E-cigarettes

The FDA's Deadly E-Cigarette Regulations

The agency's new rules threaten products that offer a much safer alternative to smoking.

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Announcing onerous new regulations for e-cigarettes last week, the Food and Drug Administration claimed "FDA is taking this action to reduce the death and disease from tobacco products." If that were true, the agency would not be threatening to destroy an industry that offers lifesaving alternatives to conventional cigarettes.

Last month the Royal College of Physicians recognized that e-cigarettes have "the potential to prevent almost all the harm from smoking in society." But as far as the FDA is concerned, that's not good enough.

After the FDA's regulations take effect on August 8, e-cigarette companies will have two years to make the case that letting their products remain on the market is "appropriate for the protection of public health." If they hit that deadline, they will be allowed to continue selling their products for another year while the FDA reviews their applications.

The FDA is not promising to respond within a year, however, and if it doesn't the products will be "subject to enforcement action." The FDA might make an exception if "review of a pending marketing application has made substantial progress toward completion," meaning the survival of e-cigarette companies depends on the efficiency and benevolence of an agency not known for either.

Each application is expected to cost $1 million or more, and a separate application is required for every product variation. That requirement will be fatal for thousands of vape shops across the country that offer a wide variety of custom-made e-liquids in different flavors and nicotine strengths.

The regulations also doom businesses that let customers assemble their own vaporizers by choosing batteries, tanks, and heating elements, because the FDA wants information on how every possible combination interacts with every possible e-liquid. Similarly, the FDA wants to know how every e-liquid interacts with every vaping system, and it expects applicants to compare the health risks posed by their products to those posed not only by cigarettes, which are indisputably much more dangerous, but by "similar products in the same category" and by "never using tobacco products."

Even the few companies that can afford to file applications may not be able to persuade the FDA that their products should stay on the market. In making that judgment, the agency will take into account "the risks and benefits to the population as a whole," including not just smokers who switch to vaping but nonsmokers and former smokers who try it, like it, and eventually switch to the real thing.

There is little evidence that e-cigarettes are making the conventional kind more popular. To the contrary, vaping and smoking rates are moving in opposite directions among both teenagers and adults. But if the FDA expects e-cigarette companies to prove their products will never be a "gateway" to smoking, it is asking for the impossible.

Likewise if the FDA expects large clinical studies showing that particular e-cigarettes help smokers quit and reduce the health risks they face. The agency is sending mixed signals about whether such prohibitively expensive and time-consuming studies will be required.

The FDA says "valid scientific evidence other than controlled studies," such as "well-designed laboratory testing," might be acceptable, and new research might not be necessary if "there is an established body of evidence regarding the public health impact of the product." But it also says "nonclinical studies alone are generally not sufficient to support a determination that marketing of the product is appropriate for the protection of the public health."

In a vaping industry that includes at least 186 manufacturers and 14 importers as well as 4,250 vape shops mixing their own fluids, only the largest businesses can hope to meet the FDA's demands. Even if some fraction of the industry survives, the regulations will dramatically reduce competition and consumer choice, raise prices, and deter innovation.

Old-fashioned cigarettes, meanwhile, face no such barriers. In the name of public health, the FDA is protecting the deadliest nicotine delivery system from competition with one of the safest.

© Copyright 2016 by Creators Syndicate Inc.

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  1. FDA’s bottomless pursuit of power harms people? You don’t say!

  2. Because fuck people being able to enjoy nicotine in ways that are undoubtably safer than the alternatives. Must enforce a puritanical mandate against hedonism to keep people miserable.

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  4. “FDA is taking this action to reduce the death and disease from tobacco products.”

    Reminds me of the old ice cream joke punchline.

    “There’s no F’in tobacco!!”

      1. (Story involving guy who keeps asking for chocolate ice cream when the ice cream shop is out of chocolate.)

        Can you pronounce the ‘van’ in vanilla?
        Can you pronounce the ‘straw’ in strawberry?
        Can you pronouce the ‘fuck’ in chocolate?

        There’s no ‘fuck’ in chocolate.

        That’s what I’ve been trying to tell you!

        There’s no tobacco in vaping. Just nicotine, and nicotine is not the bad part of smoking.

        1. I hadn’t heard that particular joke, hense not having understood that part of the reference.

          Thank you.

          1. In your defense, it’s not very good.

  5. the FDA wants information on how every possible combination interacts with every possible e-liquid.

    Why can’t the FDA just skate by like they do with everything else? That is, say “These statements have not been evaluated by the Food and Drug Administration.These products are not intended to diagnose, treat, cure or prevent any disease.”

