t shown up and extended the deadline, the vaping industry would already be as dead as a doornail. But now he’s feeling the pressure from tobacco control groups and the politicians they influence. So the PMTA extension and flavors are on the table — because we’re in the midst of an epidemic.

The word “epidemic” is liberally strewn throughout both Gottlieb’s official statement and the FDA press release.

“I use the word epidemic with great care,” says Gottlieb. “E-cigs have become an almost ubiquitous ‒ and dangerous ‒ trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”

That’s the most disturbing part of Gottlieb’s new war on vaping. The suggestion that attractive alternatives for smokers could be prohibited because there is no way to prevent adolescents from wanting to use them. And the idea that preventing youth from wanting to try adult products is even possible flies in the face of all human knowledge about the teenage brain.

The entire period of adolescence is a rehearsal for adulthood: teens practice being adults by experimenting, trying adult things, and making adult decisions. Sure, parents try to guide and protect them, but you can’t bypass the period between childhood and adulthood.

Gottlieb’s willingness to trade the lives of adult smokers for the illusion of teenage purity is simply delusional. Can you think of another adult product that is prohibited because it also appeals to adventurous teenagers? If you do, let the FDA know, so they can label it tobacco and ban it.

Of course, there’s no threat to ban cigarettes. Cigarettes have never had to go through premarket review or prove to the FDA’s satisfaction that they protect the public health. “If underage consumption does not justify a ban on tobacco cigarettes (and I don’t think it does), it cannot possibly justify a ban on competing products that are much safer,” wrote Jacob Sullum today in Reason.

Commissioner Gottlieb apparently thought that wholesale disruption of the cigarette market would happen neatly, with each smoker waiting in line to exchange their Marlboros for a drab, flavorless vape that teenagers would ignore, and then all the anti-tobacco activists that depend on cigarette sales would cheer him as he walked off into the sunset.

But that’s not how disruption of a powerful market happens. And that’s not how teenagers behave. And that’s not what entrenched industries like tobacco control do when threatened with irrelevance. You might hope the world works that way, but it doesn’t.

“We need a regulatory process that requires product applications to show that the marketing of the product is appropriate for the protection of the health of the overall population,” says the commissioner. “And we need a regulatory process that keeps these same electronic cigarette products out of the hands of youth.”

Gottlieb thinks he can control market forces and steer human behavior in the direction he prefers. But that’s not how regulation works. Nothing is simple. The best he can expect now is that the unintended consequences of his new actions will be more acceptable to those he desperately wants to please than what he did before. He’s regulating based on hope. And hope isn’t much of a plan.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

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This is extremely hypocritical. I have never heard of anyone wanting to ban flavoured alcohol or prevent it’s online sales. Heck, I even see advertising for alcohol in train stations, malls, TV, and other places where teenagers frequent. I would bet good money that the amount of teenagers abusing alcohol absolutely dwarfs the amount that have tried vaping.


I agree.

Some countries think they´re more in control on youth alcohol consumption than on smoking (which is bullocks because youngsters do drink…and maybe more than smoking)

At the end it is all about the cash for both big tobacco and governments.

Taxing vape products is a bit more complicated. Technically it´s not a tobacco product and taxing ingredients you find in most food and common products would look strange.

Taxing nicotine could be but how? Looking at different strengths.

Besides, everything is available on the market including flavor kits for DIY, therefore there won´t be a full stop on vaping plus more and more countries are backing vaping now the positive side becomes more clear.

My guess, the evidence building up on a saver way to consume nicotine and to enjoy an alternative to a smoking sensation which is a tremendous help to quit regular use could trigger the big guys to become even more aggressive.

Jim McDonald

I don’t disagree, but the FDA doesn’t regulate alcohol.


Since we all seem to feel very strongly about the FDA in our homes about vaping, why dont we make it known to them? Comments here are great, however let’s bombard them DAILY with emails about how vaping has helped us quit smoking/let them know this ban crap is all about being in the pockets of BIG TOBACCO and has nothing to do with “increased youth vaping” that this is not what us Americans want. Now if you email, make sure your email sounds like you have a brain and know what your talking about. It wont do any good to send emails telling them they are full of shit and the FDA sucks ass.

