Thursday, July 25, 2013

Are nicotine e-cigarettes a tobacco product?

I frequently see vapers arguing that e-cigarettes are not a "tobacco product," because they do not actually contain tobacco. They argue that nicotine e-cigarettes are not the same as tobacco or smoking cessation products and should have a classification all of their own.

However, nicotine isn't regulated in the U.S. by what form it takes, but instead by "intended use."

If the nicotine is contained in a product with an "intended use" as a smoking cessation or other treatment, it is then regulated as a "drug" and must go through clinical trials, studies, etc., and the product must meet strict manufacturing protocols before release to the public. If the nicotine is contained in a product with an intended use of "recreational" (ie. intended for human consumption but not as a treatment of any kind) it is regulated as a tobacco product. (A third classification is a pesticide, but that form of nicotine is not allowed for human consumption.)



It was this "intended use" criteria which kept the FDA from being able to deem non-therapeutic e-cigarettes as unapproved drugs. Judge Leon gave the opinion in Sottera, Inc vs. FDA that so long as the manufacturer/retailer made no treatment/health/therapeutic claims, they weren't considered a drug. But that meant the only other option was "tobacco product." The FDA defines a "tobacco product" as any product that not only contains tobacco leaf, but also any derivative (ie. "a compound derived or obtained from another and containing essential elements of the parent substance") of tobacco. Nicotine is clearly a "derivative" of tobacco and while it is also a derivative of other plants, the nicotine in e-liquid is currently all derived from tobacco. However, since nicotine is classified by "intended use" and not the source, even nicotine from other plant material could be deemed a substantial equivalent and treated exactly the same as tobacco-derived nicotine, because of it's intended use. It's obvious to everyone that we use e-cigarettes with the same "intended use" as other tobacco products - mainly, the same way we used to use traditional cigarettes. It may be a far safer form of recreational nicotine use than regulators never foresaw, but it is still technically "recreational use" of nicotine derived from tobacco.

It's important to note that the only "bad" things about being considered a tobacco product is 1) the public perception that all tobacco products are equally harmful and 2) the threat that the FDA will regulate them as if all tobacco is equally harmful. Educating the public and correcting this perception and convincing the FDA and politicians not to regulate low-risk tobacco products identically to high-risk products is the ultimate goal of many smoking alternative advocates. Changing perceptions and exposing the lie that there "is no safe tobacco product" will also go a long way towards gaining social acceptance. Something many vapers often overlook is that if the public still believes that all nicotine use should be discouraged because it's equally dangerous or just socially unacceptable, then it won't matter if e-liquid gets a separate category. They will just regulate that "e-cigarette category" as strictly as tobacco or possibly worse. We could end up with less hoops to jump through than drug products, but far more than if we are a tobacco product.

Consider the fact that a tobacco product such as snus already has reams of scientific data showing it is an extremely low-risk product. There is far more evidence of relative safety of snus than there is for e-cigarettes, yet the product is still banned in the EU and anti-tobacco zealots in the U.S. continue to attempt to regulate snus as if it was a deadly product. Yes, it is clearly a tobacco product (as it obviously contains actual tobacco leaf) but it just demonstrates the fact that actual public health risks and science is in no way dictating reasonable regulation. Regulation is obviously being pushed by an ideological opposition to recreational tobacco and nicotine use rather than science and reason. There is no reason to believe that separate e-cigarette regulation would be treated any differently by these people. In fact, a brand new category could prove to be a gift to the anti nicotine and tobacco zealots, as it could give them a blank slate for far more restrictive regulation than currently available to them for tobacco products. The point being, tobacco product or not, we would still be in the position of arguing that there is nothing wrong with recreational tobacco and nicotine use either way.

The chance that the FDA will treat a product that is derived from tobacco and used like tobacco as a whole separate category, with fewer rules and regulations than tobacco, is extremely slim. Especially if the public continues to believe that the ultimate goal in smoking cessation is eliminating the nicotine addiction instead of eliminating exposure to smoke.

Yes, e-cigarettes are going to be classified as a tobacco product, but the point being missed by many vapers is that there shouldn't be anything wrong with that. What is wrong is how low-risk tobacco products are being irresponsibly regulated with prohibitionist ideology and lies instead of fact, science and reason. If we don't change that, e-cigarettes won't stand a chance no matter how they are categorized.

(Postscript: It has been brought to my attention that some folks may suspect this post was written in reaction to a recently broadcast, e-cigarette related internet show. The timing of this post is purely coincidental. This blog post was actually inspired by (and largely uses) my post on the ECF forum. )

22 comments:

  1. The other "bad" thing about it being classified as a tobacco product is that many states will then move towards taxation accordingly which will in many cases result in the same percentage of tax on the nicotine containing liquids.

    ReplyDelete
    Replies
    1. I agree, Aaron, yet more reason to distinguish between high-risk and low-risk tobacco products. Many states reasonably tax smoke-free tobacco at a much lower rate than cigarettes, which are perceived to be the cause of nearly all "tobacco-related" diseases. The argument remains the same, in my personal opinion: states treating low-risk products the same as high-risk products (ie. "sin taxes") is wrong. I truly believe if we stopped that unethical practice, it wouldn't matter if e-cigarettes were tobacco products because low-risk tobacco products wouldn't be unfairly taxed either.

