Tuesday, June 01, 2010

FCTC Commentary #1: Implementation Guidelines for Articles 9 and 10 are Misguided and Not Based on Science

On May 15, the Working Group on Articles 9 and 10 of the Framework Convention on Tobacco Control (FCTC) issued draft recommendations for implementation of the treaty's provisions related to the regulation of tobacco product ingredients.

The basis of these recommendations is that tobacco companies should not be allowed to add any compounds to their products which increase the appeal, attractiveness, or palatability of the product.

The draft recommendations state: "Tobacco products are commonly made to be attractive in order to encourage their use. From the perspective of public health, there is no justification for permitting the use of ingredients, such as flavouring agents, which help make tobacco products attractive."

The report goes on to explain: "The harsh and irritating character of tobacco smoke provides a significant barrier to experimentation and initial use. Tobacco industry documents have shown that significant effort has been put into mitigating these unfavourable characteristics. Harshness can be reduced in a variety of ways including: adding various ingredients, eliminating substances with known irritant properties, balancing irritation alongside other significant sensory effects, or altering the chemistry of tobacco or nicotine by adding or removing specific substances. Some cigarette-like tobacco products contain added sugars and sweeteners. High sugar content improves the palatability of cigarette-like tobacco products to smokers. Examples of sugars and sweeteners used in these products include glucose, molasses, honey and sorbitol. Masking tobacco smoke harshness with flavours contributes to promoting and sustaining tobacco use. Flavouring substances include benzaldehyde, maltol, menthol and vanillin. Spices and herbs can also be used to improve the palatability of cigarette-like tobacco products. Examples include cinnamon, ginger and mint."

Based on the above, the working group recommends as follows:

"Parties should either prohibit or restrict ingredients that may be used to increase palatability, such as sugars and sweeteners, flavouring substances, and spices and herbs, in cigarette-like tobacco products. Parties should prohibit or restrict ingredients that have colouring properties, such as inks and pigments, in cigarette-like tobacco products."

Interestingly, the working group does not call for the elimination of nicotine from cigarettes.

The Rest of the Story

In 1997, R.J. Reynolds began marketing of a newly designed Winston cigarette product, which was completely free of additives. There were no compounds added to the cigarette to increase appeal, attractiveness, flavor, color, or palatability.

Based on the reasoning of the FCTC working group, R.J. Reynolds should have been praised for producing and marketing a cigarette that would have greatly decreased appeal and therefore result in decreased smoking initiation among youths and increased smoking cessation among adult Winston smokers.

On the contrary, R.J. Reynolds was attacked as having produced a cigarette that was going to greatly increase cigarette smoking by suggesting to consumers that the product was safer than traditional cigarettes because of its lack of additives. In fact, the anti-smoking groups complained to the Federal Trade Commission (FTC), and in 1999, the FTC issued a consent decree ordering R.J. Reynolds to include a statement on Winston advertisements stating that: "No additives in our tobacco does NOT mean a safer cigarette."

Laboratory studies conducted on the re-formulated Winston cigarettes confirmed that these products were in fact 100% tobacco with no additives. Interestingly, these analytic studies were carried out by British American Tobacco, which concluded that the no-additive Winston cigarette "seems to be truly a product with no additives." There were no humectants, no added sugars, no flavorings, and no added ammonia.

But far from praising R.J. Reynolds for adhering to the very recommendations that the FCTC working group on Articles 9 and 10 has now promulgated, the anti-smoking groups blasted the company for wildly misleading consumers about the relative safety of these cigarettes. The FTC stated, quite clearly, that there is no evidence that "cigarettes without additives are safer to smoke than other cigarettes."

In fact, it might well be that cigarettes without additives are more dangerous than regular cigarettes. The tobacco in these cigarettes is constituted quite differently and the levels of chemicals in the product are very different. Some harmful constituents are found at greater concentrations in additive-free cigarettes.

For example, the no-additive, full-flavor Winston cigarettes had significantly higher levels of methylbenzene than regular full-flavor Winston cigarettes. Methylbenzene is well-known to cause respiratory tract irritation, cardiac effects, and neurotoxicity. It is entirely plausible that the higher concentration of methylbenzene and other toxic constituents in additive-free cigarettes leads to an increased risk of adverse health effects. We simply don't know.

The FCTC working group has absolutely no business mandating that cigarette companies put out products that may well be more hazardous to consumers. If it is irresponsible of R.J. Reynolds to put out such products, than it is irresponsible of health groups to require such products.

It is quite a double standard to state that when R.J. Reynolds produces an additive-free cigarette, it is a terrible scourge on the public's health, but when the FCTC working group mandates additive-free cigarettes, it is suddenly an action that promotes the public's health. You can't have it both ways.

In fact, the rest of the story is that the FCTC working group's recommendation is not backed by any science. It is quite possible that what FCTC is proposing as a mandate will result in cigarettes that are more hazardous than the current products on the market. The only way to find out will be to study these products long-term. In other words, for the FCTC working group to use smokers as guinea pigs.

In the mean time, consumers will be misled into thinking that the new no-additive cigarettes are safer than their traditional counterparts.

The situation will be identical to the fraudulent actions that anti-smoking groups accused R.J. Reynolds of taking with its no-additive Winston cigarettes, except now the very same fraudulent actions will be endorsed by, and in fact required by governments in many countries.

What the FCTC working group is proposing, then, is to simply transfer the fraudulent actions associated with the marketing of no-additive products (which consumers interpret as meaning "safer") from the tobacco companies over to the government.

