Nov 6 2013
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Regulating Tobacco: Q&A with FDA's Mitch Zeller

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Tobacco featured prominently as a public health issue at the American Public Health Association (APHA) meeting this week, including a regulatory update from Mitch Zeller, JD, who became director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products earlier this year. Zeller previously worked on tobacco issues in government as associate commissioner and director of FDA’s first Office of Tobacco Programs, and also as a U.S. delegate to the World Health Organization (WHO) Working Group for the Framework Convention on Tobacco Control.

NewPublicHealth spoke with Zeller ahead of the APHA meeting.

Mitch Zeller, JD, Director of the FDA’s Center for Tobacco Products Mitch Zeller, JD, Director of the FDA’s Center for Tobacco Products

Mitch Zeller: I think most broadly my goals are to help give the center and the agency the greatest chance of fulfilling the public health mission behind the law passed in 2009 giving the Food and Drug Administration authority over tobacco. This really is an important piece of legislation. It’s really stunning that in 2013—with everything that we know about the harms associated with tobacco use—that it remains the leading cause of preventable death and disease both in this country and globally.

There are some very powerful tools that Congress has given FDA to use wisely and supported by evidence. That’s where I think, the greatest opportunity lies: to use the tools relying on regulatory science to try to protect consumers and reduce the death and disease toll from tobacco.

There are two areas where I think these tools can make a profound positive impact on public health. The first is something called product standards, which is basically the power to ban, restrict or limit the allowable levels of ingredients in tobacco or tobacco smoke. We are exploring potential product standards in three areas: toxicity, addiction and appeal. And we are funding research in all three areas and working very hard behind the scenes to find out what our options are for potential product standards in those three areas.

The other example is if at the end of the day people are smoking for the nicotine, but dying from the tar, then there’s an opportunity for FDA to come up with what I’ve been calling a comprehensive nicotine regulatory policy that is agency-wide and that is keyed to something that we call the continuum of risk: that there are different nicotine containing and nicotine delivering products that pose different levels of risk to the individual.

Right now the overwhelming majority of people seeking nicotine are getting it from the deadliest and most toxic delivery system, and that’s the conventional cigarette. But if there is a continuum of risk and there are less harmful ways to get nicotine, and FDA is in the business of regulating virtually all of those products, then I think there’s an extraordinary public health opportunity for the agency to embrace some of these principles and to figure out how to incorporate it into regulatory policies.

NPH: The General Accounting Office (GAO) recently released a report saying that FDA needs clear timeframes for review of new tobacco product applications. Is setting clear timeframes on the center’s agenda?

Zeller: Yes, we are committed to improving our process and have set a goal that within six months we will have identified performance standards for substantial equivalence reports. We have thousands of pending applications. The overwhelming majority of those pending applications are for products that are already on the market. Since June we have started to make merit-based decisions “yay” or “nay”—something is substantially equivalent, something is not substantially equivalent—and we’re going to catch up with that queue.

GAO reported that from 2011 to 2012 we went from taking on average eight months to get from a critical phase in the review process down to two months, so we’re making progress and it’s all headed in the right direction. But this is all new for industry and us, and I’m not going to commit to any kind of timeframe for action on particular applications that I can’t stand behind.

What we can commit to is for that subset of the pending applications for which the products are not currently on the market, and that’s the highest priority for the industry because they want a “thumbs up” or a “thumbs down” on the products that currently are not being sold. We will be able to generate timeframes within six months. The companies are getting better in the quality of their submissions; historically going back two or three years there were deficiencies with virtually every single application that came in, and that’s where much of the delay came from.

The quality of the submissions is getter better. They’re more complete and so we’re able to do our job faster and that’s one of the reasons why the average review time has gone down dramatically. So we’ll catch up on the queue, and with a little more experience we will have timeframes that we can commit to for the subset of products that are not currently on the market.

NPH: What is the ongoing action for electronic cigarettes at the center right now?

Zeller: Let’s start with the regulatory status and then talk about questions that we have. If you go back to 2009, the agency tried to take an enforcement action against the import of electronic cigarettes, declaring that imports should be prohibited because the agency had concluded that these were unapproved drugs and devices. When it announced that action, FDA was sued by importers and there was litigation both in the Federal District Court and the Federal Court of Appeals. And what the courts ruled in 2010 is that it’s a tobacco product if it’s made or derived from tobacco and it doesn’t make a drug, therapeutic or treatment claim.

