The World Health Organization (WHO) Study Group on Tobacco Product Regulation (TobReg) has published a number of reports that serve as what it purports to be the "scientific basis" for the regulation of the constituents in tobacco products. The overall rationale and approach are outlined in an article published in the journal Tobacco Control.
The basic rationale presented by the Study Group is that although we don't know which constituents, and in what combinations, and at what levels, are responsible for tobacco-related disease, it nevertheless makes sense to regulate the permissible levels of a select few of these constituents.
The ultimate recommendation of the Study Group is as follows: "TobReg recommends a strategy for regulation based on product performance measures with the goal of reducing toxicant levels in mainstream cigarette smoke measured under standardised conditions. It recommends establishing levels for selected toxicants per mg nicotine and prohibiting the sale or import of cigarette brands that have yields above these levels. ... Mandated lowering of levels of toxicants per mg nicotine in cigarette smoke will make regulation of cigarettes consistent with other regulatory approaches which mandate reduction of known toxicants in products used by humans."
The Rest of the Story
There is absolutely no scientific basis for the recommendations of TobReg, nor is there any evidence that these recommendations would lead to an improvement in the public's health. It is just as likely that the proposed policy would result in more dangerous cigarettes and/or an increase in cigarette smoking, and therefore, in an increase in tobacco-related morbidity and mortality.
Because less than 40% of the constituents in tobacco smoke have been identified, we have no idea whether decreasing the levels of certain chemicals will result in increases in the level of other chemicals which are harmful. We have no idea what the effect of decreasing yields of certain chemicals will be on smoking behavior, and therefore, on actual human exposure. Moreover, we don't even know whether lowering exposure to any given specific chemical will result in reduced product risk.
For example, one the chemicals that TobReg has targeted for mandatory reductions is tobacco-specific nitrosamines. A sure way of reducing nitrosamine levels would be to switch from burley to flue-cured tobacco. However, doing this would likely increase the overall tar levels, as well as the level of benzo[a]pyrene. Therefore, we simply do not know whether lowering nitrosamine levels would result in a safer product.
In fact, the tobacco industry itself acknowledges this. Rodgman and Perfetti, in their book entitled "The Chemical Components of Tobacco and Tobacco Smoke," write that: "whether the reduction or elimination of TSNA's [tobacco-specific nitrosamines] from MSS [mainstream smoke] will result in a 'less hazardous' cigarette is unknown."
What TobReg is proposing, then, is simply a repeat of the low-tar fiasco perpetuated by the tobacco companies, for which anti-smoking groups have accused them of fraud and have pursued a racketeering judgment against them. The only difference is that instead of the fraud being committed by the tobacco companies, it will now be committed by TobReg. Lower yield products will be marketed to consumers throughout the world, misleading them into believing that these products are safer, but without any evidence that they are actually safer.
There is absolutely no difference between what TobReg proposes to do here and what the tobacco companies have found themselves guilty of perpetrating by Judge Kessler: deception of the public about the relative safety of lower-yield products without scientific evidence to substantiate the improved safety of these products.
What makes this fiasco particularly disturbing, however, is that TobReg is apparently aware that they are recommending a policy for which there is no scientific basis and which may well result in no health improvement. TobReg is aware that its recommendations are tantamount to misleading and deceiving consumers throughout the world!
How do we know this? Because TobReg grows to great pains to make sure that consumers do not become aware of what TobReg is proposing be mandated. The Study Group insists that countries take intrusive (and in the U.S., clearly unconstitutional) measures to restrict the free speech of tobacco companies so that they cannot even inform consumers that the levels of certain toxicants in the smoke have been lowered.
The TobReg Study Group is so sure that its proposed standards are not going to necessarily improve the public's health that it urges countries to ban the tobacco companies from telling the simple truth: that new product safety standards have been set and that the companies comply with those standards: "Use of the results of the testing, or of relative ranking of brands by testing levels, should be prohibited as are statements that the brand has met governmental regulatory standards. ... TobReg recommends that any regulatory approach specifically prohibit the use of the results of the proposed testing in marketing or other communications with the consuming public including product labelling. It is also recommended that manufacturers be
prohibited from making statements that a brand has met governmental regulatory standards, and from publicising the relative ranking of brands by testing levels."
So let's get this straight: TobReg recommends safety standards based on a ranking of toxicity levels, but it has such little confidence that this ranking means anything that it must prohibit companies from letting consumers know the ranking of their own products.
How ridiculous is that? It would be like the U.S. Department of Agriculture setting a grading standard for meat quality but prohibiting meat producers from informing consumers of what grade the meat is that they are buying.
To make matters worse, TobReg is aware that machine-measured cigarette yields are meaningless: "There is a current scientific consensus that these per cigarette yields do not provide valid estimates of human exposure or of relative human exposure when smoking different brands of cigarettes. Communication of these measures to smokers as estimates of their exposure or risk creates harm by misleading smokers to believe that differences in exposures and risk are likely to occur with switching to cigarette brands with different machine measured yields."
Worse still, TobReg recognizes that its standards of constituent yields per milligram of nicotine are also invalid: "Normalisation of the machine generated yields per mg nicotine, or per mg tar, does not eliminate the variation in the values measured by the different machine regimens."
Worse even still, TobReg recognizes that there is no reliable relationship between its proposed product "safety" standards and actual product safety: "none of these measures have been validated as reliable independent predictors of differences in tobacco related disease risk among smokers using different products."
And the icing on the cake is that TobReg acknowledges that its proposed "safety" standards are meaningless and invalid, that they have nothing to do with actual product safety, and that they are not valid to compare the relative safety of different products:
"There are obvious limitations to the methodology used here for ranking individual cigarette smoke toxicants. 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. 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. 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. These limitations preclude use of these indices as 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."
In a separate report, TobReg also recognizes the same: "Science has not established that reduction of any individual toxicant in machine- measured cigarette smoke, including those proposed in this report, will reduce actual human exposure or disease risk. Mandating lower levels and removing some brands with higher levels from the market do not constitute a statement that the remaining brands are safe or less hazardous than the brands removed."
And, even worse, TobReg acknowledges not only that its "safety" standard has nothing to do with "safety," but also that its standard will not necessarily even lower exposure to hazardous substances: "It is not known whether reducing the levels of the high-priority toxicants identified in this report will actually reduce harm or even reduce actual exposure to these harmful compounds."
So TobReg acknowledges that it is recommending "safety" standards that have no established relationship with product safety. At the same time, these standards will deceive consumers into thinking that cigarettes are safer, leading to increased cigarette consumption. Not only is this evidence-blind public policy, it is also public health malpractice.
Why would TobReg recommend the promulgation of "safety" standards that have no established relationship with product safety? My only hypothesis is that this represents regulation for regulation's sake alone. It would be a comical waste of international bureaucratic time and resources, if not for the fact that it represents government fraud, experimentation with smokers by treating them as human guinea pigs, violation of consumer rights by hiding important and truthful information from them, and a devastating blow to the protection of the public's health by misleading consumers and undermining their appreciation of the hazards of smoking.