FDA Fuming Over E-Cigarettes

It’s been a busy week of letter-writing for the FDA. First, they sent out miffed missives to Canada Dry and Lipton over their questionable claims about their green tea drinks. Now the regulators are going after five manufacturers of electronic cigarettes for what the FDA alleges are illegal marketing tactics.

For those not aware of e-cigarettes, they are little battery-powered sticks that look like cigarettes but provide the user with vaporized nicotine instead of tobacco smoke.

What has the FDA riled up are claims made by ads for e-cigarettes that say e-cigarettes can curb or cure nicotine addiction. And according to the Federal Food, Drug and Cosmetic Act, any product that claims it can be used to treat a disease — in this case nicotine addiction — is therefore classified as a drug and needs to meet different standards for safety and effectiveness.

“We are interested in finding out whether e-cigarettes can be proven safe and effective. That is why we sent out the letter to the Electronic Cigarette Association,” a rep for the FDA’s Center for Drug Evaluation and Research explained.

The five companies receiving warnings from the FDA are: E-CigaretteDirect LLC; Ruyan America Inc; Gamucci America, also known as Smokey Bayou Inc; E-Cig Technology Inc and Johnson’s Creek Enterprises LLC.

Also peeving the FDA is the fact that some of these companies don’t limit their e-cigarette use to just nicotine, selling liquid versions of other drugs for purposes of vaporizing.

Writes Reuters:

E-Cig Technology, for example, markets the erectile dysfunction drug tadalafil, sold by Eli Lilly as Cialis, and a liquid version of the weight-loss drug rimonabant or Compal, a Sanofi-Aventis drug that never won U.S. marketing approval and was pulled from the market in Europe because of safety concerns.

FDA cracks down on 5 makers of e-cigarettes [Reuters]


Edit Your Comment

  1. Loias supports harsher punishments against corporations says:

    Aren’t there E-cigs that just have water vapor? Or is that these, and only expell water vapor?

    • humphrmi says:

      Inhale water vapor infused with nicotine. Exhale water vapor (and probably some excess nicotine).

    • El_Red says:

      Nope, some test were done in Canada. It has a lot of crap, including traces of window’s wash liquid.

      • nova3930 says:

        As opposed to tobacco smoke which is full of rainbows and puppy dog tails….

      • RvLeshrac says:

        Propylene Glycol is non-toxic. It is used to replace traditional antifreeze in things like home window-units, so that a leak doesn’t kill children or pets.

        It is also used in soap, perfume, etc. So if you have a problem with e-cigarettes containing “window’s wash liquid(?),” I hope you read every ingredient on every toiletry you purchase.

    • DjA says:

      There are some that have nicotine free vapor.


      However, from the website: “The vapor is primarily purified water, nicotine, propylene glycol and flavor.”

      So even if you take the nicotine out, you still have the propylene glycol, which is the stuff used in smoke/fog machines. You also have whatever is used for the flavor.

    • Big Mama Pain says:

      You can get cartridges that have no nicotine in them, but the water is flavored to simulate the taste of tobacco, so who the hell knows what’s in that!

  2. oldwiz65 says:

    Looks like the makers forgot to send in their contributions to the FDA gift fund.

  3. pantheonoutcast says:

    Thanks to e-cigarettes, I haven’t had, or wanted, a real cigarette in 3 and a half months. In fact, three people at my job quit smoking completely because of e-cigarette use. The company that I buy from does not make any such claim as to their product’s effectiveness in helping people quit. In fact, they go out of their way to say that their product is NOT intended to be a smoking-cessation product.

    I find it interesting that the FDA wants to regulate something that does a pretty damn fine job of helping people quit smoking, but the only regulations the FDA has for tobacco concerns the way that it is marketed.

    And by “interesting,” I mean, “fucking stupid.”

    • Loias supports harsher punishments against corporations says:

      Really? So, if it anecdotally helps smoking cessation, then by all means let it bypass the same regulations for all other smoking cessation products?

      And by the way, e-cigs still have nicotine in them. So you are, in fact, still smoking. No cessation yet.

