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FDA Plans to Regulate E-Cigarettes as Tobacco Products, Not Drug-Delivery Devices

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The U.S. Food and Drug Administration (FDA) announced it will regulate smokeless electronic cigarettes as tobacco products, treating them the same as traditional cigarettes.

The FDA said it will not try to regulate e-cigarettes under stricter rules for drug-delivery devices, the Associated Press (AP) reports. E-cigarettes are designed to deliver nicotine in the form of a vapor, which is inhaled by the user. They usually have a rechargeable, battery-operated heating element, a replaceable cartridge with nicotine or other chemicals and a device called an atomizer that converts the contents of the cartridge into a vapor when heated.  E-cigarettes often are made to look like regular cigarettes.

The AP says that the FDA’s announcement, made in a letter to stakeholders, is considered a victory for makers and distributors of e-cigarettes. The devices’ makers say e-cigarettes allow people to smoke without being exposed to the more than 4,000 chemicals in regular cigarettes. E-cigarettes have been available in the United States since 2006 and are used by several million people worldwide, the article says.

Last year the FDA lost a court case after it tried to treat e-cigarettes as drug-delivery devices, which must satisfy stricter requirements than tobacco products, including clinical trials to prove they are safe and effective. FDA tests found that the liquid in some e-cigarettes contained toxins besides nicotine, as well as cancer-causing substances found in tobacco, the AP reported. Some public health experts say the level of the cancer-causing agents is similar to those found in nicotine replacement therapy, which contains nicotine extracted from tobacco.

21 Responses to this article

  1. D King / September 17, 2014 at 12:05 am

    I would like to point out that every container I have received either in the mail or in a vape shop “Even empty bottles for mixing my own juice” are child proof. Even all the bottles I have seen online and the ones my friends have. Hell i haven’t even seen a non child proof bottle yet. The vape shops I go to will not even allow you in unless you are 18 or older. You need to look at the parents of these kids and punish them for allowing their children to get a hold of the juice. It is harmful if you drink it just like any cleaning product or medication.

    As for the “they don’t tell us what’s in the juice” actually they do just not on the bottle contact any maker they will tell you the same thing vg pg nic and flavors. I am also learning a lot of the flavoring is all natural as well. Go look in your kitchen cabinets and tell me how many products you find that have artificial flavor added? What about harsh preservitives? E juice doesn’t need preservatives vg and pg both have antibacterial and antiviral qualities. So before you try to tax the crap out of my vape juice look around your house and think how it would be for you if the government decided to tax everything that had anything artificial or potentially harmful. Candy sweets artificial sweeteners soda bread veggies sprayed with pesticides basically everything in your kitchen medicine cabinet. What we really need is public awareness about everything e cig. The good and the bad. I also agree more reaserch should be done but I think it should be done by independent labs that have no stake in the issue. As for second hand vape give me a friggen break unless your making out with me while I vape your not getting any just the pleasant smell of vanilla custard. :)

  2. Brett / August 7, 2014 at 3:57 am

    These e-liquids people are so “scared” of contain four types of ingredients. 1. Vegetable Glycerin 2. Propylene Glycol 3. flavoring 4. nicotine. That simple. Things already found in our food and products we use in our every day life. Most if not all companies have child proof caps now and do not sell to minors at all. This fear mongering has to stop. The FDA would kill the vaping industry over night and put many businesses out in the cold. Regulation of these products at the extent they want would only leave these smokers who want to leave the cigarettes behind at the mercy of the tobacco companies again. Vaping has helped so many people quit including myself. Please explore the facts and ignore the junk science these companies are putting out there to deter people from using e-cigs.

    • nicole / August 11, 2014 at 4:44 pm

      Why would you not believe what the FDA has reported to be in e – cigarettes? The FDA was designed to protect the public’s health. And if all of these e – cigarettes have childproof packaging then why has there been a sudden increase of children being poisoned from the ingestion of the nicotine liquid? It has not been proven that these e – cigarettes are a safe method for quitting smoking. I wouldn’t believe anything that the manufacturers say about these e – cigarettes until clinical trials have been performed to determine ALL of the ingredients and efficacy of these products. More and more children are smoking these products. We have to protect both children and adults.

  3. Nicole / July 30, 2014 at 12:34 pm

    These electronic cigarettes need to be regulated by the FDA or these tobacco companies will not disclose what is in these products. Poison control calls have increased from 1 to 250 calls per month because young children are ingesting the nicotine liquid from these cigarettes. These manufacturers are not going to make these packages childproof unless their regulated by the FDA. And no know exactly what is in these vaporized cigarettes. The FDA has found that 2 of the many brands of electronic cigarettes have components of antifreeze and carinogens. And it has not been proven to be a safe smoking cessation aid by the FDA. Clinical trials need to be done on these products to determine the efficacy and safety that are claimed by these manufacturers. Additionally, electronic cigarettes that claim to have no nicotine actually do have nicotine in them. The FDA has to regulate these products for the safety of Americans.

