Thursday, July 15, 2010

FDA Regulatory Scheme is Severely Flawed and Actually Requires that All Cigarette Additives Be Eliminated

In this post, I explain why the anti-smoking groups and policy makers who crafted and supported the Family Smoking Prevention and Tobacco Control Act have dug a hole for themselves by establishing a regulatory scheme that is based not on science, but on politics. In particular, the ban on cigarette flavorings has established as a criterion for judging tobacco ingredients whether or not a particular ingredient enhances the appeal of the product. There is no evidence that flavored cigarettes are more harmful than regular cigarettes. Clearly, the criteria used to ban these cigarette brands was that no additive should enhance the appeal of the product, especially to young people. As I will show, by this criterion, all cigarette additives now need to be banned. This is an absurd result which will not, I argue, necessarily yield any significant public health benefits. But it does demonstrate the absurdity of this entire approach to tobacco product regulation.

The Rest of the Story

Here is the basic argument: Since the criterion being used by Congress in banning flavored cigarettes was that tobacco companies should not add any ingredients to their products which enhance their appeal and help them market the products successfully, especially to youths, I believe that all cigarette ingredients fall into this category. By definition, ingredients are not added to a product unless they ultimately enhance the appeal of the product and improve the bottom line: product sales. It would be a waste of expenditures for tobacco companies to spend large amounts of money purchasing chemicals if the use of those chemical additives played no role in enhancing product appeal.

Therefore, I believe that the FDA Tobacco Products Scientific Advisory Committee has no choice but to recommend a ban on all cigarette additives. The charge given to the FDA by Congress clearly was to eliminate ingredients that enhance the appeal of cigarettes to consumers. Candy and fruit flavorings are actually the least important of the additives used to enhance product appeal. Cigarette companies use a host of additives to enhance the taste and appeal of their products. Given the regulatory framework of the FDA tobacco legislation and the fact that Congress has banned fruit flavored cigarettes based on a desire to disallow tobacco companies from enhancing the appeal of their products, I believe that there is no justification for the FDA to allow any additives to be used in the production of cigarettes.

For example, R.J. Reynolds readily acknowledges that it uses brown sugar to “enhance tobacco product quality by balancing sensory attributes and developing certain desired taste and/or flavor characteristics,” and that additives such as butyl alcohol, ethyl vanillin, ethyl phenylacetate, and methyl dihydrojasmonate are “used to impart or help impart, or enhance or modify, a taste or aroma” in some of its cigarettes. This is precisely the same function that R.J. Reynolds cites as the reason for the addition of menthol to some of its cigarette brands. There are literally hundreds of flavorings used by tobacco companies to enhance the appeal of their products. The criterion established by Congress in banning the use of chocolate, strawberry, and banana – that cigarettes should not contain any flavoring that enhances the product’s appeal to young people - applies equally to the hundreds of other flavors that are added to cigarettes.

I believe that a “scientific” approach to the issue at hand would look broadly at all of the additives used to enhance the flavor and appeal of cigarettes, rather than just at a few hand-chosen ones, in order to develop the most appropriate, science-based policy. And in my view, based on the criteria clearly established in the Family Smoking Prevention and Tobacco Control Act, I believe that the FDA therefore has no choice but to ban the use of all additives in cigarettes, since there are hundreds of additives which the tobacco companies acknowledge play essentially the same role as menthol. All additives are used to enhance the appeal of the product; they would not be in the product if the companies did not think that they enhanced product appeal. Under the regulatory framework set out by the Family Smoking Prevention and Tobacco Control Act, the FDA has no choice but to ban the use of all of these additives.

I note that the banning of all cigarette additives will not result in a safer cigarette. There are existing cigarettes on the market – such as Winston and American Spirit – which contain no additives. I do not believe there is any evidence to support a contention that the removal of all additives from cigarettes will result in a safer product. In addition to banning all additives, the FDA should therefore conduct a public education campaign to inform consumers that the changes it is requiring in cigarettes will not make these products any safer.

Finally, I note that the removal of all additives from cigarettes will not necessarily result in any decrease in adult or youth smoking. Winston cigarettes, which do not contain any additives, are still popular among many smokers. Cigarette companies can find ways to alter the tobacco blends and use reconstituted tobacco in ways that produce cigarettes which still appeal to consumers. That the removal of all additives – which I believe is consistent with the approach taken by the Family Smoking Prevention and Tobacco Control Act – will not necessarily produce any public health benefit demonstrates the absurdity of the approach that was taken by the policy makers and anti-smoking groups who supported this legislation.

Regulation of the content of a product that is inherently deadly is not an appropriate approach to the problem. There is no such thing as a “safety standard” for cigarettes. Until they acknowledge this, the FDA and the anti-smoking groups will lead us down a road of bureaucratic fumbling that may feel good and generate positive public opinion, but it will accomplish nothing in terms of protecting the public’s health. The money being wasted on bureaucratic study of ingredients in tobacco would be better spent on a public education and media campaign, which has been demonstrated to be one of the most effective approaches to reducing tobacco use.

No comments: