The FDA gets into the business of regulating tobacco today

The regulation of tobacco is now a reality. Today marks the first public meeting of the Food and Drug Administration’s advisory panel menthol cigarettesset up to deal with complex scientific issues involving tobacco. Last year, legislation was enacted that for the first time authorized the FDA to regulate cigarettes and other tobacco products. One of its first charges is to answer the question – does menthol make cigarettes more harmful?

The overwhelming weight of highly credible and reliable science suggests that the answer is no. The use of menthol in cigarettes is an area in which extensive scientific studies have actually taken place. At least a dozen epidemiology studies, as well as several large smoke exposure biomarker studies have been conducted. Menthol in cigarettes has no meaningful effect on public health.

Advocates of a ban on menthol focus on two main topics – initiation and cessation. They claim that youth start smoking with menthol over non-menthol cigarettes. And, they allege that quitting smoking is far more difficult for those who smoke menthols.

Let’s start with cessation. Quitting smoking can be difficult for all smokers. Several large national studies have shown no differences in dependence or cessation for menthol cigarettes. These studies are broadly representative of the total smoking population. Further, the overwhelming weight of epidemiology shows that menthol and non-menthol cigarettes are the same in terms of disease occurrence across races and sexes, and is strongly consistent with the conclusion that menthol cigarettes are no more difficult to quit.

No one wants kids to smoke. Through positive steps that public health advocates and tobacco companies like mine have made resulting from the tobacco Master Settlement Agreement, youth smoking is at an all time low.

The majority of underage smokers report that their usual brand is not menthol. In fact, when you take a close look at the impact of menthol cigarettes on youth smoking rates, the data show that the use of menthol cigarettes may actually have a slight inverse relationship to the rate of youth smoking. Twenty-one states have a menthol market share that is higher than the national average. Of these, twenty have a youth smoking rate lower than the national average.

Based on these measurable outcomes, menthol cigarettes are clearly not associated with higher youth smoking rates.

Lorillard is dedicated to doing everything within our power to follow the new rules and regulations. Implicit in our commitment is an expectation that the FDA will likewise follow its rules and regulations, providing a fair hearing and assuring its actions are based on legitimate and objective scientific data.

Legitimate, objective scientific data should be a critically important component in this regulatory proceeding, just as it should be in any other FDA proceeding that deals with drugs or medical devices. Our nation is built on the foundation that regulatory agencies must base their decisions on the best science available. Good science should not become “science that supports what we want to do.”

Good science should seek to apply rigorous empiricism to marshal relevant facts. That type of science should be paramount in the FDA’s process, not anecdotal or behavioral surveys that are subject to bias and cannot be replicated.

It is critically important that menthol be evaluated without emotion or invective. This can only be accomplished if the FDA and its scientific advisory committee follow a course of meticulous objectivity in examining the conclusions reached by various scientific studies and the design and integrity of these studies – and, importantly, the motivations of those authors.

The challenge to adhere to the science must be met successfully by the FDA. Doing otherwise would undermine the integrity of this important regulatory agency. And it could well lead to unfair and unnecessary regulation of other legal products or industries, depriving citizens of their right to choose products that may be controversial or unpopular.

By Mr. Orlowsky is Chairman, President and CEO of Lorillard Inc., which manufactures Newport, the nation’s best-selling-cigarette-brands.

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