Bureaucrats and Politicians Seem Determined To Cripple a Lifesaving Alternative to Smoking

E-cigarette regulations and taxes threaten an industry that could prevent millions of premature deaths.


Electronic cigarettes, which deliver nicotine without tobacco or combustion, are the most important harm-reducing alternative to smoking ever developed, one that could prevent millions of premature deaths in the United States alone. Yet bureaucrats and politicians seem determined to negate that historic opportunity through regulations and taxes that threaten to cripple the industry.

When a court-set deadline for "premarket" approval of vaping products came and went on September 9, the Food and Drug Administration (FDA) had received millions of applications but had not approved any. As a result, the agency says, every vaping device and nicotine liquid sold in the U.S. is "marketed unlawfully" and "subject to enforcement action at the FDA's discretion."

Seven years after the FDA officially declared its intention to regulate "electronic nicotine delivery systems" (ENDS) as "tobacco products," the industry remains in legal limbo, existing only thanks to the agency's enforcement discretion and limited resources. Despite the FDA's promises of regulatory flexibility, it is perpetuating a situation in which manufacturers don't know whether they will still be in business next week, next month, or next year.

The FDA has rejected millions of applications for nicotine liquids in flavors other than tobacco, which are the products that former smokers overwhelmingly prefer. Because those flavors also appeal to teenagers, the agency says, they will be approved only if manufacturers present "robust," "reliable," and "product-specific" evidence that their benefits in helping smokers quit outweigh the risk that they will encourage underage vaping.

No one really knows what that means, although the FDA says "the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study." Such research is beyond the means of all but the largest companies, and even they may have trouble persuading the FDA that approval of their products is "appropriate for the protection of public health," taking into account "the risks and benefits to the population as a whole."

Under that highly subjective standard, which is mandated by the Family Smoking and Tobacco Control Act of 2009, it is not enough for a manufacturer to show its products are far less hazardous than conventional cigarettes. Nor is it enough to show that nontobacco flavors are enormously popular among former smokers, because the FDA might still conclude, however implausibly, that the risk of underage consumption outweighs the welfare of smokers interested in making the potentially lifesaving switch to vaping.

Survey data indicate that the vast majority of teenagers who vape regularly are current or former smokers, which means the FDA's fear that ENDS are causing an "epidemic" of adolescent nicotine addiction is overblown. So is the fear that vaping is a "gateway" to smoking among teenagers who otherwise never would have tried nicotine; if anything, recent trends suggest, the availability of ENDS has accelerated the downward trend in adolescent smoking.

The folly of the obsession with preventing underage vaping was apparent in San Francisco, where a ban on flavored ENDS seems to have boosted smoking by teenagers and young adults. That cautionary example has not deterred other jurisdictions from considering the same counterproductive policy.

In case heavy-handed federal and local regulations are not enough to stop smokers from quitting, House Democrats have proposed excise taxes that would double or triple the price of e-liquids. "This tax will not only kill my business," a Georgia vape shop owner told my Reason colleague Christian Britschgi. "It will kill Americans."

Last month in the American Journal of Public Health, 15 prominent tobacco researchers warned that "policies intended to reduce adolescent vaping may also reduce adult smokers' use of e-cigarettes in quit attempts." They emphasized that "the potential lifesaving benefits of e-cigarettes for adult smokers deserve attention equal to the risks to youths."

Although the FDA acknowledges the harm-reducing potential of ENDS, in practice it is giving that benefit short shrift. Other policy makers, meanwhile, are proceeding as if the lives of smokers count for nothing.

© Copyright 2021 by Creators Syndicate Inc.

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47 responses to “Bureaucrats and Politicians Seem Determined To Cripple a Lifesaving Alternative to Smoking

  1. Vaping, cross-dressing and Hondurans.

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  2. Vaping has joined immigration, butt sex, and weed. How many articles is this over the past couple weeks?

    1. Uncle Charles must own a couple of vape juice producers.

    2. Vaping THC oil while having buttsex is the Reason triathlon.

  3. So the FDA can fast track a vaccine (under duress) and yet vaping needs more study compared to tobacco.

    Look I don't care what you ingest or smoke or inject, but if you're hoping the bureaucrats in DC will help you decide good luck with that.

  4. You don't seem to understand what's going on here. Under the Tobacco Control Act, passed during Democrats' 60 votes in the Senate back in the dark ages, the two Democrat administrations have consistently sought to ban smoking entirely through administrative rulemaking.

    The FDA plans to (if they haven't already) make rules requiring the nicotine content of all cigarettes is a tiny fraction of its current level. Such that cigarettes couldn't be used to service a nicotine addiction.

    So there are no benefits from vaping to be realized. All smokables will be banned before long, unless there is a long period of unbroken Republican control of the government to repeal the TCA - because that's what it would take to stop a Democrat's FDA from eventually doing it in.

    I'm not even sure the remaining Biden term isn't enough to kill the tobacco industry, regardless.