If we all work together and try as a vaping community, you never know what mountians could be moved.
Pass around to your friends/family that vape. Let them know of the possible FDA regulations coming of no flavors/online sales.

Alex M. Azar II..(Gottliebs boss)
[email protected]

Scott Gottlieb M.D. email
[email protected]

Center for Tobacco Products
[email protected]

This is the only way I found to “email” Trump.

Jim McDonald

Thanks for this, Amy. My one caveat to this is that the FDA is not a political organization — or at least isn’t supposed to be. They give the public a chance to comment on proposed rules (as in the case of flavors, and the Deeming Rule itself), and that’s really the only time they’re required to acknowledge public input in their work. That said, I see nothing wrong with vapers engaging the leadership at FDA and their bosses at HHS and in the White House.


Ok I get the fact that Gottlieb wants to protect our youth, BUT, what is he doing about our youth smoking the traditional cigarette and all the underage drinking of alcohol that is taking place, better yet all of the deaths of our youth from illegal drugs and oh let’s not ignore all of the deaths of our youth from texting and driving, WHAT EXACTLY IS GOTIEB DOING TO PREVENT THESE AFOREMENTIONED EXAMPLES FROM HAPPENING

Jim McDonald

I’m on your side, but the FDA isn’t in charge of any of those things.


This sucks, like there is zero harm to people from e cigs, they might as well ban dog machines then too right??? And every shop I go to even as a regular I get carded every time, what’s funny is certain gas stations I dont get carded to buy ciggs. No I dont smoke but my dad does. And when he drinks he won’t drive so i run up to gas stations.


Jim, Could you give me a source on the quote from Gottleib “But in view of the accelerating use among youth,” he says in an official statement, “we’re actively considering whether we will enforce the premarket review provision earlier, when it is apparent that these products are now subject to widespread youth use.”

Jim McDonald

It’s the same official statement linked in the paragraph above that quote.


They need to ban cigarettes if they are truely concerned with the youth of America. I guess they think its okay for kids to smoke cigarettes.. Smh.. Pathetic, young people are smoking cigarettes they could care less about vaping my daughter is 18 and she smokes cigarettes because all her friends smoke cigarettes, she has absolutely no interest in vaping. This is a ploy from the Big Tobacco companies and it isnt right. If they are going to ban flavors or ban vaping then ban cigarettes and alcohol as well. Hypocrites!

Jim McDonald

The FDA can only do what it’s allowed to by the Tobacco Control Act. That law prevents FDA from banning cigarettes. They are, however, in the process of trying to make a rule that will eliminate almost all of the nicotine in cigarettes.


Very good article. Very similar situation in EU right now. In Slovakia, we are at the chapter, where vaping products are going to be labeled as “tobacco products” oficially. Just to tax it.

If only vapers were active and fight together. Not to allow someone to change the law behind our back. We should fight at least for the public health interest, fight for the future.

Jim McDonald

Trump needs to fire this guy. This is the pure definition of unnecessary and abusive regulation at the expense of American small businesses and the American middle class. Vaping gets people OFF OF CIGARETTES. ZERO harm proven.

The onus isn’t on us to prove safety. The onus is on YOU to prove harm before destroying our industry!!


What an absolute crock of shit. This has gone too far. The fact that vaping is labeled a tobacco product at all is absolutely ridiculous and only a means for the government to regulate it. This isn’t regulation this is prohibition. Good to know that there will be a new BLACK MARKET for juice coming soon.

But that’s the United States government for you, Money Talks and ignoring science and factual numbers is the name of the game. Just look at the party that’s in control right now. The Republicans completely deny Climate change. Against all of the science and facts may just say it’s bullshit. The Democrats on the other hand accept the science behind climate change but ignore the science on vaping. Go figure. It’s all about money. Pathetic. Ever since Trump got elected I’ve been embarrassed to be an American, now I’m embarrassed and disgusted.


