The draft list contains 108 chemical constituents that have been demonstrated to be either carcinogens, cardiovascular toxicants, respiratory toxicants, reproductive/developmental toxicants, or addictive components.
The Rest of the Story
To me, this seems like a pointless waste of time.
First of all, there is nothing new here. We have known about the harm or potential harmfulness of these 108 chemicals in tobacco smoke for many years.
Second, and more importantly, who cares?
Compiling this list does absolutely nothing to protect or improve the public's health. The only way this list would make a difference would be if the FDA were going to, or could, actually do something to remedy the problem.
However, the FDA tobacco law does not allow the FDA to get rid of all of these harmful constituents. At best, the FDA can require the selective removal of one or a handful of them. There is no evidence that such an action would make smoking any safer. It would, however, lead smokers to believe that cigarettes were safer. Such an action would essentially represent fraud against American consumers, similar to the fraud tobacco companies were accused of with their low-tar, "light" cigarette deception.
Moreover, such an action would undermine the public's appreciation of the hazards of smoking and could lead to increases in cigarette consumption, resulting in significant harm to the public's health.
There is only one way to remedy the harm caused by these toxicants and that is to remove them from cigarettes. The only way to do this is to produce a cigarette that delivers nicotine without the use of tobacco. This technology does, in fact, exist. It is called an electronic cigarette. The electronic cigarette delivers nicotine to users without 107 of these 108 chemicals (only nicotine is present in anything more than trace quantities).
Ironically, the FDA has essentially banned electronic cigarettes, or at least threatened to take enforcement action against companies which import or distribute these products.
This reveals the utter absurdity of the entire FDA tobacco regulatory scheme:
The product which contains only 1 of the 108 harmful chemicals is banned.
The product which contains 108 of the 108 harmful chemicals is approved for marketing and sale to millions of consumers, including hundreds of thousands of youth.
Now that makes great sense!
This whole exercise strikes me as not only a waste of time and resources, but as a huge hoax. It is giving the public the impression that the FDA is doing something to make cigarettes safer by compiling a list of harmful constituents in tobacco smoke. But nothing could be further from the truth.
Compiling a list protects nobody. The only thing that would protect the public would be to remove the 108 harmful chemicals. This would require the development of a cigarette that does not contain tobacco (it is called an electronic cigarette).
Why could the FDA not simply ban these 108 chemicals from cigarette smoke? Because there is no technology to remove all of these 108 chemicals. Placing a ban on these 108 chemicals would amount to a ban on existing cigarettes, which is specifically precluded by the Tobacco Act.
Thus, this entire exercise is an exercise in futility. A waste of time and resources. A fraud and a deception. A public hoax.
Despite the Tobacco Act's primary stated intention of making cigarettes safer by giving FDA the authority to regulate the constituents of the cigarette, even Dr. David Kessler - a staunch supporter of the bill and former FDA Commissioner - admitted that it was neither the intention nor the expectation of the bill's supporters that the bill actually achieve this purpose. He readily admitted that there is no scientific way for the FDA to make the product safer -- it's not even possible, he said: "I'm not sure that scientifically we're smart enough to know how to do that or that's possible when you're burning a tobacco leaf or you're inhaling all these chemicals that are very reinforcing."
Despite Kessler's proper understanding of cigarette toxicology, the science (i.e., the truth) did not stop him from joining many anti-smoking advocates and groups in pulling a hoax on the American people. And a hoax of massive proportions, I would add.
Just look at what supporters of the legislation told and continue to tell the American people. For example, Senator Christopher Dodd (D-CT) boasted that because of this legislation, cigarette manufacturers will "be forced to stop using some of the most dangerous ingredients." As if that makes any difference. There are more than 10,000 chemicals in cigarettes and there is no evidence that removing "some" of the most dangerous ones will result in a safer product. But this scientific fact did not stop Senator Dodd from pulling the wool over the eyes of the public and contributing to the public hoax.
Even the late Senator Ted Kennedy played a part in this hoax. He told the American public that the legislation would "help addicted smokers quit" and that it would "require manufacturers to make tobacco products less toxic and less addictive for those who continue to use them." But the law does nothing to help addicted smokers quit. There is no support of smoking cessation programs. There is no money for smoking quitlines or any inteventions that will help smokers quit. There are no funds for campaigns to motivate smokers to quit. In fact, the only relevant power the law gives the FDA is to reduce nicotine levels in cigarettes. However, we know from the scientific evidence that this will just result in smokers smoking more not less, as they need to compensate to maintain a constant dose of nicotine.
As John Jonik pointed out in a letter to the editor in the Seattle Times, Senator Kennedy's false promise was merely a continuation of the tobacco industry's fradulent statements about the benefits of low-nicotine cigarettes. In fact, Senator Kennedy's claim is probably worse because while the tobacco companies merely implied that "light" cigarettes might be less addictive, Kennedy was clearly asserting that low-nicotine yield products will be less addictive. Why is it that the tobacco companies were found guilty of fraud for making the same statement (in an even less assertive way) that Kennedy made?
Moreover, Senator Kennedy's assertion that the law will require manufactureres to make tobacco products less toxic is also false - another hoax. As Dr. Kessler admitted, there is no expectation that FDA regulation of certain of the ingredients in tobacco will be able to make cigarettes safer. Senator Kennedy, too, pulled the wool over the eyes of the American public.
