Thursday, July 23, 2009

FDA Lunacy: Product We Know Will Kill 400,000 People This Year - APPROVED; Product that May Well Help Prevent Many of Those People from Dying: BANNED

Yesterday, the FDA held a major press conference to announce that there are traces of tobacco-specific nitrosamines in electronic cigarette cartridges and that diethylene glycol was detected in one cartridge. Based on those findings, the FDA expressed grave concern over the safety of the product - which is being used by thousands of smokers, literally hundreds of whom have testified that it is more effective than NRT in helping them to stay off cigarettes - and essentially banned the marketing of the product, even threatening criminal action against those who market or sell e-cigarettes.

At the same time that the FDA made a big hullabaloo over the finding of traces of carcinogens in electronic cigarette cartridges, the FDA hid from the public the fact that it would be nearly impossible not to have detected these carcinogens in the cartridges because the nicotine is derived from tobacco and there are residual traces of carcinogens even in nicotine replacement products.

Moreover, the FDA also hid from the public the fact that conventional cigarettes contain and result in human exposure to diethylene glycol, not to mention the fact that they also deliver extremely high exposure to more than 40 different carcinogens, just a few of which are tobacco-specific nitrosamines.

While there is a theoretical risk posed by the diethylene glycol (DEG), it is not clear how high the level of DEG is in the vapor produced by the electronic cigarette and thus the dose delivered to the user is unclear. It is also not clear whether the DEG is present in just this one cartridge or whether the problem is more widespread. Thus, there is no clear evidence that e-cigarettes pose any harm.

What is clear, however, from the FDA testing, is that electronic cigarettes are essentially confirmed as being far, far safer than conventional cigarettes.

Thus, the FDA's decision to ban the much safer electronic cigarettes while approving the deadly conventional ones, is nonsensical.

I prepared the following table to illustrate the FDA's inconsistent treatment of various types of nicotine-delivering products:

Nicotine-Delivering Product

Known Serious

Health Risks

Known Serious

Adverse Effects

Effectiveness for smoking cessation

FDA Position

Electronic cigarettes



No proof, but anecdotal evidence suggests they are more effective than NRT





No evidence they are more effective than cold turkey quitting





No evidence they are more effective than cold turkey quitting



Will kill more than 400,000 people this year

Will kill more than 400,000 people this year



You can easily see the insanity here. The product that we know will kill more than 400,000 people this year is APPROVED. The product which has no known serious health risks (although there remains some concern about DEG in some varieties) is BANNED.

The product which delivers nicotine, DEG, and 10,000 other chemicals (including toxins and carcinogens) is APPROVED. But the product which delivers nicotine, DEG, and none (or only traces) of the other 10,000 chemicals, toxins, and carcinogens is BANNED.

Even the FDA's position on Chantix is inconsistent with its position on electronic cigarettes. E-cigarettes are not known to be killing anyone, but they are BANNED. Chantix has been documented to have death as a serious side effect, and it is APPROVED.

Once again, I'm not calling for the removal of Chantix from the market or for the stricter regulation of NRT products (despite what I see as a lack of evidence of their effectiveness). However, I am calling for a more sensical treatment of electronic cigarettes.

While the FDA framed its findings yesterday as demonstrating that electronic cigarettes are dangerous products and that smokers should not use them, I see the results differently. I see the results as confirming the earlier testing of Ruyan e-cigarettes, and as demonstrating that these products almost certainly (beyond any reasonable doubt) present far fewer risks than conventional cigarettes.

Thus, I think that smokers should be encouraged to consider using electronic cigarettes in an effort to quit if they are unable to quit on their own and without nicotine replacement. Smokers who have failed to quit using NRT should also be encouraged to try these products, since there are hundreds of testimonials from smokers who assert that while NRT was inefffective for them, electronic cigarettes have been very effective.

It's clear that the FDA and anti-smoking groups don't realize it, but electronic cigarettes are exactly the kind of safer nicotine-delivery product that we desperately need. The problem with NRT products is that while they effectively deliver nicotine, they do not simulate all the other aspects of smoking, and thus they are ineffective in keeping smokers off of cigarettes.

The beauty of e-cigarettes is that they not only deliver the nicotine, but they almost completely simulate the act of smoking. This is what vapers (e-cigarette users) consistently cite as being the reason why they are far more effective than NRT products.

You see, addiction to smoking is about far more than just addiction to nicotine. The entire act of smoking - all aspects of the behavior - are part of the addiction and enticement of the act. You can replace the nicotine, but you are still not replacing all the various aspects of the behavior. Electronic cigarettes come as close as is yet possible to doing this, and for that reason, they appear to be more effective than any other smoking cessation medicine/device.

In fact, the factor that makes the electronic cigarette so apparently effective is the precise factor which makes it so distasteful to anti-smoking groups. These groups just cannot tolerate the idea that a smoker would continue to go through the act of smoking. The issue of whether or not the behavior is orders of magnitude safer is not relevant in the anti-smoking mindset (or in the FDA's mindset, apparently). All that matters is that the smoker achieve abstinence. And it is not abstinence from nicotine they are talking about. It is abstinence from the act of smoking.

The CDC argued during yesterday's press conference that electronic cigarettes are going to encourage youths to smoke because it looks like someone is smoking. In other words, the CDC readily admitted that what is troublesome is the fact that these products simulate smoking, not that they are actually going to be more harmful to smokers. Other anti-smoking advocates predicted that these devices or going to attract youths, largely because the nicotine comes in flavored varieties.

But how genuine are these concerns? The FDA just approved cinnamon and cherry-flavored nicotine lozenges, and the anti-smoking groups expressed no concern over those products.

I don't think there's any question that the lozenges pose a far greater danger of youth abuse than e-cigarettes. Why? Because they are readily available and relatively inexpensive, while the electronic cigarettes require a youth to shell out 100 bucks, and that doesn't even get them the cartridges.

This doesn't mean that there aren't problems with e-cigarettes that need to be addressed. This doesn't mean that e-cigarette manufacturers shouldn't be asked to make certain changes, such as instituting tighter quality control procedures and making sure that the propylene glycol is devoid of diethylene glycol. This doesn't mean that there shouldn't be restrictions on the sale of these devices to minors. But it does mean that it is lunacy to ban the product, especially in light of how the very same FDA is now approving the well-known to be deadly Marlboros, Winstons, Kools, Newports, Camels, and others.

The rest of the story is that the FDA and anti-smoking groups have apparently lost sight of the actual objective of public health regulation: to improve the overall population's health. The combination of FDA approval of conventional cigarettes and FDA banning of the much safer electronic ones is ludicrous, will have detrimental population health effects, and sends exactly the wrong message to the public.

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