July marks the five-year anniversary of President Obama signing 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 general session to take a look at two of the most hotly debated issues during the U.S. Food and Drug Administration’s (FDA) reign over tobacco products.
“Menthol and electronic cigarettes are just two illustrations of how regulatory oversight has changed and will continue to change our business and your business,” he said. “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.”
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.
In July 2013, 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 its evaluation, but cited the behavioral science of initiation, dependence and cessation in support of its intended menthol regulations.
When it came time for the required commenting period, however, the FDA faced a flood of dissent. “Nearly all of these comments were united that menthol regulation would do little for public health, but would have a devastating impact,” Kessler said. Of the more than 200,000 comments, 99% opposed menthol regulations.
The FDA is legally required to consider and respond to all of these comments. That, along with the additionally commissioned long-term studies, will 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.
Enter the E-Cig Era
“Electronic cigarettes, on the other hand, deserve FDA scrutiny,” Kessler said.
Lorillard was the first major tobacco company to enter the e-cig arena with its April 2012 purchase of blu. Kessler believes the segment “has the potential to be as disruptive to our industry as the digital cameras were to the photography industry” and represents “a game changer.”
Unfortunately, not everyone shares that belief. With cities such as New York, Los Angeles and Chicago enacting e-cig bans and states such as New Jersey proposing heavy taxation, Kessler said the time has come for a “scientific intervention.”
Those who call for cessation-only approaches and/or an all-out tobacco prohibition are not helping public health, Kessler said. Besides the fact that Congress has explicitly forbidden an outright ban of cigarettes and other tobacco products, history shows that prohibition simply does not work.
“The prohibitionists have it wrong,” he said. “Harm reduction should include abstinence but should also include options to give more flexibility to tobacco users who don’t want to quit. After all, it is the mission for public health to make people better, not make better people.”
How do we go about making people better? Kessler says step back, listen to the science and apply a “dollop” of common sense.
Kessler believes lawmakers (including the FDA), public health advocates and the tobacco industry must focus on science, base policies on how consumers are actually using the products, work together and educate the public on new, less-harmful tobacco products.
“The opportunity to get harm-reduction policy right is in front of us,” he said. “For one, I’d prefer not to fight the traditional tobacco wars of earlier days. If we decide on nothing else, we should use this as our foundation: Reasonable regulation can reduce harm by providing accurate information and alternate products to adult tobacco consumers.”
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