Frankly, this entire approach by the FCTC working group is completely misguided, in my opinion. It is based not any any science that I can discern, but instead, on an apparent desire to regulate for the sake of regulating.

Shouldn't the FCTC working group have realized that something was wrong with its proposed approach when its proposal ended up looking exactly like R.J. Reynolds' proposal to market a new, no-additive cigarette to consumers?

I believe that if the FCTC working group's recommendations are actually followed, it will result in a public health disaster. Consumers in countries around the world will be wildly misled into thinking that because the additives have now been removed from cigarettes, these products are now safer. The result will be increased rates of cigarette smoking and a reduction in attempts to quit or to switch to less hazardous nicotine-delivery products.

There is scientific plausibility behind the notion that mandating no-additive cigarettes could result in a more hazardous product. Such a mandate would almost certainly result in higher use of flue-cured, rather than burley tobacco in cigarettes because burley tobacco produces unpalatable smoke unless flavorings or sweeteners are used. Thus, such a mandate would cause tobacco manufacturers to shift towards higher amounts of flue-cured tobacco.

However, there is scientific evidence that flue-cured tobacco yields higher levels of benzo[a]pyrene and tar than burley tobacco. Since tar and benzo[a]pyrene are associated with cancer risk, it is at least plausible that the FCTC working group's recommendation would increase the global burden of cancer, which is not exactly a health- or science-based policy objective.

The working group's recommendations are also misguided because they make no sense to begin with. If your basic premise is that the way to handle the cigarette problem is to require manufacturers to make the product as unappealing as possible, then what justification is there for failing to require cigarette companies to add unpleasant substances to cigarettes that will make the products taste bad and therefore be much less appealing to consumers?

Why not, for example, require that all cigarette manufacturers add small amounts of hydrogen sulfide to their products to make them foul-smelling. For those unfamiliar with this potential additive, it is the breakdown product of organic matter in low-oxygen environments such as sewers and swamps and it contributes a characteristic rotten-egg odor.

Or what about requiring the addition of methanethiol to cigarettes? For those unfamiliar with this additive, it is the constituent that must be added to natural gas to give it its unpleasant odor, thus saving many lives by warning people of gas leaks.

The basic premise of the FCTC working group - that cigarette manufacturers must not put anything in the product to make it more appealing - would lead inevitably to a policy of simply not allowing any additives. All cigarettes would essentially be "Winston" cigarettes. Would that make it a safer world? Would there be a reduction in cigarette smoking? Would huge numbers of smokers quit? I doubt it and there is no evidence to support such an assertion. Moreover, there is strong evidence that such an action would undermine the public's appreciation of the hazards of smoking, make consumers think that cigarettes are now safer, and thus lead to an increase in smoking rates, disease, and death.

I believe that regulation of the constituents of cigarettes is a misguided approach to tobacco control, for which there is no scientific basis, and by which the public's health will actually be harmed more than helped.

Making matters worse, the FCTC working group claims to believe that cigarette manufacturers have no right to put anything in their products which increases their appeal, yet the working group failed to recommend banning the one component of cigarettes which undoubtedly contributes most heavily to cigarette addiction: the nicotine. Clearly, the working group is little more than a stage show, trying to make it look like the international community is taking efforts to address the tobacco epidemic but when it comes down to it, not doing anything that will actually protect the public's health, such as massively decreasing smoking initiation by phasing out the nicotine.

While I'm not calling for a ban on nicotine (I don't think cigarette product design regulation is an appropriate approach), I am pointing out the hypocrisy of the FCTC working group, which is putting on a scientific mirage for political gain.

An additional adverse effect which the working group's recommendations would have is the virtual if not complete economic destruction of the burley tobacco growers. Why? Because unlike flue-cured tobacco, burley tobacco has very low sugar levels and without additives, produces an unpalatable smoke. No-additive cigarettes would almost certainly have to be manufactured without much, if any, burley tobacco, decimating burley growers in the United States. There is no justification for producing such an effect absent a health justification for the policy.

Since I see no health justification for a ban on cigarette additives (in fact, I would argue that such a policy runs counter to the protection of the public's health), any country which follows the working group's recommendation would be violating international trade policy, as I believe Canada did in implementing its C-32 legislation (which bans all flavor additives except menthol) and as the U.S. itself did in banning all cigarette flavorings with the exception of menthol.

In the case of Canada's law, there is no health basis for a policy that bans all flavor additives in cigarettes but exempts menthol. Clearly, policy makers in Canada are simply trying to score political points for making it look like they are doing something to protect the public's health, but in fact the policy will have no positive health impact and actually, it protects the one flavoring which is most used by cigarette companies to attract Canada's youth to cigarettes. Since there is no health justification for the policy, and since the policy essentially bans the use of burley tobacco, it ensures that Canadian-produced tobacco (which is almost exclusively flue-cured) will not be threatened by imports from the United States. In addition, this policy ensures that the highest possible levels of benzo[a]pyrene and tar will be present in Canadian cigarettes. It is plausible, based on the evidence I discussed earlier, that such a policy will actually increase the burden of cancer among Canadians.

In conclusion, I believe that Articles 9 and 10 of the Framework Convention on Tobacco Control have no basis in science. Inevitably, they will lead to inappropriate laws that produce no public health benefit and may very well harm the public's health instead. The very idea of regulating the constituents of tobacco products makes little sense, given that there is simply not an existing scientific basis to link the presence of levels of specific constituents to disease risk. Certainly, as the working group recommendations reveal, the interest is in scoring political points and making it look like the problem is being addressed, while at the same time avoiding real solutions and simply putting the government in the business of regulation for regulation's sake.

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