Q&A: Mitchell Zeller on the FDA and Tobacco

The agency will rely on evidence from studies to inform tobacco-related policies and regulations

Passed in 2009, the Family Smoking Prevention and Tobacco Control Act granted the U.S. Food and Drug Administration (FDA) the authority to regulate the manufacture, marketing, and distribution of tobacco products, responsibilities now handled by the agency's Center for Tobacco Products (CTP). Mitchell Zeller, JD, who became CTP director in March 2013, spoke with Cancer Discovery's Suzanne Rose about how the center, through its research, public education, and enforcement activities, aims to fulfill its mission to “make tobacco-related death and disease a part of America's past.”

How does the FDA develop tobacco-related policies?

We need evidence to support any policy that we might enact, because it carries the force of law. When we are exploring our regulatory policy options, we focus on those that have the strongest support in the science base. Looking at the products that we currently regulate—cigarettes, smokeless tobacco, and roll-your-own tobacco—and all of the other nicotine-delivering products out there that one day we might regulate, we need to know as much as possible about the products, including what's in them and how they are being used by consumers, to develop effective regulations. That's why we need research.

What types of tobacco research does the FDA fund to inform policy?

I can give you two examples. At the end of September, working with the NIH, we announced a series of awards for 14 Tobacco Centers of Regulatory Science [TCORS], an investment of about $270 million over 5 years. A lot of that money is going to be invested in answering questions about the products themselves and users' behavior. Because the marketplace for tobacco and nicotine is evolving at a head-spinning pace, the traditional approach to research—“Here's your money, we'll see you in 5 years with your answers”—isn't going to work. Each of the funded investigators had to prove to us that they have the capability to do rapid-response research.

Second, there's never been a massive, large-scale longitudinal study of tobacco use. Now we're doing it. It's called the PATH [Population Assessment of Tobacco and Health] Study. It will follow 60,000 people ages 12 and older who use tobacco or are likely to start using it, for at least 3 years. This study will give us a much better handle on how behaviors, knowledge, attitudes, and beliefs related to tobacco are changing. We'll also collect biospecimens—urine, blood, and saliva. We'll pair up what participants are saying about their behaviors with what analyses of their body fluids are showing in terms of exposure to various compounds. This kind of information will go a long way to informing regulatory policy.

What is the CTP doing to educate teens about the dangers of tobacco use?

Educating the public—especially young people—is a huge priority. Every day, more than 3,000 kids light up a cigarette for the first time. They experiment. Every day, about 700 to 800 kids make the progression from experimentation to regular smoking. For every five addicted adults who die or quit each day, they are being replaced by three or four kids who have made the progression to regular smoking. With all that we know about how harmful tobacco use is, how is it that we still have such high numbers when it comes to daily experimentation and daily progression to regular tobacco use? Clearly, as a society we're failing kids.

We are going to launch a series of public education campaigns this year. We're starting with a general-market campaign to reach all at-risk 12- to 17-year-olds, because we know that nearly 90% of adult daily smokers had their first cigarette before they were 18 years old. Companion campaigns will be aimed at lesbian, gay, bisexual, and transgender youth; minority youth; rural youth; and Alaskan native and Native American youth. Those are the subpopulations at greatest risk.

How else will CTP help prevent tobacco use by teens?

One of the FDA regulations says you can't sell tobacco products to anyone under the age of 18. [By law, cities, towns, and other jurisdictions can set higher minimum ages.] We now have enforcement contracts with 45 state and local jurisdictions where we commission and train adults and minors to make sure that retailers comply. When it comes to youth access, a trained adult and minor go into a store together, and the minor tries to buy tobacco. If they succeed, the first violation results in a warning letter from the FDA to the retailer. Starting with the second violation, there are civil money penalties. We've conducted more than 200,000 compliance checks and issued more than 10,000 warning letters to retailers. We have also begun to collect civil money penalties from repeat offenders.

Why not simply ban cigarettes?

Congress has said that we can't ban cigarettes or any other category of tobacco products. But there is a section in the law that gives us the authority to completely ban, or restrict to certain levels, ingredients, additives, constituents, compounds—anything that could be delivered to a tobacco user—in products that we regulate through what we call product standards.

We're funding research that could help us answer questions about a product standard that would reduce nicotine below a level that might create or sustain addiction in some or all of the tobacco products we regulate. The only limitation in the law is that we cannot take nicotine levels down to zero. I'm not saying we'll do that, but imagine a world where the only cigarette that a kid could experiment with is one not capable of creating or sustaining addiction. Experimentation would be much less likely to lead to regular smoking, disease, and premature death.

What types of scientific data need to be gathered to assess new products?

We need to invest in research to understand the toxicity profile of new products on the market. Even though we currently don't regulate e-cigarettes, we're making an investment in research, including through the TCORS, to better understand how the products work, the toxicity profile of what's inside of them, and what's being delivered to the user.

On the behavior side, research needs to tell us who uses these products and how they are being used. One could say, for example, that an e-cigarette is less harmful than a cigarette. But how is that supposedly less-harmful product being used? Are nonsmokers initiating use? Any initiation is bad. What about those who are already using tobacco and are addicted to nicotine? Are they switching? Or are they engaging in dual use? Among those engaging in dual use, are any of them people who otherwise would have figured out a way to quit? We need to know what's going on at the population level so that we can better assess the impact of any of these products.

The FDA doesn't currently regulate e-cigarettes but plans to do so. What will happen after that?

We've been on record as saying that we intend to create the regulatory framework for e-cigarettes, and we're working on that. I can't disclose the details of what our intentions are, but we've submitted the document to the Office of Management and Budget, and it's currently under review.

After the proposed rule is published, all interested parties will have an opportunity to submit comments and provide evidence in support of what we're proposing or in support of alternative approaches. We take all information that is submitted during the public comment period very seriously. We will take whatever time is necessary to review every single comment. We will reflect back on everything that we had proposed and the rationale behind it, and figure out what should stay the same and what should change. Then we draft a final rule.

Do you ever feel overwhelmed by all there is to do?

It is amazing that, with everything we've learned about the harms of tobacco use, we seem to have flatlined in terms of smoking rates nationally. One out of five adults still smokes, and too many kids become regular smokers. We have a lot of work ahead. Yes, it's a challenge to get things through the system. It's a challenge to make sure that you have all the possible evidence in support of the policies that you want to make. Yet with every challenge comes opportunity, and we have an opportunity to make a profound positive impact on public health.

This article is being published as part of the AACR's commemoration of the 50th Anniversary of the Surgeon General's Report on Smoking and Health. You are encouraged to visit http://www.aacr.org for information on additional AACR publications and activities related to the recognition of this important anniversary.