The Government’s Tobacco Regulator Is About to Get Tough

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The Food and Drug Administration announced last week it was seeking public input on regulating menthol cigarettes, a necessary step toward banning or restricting sales. That’s the second major move since Mitch Zeller took the reins of the FDA’s Center for Tobacco Products in March. Zeller, who worked at the FDA in the 1990s, has been active in the public-health community for two decades and criticized the agency’s slow progress in the wake of the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the FDA unprecedented authority to regulate tobacco products. Edited excerpts of his conversation with National Journal follow.

What are the big issues?

With all the progress that has been made over the last half century on tobacco use, it’s still the leading cause of preventable death and disease in this country. With over 440,000 people dying each year prematurely from tobacco use, we have over 300,000 kids becoming regular smokers every year. They’re not quite replacing those who are dying one for one, but three of every four smokers who die prematurely each year are being replaced. Every day, we have over 3,500 kids who light up for the first time. We have so much more work to do on this most urgent of public health issues, and our commitment to prevention is paramount.

What message works?

Don’t preach. Don’t lecture. Don’t just talk about the harms. Figure out a way to reach kids with an approach that will get their attention, that will make them more interested and more concerned, but that ultimately leaves the decision to them. But [help them] make that decision in a more informed, enlightened, self-confident way. We’re just in the research phase of the FDA commitment to public education; the first pieces of this campaign won’t start being unveiled until late in the year.

Last month, the FDA blocked four tobacco companies from introducing new products in the U.S.

Historically, in the unregulated marketplace, tobacco companies decided which new products were brought to market. For the first time, a science-based regulatory agency said some new products could come to market under the “substantial equivalence pathway” [proving they were no more harmful than products currently available], and some new products could not.

When is the decision on regulating electronic cigarettes coming?

When Congress passed the [Tobacco Control Act] four years ago, the initial grant of authority was only over cigarettes, roll-your-own tobacco, and smokeless tobacco. FDA intends to expand its regulatory authority over all products that meet the definition of a tobacco product. We’re getting closer to being able to do that.

How will new FDA regulations affect innovation in the tobacco market?

It’s hard to say. E-cigarettes seem to be an example of consumers voting with their pocketbooks, that they are open to new and more novel ways of getting their nicotine. If the day comes when we have a more fully regulated marketplace for nicotine products, FDA will be closer to what I call a “comprehensive nicotine regulatory policy” that could respond to what consumers may be saying, which is, “We’re interested in products that may pose less risk.”

What are your own benchmarks for success?

[Making] an investment in enforcement, an investment in science. We have a major commitment to public education, and this is going to start to unfold, mostly in 2014, with a focus on educating kids in a meaningful way. A researcher in the United Kingdom, Michael Russell, wrote in the 1970s that people smoke for the nicotine, but they die from the tar. FDA has an opportunity to create a comprehensive nicotine regulatory policy that recognizes that at the individual level, there’s a continuum of risk. Different products with how long does nicotine withdrawal last pose different levels of risk. And FDA now regulates the full spectrum of nicotine-delivering products, from conventional combustible cigarettes to medicinal nicotine products at the other end–the gum, the patch, the lozenge. Policy gets made at a population level, not at the individual level. But within this framework of a comprehensive nicotine regulatory policy, [we can drive] current cigarette smokers who are unable or unwilling to quit from the most harmful form of how much nicotine in a cigarette delivery to the least harmful form.

Any other reflections on your first few months on the job?

I’ve been struck by, even in the discussions with the tobacco industry, the candor that has been mostly present.

Were you a little hard on your predecessors about the speed of change?

Yes. There’s been a certain reality check that has occurred as I’m back inside of government, and I see what–because of the way the law and the rules work–the public just doesn’t see, which is, these things take time. But having said that, there is still an opportunity to try to move things through with some speed.

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