FDA Is Ready to Restrict E-Cigarettes Based on Data We're Not Allowed to See

Food and Drug Commissioner Scott Gottlieb's claims about an "epidemic" of underage vaping are hard to evaluate without access to the survey results he cites.



When Food and Drug Commissioner Scott Gottlieb threatened to crack down on vaping products last month in response to "an epidemic of e-cigarette use among teenagers," he alluded to "preliminary data" showing that "youth use of e-cigs is rising very sharply." Although we still have not seen those numbers, that has not stopped Gottlieb from making policy decisions based on them, including changes that could limit the appeal and availability of products he concedes have enormous potential to reduce the harm caused by smoking.

"From 2017 to 2018, according to new preliminary data from the National Youth Tobacco Survey, the number of high-school-age children reporting use of e-cigarettes rose by more than 75 percent," Gottlieb and Secretary of Health and Human Services Alex Azar said in an October 12 Washington Post op-ed piece. They linked not to the NYTS results, which have not been released yet by the U.S. Centers for Disease Control and Prevention, but to a September 12 Post story that said, based on information from unnamed officials, "The latest data, not yet published, show a 75 percent increase in e-cigarette use among high school students this year, compared with 2017." In other words, Gottlieb backed up his claim about unpublished survey data by citing a leak to the Post that probably came from him or someone he authorized.

Gottlieb was less coy in an interview with CNBC on Friday. "We've seen a sharp spike in e-cigarette use among minors in the past year, from 2017 to 2018," he said. "Youth use…has increased 77 percent among high school students, around 50 percent among middle school students….When all the data comes in—we're going to be publishing it next month—it's going to look like around 20 percent of American kids are using e-cigarettes." Specifically, the Winston-Salem Journal reports, "about 20 percent of high school students" in the 2018 NYTS said they had used an e-cigarette "at least once over a 30-day period."

That's up from 11.7 percent in 2017, which would be a 71 percent increase. But it's not clear how many of those high school students were vaping often enough to get addicted to nicotine. In 2015, when past-month e-cigarette use peaked at 16 percent, 2.5 percent of high school students (16 percent of past-month vapers) reported vaping on 20 or more days in the previous month, and almost all of them were current or former smokers.

Gottlieb told CNBC the NYTS figures may underestimate the percentage of teenagers who vape because some of them may not recognize Juul, by far the most popular brand, as a kind of e-cigarette. "We think the figure might actually be underreported," he said, "because some kids, when you ask them if they use e-cigarettes, and they're using a Juul product, they refer to it as juuling…and they don't consider it an e-cigarette." I'm not sure how plausible that concern is, since the NYTS questionnaire, as of 2017, described e-cigarettes as "battery powered devices that usually contain a nicotine-based liquid that is vaporized and inhaled," adding that "you may know them as vape-pens, hookah-pens, e-hookahs, e-cigars, e-pipes, personal vaporizers or mods."

Critics have noted that the 2017 questionnaire did not include Juul on its list of brand examples, which were limited to NJOY, Blu, Vuse, MarkTen, Logic, Vapin Plus, eGo, and Halo. Did the 2018 questionnaire add Juul to the list? Gottlieb's comment suggests it did not, but we don't know for sure, because the CDC has not posted the questionnaire yet. Gottlieb said the 2019 questionnaire will include, at the FDA's request, a question about e-cigarette brands. But that does not answer the question of whether the 2018 questionnaire was revised in an attempt to identify Juul users who don't consider the product to be an "e-cigarette," "vape-pen," or "vaporizer." If the wording was revised, some of the increase that alarms Gottlieb could be due to that change.

Gottlieb expressed concern that some teenagers who vape will later move on to smoking. According to a CNBC story posted on Monday, which presumably also relies on information leaked by Gottlieb or his underlings, the 2018 NYTS found that "more high school kids are smoking cigarettes." Yet CNBC says the change in past-month smoking, from 7.6 percent to 8.1 percent, "is not statistically significant," meaning we can't confidently state that more high school kids are smoking cigarettes. CNBC reporter Angelica LaVito is untroubled by that detail. "Critics have warned a surge in e-cigarette use may cause nicotine-addicted kids to migrate to conventional cigarettes," she writes. "The new data suggest this may be happening."

