Electronic Cigarette Makers Must Prove Safety Of Products

[BobatVaporsupplies]

A new report details exactly what kind of scientific proof the U.S. Food and Drug Administration should require from the makers of electronic cigarettes and tobacco lozenges to show that what they are selling is not harmful to the overall public health.

These "modified risk" products claim to offer individuals nicotine without the health risks, namely lung cancer and heart disease, that are associated with the use of traditional tobacco products such as cigarettes.

"These products are ones that might carry a claim that they have less risk to the user than a traditional tobacco product," said Dr. Jane Henney, a professor of medicine and public health sciences at the University of Cincinnati and chairwoman of the Institute of Medicine (IOM) committee that wrote the report. "We believe that if those claims are to be approved by the FDA, the sponsor will have to bring to the agency a series of data to support that claim."

These products are sold as part of a strategy to lower tobacco-related death and disease, especially among smokers who have had trouble quitting, but not much is known about the overall health risks of these products, according to the committee.

To determine that, the IOM report suggests that the FDA require testing in the laboratory and in animals, clinical trials with people, and post-marketing studies to see if any health problems show up once the products are in widespread use.

Given the "tobacco industry's well-documented history of improper conduct," the committee believes these studies should be done by independent third parties.

The authority for this kind of oversight was included in the 2009 Family Smoking Prevention and Tobacco Control Act, which requires that modified risk tobacco products undergo an approval process similar to drugs and medical devices.

Several groups applauded the IOM report's recommendations.

"The American Lung Association commends the IOM for its recognition that if a tobacco product is allowed to be marketed as 'safer' that the product must actually be safer," Charles Connor, president and CEO of the American Lung Association, said in statement.

"Decades ago, the tobacco industry developed light and low tobacco products that were no less harmful than those already on the market. Millions of Americans, who switched to those so-called 'light' and 'low-tar' products instead of quitting, died as a result of these claims. The scientific standards recommended by this expert panel are designed to prevent a repeat of similar attempts to deceive the American public. We encourage the FDA to heed these lessons and never lose sight of the deception and fraud perpetrated for decades by Big Tobacco," Connor said in the statement.

"This report lays out a comprehensive scientific roadmap for the FDA to follow in reviewing applications for modified risk tobacco products," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

"It demonstrates the need for rigorous science, conducted and evaluated independent of the tobacco industry, before the industry is allowed to market any modified risk products," he added. "It underscores the importance of the FDA considering the broad public health impact of introducing such products, and not just the impact on individual tobacco users. And it properly puts the burden on tobacco manufacturers to produce adequate scientific evidence before allowing them to claim that any tobacco product reduces the risk of disease."

David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies at the Legacy Foundation, said he believes the IOM report is right on target.

"These products are worthwhile, provided the overall public health message is adhered to," he said. "It could cause, overall, long-term public health damage. For example, if it was more appealing to youth and young adults it might have a little less harm, but a lot more people would use it and that would violate the public health standard."

According to the report, among the things studies should look at are whether the product is addictive and whether the components of the product are harmful to health. In addition, these products should be tested on current and former smokers, new smokers, adolescents and groups at high risk for tobacco use.

Tests also have to "evaluate whether this product would draw people to the use of this product who now don't smoke, or who might have quit smoking and would be drawn back into this habit and therefore increase their risk," Henney said. "These products should only be targeted to individuals who absolutely have been unable to stop smoking."

The process should also be transparent, the report stated, with the companies and the FDA making all the data available to the public.

However, Ray Story, CEO of the Tobacco Vapor Electronic Cigarette Association, doesn't see safety and public health as the driving factors behind the IOM recommendations, but thinks instead it is a conspiracy by tobacco companies, drug companies and the federal government to keep these products off the market.

"I've been fighting this issue for quite some time, but you are fighting much larger groups," he said, noting that electronic cigarettes deliver nicotine without the risk of fire. "It does the same thing as a cigarette, without the 7,000 harmful chemicals and 65 carcinogens."

