FDA releases proposed e-cigarette regulations

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By Saundra Young

CNN

(CNN) — The Food and Drug Administration is making another attempt at regulating electronic cigarettes and other tobacco products.

On Thursday, the agency proposed rules that call for strict regulation of electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe tobacco and hookahs. Currently, the FDA only has regulatory authority over cigarettes, smokeless tobacco and roll-your-own tobacco.

When these recommendations are finalized following a 75-day public comment period, the age limit to buy the products is expected to be at least 18, although individual states could choose to set it higher.

Health warnings would also be required and the sale of the products in vending machines would be prohibited. Initially, the only health warning required for e-cigarettes would be about the potential for addiction to nicotine.

Manufacturers would be required to register all their products and ingredients with the FDA. They would only be able to market new products after an FDA review, and they would need to provide scientific evidence before making any claims of direct or implied risk reduction associated with their product.

Companies would also no longer be allowed to give out free samples.

After the public comment period and once the proposed rules are finalized, manufacturers will have 24 months to submit an application to allow their products to remain on the market or submit a new product application.

E-cigarettes deliver nicotine to the user as a vapor. They are usually battery-operated and come with a replaceable cartridge that contains liquid nicotine. When heated, the liquid in the cartridge turns into a vapor that’s inhaled.

Most look like cigarettes, cigars or pipes, but some resemble pens or USB memory sticks. Because they have not been fully studied, the FDA says it’s unknown what health risks they pose, how much nicotine or other chemicals are actually being inhaled or whether there is any benefit to using them.

Last year, the Centers for Disease Control and Prevention reported that the percentage of high school students who reported ever using an e-cigarette more than doubled in one year, from 4.7% to 10% between 2011 and 2012.

As electronic cigarettes have increased in popularity, so have the number of calls to poison control centers nationwide. According to a recent CDC report, poison control centers logged 215 calls involving e-cigarettes in February alone. Of those calls, 51% involved children.

“It’s really the wild, wild west out there,” says Margaret Hamburg, FDA commissioner. “Because e-cigarettes are increasingly in the marketplace. They’re coming in different sizes, shapes and flavors in terms of the nicotine in them, and there’s very worrisome data that show that young people in particular are starting to take up e-cigarettes, especially the flavored ones and that might be a gateway to other harmful tobacco products.”

Hamburg says they don’t know how many types are on the market, another reason why regulation is critical.

“We’re already conducting research and working with partners in the research community to better understand patterns of use of these e-cigarettes and to learn more about the way in which they work and the delivery of the nicotine through e-cigarettes. But until we can really regulate them, we can’t have all the information we need and we can’t take all the actions that we might want to to be able to best address the public health issues associated with them.”

Nicotine is a drug and poison experts say the concentrated liquid form used in e-cigarettes is highly toxic even in small doses. It can be inhaled or absorbed through the skin.

“Responsibly marketed and properly regulated, it is possible that e-cigarettes could benefit public health if they help significantly reduce the number of people who use conventional cigarettes and die of tobacco-related disease,” Matthew Myers, president of Campaign for Tobacco-Free Kids, said in February.

But a lot of unanswered questions remain, according to Dr. Michael Eriksen, dean of the School of Public Health at Georgia State University, one of 14 U.S. institutions conducting FDA-funded research on electronic cigarettes,

“How concentrated is liquid nicotine? Are there impurities in it? Is it properly handled like a pesticide?” he says. “Nicotine is a pesticide fundamentally and we take so many precautions about pesticides for our lawns and how to wear gloves. But what precautions do consumers take when they put the nicotine vials in? People treat it [liquid nicotine] as sugar when it’s a toxin.”

Harold Wimmer, president and CEO of the American Lung Association, believes nicotine is highly addictive whether used in a regular cigarette or an e-cigarette.

So how safe are e-cigarettes? Hamburg says it’s buyer beware.

“We think that there’s a lot of information that needs to be understood about e-cigarettes and their use. We’re trying to help provide some of that information through research that we’re conducting,” she says.

“But we need the tools that regulation provides to be able to get critical new knowledge about e-cigarettes and to be able to put in place a framework that will protect the American public and potentially e-cigarette users, and really address the issues of what are the health consequences and what are the potential benefits.”

Hamburg believes these new rules will change the landscape.

If the FDA broadens its authority to regulate tobacco products, she says, it will make a major contribution to the health of Americans.

The-CNN-Wire
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33 comments

  • Myron Horvath

    The government agencies need toe just leave this alone! Common sence is needed on behalf of users handling e-juice, but not really beyond that! Everything that is in the e liquid is safe for human consumption and it’s en what you eat now already! The main underlying reason they want to mess around with it is MONEY! It has almost nothing to do with safety. My family doctor has even stated that nicotine is not harmful to you in the quantity you get from an e-cig product and it poses no risk to non users. The government want more of your hard earned money. Don’t they get enough already??