      • digital0verdose says:

        But all he is getting is the nicotine rather than all the crap that actually kills you.

        • mac-phisto says:
          • digital0verdose says:

            Read it. I like the part where they say that smoking is “far more dangerous” than the nicotine supplements.

            • mac-phisto says:

              yes, but nicotine is hardly a “safe alternative” or “cancer-free”, both of which i have heard in radio ads for e-cigs.

              • digital0verdose says:

                That is what you were talking about in your original response to pantheonoutcast, but that has nothing to do with my response to Loias.

                • mac-phisto says:

                  “But all he is getting is the nicotine rather than all the crap that actually kills you.”

                  it is unknown whether nicotine kills you or not. that’s why i responded with the study. there is little research into nicotine delivery outside of the traditional tobacco uses, but already studies (such as the one i linked) indicate that nicotine alone isn’t necessarily safe. so, it would be more accurate to say “but all he is getting is one dangerous & possibly deadly chemical rather than all the other dangerous & possibly deadly chemicals.”

                  • Julia789 says:

                    What about previous reports that random e-cigs tested had some very dangerous, unlisted chemicals in them (along with the nicotine) as they were coming from overseas and were untested/unregulated? Does that concern you?

                • Radiating says:

                  It’s obvious that the companies advertise it as 100% safe instead of 90% safer which is what they actually are. This is simple marketing. If these replaced cigarettes the world would be a better place, end of story.

              • Pax says:

                It’s safer for ME, the non-smoker, standing four feet down-wind of a trio of people using tHOSe instead of real, actual cigarettes.

        • Loias supports harsher punishments against corporations says:

          Nicotine is what feeds the addiction. He’s still addicted. Now he’s just addicted to e-cigs.

          • pantheonoutcast says:

            I’m not though, and believe me, I thought about it – switching one addiction for another. I used to smoke a pack, pack and a half a day, everyday for 19 years. Each e-cig nicotine cartridge equals about 1 pack of cigarettes and I go through one cartridge every three-four days (that also only costs me about $12 a week, rather than $7 a day). That’s a huge change. Plus, as I’ve pointed out, there’s no tar or carbon monoxide, or any of the other 400 toxic chemicals in e-cigs.

          • huadpe says:

            Which is a much, much less dangerous addiction.

            Most of what kills you in cigarettes is a function of the burning, not the nicotine. If you stood over a campfire instead of smoking, your lungs would be getting the same treatment.

            No, nicotine is not harmless, but the crap that comes from burning plant matter is much, much more harmful.

      • pantheonoutcast says:

        I realize that my experience is purely anecdotal, but Nicotine =/= Smoke. If I switch from Coke to Coffee in order to get my caffeine fix, you wouldn’t say, “Hey, but you’re still drinking soda!”

        Also, I have not had an ounce of tar, ammonia, benzene, or toluene in my body for a quarter of a year. I see that as a plus.

      • aloria says:

        You can buy e-cig cartridges without nicotine. A friend of mine quit smoking cold turkey, but needed something to do with her hands/mouth, so she got the e-cigs with the nicotine free packs.

      • dolemite says:

        The major problem with smoking is carcinogens found in smoke. Not nicotine. While it is ideal for you to not be addicted to anything in your life, most of us are addicted to one thing or another. If you cut out 99.99% of the cancer causing agents in the cigs, I’m not sure there is that big of a problem with it.

    • mac-phisto says:

      you haven’t heard the radio ads near me – “100% safe! curb your smoking today with this cancer-free alternative!”

      i’ve been wondering when someone was going to take action. these may be great alternatives to smoking, but some of the marketing is downright manipulative. i commend the FDA for doing something about it.

    • Julia789 says:

      Nice to hear they worked for you and your friends. I had wondered if they were helpful.

      I quit years ago with the patch. I tried before without any “help” and failed miserably. The patch gave me my drug while I dealt with the psychological changes of habit. Then I did smaller and smaller patches until there were none.

    • NarcolepticGirl says:

      My grandmother quit using these as well.

    • sleze69 says:

      My then fiancee (now wife) used them to quit. The FDA really has their panties in a bunch about these things. They may turn out to be dangerous but so far, there is no data proving so.