    • T. Lisk / August 8, 2014 at 1:06 am

      I would also LOVE to see where you are getting your data regarding the poison calls. About the antifreeze and carcinogens, you are talking about regular cigarettes. E-Cigs and mods are PG (polypropylene glycerol) which can be found in most candy/baking flavoring. VG (Vegetable Glycerin) which like it sounds comes from vegetables, and the last is yes liquid nicotine which by it self in small doses like that found in e-cig’s are pretty harmless. Granted if you tip the bottle of liquid nicotine and drink it bad things are going to happen, but, isn’t that a call for increased parenting not regulations and most likely taxes on e-cigs/mods. I am and I know a LOT of people who were long time smokers and quit using both e-cigs and mods, and now you are telling me all these people should die of smoking because there is a CHANCE that someones child (which should be watched by a parent) can get into them? In that case lets ban all electrical outlets, there dangerous. OH HEY and lets get rid of those pesky stoves for fear of kids getting burned… you see where I am going with this!

      • Nicole / August 11, 2014 at 5:39 pm

        The CDC reported the statistics of the increasing number of children being poisoned from the ingestion of the nicotine liquid.

        http://www.cdc.gov/media/releases/2014/p0403-e-cigarette-poison.html

        Here is an article from The American Association of Poison Control Centers providing statistics of the poisoning rates of the nicotine liquid found in e-cigarettes. http://www.aapcc.org/alerts/e-cigarettes/

        The NY Times reported that Chip Paul, the chief executive officer of Palm Beach Vapors, stated “It’s the wild, wild west right now. Everybody fears F.D.A regulation, but honestly, we kind of welcome some kind of rules and regulations around this liquid.” If one of the chief executive officers of a e-cigarette producer is not afraid of the regulations of e-cigarettes why should the consumers of the products be afraid?

        Richtel, M. (2014, March 23). Selling a poison by the barrel: Liquid nicotine for e-cigarettes. The New York Times. Retrieved from http://www.nytimes.com/2014/03/24/business/selling-a-poison-by-the-barrel-liquid-nicotine-for-e-cigarettes.html?_r=0

        And yes, carcinogens and components of antifreeze have been found in e-cigarettes.
        http://www.cancer.org/myacs/eastern/areahighlights/cancernynj-news-ny-ecig-health-vote

        http://health.howstuffworks.com/wellness/smoking-cessation/10-facts-about-e-cigarettes.htm#page=4

        This same article talks about the potential health problems e-cigarettes can produce. “Despite the marketing claims that e-cigarettes are safer than smoking tobacco, researchers are finding e-cig users experience diminished lung function, airway resistance and cellular changes, regardless of whether or not they currently (or ever) smoke cigarettes. And in the lab, cells exposed to e-cigarette vapor show unhealthy changes similar to cells exposed to tobacco smoke. Users who vape nicotine-free e-cigs can’t escape the effects, either; they also experience airway resistance and other signs of inflammation as side effects of e-cigarette use.” http://health.howstuffworks.com/wellness/smoking-cessation/10-facts-about-e-cigarettes.htm#page=10

        • Freeman / August 17, 2014 at 12:47 am

          Nicole,

          Your post is well cited; however, you broke the first rule of critical thinking: consider your source. I followed your link to the ACTUAL study performed by the FDA, which is where the source you provided cherry picked their information. It is true, the FDA did find TRACES of nitrosamines within whole high and medium nJoy e-cigarette cartridges, but if you do some research you will notice nitrosamines are also in: beer, vegetables, cured beef, salted fish, and food preservatives.

          Here is the link to the experiment: http://www.fda.gov/downloads/Drugs/ScienceResearch/UCM173250.pdf

          Moreover, your other sources, specifically New York Times, have completed framed their cherry picked statistics, so people who only care about the headlines will visit their site or buy their newspaper. Consider the CDC quote you linked. The author states:

          “The analysis compared total monthly poison center calls involving e-cigarettes and conventional cigarettes, and found the proportion of e-cigarette calls jumped from 0.3 percent in September 2010 to 41.7 percent in February 2014.” (“New CDC study finds dramatic increase in e-cigarette-related calls to poison centers”, 2014)

          Of course there was a 41.7% increase because electronic cigarettes are that much more popular now than in 2010! What is more concerning about this “report” is that there aren’t references for these figures! The only reference they list is a link to a pretty graph that is stamped CDC!

