Monday, June 18, 2012

FDA Regulation Could Make E-Cigarettes Less Effective


E-cigarette designs have changed and improved dramatically
since the introduction of the original "cigarette look alikes."
Photo Credit: youtubecommercial on ECF
By
Elaine Keller

In an April 25, 2011 letter to stakeholders, the FDA described its intention to regulate electronic cigarettes (e-cigarettes) “and other tobacco products.” The FDA plans to impose Section 905(j) of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) on e-cigarettes. Specifically, the FDA will consider any product that was not being marketed before February of 2007 a “new tobacco product and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action.”
Translation: The FDA failed to ban e-cigarettes by regulating them as drug-delivery devices, so the Agency has found a way to ban all but the most primitive early models of e-cigarettes by applying a section of the law that is inappropriate for this type of product. Section 905(j) was intended to stop the proliferation of new brands of combusted cigarettes.
Unlike tobacco cigarettes, e-cigarettes are high tech devices. Compare the features and performance of the computers or cell phones being sold five years ago to today’s products. Technology develops at a very rapid pace. The batteries in the 2007 models of e-cigarettes went dead after a couple of hours. Cartridges were poorly constructed and often leaked nicotine-laced liquid onto the user’s skin and even into the user’s mouth. Vapor production was sluggish, and as the liquid levels in the cartridge went down, users needed to inhale more and more strongly to produce vapor.
Researchers at the University of California, Riverside, documented these product deficiencies. [Trtchounian A, Williams M, Talbot P. Conventional and electronic cigarettes (e-cigarettes) have different smoking characteristics. Nicotine Tob Res. 2010 Sep;12(9):905-12. Epub 2010 Jul 19. http://www.ncbi.nlm.nih.gov/pubmed/20644205]
Today’s products are a vast improvement on the original models. Larger and more powerful batteries last all day, and even several days for some users. Modern designs that don’t contain the fibrous filling used in the original products eliminate the need to increase puff intensity as the liquid is used up. Clever inventors have figured out ways to eliminate the leakage that plagued the original products.
More importantly, today’s products are more effective than their predecessors. Many people tried to use the early models of e-cigarettes as a replacement for smoking and were unable to do so, mostly due to inadequate vapor production and inefficient delivery of nicotine.
In order for a product that was not on the market prior to February 2007 to be approved for sale, it must prove that it is “substantially equivalent” to a “grandfathered” product that was being sold. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.” http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf
“Substantial Equivalence,” according to the Guidance document, means that the new product has the same characteristics as the predicate tobacco product, or has different characteristics and the report submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates the product does not raise different questions of public health.
The FDA defines Characteristics as “the materials, ingredients, design, composition, heating source, or other features of a tobacco product.” So the definition of characteristics is extremely broad, the required proof may be time-consuming and expensive to gather, and the criteria for approval is highly subjective.
How long will it take before there is a government stamp of approval on modern, effective e-cigarette models? Many long-time smokers don’t have any time to waste. The damage has already started and will continue until they find a way to stop inhaling smoke.

7 comments:

  1. This will do nothing at all beyond pushing more people into using home made and unsafe devices, resulting in more accidents, battery explosions and more overall smokers. Though, this is probably by design, as the more people who quit smoking, the less taxes are gathered on cigarette sales. For a prime example, look at the 10 year finances of the state of California and the impact of the loss of smokers affecting the state's revenue!

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  2. I have to say that although I agree with mom2matoskah for the most part, the incident of the exploding e-cig was a very rare thing. With over 2.5 million people trying them in the last year, we have only heard of one or two...so this is really a safe market- more exploding battery powered tooth brushes, for instance- but we don't hear about that- not like e-cigs. So any controversial product is going to get the spotlight and the media's twist. The e-cigs that went off were due to mismanaged batteries from what I understand. The market already is huge with many devices that it cannot be stopped now. Like other "products" that are illegal, if the FDA were to impose laws and restrictions, these devices would be just be sold as devices for zero-nicotine. So I don't see folks making their own so much, although thousands already are and actually doing a good job with them. People would get their nicotine from other sources- now that could be a problem. Anyway, I agree about the tax revenue but even more than that, it's the FDA that e-cigs hurt because they are largely funded by big pharmaceutical companies. Of course they want them banned or at least severely restricted to the point that they are are ineffective and don't put a dent in what big pharma is already marketing for folks to quit smoking (which isn't very effective). I say there is room for all of this. Big pharma needs to do a better job of helping people instead of just taking their money and the FDA needs to wake up and finally recognize harm reduction rather than their "quit or die" policy. It's outdated and most people know this.

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  3. More control over what adults choose to do is apparently what the government and the FDA do best. "Give us your cash,freedom of choice and your mind and believe we're here to help you!
    The FDA has our best interest at heart don't you know that? Skeptics!

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  4. Don't you get it? they do not want people to quit smoking! the taxes the get from tobacco, the money they make from people getting cancer there would be way too much money loss if people were to quit not only that but i just read an article talking about how it would cost the government a LOT more money in medicare and social security because people would live longer so if they can make the money off of smokers (by way of Taxes) and the get sick they make money off of all the (medical)then when they die they make money by not having to pay out in Medicare and social security benefits, as long as they would with a healthy person THEY DO NOT WANT US TO QUIT SMOKING !!

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