    1. Because how would that give them the thrill of commanding productive people?

    2. Does the FDA trust Big Tobacco to provide this type of information on cigarettes, or does it do its own research? (I think I know the answer)

      1. “You *know* we don’t have the resources to do that!”

      2. It’s always on the applicant, which would be Big Tobacco in that case. FDA does its own research only in some very narrow areas.

    3. Because that was a special carve-out for dietary supplements, legislated in 1992 after a lot of lobbying of Congress by health food interests. It is, however, likely that vape fluids made from food organisms could be considered dietary supplements if the instruction is to puff on them, holding the vape in one’s mouth rather than primarily inhaling it.

  6. To me, this is just the precautionary principle carried to the government level – if the government has not explicitly given you permission to do something then you probably should not be doing it because there’s too great a risk that it’s going to be something dangerous. It’s the assumption that, even if the government doesn’t know everything, it knows almost everything, so much so that what it doesn’t know is almost certainly something nobody else knows either. You cannot be trusted to do things the government has not approved of because if the government has not studied it enough to approve it, it must be something nobody knows anything about.

    If you accept this sort of reasoning, you are all but worshipping at the Church of The Almighty State, and yet there are a hell of a lot of people who think just this way whether they realize it or not. There’s an automatic assumption that if the government is not regulating it, it’s almost certainly dangerous – just ask Uber or Bitcoin. They don’t have to point to any particular danger or harm, the lack of government regulation itself is prima facie evidence of danger and harm.

    1. One thing that continually amazes me is that you do not (yet) require government permission to procreate.

      1. They are running a pilot project at various universities.

        1. Good observation.

      2. The government won’t require permission to procreate because too many people like to have sex. Before passing pregnancy limits Congress would have to mandate free contraception for everyone.

        Oh, wait…

  7. #WithoutGovernmentWhoWould

  8. The FDA:
    Trying to top the NAZI’s one bureaucratic murder at a time.

  9. Well, if they ban it I guess I’ll just go back to smoking cigarettes. It seems that’s what they want me to do, possibly because of the heavy taxes on cigarettes. I doubt they give two shits about my health.

    1. I know you are joking, but I thought about going back to cigarettes too. The problem is that I don’t want to. I want to vape.

    2. because of the heavy taxes on cigarettes

      Ding! Ding! Ding! Ding! Ding! Ding!

      Follow the (tax) money.

      If Congress cared a flip about “public health” the ACA would provide “free” vaping kits along with the “free” contraception.

    3. Some states are imposing obscene taxes on e-cigs (nearly 100%), which cost nearly twice as much as a pack of smokes to begin with. They will get their money one way or the other.

  10. Dear FDA,

    Smoke THIS!

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  12. This whole thing (the Family Smoking Prevention And Tobacco Control Act- My family makes me want to smoke more, by the way…) seems like an anti-trust violation and not just for e-cigarettes. It pretty much blocks any new entrants into the market and protects the monopoly of the few big tobacco companies.

    I know the DC Circuit Court, where such a case would be heard, has been sympathetic to e-cigs before. Any chance somebody will bring a lawsuit and they will overturn this stupidity?

  13. The new regulations are a horror, a tragic mistake. They will

    force thousands of small businesses (vape shops) to close because their revenues come mostly from the sale of e-juice;

    enrich the large tobacco and pharmaceutical companies that, alone, will be able to afford to meet the FDA’s product-approval criteria;

    create a dangerous black market with all its attendant criminal horrors; and

    cause millions of deaths of people, including large numbers of underage people, who, rather than smoke the terrible tobacco- and menthol-flavored products offered by the large tobacco companies and approved by the FDA, will go back to smoking cigarettes that, unlike the far, far safer e-cigarettes, are ALMOST CERTAIN to kill them.

    Millions will die as a result of this FDA action. Inevitably. What a horror!

  14. Thank you, Mr. Sullum, for this timely and incisive article.

  15. A prog told me even smoking a zig zag rolling paper with nothing in it is bad and must be taxed regulated.

    That’s why the prog wants the reefer not re-legalized but taxed and regulated.

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  24. Having been told in detail about the new FDA regulations I admit they have obviously lost their collective minds (or been bought and paid for by very deep pockets). To use the same logic (term used loosely) they should also apply the regulations for alcohol to soda and fruit juice, the most common ingredients in a mixed drink. Obviously those are alcohol too. They also need to classify blenders as an alcohol product, ever make a frozen margarita without one? Let’s not stop there, ice needs to go on that list too, can’t have bourbon on the rocks without it. Why has no one pointed out the obvious to these tools? I am absolutely in favor of controls/regulations for vape products. Sale to minors should not happen. Pre made e-juice should be fully labeled as to its contents. Devices should meet safety standards or not be sold. Common sense takes you much further than knee-jerk reactions based on false science and opinion.

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