Smoking by teenagers has in fact been declining for years, notwithstanding a sharp rise in e-cigarette experimentation, and last year reached a record low. In this context, it is reasonable to question the public health significance of the statistically insignificant blip that Gottlieb or someone else at the FDA described to CNBC. But that sort of analysis is hard to do as long as we are limited to secondhand accounts of the survey results.

If Gottlieb does release all of the relevant NYTS data, along with the questionnaire, next month, we should have answers to these questions. In the meantime, he is making policy decisions that could affect adult smokers' access to vaping products based on data the public is not allowed to examine.

It is hard to be sanguine about Gottlieb's use of this secret information after watching the CNBC interview. He talked about banning online sales of e-cigarettes, for example, even though online vendors such as Juul use age verification systems and the vast majority of illegal sales to minors occur in brick-and-mortar stores (as Gottlieb conceded).

"We recognize [e-cigarettes] as a viable alternative for adults smokers who want to get access to satisfying levels of nicotine without all the harmful effects of combustion," Gottlieb said. "If we could switch every adult smoker to an e-cigarette, it would have a profound public health impact." Yet he is ready to discourage that switch by making e-cigarettes less appealing (by restricting flavors, for example) and harder to get (by banning sales outside of adults-only vape shops, another idea he floated), all based on an "epidemic" that is impossible to evaluate without the data he is not letting us see.

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  1. … he alluded to “preliminary data” showing that “youth use of e-cigs is rising very sharply.”

    And we all know preliminary data is always the best kind of data!

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  2. Is that guy the result of some secret government experiment, or did Ted Cruz and Marco Rubio make a baby with each other the old fashioned way?

    1. He must be really fun at parties.

      I wonder if he’s ever had sex with the lights on.

  3. Just another example of a government power grab using the old “we must do it for the children” excuse.

    Exactly why is it that the choices of adults be restricted just because someone claims that “children” are using the product?

    1. Because they think adults are children too-of big mommy government

  4. It seems that almost all press on vaping uses the same kind of hysterical hyperbole for “data” that Gottleib is spewing. Just like that kid’s science fair poster that has brought on the plastic straw bans. If right-thinking people don’t like something, facts and data don’t matter.

  5. “We recognize [e-cigarettes] as a viable alternative for adults smokers who want to get access to satisfying levels of nicotine without all the harmful effects of combustion,” Gottlieb said. “If we could switch every adult smoker to an e-cigarette, it would have a profound public health impact.”

    “That’s what makes our decision all the more duplicitous!”

    1. “If we could switch every adult smoker to an e-cigarette, it would have a profound public health impact.”

      Absolutely true statement that leads me to the conclusion that health insurance companies should give every smoker an e-cigarette starter kit, free, and every level of government should remove all restrictions on where they can use them.

      Out of the people I know who have switched, 100% have benefited, and so have the people around them.

      1. HA! A few years ago, I started vaping and had all intentions of giving up traditional cigarettes. I will admit I have not given up on this goal, but have not dedicated myself until this anti-e-cigarette moment has subsided. Regardless, I checked with my company provided health insurance carrier about e-cigarettes. According to them, there is no difference between traditional cigarettes and e-cigarettes. If I give up tobacco and go straight to vaping, and claim to insurance company that I am a non-smoker (for cheaper rates), if they find ANY nicotine in my system (during a normal blood test, say), I could be prosecuted for fraud. Hopefully this has/will change, but from my experience, insurance companies are not embracing.

  6. limited to secondhand accounts of the survey results

    If that was intentional, that was brilliant.

  7. investigating Zuul?

    1. Just look under any manhole cover in New York, so I’m told.

  8. What could go wrong with a little government regulation? After all its about the children.

  9. ‘We need to keep those kids pumping money into big tobacco so we can get our beaks wet, but don’t worry. If this effort fails, we’ll just do the same thing we did to big tobacco to big vape!’

