Public Health

Federal Judge Rebukes FDA for Seizing E-Cigarettes

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Yesterday a federal judge granted a preliminary injunction to electronic cigarette manufacturers who are fighting the Food and Drug Administration's seizure of their products as "an unapproved drug-device combination." U.S. District Judge Richard Leon concluded that the two companies, NJOY and Smoking Everywhere, have a substantial likelihood of prevailing against the FDA's claim that it has authority over e-cigarettes under the Food, Drug, and Cosmetic Act (FDCA). Leon suggested that e-cigarettes, battery-powered devices that deliver nicotine vapor, instead are covered by the Family Smoking Prevention and Tobacco Control Act, the 2008 law that authorized the FDA to regulate conventional cigarettes and other tobacco products. The act defines a tobacco product as "any product made or derived from tobacco that is intended for human consumption." Since the nicotine in e-cigarettes is derived from tobacco, this broad definition certainly seems to fit. More to the point, e-cigarettes are marketed as a smoke-free alternative to cigarettes, not as a medicine or even as a smoking cessation tool.

The FDA argued that e-cigarettes qualify as drug delivery devices under the FDCA because they are intended to affect the structure or function of the human body. Leon noted that the agency had used the same argument when it unsuccessfully tried to assert authority over conventional cigarettes under the FDCA, a gambit that was shot down by the Supreme Court:

This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable.

Leon also was not impressed by the FDA's argument that the public health benefit from blocking importation of e-cigarettes outweighs the costs imposed on the industry:

While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.

In fact, as I've noted before, there is no question that puffing on a smoke-free e-cigarette is much less hazardous than lighting tobacco (or anything else) on fire and sucking the combustion products into your lungs. This is a point so obvious that only the FDA and a certain brand of zero-tolerance anti-tobacco activist would try to deny it. Assuming that e-cigarettes do end up being regulating under the Family Smoking Prevention and Tobacco Control Act, Michael Siegel argues, the law allows them to remain on the market as a pre-existing tobacco product, provided their manufacturers stop talking about (or implying) their safety advantages. Under one of the law's many destructive, consumer-hostile provisions, that sort of comparison would render e-cigarettes a "modified risk tobacco product," meaning they could not be sold until their manufacturers had met a prohibitive burden of proof.

Leon's ruling is here (PDF). Previous coverage of e-cigarettes here.

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  1. Sounds like all the FDA has to do is change their legal cite from the FDCA to the Family Smoking Prevention and Tobacco Control Act, and they are good to go.

    Do they have less authority to act under the latter? If not, this whole exercise seems pointless (aside, of course, from the legal bills it has generated).

    1. Read the post again. Read it slowly. Read all of it.

      1. Oh yeah, the last paragraph. Got it.

        1. I’m curious. Given what you just wrote, why do you post on a Libertarian site? Doesn’t seem like the proper fit. download wall street: money never sleeps | download you again

  2. brotherben|1.14.10 @ 6:42PM|#
    Threadjack: judge rules against FDA on e-cigarettes

    No hat-tip?

    Good thing I’m obese enough to chest bump myself.

    1. Is that why you don’t work? Because you’re fat???

      1. I am fat because you work so hard that you pay too much in taxes which so the gubmint keeps giving me more of your money. It is your fault that I have gotten fat. Now, I’m gonna need even more handouts to combat my obesity disease so get back to work and stop wasting so damn much time on the interweb.

        1. I’m curious. Given what you just wrote, why do you post on a Libertarian site? Doesn’t seem like the proper fit.

          1. anonymous guy has been busting my chops for a month or two for recieving a govt. disability check instead of being a productive worker. I was being snarky for his/her benefit. I don’t in any way believe what I posted at 12:42p.m. I am, it is true, fat.

            1. So you’re saying there’s no way for you to be a productive member of society? Is that a permanent situation?

              1. Asked respectfully, BTW.

                1. My health problems and their symptoms preclude me from doing any work outside the home. My wife and I have been making jewelry and marketing it locally. It’s a slow starter for now. I have been doing some writing and am looking into work from home jobs that can be done online. I don’t consider my govt. check to be a permanent solution. It has been a necessary evil to support my family. FWIW, I was injured on the job and the private carrier of worker’s compensation stopped paying disability and refused the surgery that was requested by the doctor they picked to treat me. I certainly don’t mind explaining my situation but have grown weary of the anonymous dude’s stupid comments about me living on the dole. Concerning my posting on a libertarian site: I was a rabid liberal when I arrived here 3-4 years ago and have slowly turned in the opposite direction. My change of heart has been influenced by many great conversations on here as well as lots of reading that was suggested by commentors here.

                2. I had a long reply and the squirrels ate it as spam. My health precludes working outside the home. I have a couple things going from home to earn money and I’m looking into some work from home things. I don’t see the govt check as a long term solution but it was necessary to keep a roof over my family’s head. FWIW, I was injured at work and the work comp carrier refused the surgery that their doctor requested. The way the law is written in Alabama, with a declaration of medical stability (I’m as good as I’m going to be) the work comp has no further obligation other than paying for my long-term pain management.

