FDA Will Regulate E-Cigarettes As Tobacco Products

On Monday the Food and Drug Administration said it will not challenge a federal appeals court ruling that prevents it from banning electronic cigarettes as unapproved pharmaceutical products. In December a panel of the U.S. Court of Appeals for the D.C. Circuit agreed with U.S. District Judge Richard Leon that e-cigarettes are properly regulated as tobacco products, since the nicotine in the vapor they produce is derived from tobacco. The FDA unsuccessfully sought review of that decision by the full court, and now it says it is ready to comply rather than appeal to the Supreme Court. In a "stakeholder" letter dated April 25 (the deadline for appealing the D.C. Circuit's ruling), the FDA says e-cigarettes will be "subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for 'new tobacco products' and 'modified risk tobacco products.'"

Although it should be easier for e-cigarettes to stay on the market as tobacco products than as "drug/device combination products," the practical implications of the FDA's new policy are not completely clear. Under the Family Smoking Prevention and Tobacco Control Act, which Congress enacted in 2009, tobacco products that were on the market in the U.S. prior to February 15, 2007, are grandfathered and cannot be banned by the FDA. That provision also covers "substantially equivalent" products. Judging from a Nexis search, e-cigarettes were first sold to Americans in 2007, but there are no references to them as a product available in the United States as early as February of that year. Assuming e-cigarettes don't qualify for the grandfather clause, they would have to be approved by the FDA as "new tobacco products" or as "modified risk tobacco products." In either case, the FDA has substantial leeway to bar their sale.

The FDA can approve a "new tobacco product" only if it determines that doing so "would be appropriate for the protection of the public health." It is supposed to make that determination "with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products."

A "modified risk tobacco product"—one that is "sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products"—has to meet the same standard. The FDA also has to decide, based on evidence presented by the manufacturer, whether the product would "significantly reduce harm and the risk of tobacco-related disease to individual tobacco users." But the latter determination is not decisive, since a product could be safer (as e-cigarettes clearly are) but still be deemed bad for public health based on predictions of how consumers will respond to it. If, for example, a new cigarette is half as hazardous as existing cigarettes but the FDA thinks that fact will encourage every American to start smoking, it might decide that the net result of allowing the product on the market will be more smoking-related disease, even though the risk for any given smoker is a lot lower. Given the enormous difference between the health hazards posed by conventional cigarettes and the health hazards posed by e-cigarettes, which deliver nicotine without tobacco or combustion products, it is exceedingly hard to argue that e-cigarettes fail this collectivist calculus. But that does not mean the FDA won't try.

More on e-cigarettes here.

[Thanks to Russell Wishtart for the tip.]

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  • ||

    Smokers must be punished and shunned. Therefor, these devices must be banned.

  • Otto||

    Any product the FDA doesn't regulate is obviously inherently harmful.

  • Paul||

    *cough*war on drugs*cough*

  • ||

    Another win for e-ciggs! Word has it will take the FDA a couple of years to do their studies/analysis, in the interim e-cigg sales can continue unimpeded. Look for big Pharma to increase their lobbying efforts against e-ciggs as they continue to poach their nicotine therapy sales. Another prediction, look for big Tobacky to enter the e-cigg market.

  • PV User||

    Sadly, this is the best us ecig users could have hoped for. Two years from now I fully expect that much of this industry will be handcuffed and ripped of its diverse and competitive spirit. In the meantime, I fully plan to stock up on supplies.

  • Paul||

    If you care about protecting your right to vape, I recommend becoming a member of the Consumer Advocates for Smoke-free Alternatives Association.

  • STEVE SMITH||

    OH, RIGHT TO VAPE. STEVE GET ALL EXCITED FOR NOTHING.

  • ||

    I, for one, am still trying to figure out why e-cigs are banned on airplanes.

  • Government||

    Because I said so . . . .

  • LarryA||

    Doh. Because they're electric. If you light up the airplane will fall out of the sky. That might hurt.

  • Zeb||

    The only reason I can think of is that people using the e-cigs are somehow getting away with something. And the smoker haters can't stand it.

    I would think that airlines and airport management would want to go out of their way to allow smokers to get their fix so they can have slightly fewer outraged people to deal with. But no, it's more important to punish smokers and make them go through security every time they want a smoke. Seriously, how fucking hard would it be to build a smoking lounge with super-duper ventilation. IT's just nuts. All of the smoking regulation is about nothing but punishing smokers.

  • ||

    I live very close to Greensboro, NC. The major airport there did indeed have a state-of-the-art smokers lounge for years. I'm sure it cost thousands but after the TSA came in, they were forced to close it. Go figure......

  • Resto Druid FTW||

    I buy the non-nicotine juice... WTF? I'm sitting in my office right now puffing away on my ecig (specifically a mixture of bing cherry and vanilla cola from viking vapors).

  • ||

    Please note that e-cigarettes are NOT subject to any of the regulations in Chapter IX of the FSPTCA.

    While the FDA may propose applying some Chapter IX regulation to e-cigarette products and/or other unregulated tobacco products (i.e. cigars, pipe tobacco and nicotine gums, lozenges, patches, skin creams, nasal sprays, etc.), the FSPTCA requires the FDA to determine (based upon scientific evidence) that any new tobacco regulations are necessary to reduce tobacco disease/death and/or tobacco usage.

    Since there is no scientific evidence that e-cigarettes or other smokefree nicotine products have harmed users, it will be very difficult (if not impossible) for the FDA to determine that any newly proposed regs are necessary to protect public health.

    Besides, of the currently unregulated tobacco products, cigars and pipe tobacco are the only ones that have been found to be harmful.

    It will take several years for the FDA to promulgate any newly proposed tobacco regulations, and it is likely to be many months before the FDA proposes regulations for unregulated tobacco products.

    In the mean time, e-cigarette sales are likely to continue skyrocketing.

  • ||

    e-cigarettes are properly regulated as tobacco products, since the nicotine in the vapor they produce is derived from tobacco.

    So, an e-cig that got its nicotine from something other than tobacco would be free of the FDA?

    Interesting.

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  • VaporGod||

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  • Russ Wishtart||

    Jacob Sullum will be appearing on the internet TV show Click, Bang! tonight (5/1) at 8:00 EST to talk about these new developments and other electronic cigarette news. If you would like to watch, just click this link anytime after 8:00 - http://vapetv.com/index.php?t=vapetvlive

  • Russ Wishtart||

    If you missed the live broadcast of Jacob Sullum on Click, Bang! you can catch the replay by clicking the link below. Jacob comes on at the 14 minute mark.
    http://www.stickam.com/viewMedia.do?mId=191371808

  • Dawn||

    That the FDA wants to regulate e-cigarettes just like cigarettes is ridiculous. Without any second-hand smoke, which is what the smoking ban was supposed to be about, they have no standing. I find e-cigarettes to be a great product!

  • Jim||

    I'm sick and tired of the government meddleling in my life! Not only with tobacco, but in all things! I think they have too much time on their hands!

  • nichoel ||

    I for one love my ecigs and physically feel the same as if I had quite smoking altogether. I can smell, walk up stairs without getting winded, no longer deal with "morning dry mouth" and have stopped coughing all of the time. I have been using them for 2 years and have yet to experience ANY dizziness, nausea, or any of the other things I have read about. LOL

  • how smoking causes cancer||

    Hi, I really appreciate this blog and this is a wise step to create awareness among people about tobacco and smoking facts. Thanks.

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