Editors Note:
There appears to be considerable interest regarding CRE’s background, please see http://www.thecre.com/tpsac/?p=1132
Given the very large public response to this post, CRE will analyze the comments and prepare a White Paper for transmittal to the FDA.
TPSAC and CTR have a lot on their agenda but eventually they are going to have to develop an algorithm for addressing the “reduced harm” provisions of the new tobacco statute. In doing so they will have to be mindful of the applicability of the Data Quality Act to the resultant proceedings. Smokeless tobacco and e-cigarettes will be two issues leading the parade.
Emily Sohn–Discovery News
THE GIST
- As New York considers becoming the first state to ban electronic cigarettes, debate surrounds the devices and their safety.
- Critics worry that e-cigarettes will attract kids and create a new generation of nicotine addicts.
- The devices, which are tobacco-free, may be a safer alternative to cigarettes, say advocates.
Electronic cigarettes are handheld nicotine-delivery devices that, despite a devoted following, are currently swirling in controversy.
New York is pushing to become the first state to ban the devices, which so far remain unregulated and mostly unstudied. With cutesy colors, fruity flavors, clever designs and other options, e-cigarettes may hold too much appeal for young people, critics warn, offering an easy gateway to nicotine addiction.
But those criticisms clash with equally strong arguments for the value of e-cigarettes. The devices, which are tobacco-free, may be a safer alternative to cigarettes, say advocates, who point to testimonials from thousands of smokers who say they have used e-cigarettes to help them quit.
As the U.S. Food and Drug Administration struggles to gain regulatory control, and as safety studies remain works in progress, the debate continues.
“There really are a lot of unknowns with respect to health,” said Prue Talbot, a toxicologist at the University California, Riverside. “I don’t know of any studies in the literature which are peer-reviewed. Almost all of the studies have been paid for by the e-cigarette companies.
“E-cigarettes are often sold as safe, which is probably not true,” Talbot added. “They may not be as dangerous as real cigarettes, but on the other hand, they could be. We just don’t know.”
Electronic cigarettes typically use a rechargeable battery-operated heating element to vaporize the nicotine in a replaceable cartridge. Nicotine is usually dissolved in propylene glycol, a clear and colorless liquid that is commonly found in inhalers, cough medicines and other products.
Some e-cigarettes are made to look like real cigarettes, cigars or pipes. Others look like pens or USB memory devices. There is no tobacco involved, and no smoke either. Instead, users do what’s called “vaping.” As they inhale, they take in nicotine-filled vapor.
By isolating nicotine, e-cigarettes should carry far fewer chemical risks than regular cigarettes, said Michael Siegel, a tobacco researcher at Boston University. Tobacco contains about 5,000 known chemicals, he said, with as many as 100,000 more that haven’t yet been identified. E-cigarettes eliminate many of those ingredients.
Siegel and a colleague reviewed 16 studies that analyzed the contents of electronic cigarettes. In a paper just published in the Journal of Public Health Policy, they reported that levels of certain harmful chemicals were on par with levels found in nicotine patches and hundreds of times lower than what’s found in cigarettes.
The researchers also found evidence that vaping reduces cravings among smokers, not just for nicotine but also for the need to hold something in their hands and put something in their mouths — making the devices more appealing to them than patches or gum.
As a cigarette-quitting strategy, Siegel compared e-cigarettes to heroin needle exchange programs. It’s not that the devices are good for anyone, he said. They are just better than what they’re meant to replace.
“The relevant question is not, ‘Are these things safe?'” he said. “But are these things much safer than real cigarettes, and do they help people quit smoking? The answer to both of those questions we know is yes.”
“What New York is doing is equivalent to outlawing lifeboats on a sinking ship because they haven’t been FDA approved,” he added. “It’s a really crazy approach to public health.”
For other experts, the list of unknowns is still too large for them to consider e-cigarettes worth recommending. Some users, Talbot said, have reported problems with their lungs and throats that have forced them to stop using the devices.
And even though industry-funded studies have deemed the devices to be safe, an FDA report found levels of carcinogens and toxic contaminants that they determined to be were worthy of concern. Without regulation, Talobt added, cartridges may contain undisclosed chemicals that could end up being more toxic than tobacco smoke.
Quality control is also lacking. In a recent study, Talbot evaluated six brands of e-cigarettes acquired over the Internet. None of the devices were labeled clearly with nicotine levels, expiration dates or other information, she reported in December in the journal Tobacco Control.
Most cartridges leaked onto her hands, the study found, and all were defective in some way. Talbot also found unsubstantiated health claims on many of the company websites and print materials. One says they put vitamins in their e-cigarettes.
Other experts worry about the appeal of e-cigarettes to children. The devices are easy to buy online or in mall kiosks. They come in flavors ranging from chocolate to bubble gum. You can buy them in pink, gold or blue.