This is what money buys. I am totally against the sale to minors. I card everyone to make sure but at the same time instead of attacking a product that let’s people slowly kill themselves over the course of their entire 80 to 100 year life cause let’s be real, Even cigarette user live for quite some time amazingly, ATTACK the alcohol industry! That is more than just an issue in this country. Kids go out drinking all the time because their older family members or friends buy it for them and then they decide to go out and pick fights with people or worse, driving. So which here is worse? Someone decides to harm themselves over a period of years? Or letting kids drink and going out and killing several others with them behind the wheel?

Jim McDonald

Yeah, alcohol is a huge problem. But it’s not in the FDA’s jurisdiction.


Yet. The bottom line that everyone is missing and nobody has even said yet is the fact that teen vaping sounds to me like a lack of parenting. I don’t need the goddamn government to protect my kids that’s my goddamn job. And anyone else who has children it’s your job to take care, discipline, and bring up your own children. But hey in today’s sissy society parents want to be their kids friends they don’t want to be parents.


Teaching Teens about smoking/vaping isn’t the only thing that SHOULD be taught by parents but isn’t. Think about the many responsibilities that are left on teachers’ shoulders. They’ve become parental proxies. Because parents are often not doing their jobs, the government must feel they need to do it for them. Unfortunately, they don’t have a clue about what it’s like to be a teen. Teens will experiment. Just because they try vaping or smoking doesn’t mean they’ll become long-term vapers or smokers. Banning flavors won’t deter them. If they want to do it, they’ll do it. I recall reading that since teens are doing things like vaping to emulate adults, they’re more likely to vape “adult” flavors like tobacco or menthol instead of fruit or dessert flavors. I don’t know how true this is, however. But I feel having the government playing parent to our nation’s children is wrong.


I’d love to hear more on this subject

Jim McDonald

Which subject, Rick?


Just kill em all and everybody gets what they want. Problem solved.


Look at the soft drink industry for example, all these highly caffeinated drinks that are being shoved down the throats of the American youth. Caffeine has almost identical affects on the human body as nicotine but what do we see more of? Kids with vapes or kids with Monster Energy drinks, all in a variety of flavors I might add.

There is no REAL concern for the youth in this country there is only concern about an age old industry that has been killing people for years.

It’s about time this administration was called out for their real agenda!!


This is what happens when Democrats mount no holds barred resistance to a republican president.


Oh bullshit. The Republicans completely obstructed President Obama during his entire eight-year run. Like I said it’s all about money. Democrats ignore the science on vaping. And they love to regulate the shit out of everything. Republicans are no better but they completely deny climate change. Doesn’t matter which political party is in power. They’re all morons and we are all sitting back allowing them to control and do everything they want.


Gottlieb is a Republican, appointed by Trump, who enjoys his work – “Scott Gottlieb, as you know, is a star,”

Jim McDonald

Gottlieb is a Trump appointee — and his boss, Health and Human Services Secretary Azar (also a Trump appointee) is backing his statements on vaping.


Watch out the British are coming the British are coming.


Great reporting, Jim. Readable, informative, and professional (as far as I can tell, though I’m not a professional).

In the second paragraph following the picture of Altria’s stock with Christopher Russell’s tweet, the last sentence reads: “But asking vapor companies to either voluntarily stop selling their most popular products or face an FDA ban them is akin to offering the choice of suicide or murder.”

There is a problem with “face an FDA ban them”.

Jim McDonald

Looks like I missed a word. Thanks!


So the FDA wants people to go back to cigarettes thats the dumbest thing i have ever heard of. Vaping saved my life i smoked for 16 years and vaping made it easy to quit cigarettes. I hope the FDA realizes they are robbing adults of a better life if they do this.


Agree! Smoked since i was 13 and have been vaping for 6 yrs! No colds or bronchitis since vaping!


Tell me please, in the United States, can teens themselves be responsible for vaping, or can they use vaping without problems, and only sellers are liable?

It seems to me that the whole world is shifting the problem from a bad head to a healthy one accusing those who initially struggled with vaping among minors.

Jim McDonald

The laws on that vary from place to place. In most parts of the country, it’s just illegal to sell, not to use.

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