          In short, the media and certain government agencies are trying to launch a smear campaign on electronic cigarettes so they can regulate and tax these products. It is all about money, not the health of toddlers who gulped down a bottle of e-juice while their parents were posting on Facebook.We have seen this a million times, especially in the food industry, and people continue to drink the media’s Kool-aid. Nicole, if you are so concerned about carcinogens, then I believe you should start riding a bike to work everyday because your car emits more harmful carcinogens into the air than an e-cig ever will.

  4. Avatar of Elaine
    Elaine / April 28, 2014 at 5:34 pm

    If they are so worried about regulating e – cigs for public health reasons and say there are bad chemicals then how did they ever approve cigarettes in the first place. Starting to look like unless they can make money off of it; government and medical, that they want to put rules or ban things. They say that they can’t prove it helps people quit. Have they even asked us that. I smoked for 30 years. If it wasn’t for e – cogs I would still be smoking. I have gone from 24 me down to 16 since January and will continue to go down. I am healthier and breath better. I don’t see how they can even think it doesn’t help people quit. I think before they put additional rules on they need to actually do full studies to see that it is helping people. I do agree with the age regulations. I also agree that as soon as they make it that big brother and big companies are they only ones that can make e-liquids that there is nothing keeping them for putting product in that will keep us hooked. I personally have been making mine at home. I know what is in it and can actually make it to taste. I just hope that bug companies don’t get thier fingers in it and cause problems or hike the prices.

  5. Avatar of Jesse
    Jesse / April 27, 2014 at 4:32 pm

    all areas in this seem to be covered, on a smaller issue. They want to take away flavors like grape, water melon and apple. ( fruity flavors) to make it less appealing to children. Are adults not allowed to like fruity flavors? If that’s there logic behind there decision than why i sent alcohol regulated like that? how many different types of alcohol have a fruity flavor to them ? Im not going against alcohol, im just trying to make a point.

  6. Avatar of outtaluck
    outtaluck / April 26, 2014 at 10:17 pm

    Rachael, they are banning the use of e-cigs everywhere traditional smoking is banned, especially here in the Metroplex (DFW area). So, yes, they are indeed taking away more freedoms. Secondly, we are regulated enough. I don’t need someone to control what I’m inhaling as a cigarette alternative when I can’t smoke. Okay, general knowledge is smoking is bad for you. So is eating, (drive past a seafood market and take a big wiff before you complain about 2nd, 3rd,4rth, or whatever -hand smoke first.) Another thing, that little vehicle you drive, is bad for my health, it burns a chemical called Benzene, a known carcinogen…but yet you still put it in your tank at 1.6% everytime you fill up…because it’s “good for the enviroment.” It’s high time for government to get the heck out of our lives and let us live with freedom. So no, I will not calm down, because they ARE trying to take away our “vape”, our freedoms, our liberties granted to us by the Constitution of the United States of America.

  7. Avatar of matthew
    matthew / April 25, 2014 at 10:54 pm

    2 things one the fda back dated the paper work so that all products on the market today will have to justify it existence and 2 when was the last time the FDA has approved any tobacco products. They are trying to kill off e-vaping that is the goal. Most of thr e-juices put there have the choice to have nicotine in it or not. And ad for the flavours there a big part of why I quit smoking. And I plan to be nicotine free in 4-5 months. I have smoked for 20 years and this is the first thing that has really worked. So why kill the best stop smoking device ever.

  8. rachael / April 24, 2014 at 5:18 pm

    WHOA, people are freaking out. Also, just as an FYI big tobacco is taking over the e-cigarette market… I really REALLY don’t think the FDA is trying to cater to tobacco manufacturers, in fact, it seems to be quite the opposite – and all the FDA regulation does is ensure the products that people are inhaling meet regulations. Additionally, the FDA regulates all the nicotine-replacement therapies as well. Calm down guys – no own is trying to take away your “vape”

    • T. Lisk / August 8, 2014 at 1:14 am

      Think again Rachel. The e-cig and mod market is actually starting to swing away from “large” corporations and into small markets. Small “vape” shops are popping up all over the US and many (like me) are making their own mixes (e-juice). NOW, if all these mods and e-cigs are regulated the production of these items will also have to be regulated, ALSO the creation of the juice will have to be regulated. Now what does that mean too the small guy with a little shop, good luck getting the certifications for “tobacco handling” also now all vape shops will have to pay fees for selling and handling. OH and how long do you think before they put those HEAVY taxes on the juice like they do on cigarettes… is that for the benefit of the people? Tax and charge fee’s on a healthy alternative to smoking? Even though anti-smoking is the new message to everyone, why pass legislation that will make it more difficult to produce and sell products that lesson smoking? Sounds funny too me, kind of like there are politicians still in the pocket of big tobacco…. go figure.

