The FDA Warms to Vaping

Embracing harm reduction, the agency's new head tries to make e-cigarette regulations less onerous.


On the face of it, the decision that the Food and Drug Administration (FDA) announced on Friday, extending by four years a crucial deadline for e-cigarette manufacturers to seek approval of their products, was no more than a stay of execution. But the FDA also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests this reprieve could turn into a commutation.

That would be good news for smokers who want to quit and for anyone sincerely interested in helping them. For too long American public health officials have been unreasonably hostile to e-cigarettes, which are far less hazardous than the conventional kind and offer a closer simulation of the real thing than nicotine gum or patches do.

Scott Gottlieb, the new FDA commissioner, seems to appreciate the public health potential of this innovation. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," he says. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts—and we believe it's vital that we pursue this common ground."

Gottlieb's vision of nonaddictive cigarettes involves mandating a gradual reduction in nicotine content, which would increase the risks that smokers face by forcing them to absorb more toxins and carcinogens for the same dose of nicotine. But his interest in less dangerous alternatives to cigarettes is encouraging.

The FDA says "a key piece" of its new approach is "demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." The agency wants to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes."

Toward that end, the FDA is giving e-cigarette companies until August 8, 2022, to apply for permission to keep their products on the market under regulations published last year, rather than the original deadline of November 8, 2018. The agency says it will use the extra time to seek additional public comment and develop clearer guidance for the industry.

The 2016 regulations require manufacturers of vaping equipment and e-liquids to demonstrate that approval of their products "would be appropriate for the protection of the public health." It is not clear what that means in practice, but the FDA projected that applications would cost hundreds of thousands of dollars per product, and many observers thought that was an underestimate.

To give you a sense of how expensive and burdensome the process was expected to be, the FDA anticipated that it would receive applications for just a tiny percentage of existing products. The implication was that the regulations would drive the vast majority of companies out of business.

If the FDA is serious about making "less harmful sources" of nicotine "the cornerstone of our efforts," it will develop transparent, straightforward, and practical criteria for approval of current and new vaping products. Standing between smokers and products that can save their lives is surely not "appropriate for the protection of the public health."

Nor is making those products less appealing by arbitrarily restricting flavors. Since supposedly "kid-friendly" e-liquids are very popular among adults who switch from smoking to vaping, it's a bit worrisome that the FDA plans to solicit public comment on regulation of flavors, which it acknowledges may be "helping some smokers switch to potentially less harmful forms of nicotine delivery."

A recent BMJ study suggests that e-cigarettes have accelerated the downward trend in smoking and may account for the first increase in the cessation rate since the early 1990s. "These findings need to be weighed carefully in regulatory policy making," the researchers conclude. Gottlieb's avowed commitment to harm reduction gives us reason to hope the FDA actually will do that.

© Copyright 2017 by Creators Syndicate Inc.

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  1. Uh, the key takeaway here is not that the FDA is cool with vaping but that they’re contemplating declaring a total War on Nicotine. I’m not lumping Jake in with this crowd but elsewhere progressive Cuckatarians are celebrating the FDA’s proposed nicotine reduction regulation.

    1. Agreed. It’s hard to celebrate any sort of win. It’s not really any better, it just sucks a little less. It appears to me that shenanigans are still being played behind closed doors and someone lost this round, but they got in enough concessions to make their original stance still heard.

    2. declaring a total War on Nicotine.

      A self-admittedly idiotically selective War on Nicotine. At this (that) point, it would become worse than the AGW debate. Like if the AGW advocates admitted that carbon was a poor indicator of warming but that we really should try to keep our carbon levels down so we aren’t addicted to it.

      1. They can’t single out nicotine just for being addictive when you have caffeine and alcohol freely available. Of course, that’s never stopped the government before…

        1. Right. It’s rather decidedly known/understood that the ancillary combustibles in cigarettes are largely responsible for cancer, emphysema, etc. Nicotine isn’t very carcinogenic at all and is only really bad (if at all) after 20+ yrs. of constricting your arteries with it on a daily basis. And the secondhand nicotine components are on par with natural consumption of nightshade-family plants (i.e. one shift sucking down secondhand vaping products would be akin to eating one serving of eggplant marinara nicotine-wise).

          It would be even more specifically/blatantly about behavior control and just fucking with people rather than any sort of positive outcome.

    3. And the actual evidence that nicotine is “addictive” is pretty thin.

  2. I saw Altria stock was down nearly 20% for a while. Would have been nice to shift my whole Roth IRA into it at that price. Maybe the feds will give them a future monopoly on non-cigarette nicotine delivery.

    1. Maybe the feds will give them a future monopoly on non-cigarette nicotine delivery.

      Well their Mark VII e-cig sucks, so unless they acquire some other e-cig manufacturers, that would be a bad thing.

  3. Prog media take on this: “Trump’s FDA helps Big Tobacco hook more teens on vaping.”

    The NYT should pay me to write headlines for them.

  4. to apply for permission to keep their products on the market

    Fuck off, slaver

  5. It’s simple, FDA lawyer told them they could face a big classe action in 10 years if it is prooved e-cig saved thousands of life.

    1. Actually, I read some where that an e-cig prototype was developed as early as 1963 but would have been far too expensive to bring to market at the time. Some enterprising lawyer might make a case that they had this technology for 50 years and knew it was safer, but kept on selling cancer sticks instead.

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  7. I make my own fluid. Nicotinic acid is readily available from most chemical supply houses. So is propylene glycol and glycerine. If they make it illegal, I’ll make a fortune on the black market.Currently it costs me less than $10 to create the equivalent of a carton of cigarettes.

  8. “If the FDA is serious about making “less harmful sources” of nicotine “the cornerstone of our efforts,” it will develop transparent, straightforward, and practical criteria for approval of current and new vaping products.”
    No. I do not need nor have I asked for the government’s permission to inhale vapor. They can fuck off.

    Having said that, Trump has fucked up everything he has touched except regulation. This is very good news indeed.

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