  • Tim Brennan

    I used to smoke 30 cigarettes a day atleast and that’s not including on the weekends(Sat Sunday 2 packs a day easily). I tried all the gums, patches,pills out there with no results. Finally one day someone introduced me to the world of vaping (eciggs) and it’s been a year now zero cigarettes. In the article eciggs are referred to as a gateway to smoking, well I say it’s the opposite. It’s the gateway to freedom from smoking and has saved countless life’s myself included. Having very little knowledge on the subject of vaping has sent people running for the torches and pitchforks because of a lack of understanding what vapers true goals are and that’s to keep off of smoking. This is one area where the government needs to not tax and control and let people be responsible adults. There are many more harmful things laying around any household then a bottle of 12 mg ejuice. As for the flavors… Adults like flavors! Just look at all the flavored liquor out there. We have taste buds and by limiting flavors your taking away a major appeal of luring smokers over from the darkside. I am unsure who will if any one will read this but it is my hope someone in a position of power will take this into consideration before they do damage to a community that has been flourishing without government interference.

    • Bob

      And yet people try to tell me that nicotine isn’t addictive?? Thank goodness for Utah’s Clean Air Act!

  • Joseph Muolo

    So we are going to rely on the FDA to regulate E-Cigs? They already regulate tobacco products and look at all the harmful chemicals they allow in those? How many carcinogens are in regular cigarettes that the FDA is OK with?

    The government wants people to stop smoking, yet they are vilifying one of the only ways that actually helps people to get off cigarettes. If desired, E-Cig users and even reduce the amount of nicotine they get to zero to break the addiction. Can you get regular cigarettes with lower nicotine levels? NO!

    I’ve tried approved methods to quit smoking such as the nicorette lozenge. What ended up happening was me becoming addicted to having a lozenge in my mouth and smoking at the same time.

    This is all about money for big tobacco. The tobacco companies have their lobbyists lining the pockets of politicians and putting out bad press on E-Cigs because they are losing money.

    The United States government needs to stay out of peoples personal lives and let them decide for themselves what is best for them.

  • Ronna

    “People treat it [liquid nicotine] as sugar when it’s a toxin.”

    Where on earth did this person ever get this idea? No one using e-cigs treats nicotine like it’s sugar.

    The ignorance is just too much to bear.

  • Randy

    We have all heard this rhetoric before. They speak on the number of calls to poison control. But, not of the content of those calls. Someone calls them says” e-cig” and “child” during the call. And they log it as a call about e-cigs. I would be willing to wager, tty hat behind this nonsense is some big tobacco rep worried about their paycheck, not the safety of consumers.

  • Patricia Waters

    PLEASE READ THIS POST.

    http://antithrlies.com/2013/08/08/breaking-news-new-study-shows-no-risk-from-e-cigarette-contaminants/

    THIS IS SO IMPORTANT TO ANY DECISION MAKER.

    Also – Nicotine IS NOT a ‘pesticide’!!!! Where on earth did that come from Dr. Michael Eriksen – Dean of the school of PUBLIC HEALTH?
    Do you actually know anything about anything with respect???
    Here you have a once only chance of saving millions of lives – GRAB IT WITH BOTH HANDS PLEASE.

  • Michael Miraglia

    All of the talk they do is about liquid nicotine and how dangerous it is but not one person in the world is vaping 100% nicotine you would die. The people buying it couldn’t get 100% nicotine if they wanted to, it is regulated and the highest amount I have seen possible to buy is 2.8% nicotine. If the problem is children there is no reason it should effect adults, how many calls to the disease control center were made this year from chemicals that parents left out? (bleach, Windex, Lysol exct.) Any chemical is dangerous to children if swallowed but it has nothing to do with e-cigarettes. All of this has to do with the government not being able to get a high enough TAX on this, they aren’t happy because it’s not putting money in their pockets. ANY ONE INVOLVED IN THIS CAMPAIGN IF YOU THINK I SHOULD GO BACK TO SMOKING CIGARETTES BECAUSE THIS ALTERNATIVE IS NOT SAFE PLEASE MAKE A STATEMENT ON NATIONAL TELEVISION TELLING EVERYONE TO STOP USING E-CIGARETTES AND GO BACK TO CIGARETTES. There are no studies that show that e-cigarettes or vaping cause any health risks, we know that nicotine has addictive tendencies but that is the risk we are taking. I quit smoking cigarettes 8 months ago and started vaping, I now vape with no nicotine at all. I do it for the feel of smoking that I enjoy and the taste of the juice I chose to vape. So if the worry is all about NICOTINE WHAT ABOUT THE JUICE THAT HAS NO NICOTINE IN IT AT ALL?

