Regulate tobacco and nicotine based on risk

A Senate health committee is expected to approve historic legislation to give the Food and Drug Administration (FDA) oversight over tobacco products. As a public health measure this legislation is long overdue. Having worked on this issue for over 15 years I am elated on the one hand that this issue is finally getting the attention it deserves. On the other hand, I am concerned that the legislation as currently drafted seems more akin to legislation that might have been introduced in the mid to late1990s — not in 2007.

Much has changed in the tobacco and nicotine environment and much will continue to change. Methods for curing tobacco, technology advances and the development of new tobacco and nicotine products are forcing changes on the industry that were unforeseen just five years ago. In order to craft legislation that will meet the need for the next decade and beyond we must openly discuss and debate provisions of the legislation for which there are legitimate concerns, ideas and suggestions for improvement. Unfortunately however, the process that has been followed in Congress thus far has stymied dialogue and engagement. In the case of this legislation, a backroom agreement between Philip Morris and the Campaign for Tobacco Free Kids seems to have been concluded even before the legislation was officially introduced — making moot any comprehensive substantive hearings and suggested changes.

The agreement, while understandable in some ways, is far from being transparent and reflective of open and deliberative government. It fails to provide opportunities for discussion about how the legislation can be improved. A case in point is the topic of the role that the development and availability of science-based products could play in providing cigarette users lower-risk alternatives to their deadly cigarettes.

In spite of the fact that there seems to be a general scientific consensus that noncombustible products are as much as 90-plus percent lower in risk than the high toxic combustible cigarettes, the legislation discourages the development of such products and raises the bar so high as to make it next to impossible for these lower-risk products from ever entering the marketplace or for companies to be able to provide truthful information to consumers.

While these products are already much lower in risk, there may even come a day in the very near future when some of these noncombustible tobacco-based products could have a risk profile so low as to be comparable to nicotine replacement therapies (NRT), products which —interestingly enough — almost all contain nicotine derived from tobacco. No one disputes the fact that it will be essential to monitor these products to see who is using them, and how they are being used.
No one disputes that it will be essential to set parameters and guidelines as to how these products should be labeled and marketed.

There are many other issues to consider and which could make the legislation stronger and more effective, including providing incentives to tobacco, pharmaceutical and biotech companies and producers to develop lower-risk tobacco and tobacco  products; allocating a small portion of “user fees” to independent research; expanding the membership and authorities of  the scientific advisory committee; establishing better coordination between various governmental agencies; ensuring that  tobacco growers are part of the decision-making process; and most importantly, bringing all tobacco and nicotine products under the same regulatory umbrella. So if we aren’t going to ban tobacco outright, let’s get beyond the outdated and scientifically inaccurate arguments that all tobacco is “bad.” Let’s start having a serious, transparent, open dialogue on how to ensure that consumers and the public understand the risks and relative risks of all tobacco and nicotine products. Regulation coupled with competition can be a win-win. If done correctly, in the end, public health wins, consumers win, tobacco growers win, and responsible and accountable tobacco and pharmaceutical companies win.

Let’s hope that if and when this legislation is considered in the House it will be handled openly, transparently, and democratically as promised by the new House leadership. One place to begin is in the House Committee on Oversight and Government Reform, where stakeholders can be given the opportunity to present their views and where tough questions can be asked of the tobacco industry.


Ballin is a former vice president and legislative counsel of the American Heart Association, the past chairman of the Coalition on Smoking OR Health, and a member of the Steering Committee of the Alliance for Health, Economic and Agriculture Development (AHEAD).