      • Loias supports harsher punishments against corporations says:

        I think their problem is just that – there is no data. So why make claims without data?

        • Beeker26 says:

          This. The FDA isn’t trying to shut them down or change the products. It just wants to review things to make sure it’s safe. If it’s all on the up and up nothing’s gonna change.

          • jefeloco says:

            Except that if the companies continue to make the claims as the are currently, they will have to re-certify as a drug and go through expensive qualification processes. The FDA did the same thing to Cheerios over the claims of reducing cholesterol levels. I think that would effect some sort of change along the line unless they stop with the claims.

            • Beeker26 says:

              Well they’ll be given a choice — either stop making said claims or be subject to classification as a drug. Neither necessarily demands a change in the product.

              Considering what has to happen to get FDA approval I suspect these companies are just going to change their marketing, and perhaps be forbidden from distributing prescription medications.

      • RvLeshrac says:

        Here, drink this random substance I’ve given you. It *might* kill you, sure, but there’s no evidence to back that up.

    • JamieSueAustin says:

      Here Here! Thanks to e cigs I haven’t had a real cig in a YEAR (I haven’t used the e cig in 6 months.)

      Where the patch, the gum, the pills, the patches, and all else failed. These succeeded. I hope for the sake of others that they stay on the market.

  4. BuyerOfGoods3 says:

    Yeah…they post on my local CraigsList in the Gig section — Looking to pay “hot women” to go into Clubs and “promote” their product.

    **Hint Hint: That hot girl/guy in the club IS ALWAYS SELLING YOU SOMETHING.**

  5. Hi_Hello says:

    snickers, the candy bar…it helps curb or cure nicotine addiction… they don’t say it.. but if they did, does that mean it’s drug?

    I wonder if you can market sex? sex curb/cure nicotine addiction.

  6. majinbijiita says:

    I don’t like the FDA in most cases, but this is a reasonable request. However, the claim that they would like to see if e-cigarettes work is bogus. I was prescribed nicotrol inhalers when I was a teenager to help quit smoking, which is basically this plastic tube with a small puncturing device and nicotine canisters, so it’s vapor as well. They already have this…

  7. knoxblox says:

    And yet the iRenew bracelet, which makes even more outlandish claims to benefit our health, is still on the market.

  8. humphrmi says:

    You are not burning carcinogenic products and inhaling (or exhaling) their smoke. You’re directly inhaling nicotine, without any tar or other additives, and exhaling steam. Nicotine in and of itself has some health issues, mainly cardiovascular, but not nearly the problems that a burning cigarette causes (both to the smoker and the people around him.)

    Then there’s the matter of addiction.
    This really isn’t any different than nicotine gum or the patch. You can adjust the level of nicotine that the chamber infuses, so you can (theoretically) gradually reduce your intake until you are no longer addicted.

    I’m fine with the FDA exerting some control over these products, but in the end I don’t see how eliminating the product is going to “save” anyone.

  9. Sure I could agree with you, but then we'd BOTH be wrong. says:

    of COURSE they should be treated as a drug — Nicotine IS a drug.

    It is a stimulant.


  10. Mecharine says:

    I did not know there was a market for liquefied tadalafil vaporizers. That is pretty damn disturbing.

  11. DanRydell says:

    Do people ever click the links to tangentially related articles that are always at the beginning of Consumerist articles? They make the intro awkward and never add anything to the article.

    • Cantras says:

      I click them by accident sometimes instead of the title or “more” or whatever. Sometimes leads to me thinking “Wow, this guy just copy-pasted his comment from the last one” before I notice.

  12. Pax says:

    Those electronic things reduce second-hand-smoke. Maybe eliminate it. So unless they’re significantly more dangerous to the user than an ordinary cigarette, it’s IN THE PUBLIC INTEREST to allow them to be sold.

    • aloria says:

      I’d rather people use these INDOORS then have to inhale a cloud of smoke every time I walk past a bar or workplace.

    • Loias supports harsher punishments against corporations says:

      Show me research that shows that, and I will buy you a pack.

