SILVER SPRING, Md. — While Mitch Zeller, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) director who retired this April, doesn’t have a crystal ball, he has some opinions on where the future of tobacco regulation might be headed.
Zeller reflected on his time with the agency in a Q&A published on the FDA’s website, which included some musings about the future of tobacco and the biggest challenges that lie ahead for the CTP.
Zeller worked with the FDA in the ‘90s before joining the CTP as director in March 2013.
“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,” Zeller said. “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.”
Here are excerpts of how Zeller answered questions involving tobacco regulation and the premarket tobacco product application (PMTA) process ...
What Challenges Lie 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% 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.”
Where is Tobacco Regulation Heading in the Next Decade?
“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 (ENDS), 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.”
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.”