                  I arrived at this libertarian site as a rabid liberal about 3-4 years ago. Through some great conversations and heated arguments, I have slowly leaned increasingly to the right. I also have done a bit of reading about economics that was suggested by commentors here. It has given me a much better understanding of how this country is designed to work.
                  I don’t mind answering questions about my health. I just have gotten tired of being maligned for reciving assistance. We have safety nets for a reason. I don’t consider it a long term safety hammock.

    2. Does that mean you can clap with your mantits?

      1. Depends on how much cash you have there big fella ; }

  3. Even if e-cigs are granted legal status by our benevolent overlords, who wants to bet that they’d be outlawed in businesses, restaurants, public transit, within 1000 feet of a church, playground, school, 7-Eleven, traffic light, sidewalk or Starbucks?

    1. Being a somewhat optimistic person and seeing that regular cigarettes are not subject to such restrictions (where I live anyway), I will not take that bet.

      1. You can smoke in businesses and restaurants and buses where you live? Is it a “red” state by any chance, or a whole other country?

        1. where i live they have just passed the no smokin nowhere rules. have convinced one bar not to give in and have funds for first several tickets. It is a two and a half hour ferry ride to court. And i am positive noone will go to testify. after a few tickets get written and cannot be prosecuted we believe we will be left alone to smoke in peace.

  4. e-cigarettes are advertised extensively on satellite radio. The ad actually says something like “We can’t say our product is much safer than smoking, but you do the math”. It’s just like making “campaign” ads illegal.

  5. Dude, this is like totally insane.

    RT
    http://www.online-anonymity.se.tc

  6. Sine any honest person with an IQ above room temperature would recognize that e-cigs are safer than conventional ones, I’m force to conclude the bureaucrats at the FDA are more concerned with expanding their fiefdom than they are about reducing the harm to people who chose to ingest nicotine.

    Benevolent government my ass.

    1. It’s mostly that, and a tiny bit a convoluted argument that “if people realize that e-cigs are safer, then they’ll start smoking them when maybe they would be scared away from nicotine entirely, and that could be bad for their health, and also maybe would lead to them smoking real cigarettes.”

      But mostly it’s that the FDA really hates the idea that anything’s outside their purview. They make it illegal to make factual claims about a product if you haven’t run in by them first. Particularly if you include numbers.

    2. Actually, a lot of smart e-smokers concede that e-cigs are only probably safer than cigarettes. The manufacturers’ characterizations of e-smoking chemistry sound fishy, and nobody has a great deal of confidence in the quality control of the e-fluid makers. We simply ask for the right to make up our own minds.

  7. Government, save us from ourselves!!!

  8. I wonder how hard it is to make synthetic nicotine. If that were economical, they could dodge the whole tobacco product thing.

    1. They could also dodge it by stating that nicotine is an alkaloid found in the nightshade family of plants. This includes but is not limited to: Tobacco, potato, tomato, aubergine or eggplant and chili pepper.

  9. The FDA argued that e-cigarettes qualify as drug delivery devices under the FDCA because they are intended to affect the structure or function of the human body.

    Like coffee makers?

    1. Like coffee makers?
      More like straws.

  10. Between this and the MA court decision that the state’s winery protectionism is illegal, I am surprised to find so many judges (that is to say, 2) who can use their gavel for something other than a rubber stamp.

    Woot from the Commonwealth’s North Shore.

  11. Hmmm, looks enjoyable but doesn’t conform to my view of how people should enjoy themselves.

    BAN!

  12. It is interesting to look at the history of tobacco over the past 3 centuries. It’s always been about money and control for the government. E-cigs are a great way to break the chains of addiction. I got one about 6 months ago from SafeSmokes.net in Michigan, just after they raised taxes on cigs by a $1 per pack. For under $40, I got the starter kit and haven’t had a cigarette since. I use the e-liquid to refill the cartridges and have saved thousands of dollars compared to my old 2 pack a day habit. If you are serious about quitting once and for all…check it out for yourself.

  13. just curious but… would using synthetic nicotine, or nicotine derived from other plants (many plants in the Nightshade family produce nicotine) be a way to get around the FDA’s controls on tobacco?

    1. Probably. But just long enough for you to sink a huge investment into the process. Then the nannys would change the law and leave you holding the bag.

    2. No. Then it would be a drug or delivery device requiring FDA approval that would be prohibitively expensive to get.

      1. why couldn’t it be a vaporizing device for an herbal supplement extract, that would mean they could barely regulate the damn thing.

    3. No, the more actual science you employ, the more likely the FDA is to crack down.

  14. This is great news, Chaulk one up for the little guy.

  15. What the FDA fails to understand is the comparison of e-cigs to tobacco cigarettes is what should be considered. Most informed e-cig users are not claiming they are 100% safe. The FDA press release did not say that e-cigs have 1/1400 the amount of nitrosamines as a cigarette and none of the tar and other carcinogens. So, if they’re only 99% safer than cigarettes, wouldn’t you prefer your loved one to switch? I do. That’s why we sell them at http://www.discountsmokestik.com

  16. The government only wants what’s best for us. (tongue so far in cheeck I’m gagging )

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  18. the FDA is just looking to get there money from e-cigs….however, there not doing so well.

    e-cigs are not going anywhere thank god.