      Anecdotal evidence cannot be used as scientific research. Frankly, these companies probably don’t want reserach because it will outline what is still very bad about these.

      And in addition, just because it doesn’t contain all the bad things in cigarettes doesn’t mean they weren’t replaced with equally bad or worse checmicals.

      Again, we need research first.

      • Pax says:

        First off, I’m talking about second hand smoke. These things do not produce smoke, neither of the first-hand nor the second-hand variety.

        Second off, why would you offer to buy me a pack? Do you really think only smokers would defend these things?

        I don’t smoke. I’ve never smoked a cigarette (nor anything else) in my entire life. My conce4rn is for second-hand smoke … and if these things reduce or eliminate that, then I’m all for them.

  13. The cake is a lie! says:

    The problem I had with these is that while you get the nicotine, you don’t get some of the other affects that cigarettes give you. You get a nice throat hit, but you don’t get the head rush that I personally hold as the reason I smoke at all. I’m what I would call a casual or social smoker who probably smokes less than three packs a year, but with the ecigarette I probably increased my nicotine intake by a thousand percent because it was too fun to blow the smoke. So what I do is buy the 0 nicotine cartridges and continue to smoke my two or three cigarettes a month with friends. I do find the smoking of vapor relaxing even without any drugs being dispensed. If I could find a way to put other medications in the cartridges like vitamins or even something to make my nose less stuffy, then I’d probably go for that too.

    • JamieSueAustin says:

      You know… I was thinking that back when I was using them… why can’t my menthol flavored cartridge help my congested sinuses.

  14. blakek says:

    Not to be all paranoid, but they seem more dangerous to the profits of tobacco companies and whoever gets cigarette tax revenue than anything else. Er, I suppose I’ll grant that if they sell cartridges with prescription drugs in them those should be regulated in the same way the drugs are.

  15. human_shield says:

    These companies will simply change their marketing and advertising strategies. Unless they have a bank account like Pfizer, the cost and lengthy process of FDA drug approval would likely bankrupt them, or raise the price of the e-cigs by 1,00%.

  16. VocalEK says:

    The Chinese company E-Cig Technology was the ONLY one of the five letter recipients that markets anything other than cartridges with nicotine. To imply that the other four companies would do such a thing is reprehensible on the part of the Reuters reporter and and irresponsible on the part of the Consumerist for perpetuating this untruth.

    Read the five letters the FDA sent to these companies, available on the FDA web site. Each of the letters contain text that the FDA alleges are unproven health claims, copied from the company web sites. The companies are not saying the e-cigarettes “can curb or cure nicotine addiction.” They are saying, quite truthfully, that the products can help people to stop smoking. The products accomplish this feat by functioning as an alternative source of nicotine–a replacement for smoking. In view of the fact that smoking is not a disease, it is not a health claim to say that a product helps people to stop smoking. People who switch to e-cigarettes are experiencing health improvements, but not due to any direct action on the part of the products. The health improvements are an indirect effect of the products. The direct cause is that the people are no longer inhaling cigarette smoke.

    I smoked for 45 years and tried multiple times, using multiple FDA-approved medications to stop. I began using an electronic cigarette as a replacement for all my tobacco cigarettes and have been smoke-free since March 27, 2009. As a result of being smoke-free my lung health has seen a dramatic improvement. The wheezing that used to keep me awake at night is gone, as is the “smoker’s cought.”

  17. pot_roast says:

    I’m against smoking, but I would much rather have these in restaurants than clouds of cigarette smoke from insensitive smokers wafting everywhere.

  18. Instead_E-Cigarettes says:

    Couple things: The vapor from e-cigarettes is mostly propylene glycol, not water. Secondly, the FDA has already been told by a federal Judge that the e-cig should be regulated as a reduced harm tobacco product rather than a new drug. So, this isn’t about regulation or safety, because if it was the FDA would regulate the product fairly inline with it’s competitors (tobacco).

    But yes, there are some companies doing bad things like putting other drugs into the liquid. Read: http://www.e-cig.org/2010/09/14/fda-letter-to-5-electronic-cigarette-companies/ for our opinion on the letters and the companies in question.