    -Scott Gottlieb, probably.

    Of course, if they pass these laws suggestions with force of law I’ll just need to buy my stuff from China or Europe directly.

  10. Okay, let’s assume that the rise in vaping will not stop, and soon 100% of teens will be hooked on nicotine. So what?

    There are no proven health risks from nicotine use, just disputed literature that it might pose cardiovascular risk to people with cardiovascular disease and might promote tumor growth in people with cancerous tumors. Even if both of those are true, the net population health effects might well be offset by nicotine’s effective role in weight management by promoting higher a metabolic rate and suppressing appetite.

    Seriously, can we please have at least real evidence of net harm to teens before we actually invoke them as an excuse for government action? That’s not even a libertarian principle, that’s just a pro-sanity one.

    1. Seriously, can we please have at least real evidence of net harm to teens before we actually invoke them as an excuse for government action?

      Didn’t stop them from banning pot for the past 80+ years, did it?

      That’s not even a libertarian principle, that’s just a pro-sanity one.

      Hence why it is not a government principle

    2. It’s also disputable that nicotine is even addictive. Millions of cigarette smokers have used nicotine substitutes (gum, patches, lozenges etc.) for decades but are no more likely to quit smoking than those who go cold turkey. And there is no evidence that not smokers use these products for the mythical nicotine high.The notion that people use tobacco because they are addicted to nicotine has been the conventional wisdom for well over a century but common sense dictates otherwise. You’d be hard pressed to find any actual verifiable evidence that nicotine is any more addictive than caffeine, sugar, bacon or anything else that humans enjoy. It’s simply assumed. There are plenty of ways to get get nicotine into your bloodstream that don’t involve tobacco but they do not stop smokers from smoking. Vaping on the other hand, with or without nicotine, has helped millions quit or reduce tobacco consumption.

      1. Addictive is never defined, so it applies to gum, girls, hair tonic, video games… And the Drug Nazis ban testing, else we could watch a Pepsi Challenge between a restless cigarette habitu? and a slobbering, drooling, heroin addict convulsing in diapers.

        1. “Addiction” is deliberately vague. It’s a thought-terminating cliche to justify government intervention.

      2. Never been a smoker huh?

        I mean, you can perhaps play with how you define addictive… But I’d say it’s addictive.

        You definitely crave it, and not like I crave bacon. Like a whole different level of desire. Caffeine is in fact also chemically addictive supposedly, but I crave that even less than nicotine. When you DON’T get your fix, I personally kind of feel like somebody is trying to rip my heart out through my chest… If that makes sense?

        AKA It sucks.

        So I’d say it’s addictive. But nicotine itself seems to not be very harmful, if it is at all. I switched to vaping, and it’s pretty sweet. You can taper down your nic level incrementally, which I have done. It’s good stuff overall. I may quit even vaping at some point, not sure really. I don’t really care much anymore since I feel soooo much better than when I smoked.

        1. As a 35 year smoker, I firmly believe that cigarettes are much more HABITUAL than they are ADDICTIVE. This is another reason vaping works so well…you still go through the habit of holding and sucking on a “cigarette”.

          1. My thoughts exactly. Teen vaping has doubled. Who gives a shit?

          2. Yeah, well that’s the debate with a lot of stuff. Habituating, or addicting. Personally, I think smoking is both.

            Main reason I would say this is that when I went to vaping, and started tapering down the nic levels… I COULD TELL. Like I NEEDED to hit it way more at the new lower levels, because there was an outright craving.

            So I think it is addicting, AND habituating on top of. That’s why overall people have lower odds of quitting smoking than quitting heroin supposedly!

  11. The power of the FDA to “deem” things at a whim is fucking ridiculous.

    Deeming e-cigs “electronic nicotine delivery systems” when NO nicotine is required for use – is the same as deeming pipes “tobacco products”. Which, btw, is totally at odds with the FDA’s statement: “We’re also taking steps to remove outdated regulations or advance new rules to promote efficient patient access to innovative products.”