    I’m sure we wont get any responses to anything we all write on here, and nothing will be done to help those who have changed their lives from vaping but I feel better voicing how I feel about this, and the more people who do tell their story of how it helped we might actually be heard.

    LIVE LONG AND VAPE ON!!!!

  • Bob

    Infants rely on a binky to get them through the day. It helps if mommy puts some honey on it.

    Why in the world do grown men and women have this moronic need to run around with something sticking out of their mouths? If their need is really that bad how about sticking an e-cigarette out of both sides of their mouths to double the pleasure.

    • Joseph Muolo

      Does the ignorance of this post even deserve a response? Hey Bob, do you drink coffee? Why? How about you walk around with a coffee IV.

      Tell me you have no vice and then look in a mirror to view a liar. Just because smoking or using an ecig is not YOUR vice, doesn’t make it any sillier then your vices.

      • Bob

        Hey Joseph Muolo, take a look around and compare the people who are smoking with those who don’t. That’s right, the educated folks who are making something of themselves are smart enough to choose vices that don’t cause lung cancer.

      • Joseph Muolo

        Hey Bob, guess what? This article isn’t about smoking. They must not teach reading in Utah.

        This is about electronic cigarettes so people can quit smoking. And vapor doesn’t have the horrible smell of cigarettes. So I no longer smell like an “oil refinery” either. And I can taste my food again. That’s why I’m trying to protect my right to vape.

        Try educating yourself on the topic or at least have someone read you the article if you can’t. It will still take a little comprehension though, so I’m not very hopeful for you.

    • Joseph Muolo

      Are you joking? Do you live under a rock? I know doctors that smoke, lawyers that smoke, CEOs that smoke, a President of the United States that smokes. And let me guess, you are smarter then all of them.

      Apparently not, and you ignorance proves it.

    • Never you mind

      Bob, all I can say is how sorry I feel for you. You obviously don’t have much of a life amongst society in general and have learnt nothing. You have an ear on each side of your head don’t you? Well listen out to the rest of the world – it’s not all about you believe it or not.

      • Bob

        Never you mind, Utah’s Clean Air Act proves that thinking Utahn’s were willing to stand up to the minority who didn’t have the courtesty to keep their smoke and stench to themselves.

        No need to feel sorry for me. I don’t smell like an oil refinery, and unlike smokers I can actually taste my food.

      • Joseph Muolo

        Hey Bob, guess what? This article isn’t about smoking. They must not teach reading in Utah.

        This is about electronic cigarettes so people can quit smoking. And vapor doesn’t have the horrible smell of cigarettes. So I no longer smell like an “oil refinery” either. And I can taste my food again. That’s why I’m trying to protect my right to vape.

        Try educating yourself on the topic or at least have someone read you the article if you can’t. It will still take a little comprehension though, so I’m not very hopeful for you.

  • Megan

    Nicotine is not highly addictive. Studies done on nicotine proved it is about as addictive as caffeine. They could not get lab animals to self dose with nicotine like they will with cocaine or heroin. The real addiction of smokers has much more to do with monoamine oxidase inhibitors (MAOI’s) found in cigarettes which boost serotonin levels in the brain. Not nicotine. Nicotine doesn’t harden the arteries, doesn’t cause heart disease or cancer, in fact nicotine is being used medically on people with Alzheimer’s, schizophrenia and Parkinson’s disease because it has cognitive benefits. The issue with children drinking the liquid has everything to do with parenting and nothing to do with this product. Everyone keeps potentially harmful substances in their home. If they can keep a bottle of candy coated ibuprofen away from their child they can sure as hell keep a bottle of e-liquid away from them too. The other two ingredients in the e-liquid, propylene glycol and vegetable glycerin: propylene glycol is in I’ve cream, it’s in asthma inhalers (has been since the 1940’s) it’s pumped into the air at hospitals because it has antibacterial qualities. Vegetable glycerin: is in tons of products, shampoos, conditioners, soap, skin care products. The studies are all out there, and this stuff is PROVEN. Grrrr.

    • Bob

      Megan says “nicotine is not highly addictive”. Probably why smoking is so easy to quit that even a child can do it.

      Nicotine is not highly addictive, smoking doesn’t cause cancer, and the moon is made of green cheese.