And now, albeit not by specific intention, the FDA and its Tobacco Products Scientific Advisory Committee are continuing to carry out this hoax on the American public by going through the motions of pretending that by making a list of the constituents in tobacco smoke, it is magically going to result in a safer cigarette.
The Regulatory Scheme Established by the Legislation is Pure Lunacy
The system of tobacco product safety standards set up by the Tobacco Act is pure lunacy. Although the rhetoric by groups like the Campaign for Tobacco-Free Kids sounds great, the truth is that there is no evidence that these standards would actually result in a safer product.
The problem is that we simply do not know which of the constituents in tobacco smoke, and at what quantities, are responsible for what diseases. So the Campaign for Tobacco-Free Kids can talk all they want about how FDA will be able to reduce levels of certain toxins and produce a safer cigarette, but that's a pipe dream. It would take difficult to conduct, long-term epidemiologic studies, where you'd have to follow smokers of conventional vs. new products for 10-20 years, before you could have an answer to this question. But in the mean time, we wouldn't know what the risks are - or even if the risk could be decreased.
Essentially, the law gives the FDA a mandate which it cannot carry out. The only way to know whether any particular reductions in specific smoke constituents would result in a safer product would be to carry out long-term epidemiologic studies, using smokers as guinea pigs. Perhaps some would view that as acceptable because the product is dangerous anyway. However, the problem is that smokers are going to naturally assume that these products are safer - and we won't know that is true. This law greatly deceives smokers into thinking that the product is safer, when it may well not be any safer at all, and could potentially be more hazardous.
Unfortunately, we simply do not have any idea whether it is even possible to reduce the toxicity of cigarettes by reducing the levels of specified components.
The entire approach is flawed, because if you want safer cigarettes, you need to use the free market approach to set up competition between the companies for a safer product. This legislation does the opposite. It takes away the free market completely and puts all decisions into the hands of FDA. But it gives the FDA a mandate which sets up impossible standards that could never be met for new products. What it really does is ensure that existing products will be institutionalized and protected from competition. This, indeed, is the reason why Philip Morris supported the bill, and all the smaller companies opposed the bill. What the smaller companies despised is the removal of any serious chance to compete in the market - and largely, the market we are talking about is potentially safer products.
Philip Morris wanted to freeze the market as is, so that Marlboro - one of the highest risk products imaginable - will be able to continue to dominate the market in perpetuity, without any serious competition from potentially safer products which could advertise themselves as being safer than Marlboro and thus gain market share among the "health-conscious" segment of smokers who are looking to reduce their risks while still satisfying their demand for cigarettes.
If you really think about it, you'll see that the approach of trying to reduce the levels of specific smoke constituents is complete lunacy. When you have no idea which constituents, in what combination, and at what concentrations, cause which diseases that are associated with smoking, then it is impossible to produce a cigarette that you know will be safer simply by mandating a reduction in the levels of various smoke constituents.
The one thing you will never hear the supporters of the Act do is estimate the number of lives they think this legislation will save. All they can do is talk about "countless" lives being saved. And they are quite correct. The lives are countless. You cannot count them because they do not exist.
It is estimated, for example, that there are over 60 compounds in tobacco smoke which cause cancer. So what sense does it make to require the companies to take out two or three of them? What if they take out the wrong ones? What if the actual compound which causes most of the cancer is not one of those chosen to be removed? What if smokers believe that this is a safer product and start smoking more? This approach could actually kill people, rather than save lives.
And it could also kill people by reducing youths' perceptions of the hazards of cigarette smoking. If youths are led to believe –correctly - that the FDA now regulates every ingredient of the cigarette and that – incorrectly - because of this, countless lives will be saved, does it not make sense for these kids to infer that cigarettes are not as bad as they used to be? We know for a fact that any decline in the perceived harm of cigarettes results in an increase in youth smoking. So the law could well kill more people than it saves.
To be clear, I am not necessarily blaming the FDA entirely. The Agency was given a mission (albeit an absurd and pointless one) by the statute, and to some extent, the Agency has to carry out this mission. However, I don't believe the statute requires the FDA to deceive the American people into thinking that this particular task (compiling a list of harmful chemicals in tobacco smoke) has any relation to protecting the public's health.
Nor do I believe the statute requires the FDA to take the ridiculous (and ironic) step of approving the products with these 108 harmful chemicals and banning the products with only 1 of them.
It is ironic that the very best the FDA could do - require the elimination or near elimination of each of the 108 harmful constituents except nicotine (which cannot be eliminated, by statute) - would be to mandate that cigarettes essentially become electronic cigarettes. In other words, that companies must develop products that can deliver nicotine without the harmful chemicals. Of course, FDA can't do this because it would amount to a ban on all existing cigarettes. But the point is that the best the FDA could do, even in theory, is to mandate a product like electronic cigarettes. Yet the Agency is warning the public that electronic cigarettes are potentially toxic and carcinogenic and recommending that smokers not quit smoking via the use of electronic cigarettes.
The rest of the story is that the production of a list of harmful chemicals in tobacco smoke is a waste of time and resources and will do nothing to protect the public's health or contribute to the betterment of the public's health in any way. Instead, this approach threatens to put an unnecessary burden on tobacco companies to comply with regulation simply for the sake of regulation, with no documentable public health benefits. In fact, the regulatory actions that are allowable under the statute would almost invariably lead to harm of the public's health and the fraud previously committed by the tobacco companies in deceiving consumers about the relative safety of reduced exposure products would simply be transferred over to the federal government.
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