LAS VEGAS -- This July marks the five-year anniversary of when President Obama signed the Family Smoking Prevention and Tobacco Control Act into law, forever changing the landscape of the tobacco industry. Murray S. Kessler, chairman, president and CEO of Greensboro, N.C.-based Lorillard Inc., used his NATO Show general session to take a look at one of the most hotly debated issues during the U.S. Food and Drug Administration’s (FDA) reign over tobacco products: menthol cigarettes.
“Regulations must be grounded in both science and the law, otherwise we simply slip back to courtroom battles and miss the opportunity to make significant change,” he said. “We believe it imperative to get each issue right, by making sure each is judged solely and independently by sound, regulatory science.”
It’s possible that Mitch Zeller, director of the FDA’s Center for Tobacco Products, agrees with Kessler: Last summer, Zeller responded to the menthol issue by saying, “The FDA can only go as far as the regulatory science will take us, and the bottom line is we need more information.”
“With statements like that, it is clear that something very different and very interesting is afoot when it comes to our nation’s tobacco discussion,” said Kessler.
Last July, the FDA published both a preliminary scientific evaluation on menthol and an advanced notice of proposed rulemaking. The FDA agrees that menthol cigarettes do not pose more disease risk and stated as much in their evaluation, but cited the behavioral science of initiation, dependence and cessation in support of its intended menthol regulations.
Lorillard, other manufacturers, retailers, wholesalers, law enforcement organizations, health groups, community organizations, unions and state legislators all voiced their disagreement with the FDA’s behavioral assessment during the required commenting period.
“Nearly all of these comments were united that menthol regulation would do little for public health, but would have a devastating impact on communities, help foster more illicit tobacco sales and hurt jobs,” Kessler said, adding that 99% of the more than 200,000 comments opposed menthol regulations.
Although Zeller repeatedly said the FDA had met its Congressional mandate on menthol by forming an advisory committee to study menthol and publishing the preliminary scientific evaluation, the agency has now commissioned additional studies on menthol, including several long-term studies that will take years to complete.
“To us, this was a significant step overlooked by the media,” said Kessler. “The FDA is in an information-seeking mode now. We don’t know what’s next on menthol regulation, or if there is even a next in the near-term.We’re in a wait-and-see mode.”
When it comes to menthol, the one known is that the FDA is legally required to consider and respond to all of those 200,000 comments that were submitted. That, along with the additional research, will undoubtedly take time.
“Ultimately, we believe that sound regulatory science will show there is no justification for regulating menthol cigarettes any different from non-menthol cigarettes,” Kessler said. “We also firmly believe that menthol is a distraction to what Congress intended when they gave FDA authority to regulate tobacco. It is similar to many wasteful battles of the past and ultimately, would have no impact on public health.”
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