  • Ray Yeates

    Following is the FDA own admissions on the concerns about nicotine.
    Ultimately it is the tool provided by the FDA themselves there is no need to be concerned over the electronic device called an e-cig. Sensible regulation yes. But the recent information released by the FDA counters this. Stakeholders …would that be sister Pharma?…who gets nicotine from Big Tobacco?….who has FDA ignoring the other chemicals in smoke! 75 days people to make this happen…..or be controlled once again in silence and allow the other 6, million deaths over the next 12 months from ….SMOKING! Please do the right thing and stand out! Thank you .

    In recent years, a number of stakeholders in the public health and health care provider communities have suggested that these labeling statements act as barriers to the effective use of OTC NRT products for smoking cessation. These stakeholders have argued that the statement advising against concomitant use of the NRT products with cigarettes may cause some smokers to abandon quit attempts if they experience a lapse (e.g., if they have a cigarette while using an NRT product). Stakeholders have also argued that use of more than one NRT product (e.g., patch plus gum) is more effective for some smokers than use of a single NRT product in achieving cessation, and that current labeling discourages such use. With regard to duration of use, stakeholders have argued that the use of OTC NRT products beyond the labeled treatment period may increase the chances of quitting for certain smokers. [2] These stakeholders have asserted that there are no safety concerns associated with concomitant use of OTC NRT products with other nicotine-containing products, or with the use of OTC NRT products for longer than the labeled duration of use.

    Over the nearly 30 years since NRT products were first approved, evidence has accumulated to suggest that the current labeling provisions on concomitant use and duration of use may no longer be necessary to ensure the safe use of OTC NRT products for smoking cessation. Based on this evidence, FDA has concluded that the current labeling statements for OTC NRT products concerning concomitant use and duration of use can be modified as described in this document. We invite the products’ sponsors to submit supplemental NDAs (labeling supplements) to modify these statements in the labeling of their drug products. To facilitate the process, the Agency has identified revisions to the labeling of OTC NRT products that can be included in these labeling supplements. Those revisions are set forth in section II.

    https://www.federalregister.gov/articles/2013/04/02/2013-07528/modifications-to-labeling-of-nicotine-replacement-therapy-products-for-over-the-counter-human-use

  • Joseph Muolo

    Plain and simple, this is a money issue. Take New York state for example. New York places a minimum $5 tax on every pack of cigarettes. If only 100,000 people in New York smoked a pack a day, the state is receiving $500,000 a day in taxes. Anyone here think the state wants to lose that money?

    The government claims to want people to quit, yet the FDA doesn’t regulate what goes into cigarettes. If they didn’t want people to start smoking, just take out all the additives that make them taste better and the added nicotine. Anyone tasting straight burning tobacco leaves probably wouldn’t stick with it too long. You don’t see people raking the leaves in their yard to roll up and smoke.

    • Bob

      For decades the tobacco industry denied the link between cancer and smoking. Why take the risks associated with nocotine when you could spend that money on something more benificial.

  • Bob

    There is one thing that is often overlooked and which cannot be denied:
    Walking down the street with an e-cigarette hanging out of your mouth demonstrates both your maturity and sophistication. It makes women look so feminine and the men so masculine.

    Some people are smart enough not to get hooked on cigarettes in the first place.

  • Never you mind

    Bob – THIS IS NOT ABOUT SMOKING!!!! It’s about using electronic cigarettes WHICH DO NOT SMELL AT ALL. Can’t you read!????

    • Joseph Muolo

      Bob i from Utah, therefore cannot read. Bob drinks coffee and doesn’t see his own addiction or realize how vile the smell of coffee is to some non-drinkers. Bob thinks that anyone who smoked a cigarette is unintelligent. This includes the hundreds of thousands of soldiers that died in WWII for his freedom that were given cigarettes by this great government and got them addicted in the first place.

      Bob is so narrow minded that he can’t see that not everything is black and white.

    • Bob

      You do something different with and electronic cigarette? I thought it goes in your mouth and you inhale on it. My mistake.

      • Joseph Muolo

        So now Bob is lumping people with asthma in with smokers. You know, because they put an inhaler in their mouth and inhale.

        Hey Bob, if there isn’t any smoke, then you’re not smoking.

  • phil traywick

    This is unbelievable. They need to get a life. It’s all about money to them. I’ve been analog free for 6 mos and I love my ecig. I feel better than I have since high school. They may as well just more regulate regular ciggs and leave the vapin world alone.

  • Bob

    Go get yourself a good starter kit for $80 some refills for $10 and vape away. Sounds childish, and looks foolish.

    Option #2: Kick the nicotine addiction and spend your money on something more profitable.

    • Bob

      Educated people are smart enough to stay away from nicotine in the first place. They don’t have to spend money later on nicotine patches as they try to kick the habit, which of course every smoker will tell you isn’t adictive. Yeah, right.

Comments are closed.