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[Uma]

Here's a thread by Bill Godshall that goes into even more honest detail. IOM

(a must read!)

[calebw]

Thats bull****!!! eCigs can no way be as harmful as real cigarettes. And how many thousands of years have those been around???

[jamfran]

e-cigs are less unhealthy compared to cigarettes, which makes them a better alternative..i do hope for the quality of the devices to be regulated ..and also more guidance on the nicotine intake for vaping to make sure one does not overdo it..

[kitsune]

The forums are one huge study group. Many of us have been vaping for a couple years with no ill effect. They just need to compile information from the forums.....

Inhaling anything into your lungs isn't healthy, that being said...I feel so much better now than I ever did when I was smoking. I certainly can breath better.

If any product makes health or medical claims, they do need to back it up.

[jamfran]

Yes, I do feel much better compared to when I was still smoking cigarettes. I breathe easier and have more energy.

[mega]

i feel almost 100% since i quit smoking. honestly I dont remember the last time i felt like this.

[willmon22]

The only thing I am wondering about is propylene glycol as I seen on this page: http://www.natural-health-information-centre.com/propylene-glycol.html that it liver abnormalities and kidney damage. But of course it doesn't say in what form of propylene glycol. I looked into vegetable glycerin and didn't really see anything on it. What I did find was this page: http://www.livestrong.com/article/519369-side-effects-of-vegetable-glycerin/ which didn't say anything harmful but mentioned propylene glycol

propylene glycol, can have toxic effects when consumed in high quantities. It doesn't say how much high quantities is but I would say there is no way there is enough to really even cause liver abnormalities and kidney damage. Anyways that is what I found which I am sure most have already read and agree that either probably don't really have any effect compared to smoking an analog over an ecig I am sure everyone agrees.

[mega]

pg you have to drink alot i mean alot. they feed it to cows for ketosis. vg is dangerous.here a little article on it.

Propylene Glycol (PG) has a boiling point of 188 degrees Celcius and there are no breakdown chemical reactions before this temperature. It can't reach a higher temperature in an e cigarette. PG is very safe in the quantities used when e smoking unless one is allergic.

Glycerol (VG) has a boiling point of 290 degrees Celsius which is far higher than PG so obviously it is less efficient at vapourising which makes PG the winner as an e smoking liquid. VG might make visible vapour but it is guarateed to vapourise less liquid and nicotine in total using the same energy generated from the ecigarette by the laws of physics.

But this is not the real concern, the real concern is that beyond 280 degrees VG starts to break down into HIGHLY TOXIC ACROLEIN this 10 DEGREES LOWER that the biling point for VG!

Now I dont think atomizers get hotter than 280 degrees normally but what about a malfuntioning one? I am not about to get acrolein poisoning to find out.

Finally, the maximum efficiency of the atomizer is when the liquid reaches its boiling point. I'm sure that it reaches the BP of PG but if it did reach the BP of VG then you have acrolein sythesis. Two reasons not to use VG, but low efficiency aside Acrolein is not something you should risk inhaling.

heres a link to acroline poisoning.

http://www.rightdiagnosis.com/c/chemical_poisoning_acrolein/intro.htm

Edited February 11, 2012 by mega

[twelveday]

VG breaks down into acrolein at 280C which is 536F. Temperature in atomizers usually reach 180-250F so that might give you a basic idea of how hard it would be to get to 536F. Scary? Yes, something to worry about? Personally I dont think so, unless you are messing with Mods and mixmatched atomizers/voltage/batteries, but even then I think it would be difficult. Just look at how many people smoke Bobas Bounty which i think only comes in a 90vg/10pg or 100vg mix and no doubt on mods. I think its good information though for those ecig users who like tinkering with mods and such though, safety precautions are always a good thing, especially at this point in time in the ecig world.

[mega]

I only put it up because ive had acroline poisoning, not fun, but got it from pesticides at work. and i agree it will be hard for a atty to get that hot but not impossibe.