      But you are right, Aaron. We have been forced to argue that e-cigarettes aren't the same as tobacco products at the state level to fight taxation, licensing and sales restriction. But the basis for that is that they are low risk and the same can be said for many smoke-free tobacco products.

      Delete
  2. A cake contains flour. So does bread. A cake is not bread. Enough said.

    ReplyDelete
    Replies
    1. One could argue however both cake and bread are part of the same family of wheat based bakery goods.

      As an aside the same argument suggests that traditional "replacement" products such as gum or patches should fall under the same tobacco classification, as the source of the nicotine is more often than not, the tobacco plant.

      Delete
  3. I think legally any attempt to say it isn't a tobacco product is going to fail. Congress has given the FDA authority over these products. And it is Congress an appeal to common sense should be made.

    I still want to see someone litigate over whether it actually IS a tobacco product. It's a losing battle obviously but litigation can buy us more time.

    ReplyDelete
    Replies
    1. See, that's just the problem. Congress has given the FDA the power to decide what they have authority over. THAT is a problem.
      I now deem myself the King of the United States! It's just as valid....

      Delete
  4. I have used a e-cig for 8 weeks now but i have used it as an aid to quitting smoking. I have slowly been able to reduce my nicotine intake and have also been able to use my e-cig in such places as buses,restaurants,pubs,bars and even theatres & cinemas with no problems. These things are great as an AID to quitting just like the patches but better as you have the added help of seeing is believing "The Vapor" keeping my fingers busy, not to mention a very nice range of E-juice flavors comes in :D :D It is just the beginning of a very long and rocky road for these things but i for one will be stocking up on essentials to keep mine running for the future before the Governments bang a huge TAX on top of these as well, thus again making is cheaper to keep smoking rather than to use the aids that are out there to help you stop but for a much bigger in some cases price to pay..

    ReplyDelete
  5. I don't think people had too much choice at the time.
    The way the FDA was going to regulate the industry was either going to destroy it utterly (look at the E.U right now) or it was going to regulate the industry like it regulates tobacco.
    IMO neither was an ideal choice but I think there is value in the ideas people have given voice to and I don't dismiss the idea.
    I would ask if there are ideas in how to lobby the FDA to change it's regulatory stance on things?
    I think that might be the largest obsticle.
    Does anyone know any lawyers?
    I think in the short term at least they might be necessary to get this sort of campaign up to speed.
    It's a very short time until October when they said they would show us their regulations.
    So maybe we should fundraise to hire a good team to help with that.
    What do you think the next step is in getting this off the ground?

    ReplyDelete
    Replies
    1. It would be a waste of time to try to change the regulatory stance of the FDA. It's going to fail. Thinking that it has any chance of success is naive at best. The FDA are simply following the Family Smoking Prevention and Tobacco Control Act of 2009. You need to change the law as there is no category that e-cigs could be classified in but tobacco or medicine as the law stands.

      There is one other classification and that is a modified risk tobacco product (still a tobacco product). Getting classified as a modified tobacco product would cost millions in studies and is essentially impossible as it is nothing more then a catch 22 bureaucratic nightmare.

      My feeling is people are trying to run away from tobacco largely because they have fallen for the decades of demonization about tobacco. It's more an act of self-loathing then a rational approach.

      Delete
  6. Being classified as a tobacco product will be more better than being banned.The e-cigarette should ensure to survive and then kick the traditional cigarette off

    ReplyDelete
  7. As soon as ECigarettes are classified as tobacco products, they will be regulated under the tobacco laws. This means: No advertising, no flavoring and a max amount of nicotine per ml.
    Thats it - nothing more to say.

    ReplyDelete
    Replies
    1. Not true Rursus. There likely would be advertising restrictions, but not necessarily flavorings and limits on nicotine content. There are no bans on flavorings of smokeless tobacco which e-cigarettes are much closer related to then cigarettes. Smokeless tobacco also has much lower federal tax rates then cigarettes.

      Delete
  8. Great blog. Just found it, thanks to a link on the CASAA site, and really enjoying reading your well-crafted and well written arguments, exposing a lot of the nonsense that is spoken and printed about e-cigs.

    ReplyDelete
  9. This comment has been removed by a blog administrator.

    ReplyDelete
  10. Just to throw something into this mix.... most of us vape to get nicotine.. so why cant they view them as supplements, just like vitamins & diet pills?

    ReplyDelete
  11. Until they come up with legitimate justification that warrants regulation, they can go pound sand.

    I do not recognize regulations made for no reason, nor authority of those who make them. Liberty.

    ReplyDelete
  12. Any thoughts on nicotine patches? Are they any good?

    ReplyDelete
  13. Unfortunately, my health insurance has just adopted a policy of adding a surcharge for using tobacco products. I have to read it carefully, but if it says "smoking", am I in the clear as a vaper?

    ReplyDelete
  14. Great blog. E cig dosenot contain tobacco that why most people are left traditional cigarette & move to e-cig.

    ReplyDelete
  15. Absolutely right, great informative post about the FDA role in controlling the tobacco products.

    ReplyDelete