Mitch Zeller’s FDA career first began in the 90’s. Then, three decades into his public health career, Zeller joined the Center for Tobacco Products as Center Director in March 2013. During an impressive nine-year tenure, he led FDA’s efforts to reduce disease and death from tobacco use and brought previously unavailable information about its dangers to light.
In preparation for his retirement from public service in April 2022, Zeller reflects on the time he spent helping to make tobacco-related disease and death part of America’s past, not America’s future, and, by doing so, ensuring a healthier life for every American family.
1. What’s it been like working for the Center for Tobacco Products (CTP) these past nine years?
I can only describe these past just over nine years as the Director of the CTP as a labor of love. It’s been hard but it’s also been incredibly rewarding professionally. I’ve had the opportunity to work with the best, hardest working people in the world and we’ve gotten a lot done, so my time here has been a joy. I’m going to miss the people, as well as the issues.
2. What did you value the most about working at FDA?
In my two stints at FDA, first in the 90’s and then when I returned as Center Director, what I’ve valued most is the people and their commitment to the mission. The people, who are the heart and soul of CTP, really have a never-say-die attitude. We've had ups and downs. We've had good days and challenging days. The most remarkable thing to me is the ongoing commitment and dedication of the people who work at CTP.
3. What are some of the efforts you are most proud to have been involved in at CTP?
It’s difficult to pick out one or two or even three top accomplishments in my time here. I don’t want to leave anything or anyone out as it’s all been important work. When I look across the board at everything that collectively we’ve gotten done, both programmatically and operationally, over the last nine years, it’s a very long list. So, in no particular order…
It starts with continuing to stand up the Center. When I started as Director of CTP, it had its doors open for a little over three years, and we were 426 people. We’re now over 1,110. But more than just those numbers, we’ve continued to stand up a mature and robust programmatic and regulatory presence.
I’m proud of so many efforts including the incredible ongoing work from a compliance enforcement standpoint through our state contracts, all the work that we're doing at home and remotely, our remarkable public education efforts and accomplishments in the Office of Health Communication and Education, the foundational final rules that have been published that will make clear going forward the pathways for premarket application review, and the amazing review of applications that has taken place. Everywhere I look, there's a remarkable degree of programmatic accomplishment.
Since I announced my decision to retire, a lot of people have been saying some very kind things to me. From the bottom my heart, whatever has been accomplished, however long or short we want to make that list of top accomplishments, it was a collective effort of office directors and deputy office directors and key staff, supported by a remarkable degree of commitment to the operational management and infrastructure in a still-growing center.
It’s impossible to pick and choose, so I stand by having a long list of efforts and accomplishments I’m honored to have been a part of during my time at CTP.
4. What are a few things you wish you could’ve seen come to pass regarding tobacco regulation during your time at CTP?
When I think about what more could’ve gotten done on my watch as Center Director, it’s a short list. But to be completely honest, and this is no secret, I saw us as a Center work hard for many, many years on the nicotine reduction product standard. I look forward to the day when that work will bear fruit.
However, I am very excited that we are using the product standard authority to prohibit menthol in cigarettes, and all characterizing flavors, including menthol, in cigars, which will be a huge accomplishment when finalized.
5. Was there anything that surprised you during your tenure as CTP Director?
People have asked me what was unexpected when I came back for a second tour of duty at the agency, and were there any surprises. I didn’t know how, as a group, we were going to be able to handle, for lack of a better word, disappointment.
I knew that we were going to have an opportunity to take a run at things like issuing the first tobacco product standards to, for example, prohibit menthol or reduce nicotine levels in combustible tobacco products. But despite knowing that we would have that opportunity, we obviously didn’t know what the outcome was going to be. Even though we work hard internally to move forward very quickly, the regulatory process can take a long time. Much to my delight, no one’s given up.
What’s pleasantly surprised me has been the people of CTP understanding that the most profound, impactful policies sometimes take time to gather the support that they need for us to be able to move forward. In the face of some of the disappointments that we’ve experienced over the years, no one’s given up. We lick our wounds, take a deep breath, and get on with our jobs.
6. What challenges do you think remain ahead for CTP?
The Center has some ongoing challenges, none of which will come as a surprise to anyone. We’ve done an incredible job in the face of receiving applications for 6.7 million products under that court ordered deadline for submission of applications for marketing authorization for deemed products. We’ve taken action on just over 99 percent of those applications but of the approximately fifty thousand that remain, there are important decisions that still need to be made.
I’m not sure I’d call it a challenge because I know that the Center and agency are more than up to the task. However, it is a huge priority and the challenge will be in getting through those remaining applications as quickly as possible. We must be faithful to our responsibility that whatever decision we make on any of them is firmly grounded in the science, whether we’re issuing a marketing authorization or a marketing denial order.
On a more personal, human dimension, we’re coming into the beginning of the third year of a pandemic. An ongoing challenge for each of us is how we figure out how to continue balancing our work responsibilities and our commitment to our work colleagues with our responsibilities to ourselves and our families. I recognize that work-life balance continues to be a challenge.
