SILVER SPRING, Md. — Between reviewing premarket tobacco product applications (PMTAs), sifting through stakeholder comments, and pursuing new standards to ban menthol cigarettes, it’s safe to say the U.S. Food and Drug Administration’s new Center for Tobacco Products (CTP) director has a lot on his plate.
For just more than two months, Brian King has led the office, succeeding Mitch Zeller, who retired in April. King comes from the Centers for Disease Control and Prevention, where he focused on tobacco prevention and control.
CSP Daily News spoke to the new director in September to learn where the agency is with PMTA reviews, what he sees for the future of tobacco innovation and how he can better connect with stakeholders, like convenience-store retailers.
This interview has been edited for length and clarity.
Question: What has taken up most of your time and attention since becoming CTP director?
Answer: There's certainly been a lot of activity within the first two months, and the bulk of my energy has really been focused on four primary areas. The first is really continuing to work on developing and implementing the regulations in accordance with the Tobacco Control Act. We have several product standards that are currently working their way through, including menthol cigarettes and flavored cigars, and a proposed nicotine standard. We're also continuing to process and review a variety of [PMTAs]. Third, we're focusing heavily on conducting some meaningful enforcement and compliance activities. And finally, the fourth major bucket where we've had a lot of activity relates to health communications campaigns. And so that's part of our broader efforts to not only process applications and make determinations, but also continue to educate the public about tobacco products.
Q:Recently the FDA told the court it expects to finish reviewing PMTAs by June 2023. Why did the FDA need three years to complete its PMTA review?
A: It's important to note the volume of the number of applications that were received. And ultimately, after we received regulatory authority in 2016 and we were required to submit by the September 2020 deadline, we were dealing with more than 6.7 million products. We need to ensure that those reviews are not only scientifically defensible, but also legally defensible as well. And so, it's critical that we have a clear lens in terms of reviewing that content and making sure that those determinations are as robust as possible.
That said, we've made considerable progress in chipping away at those 6.7 million products. To date, we've addressed 99% of them, which is a Herculean effort in terms of the sheer volume that the staff at the [CTP] have been working diligently for many years to ensure that happens. We still have about 1% to go, but it's certainly a priority to continue to ensure that we meet all of those.
"We're focusing heavily on conducting some meaningful enforcement and compliance activities."
Q: Considering a recent appeals court decision saying the FDA did not adequately consider marketing plans for several electronic nicotine delivery systems' (ENDS) PMTAs, I wanted to ask more about what the review process for PMTAs looks like. Is it true that the FDA doesn't consider marketing plans from companies submitting PMTAs, as the court concluded? And if so, why?
A: I can't comment on the specifics for any individual applications, but I can say that we look at the robust body of evidence that is submitted by the applicant to ensure that we can make a fully informed decision.
Q: What does the future of tobacco innovation look like?
A: We're certainly seeing a very dynamic tobacco product landscape in terms of a variety of combustible and non-combustible electronic products that have entered the landscape. There's definitely a lot of discussion around the potential for these products as a reduced risk tobacco product. A key component, though, is acknowledging and reviewing the available science related to any specific product. In order for a product to receive approval, there's very clear standards that the applicant must meet, and FDA and regulatory authorities are tasked with adhering to a public health standard that weighs both the benefits and the risks of these products.
Ultimately, although there's been a lot of novel products that have been entering the marketplace, it's critical that we continue to apply this important public health lens around the potential benefits to adult smokers if people were to transition completely from combustibles, but also the important risks that could occur related to youth.
Q: Where is the FDA at with its efforts to ban menthol as a flavor in cigarettes and flavors in cigars?
A: In April, we did propose rules to prohibit menthol in cigarettes, and also flavors in cigar products. And the ultimate goal of those is to protect public health by helping current users quit the products, but also preventing future generations from becoming addicted. We know that menthol masks the harshness of tobacco products and can make cigarettes easier for youth to initiate. It can also prevent adult smokers using these products from quitting completely. The proposed policy around menthol could have a very profound public health impact, including saving many lives if implemented.
The [public] comment period [for the rules] was extended from 16 to 90 days, and we received nearly 250,000 comments on the two proposed rules for menthol cigarettes and flavored cigars. We've already begun reviewing those comments, as well as the scientific data, and the expert opinions and other facts that were submitted. In terms of next steps, we're in the process of reviewing those comments and then making a determination about the next stages of the rulemaking process.
Q: How can the CTP partner with retailers, like c-stores, to keep them updated on regulations and let their voices be heard?
A: Stakeholder engagement is definitely a key tenant of my tenure as director of CTP, and so I'd be remiss if I didn't acknowledge that I'm committed to transparent and routine dialogue between stakeholders. And that certainly includes retailers. CTP has already taken many actions over the years to help retailers comply with various tobacco product regulations.
There's also a lot of other opportunities where we welcome input from our stakeholders, including retailers, to actively engage with various national retail associations. That said, we're always open to further opportunities for engagement with stakeholders, and that includes retailers, and welcome further opportunities for input on the work we do and ways that we can further optimize a future engagement.
Q: What are you most looking forward to as you start your role as CTP director?
A: I've been in the tobacco field for the better part of the past two decades, and I think what I'm most looking forward to in the role is really continuing to work with passionate and dedicated staff at FDA. There's myriad dedicated civil servants who work day-in and day-out to ensure that we're meeting the requirements of the Tobacco Control Act and the authorities that Congress has given us.
I've worked at the federal government for over a decade, and then in tobacco for over two decades, but I'm reinvigorated by the passion and the dedication of FDA Center for Tobacco Products' staff, and I look forward to continuing to work with them to address the nation's leading cause of preventable disease and death. I think it's very important to acknowledge that a cigarette smoking alone kills more than 480,000 Americans a year. And that's a very profound number. And for every one person who dies from smoking, we've got another 30 living with a smoking-related disease. And so a very key guiding light of the work that we do at FDA is to achieve our mission, which is making sure that tobacco-related disease and death is part of America's past and not our future.
Q: Does that mean an ideal future for you, a couple decades down the road, would mean a world with no cigarettes? Or is there a balance of products?
A: Well, it's difficult to look into the crystal ball, but in terms of my vision for the long-term future, it would indeed be a society free of tobacco-related disease and death. I think that we have some great opportunities moving forward to not only prevent an initiation among kids, but also to help adult tobacco product users quit and continue to explore the available science around lower-risk alternatives for adult smokers to transition completely to non-combustible alternatives.
That said, I think the primary guiding standard for us is to continue to do all that we can to address this country's leading cause of preventable disease and death, which is tobacco use. And so I plan to expend considerable energies in my role as the director of the [CTP] to ensure that we do meet that mission and then reduce the burden of tobacco-related disease and death in this country as quickly as possible.
Q: Is there anything else that you would like retailers who sell tobacco products to know about yourself or your administration?
A: I would just like to reiterate the important role that retailers serve, particularly in preventing youth initiation. I really respect the ongoing attention of retailers to this matter. It certainly takes a village when it comes to effectively addressing this issue. And I can't reiterate enough the importance that retailers and stakeholders hold in our ongoing efforts to prevent youth initiation and use of these products.
As part of my tenure as center director, there's certainly a lot of key priorities of mine. One of those is sound sciences. It's also effective and transparent communication and also approaching things with a health-equity lens. But the fourth component is also stakeholder engagement and partnerships. And I think it's critically important that retailers continue to understand the important role that they serve in terms of tobacco prevention and control among kids. And we look forward to continuing to work with retailers at the [CTP] to make sure that we achieve our mission of making tobacco product-related disease and death part of America's past and not our future.