The FDA's Harmful Constituents in Cigarettes List: A Bureaucratic Waste of Time

The FDA's Center for Tobacco Products, as part of its new authority under the Family Smoking Prevention and Tobacco Control Act, has decided to try to protect the public's health by compiling a list of harmful and potentially harmful constituents in cigarettes and cigarette smoke (as well as other tobacco products). The Agency is seeking public comment to help prepare this list of constituents which are inhaled and which cause direct or indirect harm to cigarette users.

The Rest of the Story

In my opinion, this exercise is a pointless waste of time and resources. It would be useful only if the FDA could do something meaningful with the list. But there really is nothing that the Agency can do with the list that is permissible under the law and that would protect the public's health by making cigarettes safer.

The public needs to understand that there are between 10,000 and 100,000 chemicals in cigarette smoke, and that only about 4,000 to 6,000 of these chemical constituents are known. The majority of the constituents in tobacco smoke are a mystery. Moreover, we do not know exactly which constituents, at what levels, and in what combination, are responsible for each of the disease caused by tobacco smoke exposure. Thus, the reduction or removal of specific constituents in tobacco smoke is essentially pointless, as it will not ensure any reduction in risk.

A great example of this is the Winston cigarette, which has removed all additives and consists only of "pure" tobacco. Given the elimination of all additives, one would think that the anti-smoking groups would have congratulated R.J. Reynolds for having produced a safer cigarette. Instead, the anti-smoking groups attacked Reynolds for advertising that Winston cigarettes are additive-free, and forced the company to put a disclaimer on its packages and advertisements for Winston declaring that "no additives does not mean a safer cigarette."

Clearly, the anti-smoking groups understand that even the removal of all additives from cigarettes does not in any way imply that the resulting product is safer.

Nevertheless, the anti-smoking groups, and apparently the FDA as well, would have us believe that by limiting certain constituents - like nitrosamines - in cigarettes, the product will be made safer. Some - like the Campaign for Tobacco-Free Kids - have stated to the public that cigarettes with lower nitrosamines would be safer.

To my mind, this is fraudulent deception. It's no different from what the tobacco companies did regarding low-tar cigarettes or no-additive cigarettes, and it is precisely what they were found guilty of in federal court when Judge Kessler issued her scathing opinion.

But in 2011, it is the anti-smoking groups and the government which are perpetuating the very myths that the DOJ lawsuit aimed to dispel. And most ironically, it is Philip Morris - a defendant in the DOJ lawsuit - which is the only group to tell it like it is and provide appropriate advice to the public: If you are concerned about your health, says Philip Morris, then quit smoking.

Not so, according to the anti-smoking groups. The implication of the Campaign for Tobacco-Free Kids' public statements is that it is only a matter of time before the FDA issues regulations that will mandate changes in cigarettes to make them safer. The Campaign's de facto advice to smokers: don't quit now, because if you wait a little bit, the FDA will be mandating a safer cigarette.

The rest of the story is that nitrosamines are only one of more than 40 recognized carcinogens in tobacco smoke. Thus, lowering levels of nitrosamines is not necessarily going to lower cancer risk. It also depends on what happens to the other 39. And it turns out that the most common methods used to reduce nitrosamines in cigarettes result in an increase in at least some of the other carcinogens in the cigarette. Moreover, we simply don't know which carcinogens, at what amounts, and in what combination, are responsible for the carcinogenic effects of cigarettes. Nor do we have biomarkers that accurately predict human risk. It would take a long-term epidemiologic study to determine whether mandating reduced TSNA levels in cigarettes would result in a safer product.

There is actually scientific plausibility behind the notion that mandating lower TSNA cigarettes could result in a more hazardous, not a less 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 higher TSNA levels. Thus, such a mandate by the FDA 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 an FDA directive to reduce TSNA levels would increase the national burden of cancer.

For these reasons, compiling a list of the hazardous components in cigarette smoke is not only an exercise in futility that wastes time and resources, but it may also be providing a false sense of "security" to the public. Even if a large number of the known toxins in cigarette smoke were removed, there would be no guarantee that the resulting product would be any safer. But the FDA's regulation of cigarettes, and its emphasis on the "hazardous ingredient list" undermines the public's appreciation of the dangers of cigarette smoking and the complete lack of understanding of what is contained in cigarette smoke and how each of the tens of thousands of constituents relates to human health. It presents a false sense to the public that by virtue of FDA regulation, cigarettes are somehow going to be safer. This undermines decades of education about the harmful nature of cigarette smoking, and in my opinion, does more damage than good.