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  21. I would think so, however this is specific to the state of Washington and the judge lives in California, however he is a Federal judge. On the County website it says an out of state judge cannot perform a marriage however it doesn’t say if that means out of state state judge or out of state federal judge.

  22. Thanks for updating us with the nice information…

  23. instead are covered by the Family Smoking Prevention and Tobacco Control Act, the 2008 law that authorized the FDA to regulate conventional cigarettes and other tobacco products.

  24. E-cigs are very common nowadays, It takes away almost half of the harmful chemicals in a conventional cigarette. Quitting smoking is really hard and this would make a good substitute for a cig. The FDA is just looking for a way to juice out money out of e-cigs. I’ve seen lots of e-cigs on the net and I found the Luci E-cig it looks really cool on black. Has anyone tried this?

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  26. While FDA’s interest in protecting public health and safety is, in the abstract, paramount to plaintiffs’ purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public.

  27. the Second Amendment stated that RKBA was not to be infringed, and lacked detail as to by whom, and therefore applied to all government.a

  28. If everyone switched to electronic cigarettes the amount of deaths in the US would be reduced from 400,000 to about 4,000. Nicotine is as harmless as caffeine for the most part.
    Even our president now has his own electronic cigarette given to him by the Wendy Williams show for his birthday.
    President Obama’s Electronic Cigarette (ecig)
    Personally I like my Eluma ecig. It’s the best in my opinion.

  29. If everyone switched to electronic cigarettes the amount of deaths in the US would be reduced from 400,000 to about 4,000. Nicotine is as harmless as caffeine for the most part.

  30. its time that the FDA leaves the ecig community alone. Its getting very tiring seeing these stories come about when there is nothing wrong with electronic cigarettes and they are just being swaded by the fatcat tobacco companies

  31. the fda is so evil they only listen to the fatcat tobacco companies

  32. this site sucks and the comment process is a joke I hope this site gets buried in google

  33. A cigarette (French “small cigar”, from cigar + -ette) is a small roll of finely-cut tobacco leaves wrapped in a cylinder of thin paper for smoking. The cigarette is ignited at one end and allowed to smoulder; its smoke is inhaled from the other end, which is held in the mouth.

  34. Really this article is awesome because FDA has all the rights to ban a new product but if it is against to peoples means they have all the rights but this product is an good alternative for smoking peoples. thanks for sharing the post and this is the best way to quit smoking.

  35. This is the best post on this topic i have ever read.I am really very impressed with it.Keep blogging.

  36. I only hope that the FDA will take this issue seriously and complete the necessary studies. The people here in Kentucky and everywhere deserve a safe alternative! It isn’t easy to quit something that has been an addiction for many years for many people. Now that we have a safer alternative, of course it will have insurmountable controversy associated with it! To those that are trying to reduce their smoking habit or quit all together, I highly recommend trying any of the reputable e-cig companies out there. You don’t have to spend a fortune to try an electronic cigarette. I first tried what is called a disposable e-cig from http://www.vaporconcepts.com and after being impressed, I ordered a starter kit and haven’t looked back since.

  37. I am a Medical doctor, I presented this information to the Egyptian Medical Association, and I am suing them with the association’s support. I am also covering the case in the local newspapers to embarrass them. The ruling on the Injunction which is basically a ruling confirming Judge Leon’s Opinion that it is Tobacco, will be very helpful.
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  38. Since I see people posting coupons etc.. If anyone decides to buy an e-cigarette, don’t be sucked in by any free trial, nor by any company that charges more than $20 for a battery or any that does not sell blank cartridges. Do your own research and buy a good model under its original name from a good multi-brand vendor.

  39. I suggest going to

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    and if you want an E-cigarette.

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  40. IF THIS MADE YOU WANT TO BUY AN E-CIGARETTE DO NOT PAY MORE THEN 40$ FOR A KIT.

    a kit that include 2 batteries and 2 atomizers.

    go to http://www.e-cigarette-forum.com/forum/

    for more info

  41. IF THIS MADE YOU WANT TO BUY AN E-CIGARETTE DO NOT PAY MORE THEN 40$ FOR A KIT.

    a kit that include 2 batteries and 2 atomizers.

    go to http://www.e-cigarette-forum.com/forum/

    for more info

  42. The FDA is everywhere these days and they are taking e-cigs to a whole different level. The government is slowing destroying the US as we know it today. It’s no wonder why nothing is manufactured here anymore.

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  48. Although the electronic cigarettes are not completely safe and healthy, but in comparison to ordinary cigarettes they are much more healthier.
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  49. I think the ecigs are healthier.

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  51. the FDA is just looking to get there money from e-cigs….however, there not doing so well.

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  52. Probably. But just long enough for you to sink a huge investment into the process. Then the nannys would change the law and leave you holding the bag.

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