Thursday, April 03, 2008

Tobacco Control Gone Crazy: Study Group Calls For Regulating Smoke Constituents Without Knowing Whether It Will Help, Hurt, or Not Affect Health

In an article published in the current issue of Tobacco Control, The World Health Organization's Study Group on Tobacco Product Regulation (TobReg) is promoting the regulation of cigarettes by mandating that all cigarettes be altered (or removed from the market) so that they meet the median level (in all cigarettes) of 9 specific toxicants, measured in terms of the amount of the constituent measured per milligram of nicotine.

The recommendation calls for "establishing levels for selected toxicants per mg nicotine and prohibiting the sale or import of cigarette brands that have yields above these levels." The recommendation specifies nine toxicants that would be regulated. "The initial levels suggested for regulating [2 of the toxicants] are the median values for the brands on the market, and for seven additional toxicants the levels recommended are set at 125% of the median value of the toxicant per mg nicotine for the brands on the market being regulated."

According to the article: "Prohibiting consumer communications based on any machine measurements is a necessary condition of this strategy. Given the limitations of existing science, regulatory authorities have an obligation to ensure that the public is not misled by the results of the recommended machine testing and mandated lowering regulatory strategy, as the public was misled by the use of machine testing for tar and nicotine yields."

The Rest of the Story

While at first glance, this might appear to be a rational approach (although I'm not sure why it would), the authors of the article readily acknowledge the following:

1. At the present time, no measures -- including the measure of the level of these nine toxicants per mg nicotine -- have "been validated as reliable independent predictors of differences in tobacco related disease risk among smokers using different products."

2. "It is generally assumed that product design characteristics, constituents and additives contribute to the toxicity of cigarettes, the addictiveness of the product and the likelihood that new smokers will start or confirmed smokers will quit. ... Nevertheless, the existing science base is currently not sufficient to allow regulation of these characteristics based on their effects on toxicity of the product either by establishing product performance standards or by prohibiting the use of specific design features or constituents."

3. "Each measured toxicant is treated individually, such that the possibility of chemical interactions -- either enhancing or inhibiting the hazardous properties of the smoke -- is not taken into account."

4. "Further, it is obvious that these calculations have only been possible for those toxicants where index values have been estimated, and not for the rest of the some 4000 individual constituents in cigarette smoke."

5. Even where risk index values are available: "Since many of the potency factors have been derived from animal experiments, the obvious limitations in extrapolating from animal models to the human situation also apply."

6. "These limitations preclude use of these quantitative estimates of the likely harm or risk of exposure to these different toxicants or for comparison of the relative risk or harm of different cigarette brands."

7. Furthermore, the study authors acknowledge that limiting the concentrations of these nine smoke constituents may actually lead to increases in the concentrations of other toxicants: "when only a few toxicants are regulated there is a greater probability that reductions in one toxicant might result in higher level of other toxicants in the brands remaining on the market as an unintended consequence."

8. The authors acknowledge that "it is possible that removal from the market of brands high in levels of the regulated toxicants will leave brands on the market with high levels of those toxicants not regulated. In addition, the changes in cigarette design and manufacturing implemented to lower the regulated toxicants may have the effect of increasing the levels of other non-regulated toxicants."

9. The authors acknowledge that "Existing science does not allow a definitive conclusion that reduction of nitrosamines, or any other individual toxicants in cigarette smoke, will reduce cancer incidence, or the rate of any other tobacco related disease, in smokers who use cigarettes with lower levels of these toxicants...".

10. "Existing science has also not demonstrated that the specified changes in regulatory values will result overall in a meaningful change in actual exposure for consumers...".

11. "Mandating levels and disallowing brands with higher levels from the market is not a statement that the remaining brands are ... less hazardous than the brands removed."

So let's get this straight:

1. There is no evidence that would allow us to conclude that this regulatory approach will result in safer cigarettes.

2. There is no evidence that would allow us to conclude that this regulatory approach will even lower actual exposure to the regulated constituents.

3. There is some evidence to suggest that this approach might even increase the risks of smoking by increasing the levels of non-regulated toxicants.

4. The danger of misleading people about the risks of cigarettes is so grave that we must prohibit any and all public communications from cigarette companies indicating even that they are complying with federal regulations on toxicant levels.

5. Tobacco control scientists are recommending this as a mandatory regulation to be implemented throughout the world.

If one accepts premises #1 through #4 (which we have to, because the authors themselves state and accept these points), then it is absurd to accept point #5.

These researchers are acknowledging that we have no clear idea whether this regulatory approach will make cigarettes safer, keep them the same, or make them more harmful. Yet they conclude that this is a sensible regulatory approach. I just don't get the logic here.


Sorry to repeat this point, but it is just too baffling for me to comprehend.

Please help me understand the logic of the following: The World Health Organization's Study Group on Tobacco Product Regulation (TobReg) is proposing that we regulate cigarettes by picking nine constituents and stating that whatever the median level of those constituents currently is in all cigarettes (per mg nicotine) should be the maximum level allowed.

They are recommending this despite their acknowledgment that this approach may well increase the risks of smoking by making cigarettes more hazardous.

This is insanity. I can't think of any other way to describe it.

I have to confess that I no longer can claim to understand what is going on in tobacco control these days. I always thought that it was a science-based movement. But now I find that it is making recommendations that are not based on any science. And it admits that!

That's the thing I just don't get. This article is not trying to hide the fact that there is no scientific justification behind the regulations that are proposed. They readily admit that there is no existing science to support this as a regulatory approach. They readily admit that it could lead to increased toxicity of cigarettes. Yet they recommend it anyway!

I am getting the impression that TobReg wants to regulate cigarettes merely for the sake of regulating cigarettes, not because that regulation will make cigarettes safer. Perhaps it's not their fault. Perhaps when you charge a committee with developing an absurd approach to tobacco control, the resulting proposal they come up with is bound to be absurd.

But couldn't they at least have come back and said: "We've studied the problem, and unfortunately, the existing science base simply does not support regulation of the constituents or emissions of cigarette smoke as an appropriate and effective approach to reducing the harms related to cigarette smoking. At least not at the current time. We will be glad to revisit the issue when and if the science advances to the point that this type of regulation makes some sense."

But no - that's not what they did. Instead, they essentially said: "There is currently no evidence that regulating the constituents or emissions of cigarettes will effectively reduce the harms associated with smoking, and it might even make the problem worse, but we're going to do it anyway."

And what makes this truly tragic is that if this scheme is implemented, it is invariably going to result in the public being misled about the risks of cigarettes on the market. Even if public communications from cigarette companies about the facts of regulation are banned (which is clearly unconstitutional, at least in the United States), the public is still going to find out that cigarettes are being regulated with emissions standards (has anyone ever heard of something called the internet?).

So the public is going to naturally believe that cigarettes have been made safer. Essentially, what this regulatory scheme would do is to transfer the fraud that the cigarette companies have been found guilty of committing (by marketing "light" cigarettes as being safer alternatives) over to the federal government.

It would truly be a dream come true for the tobacco companies. Not only would they be able to reap the benefits of a public that is less concerned about the hazards of smoking, but they wouldn't have to do anything other than comply with federal regulations. The government would be doing all the work for them. And to boot, they wouldn't be liable for any damages caused by misleading the public.

They must be having a field day over at Philip Morris, Reynolds American, and Lorillard today. The insanity of the current tobacco control movement is more than they could ever hope for.

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