“Once a youth has decided to try an e-cigarette, there is nothing that protects him from getting addicted to nicotine by puffing this product,” wrote Jonathan Winickoff, a pediatrician at the MassGeneral Hospital for Children, in a letter to the FDA. “Nicotine itself is not safe for children. Nicotine addiction is one of the hardest addictions to break.”
New York’s move is a reaction to what can’t yet happen on the national level. According to a series of recent court decisions, e-cigarettes cannot qualify as drug delivery products, said Jeff Ventura, a spokesman for the FDA. As a result, the agency cannot ban them or require more arduous testing.
But even though they are now considered tobacco products, they are not mentioned in the Tobacco Control Act, either. For now, then, they remain unapproved and unregulated.
And anyone is free to buy them.
I smoked for 42 years and tried everything to quit; patches, gum, lozenges, inhalers, chantix, acupuncture. Nothing worked. I was never a heavy smoker but I smoked enough that I could feel the effects- shortness of breath, chronic bronchitis, etc.
I tried an electronic cigarette for the first time after I bought a new car and had promised myself that I wouldn’t stink it up by smoking in it. Within 3 days of trying the e-cig I had stopped smoking regular cigarettes completely without even consciously trying to do so.
It has been over two months since I smoked a cigarette and my health has improved tremendously. I had no idea that my respiratory problems caused by smoking were reversible, but apparently they are.
The electronic cigarette is a godsend to smokers who want to quit. It’s unfortunate that the US Government is so opposed to harm reduction which is exactly what e-cigs provide- a far safer alternative to a habit that is as hard to break as a heroin addiction. As far as kids getting them, that’s just a spurious argument put forward by a Government that is dependent upon cigarette tax money and the tobacco industry that will not allow anything to interfere with the money they make from a product that kills people. Kids are unlikely to invest the $40-$100 to acquire the equipment that would be needed to use the device in such a way and for a long enough period of time that they would become addicted- they are more likely to buy weed on the corner or steal regular cigarettes from their parents.
Please allow me to add my proverbial two cents to the other well written comments already posted.
First of all, to the FDA: please,please,please cease attacking our collective intelligence by pretending that these attacks on personal vaporizers are out of concern for our health. As long as tobacco cigarettes remain on the market and available for sale EVERYWHERE, it simply is not believable that your behavior toward e-cigarettes is based on protecting the public. We know what cigarettes do, yet our government continues to rely on them for the billions in tax revenue. we are also aware of how connected you are to Big Pharma and that it is their interests you are looking out for. They are the ones behind all the ‘smoking’ bans and they are the ones who stand to lose the most from the popularity of e-cigs. Your credibility hangs in the balance here.
To the American Cancer Society, American Lung Association, etc: the charade is over. At one time you may have genuinely been motivated to improve public health by attacking cigarette smoking as the dangerous addiction that it is. However, as you have become financially supported by the pharmaceutical industry you have morphed into a carnival barker , pushing their ineffective products on people who want to quit smoking. Now that smoking is banned in nearly every public place you need a new target to justify your existence. Now it’s all about third and fourth hand smoke and lies about one whiff of second hand smoke causing an immediate hardening of the arteries…..it’s just too much, and even non-smokers are starting to see your efforts as over the top. It’s like you are a long running TV sitcom that has jumped the shark and the absurd is all you have left. Of course you have to oppose any products that compete with your funding source’s stream of revenue; if they lose, you lose.
To anyone who opposes Tobacco Harm Reduction : please give me one logical reason why Harm Reduction is the most widely used approach to nearly all other public health problems………..except for smoking and tobacco use, despite common sense and actual medical research that indicates there are much less dangerous ways for people to consume nicotine. The only answer I can come up with is that there is simply too much money to be lost in taxes and from sales of inadequate (or even dangerous) pharmaceutical products to take a chance on allowing e-cigarettes to compete in the marketplace with patches, gum, lozenges, Chantix, etc. Quite simply, when it comes to the FDA, the fox has been guarding the chicken coop and people are starting to figure that out.
To anyone who doesn’t know that nicotine use does not come with the same health risks that smoking does: please educate yourself. Ask yourself why it is so important to you that others don’t use nicotine even though you can’t get out of bed without 3 cups of coffee and you have no intention of giving up THAT stimulant. Being addicted to nicotine is something that can be managed with smoking alternatives that pose no more risk than caffeine dependence. If you are addicted to caffeine, don’t kid yourself: you aren’t one bit stronger or smarter or better than those who are addicted to nicotine.
Contrary to all these false claims and fear tactics about not knowing what is in e-cigs, I believe the powers that be know exactly what e-cigs are all about and why they are becoming so popular. I believe they ARE worried, but not about the things they claim to be. Never before has any invention allowed so many people to put away tobacco cigarettes for good and Big Pharma is just ticked they didn’t get to us first.