    1. The irony is that light cigarettes cause more health damage, because of the lower nicotine levels causing smokers to smoke more, not less.

      1. Funny thing that. Like bureaucrats can't read or think, huh?
        Some think the "obesity epidemic" (like obesity is contagious) is/was caused by incessant government harping on "low fat" foods. Turns out when they take out the fat, they put in sugar so there would be at least some flavor. It is amazing to me that anyone takes the feds food pyramid seriously. Every 5 years they change it, and yet people expect it to be correct.

      2. We're talking about a level so tiny that smokers would have to be on the patch, and each cigarette essentially doesn't satisfy the nicotine craving. At the beginning, you're right, but smokers would quickly learn the cigarettes weren't addressing the need.

    2. The only reason FDA proposed reducing nicotine levels in cigarettes several years ago was so the agency could dupe Americans (and the left wing news media) into believing it opposed cigarette smoking and to deflect attention away from its already imposed Regulation that recently banned the sale of all vapor products on the US market.

      1. BTW The FDA never formally proposed a Regulation to reduce nicotine levels in cigarettes, but rather just proposed to draft regulation (that the agency hasn't taken any formal action on since).

        1. Litigation tends to slow those things down. I think it's ridiculous to assert that the FDA under Democrats isn't opposed to cigarette smoking.

          It just speaks to the incompetence of the Trump administration that the announcement of the proposed rule to essentially eradicate cigarettes happened in 2018.

          But again, it's the TCA that makes this stuff inevitable.

    3. The gov't hasn't stopped people using THC or hemp vaping , but they have gotten rid of the flavors

  5. You can easily chart the government response to Vaping, by looking at the prospects of RJ Reynolds.

    In 2015, their vaping product, the VUSE was dominating the market. They had various flavors and a relatively mature supply chain that allowed you to buy wherever you wanted it. Then came the Juul, which ate VUSE's lunch. By 2018, VUSE's market share had dropped from 33% to 9.6%. And we saw federal oversite become significantly more intrusive.

    1. There’s something to be said about the awfully bad name of Vuse in market decline.

      It is so hard to say Vuse aloud without sounding like a stroke victim. Compare that to Juul, which rolls off the tongue.

      1. Reason does not necessarily share the vuse of the commentariat.

        1. That's a juul of a comment.

      2. In Europe it's called "Vype". Well, ok, I can only speak to Germany. But the pods fit my Vuse Alto device. And they had flavors. But the nicotine levels were absurdly low. As in, the highest they had available were lower than the lowest available here.

  6. Crack down on those selling to minors, like has been done witnh cigarettes. I am not a child and don't wish to be treated as one.

    If they pass these damn fool taxes, buy from out-of-country suppliers off the internet. Fuck Congress.

  7. Really can't understand about tobacco (should be banned or not). These all surveys are nothing but bullshit. If one wants to stop the use of tobacco , he can and obviously it should be banned.

  8. Look, if we didn't want people to die, we wouldn't even have a Federal Death Administration.

  9. If they can lock down millions of people and mandate vaccines, they can sure as shit ban, regulate or generally wring the vaping industry's proverbial neck until it expires.

    1. It will never expire because it’s a superior smoking system in some respects. Low odor, can be adapted to use with drugs, currently not taxed as highly as tobacco, faster “smoke breaks.”

      The fact that it may not be safer and is definitely more polluting are negatives. But addicts don’t care.

    2. They won't let that happen, because they're going to become partners via taxes.

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  12. This smoking alternative causes Karens to have vapors.

  13. Back in 2011, I correctly predicted that FDA's yet to be proposed Deeming Rule (it was formally proposed by FDA in 2014 and then imposed in 2016) would ban the vast majority of nicotine vapor products on the market, and would likely create a new vapor monopoly/oligopoly controlled by the world's largest cigarette companies (which make far more money on cigarettes than vapes).

    Unfortunately for truthfulness and public health, none of the 15 so-called "prominent tobacco researchers" cited by Sullum would oppose the FDA's proposed Deeming Rule, most of them publicly advocated the FDA regulation they now correctly criticize, and many of them received funding from Big Pharma, FDA and others who lobbied/insisted FDA's vapor regulation was necessary to protect public health.

    Virtually everyone who advocated and lobbied for FDA's vapor sales ban (that FDA insisted would protect public health), including Big Pharma, Big Tobacco, FDA's head of its Center for Tobacco Products (Mitch Zeller) and many of their funding recipients had selfish financial conflicts of interest.

    After being marginalized by the FDA and others who lobbied for the FDA's vapor sales ban, all I can do now is say "I told you so".

  14. The most effective life-saving alternative to smoking is not smoking.

    1. ergo vape

      1. Or, don't put any extra crap in your lungs at all.

  15. The fact that it may not be safer and is definitely more polluting are negatives. But addicts don’t care.
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  17. Unless they prove some unforeseen problem with vaping, thats much worse than tobacco, they should regulate or ban the tobacco, not the E cigs. E cigs better for non smokers too!

Comments are closed.