    1. Drug companies, and now tobacco and e-cig companies too, must pay user fees to the FDA to have their products approved, and pharma pays a lot more into it than e-cig companies do and also has an interest in banning them to sell more drugs like Chantix, and approved nicotine patches and gums. So e-cigs are in direct conflict with them.

    2. Worse is the power to cast a vote for Libertarian Party candidates. There is literally no way to keep THAT information from the public–not with published vote counts still legal. The Venezuelan and Cuban governments at least take their responsibility toward their subjects’ welfare seriously enough to avoid THAT sort of dereliction!

  12. “We think the figure might actually be underreported,” he said, “because some kids, when you ask them if they use e-cigarettes, and they’re using a Juul product, they refer to it as juuling…and they don’t consider it an e-cigarette.”

    Blame Bill Clinton, who famously noted that a blowjob is not sex.

    1. Ah yes-thanks to Bill, most women under 50 don’t think a BJ is sex either.

  13. In most jurisdictions you need to be 18 to purchase the product. So why is the product the problem and not retailers. How is this different from alcohol?

  14. Taking a page from the EPA’s playbook here, who stole it from Joe McCarthy. “I hold here in my hand a list of all the studies showing the massive harms caused by vaping, especially the epidemic of teens dying, getting sick, losing limbs, turning to prostitution, playing violent video ga – What? No, you can’t see the list, it’s classified information!”

  15. He could make Jane illegal. How is that for an idea?

  16. I guess the data must be kept secret because of national security concerns, right? Or perhaps like straw bans, the data came from a 9-year-old’s school report, and the FDA is embarrassed to admit that?

    Either way, they earned my hatred about 8 years ago, when they ran an undercover sting operation to bust a bunch of Amish farmers who were selling (gasp) raw milk.

    The more one learns about these out-of-control alphabet soup agencies, the more one wishes them to to come face to face with forestry product processing equipment.

  17. This could be the worst menace since folks discovered how to use plant stimulants without chancing the hepatitis or AIDS infections government officials wanted imposed as penance. Polonium 210 and free radicals ought to at least be added by law to all vaping products or they’ll have an unfair advantage over taxed-and-regulated revenue tobacco products. Then again, what about religious vaping with DMT instead of Old Testament ayahuasca? Would not the First Amendment of the Bill of Rights protect that Free Exercise from officious coercive meddling?

  18. I bet they got their data from the New episode of South park butters been selling to too many kindergarteners

  19. What if they all did get addicted to nicotine? How does that hurt them?

  20. Why would people who were initially attracted to vape want to switch to tobacco, when tobacco was available all along? It defies common sense.

    1. Because the government is dumb. That’s why!

  21. Fuck off slaver!

  22. I have turned on around 20 people to vaping to help them quit smoking and of those two have quit completely – no vape and no smoke, four have quit smoking but still vape, and four more vape but still smoke although much less. The rest tried it, didn’t like it and keep smoking.

    The kids I give $80 setups to behind the local middle school don’t exist.

  23. These guys better not seriously fuck with vaping stuff. I quite smoking with vaping a couple years ago. It is AWESOME for quitting the real deal. You can feel your health improve too.

    1. I quit smoking (the second time) with vaping. Definitely glad that it was an option. I hope there doesn’t have to ever be a third time…

      Incidentally, the first time I quit, I had tried the gum and didn’t like it, but still quit that day cold turkey. I think it helped that I was in much better shape, and was just starting to hit the gym daily again.

    2. Former smoker here too and haven’t wanted a cigarette in almost four years. I’ve known at least twenty people in the last couple years who have quit and several of them quit nicotine entirely because of it.

    3. Yeah, it really does work well. My dad, a smoker of 40 odd years, who had half assed tried to quit a few times, and failed miserably, quit NO PROBLEM the first time he did it with vaping. I know of no other method that makes it so easy, and relatively painless.

  24. Nothing to see here Citizen, move along now.

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