So the courts ruled that electronic cigarettes, even though they don’t have any tobacco in them, contain nicotine that is derived from tobacco and in the absence of therapeutic claim, the only way that FDA could regulate e-cigarettes is under this new tobacco authority, because the nicotine in e-cigarettes is derived from tobacco. So since the spring of 2011, we have been on record as saying we’re going to create the regulatory framework to regulate electronic cigarettes that don’t make therapeutic or cessation claims under the tobacco authority, and we remain very close to being able to issue a proposed rule for e-cigarettes and any other product that meets the definition of a tobacco product that we don’t currently regulate.

The only categories of products that Congress gave the FDA the authority to regulate when the law was passed were cigarettes, smokeless tobacco and roll-your-own tobacco. But there was this other really important provision in the law that’s called the Deeming Provision, which gives the agency, through rulemaking, the power to deem other categories of products that meet the definition of a tobacco product to be within the agency’s regulatory jurisdiction, and we are very close to being able to publish that proposed rule. And it’s now public information that we have submitted that proposed rule to the Office of Management and Budget where it is currently undergoing review.

NPH: What barriers to your efforts do you worry about?

Zeller: It’s not really about barriers. It’s about what is the reality if you're in the business of regulation and what do you need to be thinking about as set policy. At the end of the day we’re regulators and because there are potential violations of law that we’re talking about, both civil and criminal, what we have to think about when we take agency action is that any interested party that disagrees with a final decision that we’ve made through rulemaking can sue us.

So, we’re always thinking about the evidence base in support of any regulatory policy decision that we’re making, knowing that there is a potential for litigation, and we have to be able to prevail in whatever litigation comes down the road following final agency action through rulemaking. That’s why we’re constantly exploring the evidence. We’re making an enormous investment in research because with these new products such as e-cigarettes, we have far more questions than answers about how they work, what kind of nicotine is being delivered, who is using them and how they are being used.

But we can only rely on evidence that’s formally in an administrative record that we can cite for either a proposed or final action. And so the message to the research community is do your research, get it published. But if that research is not submitted to FDA on an administrative record, it’s like the tree that falls in the forest. If you weren’t there to hear it you wouldn’t know that it had fallen, and in the world of regulatory science and regulation and litigation we need to be able to make the strongest possible case relying on regulatory science to support our actions so that we can win in court.

That’s what it comes down to. I don’t call it a barrier—it is a reality. It’s a reality of the business that we’re in and we’re constantly thinking about it so that we can have the strongest possible case going forward.

NPH: The 50th anniversary of the Surgeon General’s report is coming up. What opportunities does that present for the work of the Center for Tobacco Products?

Zeller: I think that the 50th anniversary of the Surgeon General’s report is an opportunity for everybody who works at any level to reduce the death and disease toll from tobacco to pause and look both back and look forward. If we look back over the past 50 years, we have come a very long way since then in terms of denormalizing tobacco use and reducing both consumption and prevalence. Extraordinary progress has been made and a lot of that dates back to the first Surgeon General’s report, which called attention to the health consequences of tobacco use.

But then we need to pivot and say: But if it’s still the leading cause of preventable death and disease, what’s the plan? What are we going to do about this so that on the 100th anniversary of the first Surgeon General’s report we’re able to say that we really made tobacco use a part of history? FDA’s piece of that is to figure out how to maximize the positive public health impact of the authority that we have and the resources that we have. I hope that down the road history will record that we used these tools given to us by Congress to maximize their positive impact on public health.

But beyond the regulatory provisions we have other tools and resources at our disposal. One of the most important things that we are going to be launching early next year is a public education campaign aimed at reducing the number of kids that progress from experimenting with tobacco products to becoming regular tobacco users, to becoming addicted, and then those decades of tobacco use that lead to horrible disease and on average 13 years of life lost. When you make an investment in prevention the payoff is further down the road. If we reduce the number of kids that progress to regular smoking, we don’t see that payoff for decades because we have to wait to see the healthcare costs averted.

I’m optimistic that with what we’re going to be doing with public education, with the continued denormalization and with everything else that’s being done to dramatically reduce the number of kids that are tobacco users, that we’ll be able to look back 50 years from now and say, wow, Congress gave the agency an amazing opportunity both with statutory authority and financial resources to make a difference, and they used the money and they used the tools wisely and they made a difference. It’s why I came back to government. After a 13-year hiatus, I see this opportunity and can tell you, having been back at FDA for the last eight months and seeing the dedication and the commitment of the people that are working day in and day out to maximize what we’re doing with these tools, I am very optimistic despite all the challenges that we face, that we are going to make a difference.

>>NewPublicHealth will be on the ground throughout the APHA conference speaking to public health leaders and presenters, hearing from attendees on the ground and providing updates from sessions, with a focus on how we can build a culture of health. Follow the coverage here.

Tags: Tobacco, Tobacco control, APHA, Food and Drug Administration, Q&A, Tobacco