7. What advice would you give to the next CTP Director?
There’s a lot of advice I might give to the next Director of the Center for Tobacco Products but here’s where I would start: You’ll see it for yourself very quickly, but perhaps before you can see it in its full scope, understand that you are inheriting an incredibly talented team.
From those that are in the Office of the Center Director to those in all of the offices, including the management and the wonderful staff—you can put a lot of faith and trust in the people you’re going to be working with because they are fantastic.
Don’t be afraid to ask the tough questions. Ask as many questions as you can of everyone, including outside CTP. You’ll be working with extraordinarily talented people in the Commissioner’s Office and throughout the agency as well as the Department of Health and Human Services. A lot of new insights and good thinking can come from people hearing a question that hadn’t occurred to them.
There are no stupid questions. Think about the issues of the day and don’t be bashful when it comes to asking questions.
8. Where do you see the future of tobacco regulation heading in the next decade?
I don’t have a crystal ball—no one does—when we think about the future of tobacco product regulation three, five, or even 10 years down the road. Yet I think that there are some predictions we can make perhaps closer to home in regards to CTP.
The work that we were able to get done on my watch built on the work of the founding Center Director. The opportunity over the next three to five years is to continue the building process. CTP remains the “baby” Center in terms of how long it’s been around compared to the other FDA Centers.
In light of that, one of the things that I think I can safely predict is that more and more of those critically important foundational regulations will be proposed and finalized. With each one that comes, CTP will become that much more mature and stood up as a center like its sister centers that have been around for many, many decades.
Where it gets a little murkier to predict is an issue that the center will have to continue to address over time. With the emerging science on alternative tobacco products, starting with e-cigarettes—will we learn more about whether there are medium-term or long-term health consequences to the use of electronic nicotine delivery systems, especially when compared to combustible products? Some of that science will begin to surface in the coming years.
Certainly, I expect to see important science related to biomarkers of exposure as well as harm for all tobacco products. What will be the regulatory policy implications of this information?
Another part of science that will likely inform policy making in the coming years is more robust science will inform other possible product standards down the road. Product standards are an incredible tool that Congress gave the agency and center to take a categorical approach to prohibiting or limiting the allowable levels of ingredients, compounds, constituents, or additives in finished tobacco products.
The incredibly large investment that CTP has made in advancing regulatory science will continue to bear fruit. How strong and robust the science base will be to inform new policy remains to be seen. However, I have every confidence the center leadership will be keeping a close watch on that. When the time is right for additional product standards, they’ll know it.
9. After having had such a rich career in tobacco regulation, what would you say to someone interested in working in this space?
After spending the last 28 years of my professional life working on tobacco regulatory policy in one capacity or another, I can say that tobacco control, regulatory policy, and product regulation are special areas to work on, with special opportunities. That’s especially the case here in the United States as well as anyone considering working at CTP. FDA is the only agency anywhere in the world with the regulatory tools and resources to take a comprehensive approach to tobacco products.
What’s kept me engaged and invested in this career is that tobacco is the leading cause of completely preventable disease and death in the country and remains so even with all the progress in reducing consumption and prevalence that has been made in the last half century. We’re talking about conservatively 480,000 preventable deaths in the U.S. each year.
If someone has a general interest in public health and are thinking about what kind of issue they’d like to make a commitment to for some part of their career, I can think of no more important issue and perhaps even no higher calling than to work in tobacco control.
It can be hard to bring about meaningful change, but it’s been a challenge I’ve been honored to take on. I would love to see the next generation of public health coming to FDA and CTP to help us because we will be continuing to grow for some years.
10. What’s next for Mitch Zeller?
I’m truly retiring. There’s no other job—I need to disengage, I need to decompress. Afterwards, I may get involved as a private citizen on an ad hoc basis in the ongoing policy issue of the day.
My larger plan is to turn to music. I want to learn how to play an instrument called the vibraphone, which is a wonderful jazz instrument that’s like an electrified xylophone. I look forward to taking lessons as well as studying music theory. I’d love to have a better understanding of the structure of music, which is something that’s always fascinated me. This is hobby stuff—I want to learn how to play this instrument better just for myself.
I’m also looking forward to spending much more time with family. That’s my vision for retirement. We’ll see what happens when I’m doing it in real time!
11. Is there anything else you’d like to leave us with that we haven’t discussed?
To the amazing people of CTP, whatever has been accomplished with me at the helm could only have been accomplished because of the incredibly hard work of all the people at the Center.
While I may be leaving, this incredible group of people will continue the important work of the Center. The leader is only as good as the people of the organization. Any credit or recognition that I get for my accomplishments over the last nine years is only because of the contributions, spirit, dedication, and never-say-die attitude of the people at CTP.
That is the greatest strength of our organization and that will continue long after I’ve retired.