  9. Avatar of mark
    mark / April 24, 2014 at 1:19 pm

    i am just beside myself at this point. FDA cares about public health???!!! really?? where were they when thousands other product from weigh loss to the damn cigarette and other quick bucks chemical killed millions? didn’t we have issues with meat and poultry product that they didn’t give a two cents in the past? now all of the sudden the big brother cares for public safety. not sure how much FDA received from big tobacco company to finally step in on a product that is made of nothing but flavor and sugar. what about the e liquid has no nicotine? whats next ” second hand vaping”? you must be kidding me. i am a hear attack survivor and if it wasn’t for e cig i was dead by now. not to mention a cardiologist recommend e cig to quit. FDA you are a joke . what else the big brother feels is in tile to decide for me and my life. what about regulating my underwear since some bright color might cause vision issue for some people. and lets not forget the children. FDA and our politician truly care for their health and only 2 out of 5 children in USA suffers from hunger. get a life FDA and all other government agencies. we solved all other problem in this country and all left is vaping. WOW. last time i checked this is still United State of america. what a sad day.

  10. cigarbabe / January 19, 2014 at 1:52 am

    What the AP is quoting is a “press release” and was not the study the FDA did. That was done in 2009 and it did not find any toxins in detectable levels. Trying to equate ecigs as smoking is simply wrong. It is vaporizing at worst. There is no “second hand vapor” no heavy metals or dangerous chemicals released. The CDC failed to tell you that all the kids they queried were using ecigs because they were already everyday smokers. Why do you folks continue to lie to the public?

    • Nicole / July 30, 2014 at 12:46 pm

      In the 2011-2012 National Youth Tobacco Survey “among middle school ever e-cigarette users, 20.3% reported never smoking conventional cigarettes; among middle school current e-cigarette users, 61.1% reported current conventional cigarette smoking.”

      “In 2012, among high school ever e-cigarette users, 7.2% reported never smoking conventional cigarettes; among high school current e-cigarette users, 80.5% reported current conventional cigarette smoking.” http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6235a6.htm

      So not all of the students surveyed were everyday smokers as you claimed. Children should not be smoking these e-cigarettes because the safety of these cigarettes have not been proven. These cigarette have to be regulated by the FDA.

  11. Avatar of dennis phelps
    dennis phelps / January 18, 2014 at 12:37 am

    You know this bothers me. Why treat it as a tobacco product. It is nothing like tobacco. vaping is the future and the FDA doesnt want to lose the big tobaco tht pays the bills. we govern ourselves. Remember tht. the only reason they want to regulate is so they can make a quick buck by taxing it as much as tobacco.
    Let it be. If u treat e cigs like real ones ill be first to tea party.

  12. Avatar of Fox Lee
    Fox Lee / July 5, 2013 at 3:33 am

    The more restriction the better!

  13. Avatar of Chasen
    Chasen / February 5, 2014 at 8:30 pm

    “More restrictions the better”???? Are you kidding me. Either you work and/or own stock in big tobacco or are just a mindless sheep that only believes the horrible plague of disinformation that’s swept through our country, regarding e-cigs. What I just said isn’t some conjecture either. The largest study ever conducted on e-cigs, which gathered information from thousands of other studies and was designed specifically to help organizations like the FDA understand the truths about e-cigs, concluded that there are no more health risks to e-cigs than there are to nicotine patches and likewise to anyone around them. There has been a malicious spread of rumors regarding the supposedly harmful effects of e-cigs but those were all a result of the tobacco companies trying to deter people from e-cigs and continue to allow them to retain their incredibly immense profits. There are numerous documented accounts and stories revealing this and explaining precisely how big tobacco funded, and I’m sure still funds, bogus studies and evidence falsely claiming e-cigs to be worse for you or equally bad as traditional cigs. Even the pharmaceutical industry has been trying to purposefully deter people from e-cigs since more people using e-cigs to quit smoking equates to less people using nicotine patches and prescription meds to quit. I bet you’re one of those annoying people that purposefully coughs when they’re next to someone vaping with an Ecig, despite the fact that not only is it completely harmless but it also smells like extremely pleasant almost like an air freshener.

  14. Nicole / July 30, 2014 at 12:55 pm

    If these electronic cigarettes are completely harmless why are these manufacturers not disclosing ALL of the ingredients of these products? And if they were completely harmless then why are poison control calls increasing from the ingesting of the nicotine liquid by children? These products need to be regulated by the FDA so these packages can be childproof to prevent children from ingesting these products. And no one is 100% certain of the safety of these products. Don’t you want to know what you’re smoking?

  15. Becky / August 8, 2014 at 7:13 pm

    The reason children are ingesting these liquids is because their parents are to lazy or to iresponsible to supervise them. Quit relying on our defunct government to protect our children.That’s your job as a parent. It’s your job as the adult to make sure these are in a safe place just like you would your normal household cleaning products.

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