Americans increasingly look to the Food and Drug Administration (FDA) to guide them in their everyday decisions regarding the foods they eat and the drugs they take. Recently, FDA Commissioner Margaret A. Hamburg reminded a drug advisory committee to “follow the science wherever it leads and the rest will fall into place.” It was a telling reminder that a science-based fact foundation is essential to the FDA’s decisions and, consequently, its mission and credibility.
Later this week, the FDA will convene another scientific advisory committee meeting to consider whether the FDA should regulate or perhaps even ban menthol flavoring in cigarettes. If this panel adheres to Dr. Hamburg’s reminder to “follow the science,” the outcome should be clear. Menthol cigarettes will be treated the same as any other cigarette.
The story of menthol in cigarettes – and the science surrounding menthol – has been unfolding before the FDA’s Tobacco Products Scientific Advisory Committee, which meets regularly in a Washington suburb. At times it is one dry presentation of scientific findings after another, but that is how it should be.
The FDA menthol hearings are an excellent case study in the widespread public debate over how science should be used to support decision-making. The term “sound science” often is tossed around cavalierly – as though anyone would ever advocate unsound science. But such issues are not ready-made for sound bites. There are legitimate concerns if decision-making is based on incomplete data or policy-driven assessments as opposed to objective, science-based analysis.
In the months ahead, questions about the legitimacy and validity of scientific findings will form an undercurrent around the deliberations by the tobacco advisory committee. As it has several times before, the committee this week is reviewing several issues related to menthol in cigarettes. Months from now, the committee will issue a report and recommendations to the FDA on whether and how to regulate menthol.
Scores of similar committees operate across the U.S. government. Many members of such committees, as is the case with tobacco, come to their job not only with expertise but also with ingrained opinions. Nevertheless, the mandate of the committee members must be to encourage scientific exchange and demand respect for alternative viewpoints.
That is, to borrow a phrase from Dr. Hamburg, in the end it comes down to following the science.
Some public controversies might seem intractable in the sense that science is unable to resolve a dispute. Such is not the case with menthol in cigarettes. Although all cigarettes are inherently dangerous, the science about menthol in cigarettes is overwhelming and clear. Smoking-related disease risks are unrelated to whether or not the cigarette contains menthol – a cigarette is a cigarette. There is no reason for the committee to recommend banning menthol.
As a science-based agency, the FDA has the obligation to follow scientific studies exclusively – and not pay heed to political or anti-tobacco rhetoric. The FDA should pursue grounded scientific study and evaluation, not anecdotal research or behavioral studies that are subjective in nature and open to bias or subjective interpretation.
When the new administration took office, the president told federal regulators to develop rules that would “guarantee scientific integrity throughout the executive branch.” We are hopeful that under Dr. Hamburg’s charge to “follow the science wherever it leads,” the FDA’s tobacco panel will adhere to that goal.