‘We need a national debate on nicotine,” said Mitch Zeller.
Zeller is the director of the Center for Tobacco Products, a division of the Food and Drug Administration created in 2009 when Congress passed legislation giving the FDA regulatory authority — at long last! — over cigarettes.
In addition, the center will soon have regulatory authority over other tobacco products, including electronic cigarettes, which have become enormously controversial even as they have gained in use. Through something called a “deeming rule,” the center is in the process of asserting that oversight over e-cigarettes.
Opponents of electronic cigarettes, which include many public health officials, hope the center will treat these new devices like it treats cigarettes: taking steps to discourage teenagers from “vaping,” for instance, and placing strict limits on the industry’s ability to market its products.
Proponents, meanwhile, hope the center will view e-cigarettes as a “reduced harm” product that can save lives by offering a nicotine fix without the carcinogens that are ingested through a lit cigarette. In this scenario, e-cigarette manufacturers would be able to make health claims, and adult smokers might even be encouraged to switch from smoking to vaping as part of a reduced harm strategy.
When I requested an interview with Zeller, I didn’t expect him to tip his hat on which direction he wanted the center to go, and he didn’t. Indeed, one of the points he made was that the FDA was conducting a great deal of scientific research — more than 50 studies in all, he said — aimed at generating the evidence needed to better understand where to place e-cigarettes along what he calls “the continuum of risk.”
Zeller is a veteran of the “tobacco wars” of the 1990s, working alongside then-FDA Commissioner David Kessler, who had audaciously labeled cigarettes a “drug-delivery device” (the drug being nicotine) and had claimed regulatory authority. Zeller left the FDA in 2000, after the Supreme Court ruled against Kessler’s interpretation, and joined the American Legacy Foundation, where he helped create its hard-hitting, anti-tobacco “Truth campaign.” After a stint with a consulting firm, Pinney Associates, he returned to the FDA in early 2013 to lead the effort to finally regulate the tobacco industry.
“I am fond of quoting Michael Russell,” Zeller said, referring to an important South African tobacco scientist who died in 2009. In the early 1970s, Russell was among the first to recognize that nicotine was the reason people got addicted to cigarettes. “He used to say, ‘People smoke for the nicotine but die from the tar,’” Zeller recalled.
This is also why Zeller found e-cigarettes so “interesting,” as he put it, when they first came on the market. A cigarette gets nicotine to the brain in seven seconds, he said. Nicotine gum or patches can take up to 60 minutes or longer, which is far too slow for smokers who need a nicotine fix. But e-cigarettes can replicate the speed of cigarettes in delivering nicotine to the brain, thus creating real potential for them to become a serious smoking cessation device.
But there are still many questions about both their safety and their efficacy. For instance, are smokers using e-cigarettes to quit cigarettes, or they using them to get a nicotine hit at times when they can’t smoke cigarettes? And beyond that there are important questions about nicotine itself, and how it should be dealt with.
“When nicotine is attached to smoke particles, it will kill,” said Zeller. “But if you take that same drug and put it in a patch, it is such a safe medicine that it doesn’t even require a doctor’s prescription.” That paradox helps explain why he believes “there needs to be a rethink within society on nicotine.”
Within the FDA, Zeller has initiated discussions with “the other side of the house” — the part of the agency that regulates drugs — to come up with a comprehensive, agency-wide policy on nicotine. But the public health community — and the rest of us — needs to have a debate as well.
“One of the impediments to this debate,” Zeller said, is that the e-cigarette opponents are focused on all the flavors available in e-cigarettes — many of which would seem aimed directly at teenagers — as well as their marketing, which is often a throwback to the bad-old days of Big Tobacco. “The debate has become about these issues and has just hardened both sides,” Zeller told me.
It’s not that Zeller believes nicotine is perfectly safe (he doesn’t) or that we should shrug our shoulders if teenagers take up vaping. He believes strongly that kids should be discouraged from using e-cigarettes.
Rather, he thinks there should be a recognition that different ways of delivering nicotine also come with different risks. To acknowledge that, and to grapple with its implications, would be a step forward.
“This issue isn’t e-cigarettes,” said Mitch Zeller. “It’s nicotine.”
‘People smoke for the nicotine but die from the tar.’
— Mitch Zeller
director of the Center for Tobacco Products