Director of FDA's Center for Tobacco Products speaks to Hanover community

by Anne George | 10/1/18 2:35am

“We are all playing catch-up with the tobacco industry — the regulators, general public, other policy makers and media,” director of the Food and Drug Administration’s Center for Tobacco Products Mitchell Zeller ’79 said in his Sept. 28 talk on tobacco in today’s America. “These are extremely smart people, and they have a 75- to 100-year head start on regulation.”

In the Osher Lifelong Learning Institute sponsored lecture called “America’s Tobacco Struggle: Wins and Losses,” Zeller discussed the FDA’s recent efforts to reduce tobacco usage. He spoke to around 20 people in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences, exploring the tobacco industry’s traditionally antagonistic relationship with regulation and what is being done today to remedy that.

After working on various FDA issues for 30 years, Zeller became director of the FDA Center for Tobacco Products in 2013. He has since been instrumental in the ongoing and widely successful “The Real Cost” campaign, according to David Bisno MALS’94, instructor and discussion leader for the Osher Institute, who introduced him at the event.

Zeller began the talk by discussing the rationale for government regulation of tobacco, citing research from as early as 1957 that recognized that tobacco was harmful. This research was ignored by the now dissolved Tobacco Institute, Inc., Zeller said, adding that it took public outcry after the release of the 1964 Surgeon General’s Report on Health and Safety to incite government regulation and call for accountability within the tobacco industry.

However, much to Zeller’s dismay, tobacco use is still the leading cause of preventable death in America — over 480,000 American deaths are linked to tobacco every year, according to his lecture. Because of this, the Center for Tobacco Products works to enforce the Family Smoking Prevention and Tobacco Control Act, which was passed in 2009 with overwhelming bipartisan support.

“The idea is, ‘Let’s add product regulation to the panoply of evidence-based tobacco control interventions that have been underway at the federal, state and local levels for decades,’” Zeller said. “The goal is to reduce the harm overall by discouraging people from starting to smoke.”

Under this legislation, the FDA has the authority to create tobacco product standards, demand detailed product information from companies, restrict changes, and control marketing and distribution. In order to better understand patterns of usage, the FDA has also begun a longitudinal study that collects the bio-data of 46,000 adults and children who engage with tobacco products, Zeller said.

Though Zeller recognized that in recent years there has been a growing denormalization of tobacco use, he said he believes that it is still important to provide education and support to at-risk populations. In particular, the FDA has found that teens within the LGBTQIA+ community and those who live in rural areas are more likely to take up tobacco.

On the other hand, vaping has become popular among teens across the board. Zeller described this trend as worrisome because it is still unclear whether e-cigarettes are in fact a safer way to use tobacco, and they often lead teens to smoke cigarettes in the future.

According to Zeller, “The Real Cost” campaigns attempt to communicate the negative effects tobacco has on lives in ways that teens will respond to. The FDA has concluded that these campaigns were independently responsible for preventing about 350,000 young adults from smoking and saved society $31 billion in smoking-related costs within two years of its conception.

After the lecture, a question and answer session took place, during which Zeller addressed topics from how the President Donald Trump’s administration’s ties to big tobacco affect FDA regulations to how tobacco producing states are being impacted by stricter regulations.

Zeller said that changes in administration have not impinged on the FDA’s mission to reduce tobacco use because of FDA commissioner Scott Gottlieb’s dedication.

“I have dealt with every commissioner for 36 years,” Zeller said. “Gottlieb is unique. He is a doctor. He is a cancer survivor. He has a breadth and depth of medical and regulatory experience. I also think the other challenge of being a regulator of a controversial product where there is politically a lot of interest doesn’t change with administrations. The legislative branch comes at this from every side. That’s their job.”

During the Q&A, Zeller also discussed how regulation of tobacco has a very small impact on state economies because there are few domestic tobacco farms. In 2008, Congress even made billions of dollars available to tobacco farmers so that they could convert to other crops.

Ana Perez Ternent ’22 said the lecture hit close to home because her closest friends all vape.

“I thought [the talk] was really great, but I also think we know these things,” Ternent said. “We know that we are 100 years late [on regulation], and I wonder if that means we are going to be 100 years late on the next step. Most of my friends are addicted. I think that the way [Zeller] spoke was very empowering, and he does want a better situation. I just think that in the long run, the FDA does not have the powers vested in them to bring about changes he wants to see.”

Briana Krewson, a masters in Public Health student at Geisel School of Medicine, attended the lecture because she wanted perspective into what the FDA is trying to do in regards to regulating tobacco.

“I think there’s sort of a lack of implementation,” she said. “They can talk and collect all this data, but if they are not able to put their foot down and make actual change, then all of this regulation goes nowhere. But I think it’s great that students at Dartmouth have the opportunity to engage with someone from the government.”

The Osher Lifelong Institute chose to sponsor this lecture because they wanted an update on the FDA’s progress on tobacco regulation and to understand how e-cigarettes are changing the progress made, according to Thomas Blinkhorn, at large member of the Osher Institute’s Leadership Council.

“People have been educated about the dangers of tobacco, but tobacco companies have come up with this clever new technology of e-cigarettes and vaping that they claim are not addictive,” Blinkhorn said. “I want[ed] Zeller to give me an honest appraisal of what is going on and what he is doing.”

Zeller hopes that his lecture shed some light on the role of regulators as “gatekeepers.”

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“We can only go as far as the science will take us,” he said. “Everything is evidence based and the one thing I want folks to know is that we take the responsibility we have under the statute very seriously, but the guide for what we do is the science. We come up with policies that make the most sense to help reduce the leading cause of preventable death. That is the part of my job I take the most seriously.”

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