e-Cigarette Makers Required to Prove Effectiveness – IOM Issues Report
Special e-Cigarette News Update! The Institute of Medicine issued its special report on December 14th outlining recommendations to the FDA for the scientific proof required for a product like electronic cigarettes to be considered “modified risk.” Other products such as dissolvables and snus would fall under the same guidelines according to the report released today and covered by major media outlets.
Restrictive Guidelines
Among the guidelines recommendations are laboratory tests and animal tests and clinical trials with human subjects. Further guidelines for a product to qualify as “modified risk” beyond actually being less harmful than cigarettes include ensuring there is no significant uptake in people other than those for whom traditional quitting methods have failed. This group would include youth, former smokers and current non-smokers.
The guidelines also recommend that tests be conducted by third party facilities as the current industry lacks the resources to conduct such tests themselves.
Prohibitionists Response
The media stories out about the report also quote a number of familiar groups amongst the prohibitionist camp. The groups were happy to link all types of products to big tobacco including e-cigarettes. Many cited the lite cigarette issue in response to this report to further demonize products like e-cigarettes.
“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.
The reality is of course that most e-cigarette companies are fairly small organizations and would be completely bankrupted having to put their products through such rigorous trials.
Harm Reduction Speaks Up
The USNews article quoted in this news update did post a small quote at the end from a pro e-cigarette organization, the TVECA. Unfortunately, it wasn’t perhaps the most sterling example of a rebuttal. The article also tried to portray Mr. Story as a bit of a conspiracy nut.
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.”
No offense against the TVECA, but there may have been a better prepared spokesperson out there. Let’s try Dr. Bill Godshall, president and founder of Smoke Free PA who issued a press release shortly after the report was released:
Statement by Bill Godshall on the IOM committee’s new report on Modified Risk Tobacco Products at:
http://www.iom.edu/Reports/2011/Scientific-Standards-for-Studies-on-Modified-Risk-Tobacco-Products.aspx
Institute of Medicine urges FDA to protect deadly cigarettes from market competition by far less hazardous smokefree tobacco alternatives.
The new IOM committee report is terrible for public health because it urges the FDA to protect deadly cigarettes from market competition by far less hazardous smokefree alternatives.
The IOM committee is basically urging the FDA to impose a several hundred million dollar tax on any tobacco company before it could truthfully inform smokers that a smokeless tobacco product is less hazardous than cigarettes.
While the report correctly points out that NRT products pose virtually no health risks, it ignores a half century a evidence documenting that smokeless tobacco products in Sweden and the US have very similar health risks/benefit profiles as NRT products.
The IOM committee report also ignores the undeniable evidence that several million smokers in the US and Sweden have already switched to smokeless tobacco products, and have significantly reduced their disease risks by doing so.
The IOM committee’s recommendation would require a tobacco company to conduct far more research than FDA requires drug companies to conduct on NRT products before they can be marketed as smoking cessation aids.
Smokers have a human right to truthful health information about far less hazardous alternatives to cigarettes. But this IOM committee obviously disagrees.
In sum, the IOM committee’s report protects cigarettes at the expense of public health, human rights and the truth.
Conclusion
I’m pretty sure this report will keep the regular e-Cigarette News Roundups hopping for quite a while. I’ve seen at least one other media article speaking out against the report, but haven’t had a chance to peruse it yet. I’m also waiting to hear what more activist groups have to say on the subject. For now, I don’t believe this will do anything to actually ban e-cigarettes, but it will seriously curtail companies ability to market on the safer aspect of e-cigarettes.
Of course this report doesn’t concern regular cigarettes, those guys are free to continue and market their product as usual. But keep the safer stuff off the market because… health! …err the kids! Something!
Fortunately, we as consumers are still allowed free speech so we can continue to tell our stories.
So why not share your story here in the comments! Maybe someone will take notice.
Image: Stuart Miles / FreeDigitalPhotos.net
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There is pending a law from FDA that would prohibit selling of e-cigs and related products/accessories over the internet or by mail and that is something I am worried about since that would make it difficult to find batteries, atomizers, liquid, etc., since there is no physical store that actually sells anything e-cig related where I live. Everything must be bought by internet and sent by mail, it's the only way to buy it.
My reply seems to have disappeared. Sorry about that, I've moved my blog to a new host recently, and there's been a few hiccups.
Anyway, we're a little way off from that happening. The FDA doubtlessly wants to do that, but first it needs to officially include e-cigarettes under other tobacco products. Once it does, then the internet advertising restrictions can be applied. I'm guessing this move might happen this upcoming spring. Keep close to CASAA.org for any calls to action, and of course watch here for news updates on the topic
More information on the FDA's restrictions can be found here: http://www.stevevape.com/fda-moving-to-ban-online…