I am 70 years old and I had been a smoker for 55 years off an on. I smoked one to three packs a day for at least 40 of those years. I have tried to quit dozens of times over the years but I never succeeded in quiting for good. About five years ago I was diagnosed with COPD and told I had to quit so I tried once again and for three years I tried nicotine gum, patches and inhalers and nothing worked. Two years ago I heard about e-cig and decided to try vaping. It worked and I’ve been off cigarettes ever since. My health has improved tremendously, I nolonger wheeze, cough or gasp for air after walking up a flight of stairs. I can carry my grandchildren up a flight of stairs now without running out of air and don’t need to use my inhaler to help me get my breath back.
My brother three years older than I died in Janurary of this year from a heart attack caused from smoking. His last few years were pretty miserable, he had to pack an oxoygen bottle everywhere he went and could barely walk to his car, all caused from smoking.
Why would people want to ban something that is saving thousands of lives and could save hundreds of thousands of lives if they were promoted instead of smokers being missled about them. These are not being targeted to kids or non-smokers just because they have different flavors and I have not heard of one person that started using one that didn’t smoke prior to using them. If some kids did use them it would still be a million times better that they did that than to start smoking. It should be against the law and it is to sell them to minors.
Please don’t listen to the special interest groups that will be financially rewarded by these being banned or by people that have never used one but listen to us that were smokers that have quit and are living much healthier lives because of them.
I smoked for 20 years, a pack and a half a day. I even quit several times, once for almost a year, but a cig always sounded good. I tried patches, lozenges and gum with no success.Within 2 days of getting a good E-cig, I knew I had found the answer. I will never go back to cigarettes. It is ludicrous that these products are being banned, while tobacco is being “regulated” by the FDA.
I’ve just turned 40, and have smoked more than half my life. It’s time to quit. For me, and my family. I have had very little success quiting in the past. I’ve tried patches, mints, pills, hypnosis and cold turkey. The longest i’ve gone is the length of a pregnancy. I’m not gulliable enough to believe e cigs are safe. But do I think they are probably a SAFER alternative to smoking…yes. Do I think they can be considered a smoking cessasation aid…yes.
If the FDA wants to warn us because they have not been extensivily tested, then get to testing. Okay, so the long term effects are still unknown, true. That didn’t stop the push to sell everyone and their smoking dog ‘Chantex” pills. And I DO know several people who took that drug, all but one suffered negative side effects.
There is talk of banning the sale of e cigs, because of concerns of their safety. Hmmmm well we ALL know how deadly regular cigs are, but I haven’t heard of a ban on the sale of those….wonder what the difference is? Oh wait, the taxes placed on these products add up to BIG BUCKS. Same with alchol. If you want to start banning things that will harm us, start with tobacco, then booze, and caffine isn’t doing us any favors, lets get rid of sugar, cars that go over 40 miles an hour, motorcycles, guns, french fries, matches, tanning beds, and might as well give the boot to my buddies Ben 7 Jerry while we are at it, the list could go on for days. Sound ridiculous? I agree, but so does banning a less harmful product, while it’s ‘real’ twin is sold hand over fist.
I’ve also heard that there is concern over putting the used cartridges into our landfills. Some of the brands sell cartridges that are equal to two packs of cigs. That’s forty cig butts. Is one spent cartridge worse than 40 cigerette butts lying on our sidewalks, in the parks, on the beach, etc?
So what are we doing here, trying to control the product, or the consumers?
I’m giving it a shot. I know of a few that have tried the product and had great success. I’m not going to let someone else tell me that I shouldn’t at least take a chance to cut my risk down. And unless the FDA finds solid proof and data that says ‘e cigs are more dangerous than traditional tabacco cigs’ within the week, i’m ordering, lol.
My husband and I have smoked for years. Myself, over 40 years. We have tried Nicotine lozenges, Chantix, Nicotine gum, Nicotine Inhalers, Cold turkey!! Nothing has worked like Electronic Cigarettes. I could feel my lungs opening up, I could breath again. I could finally relax and enjoy a cigarette. I now smoke them with 0 nicotine, just for their flavors and how moist it make my chest feet.
I hope there are open ears. I hope you are actually reading this. I hope you see what people are saying here. These are life saving devices, and I have not heard of anyone having problems with them. Even my NON smoking daughter is applauding! She hates cigarette smoke. She has witnessed the difference.
PLEASE be open when reviewing these! Can you imagine a smoke free AMERICA? Wow!
Hi….I am in favor of electronic cigarette because first and foremost this doesn’t contain any carcinogens which is very much present in the everyday tobacco smoke…But As what I have read in lot of reviews the effectiveness of this stuff is not yet proven…I wonder if it will really be good for us….But scientists are positive about these product….Are you in favor also about the safety of electronic cigarette?
Do not buy any electronic cigarettes!!! Believe or not they are worse than real cigarettes!
They are definitely not worse than real cigarettes…not saying they are good for you but they’re not worse. And they helped me quit smoking!