WASHINGTON -- Fifteen months into his tenure as director of the U.S. Food & Drug Administration's (FDA) Center for Tobacco Products (CTP), Mitch Zeller admits there are some limits to what he has been able to focus on.
"When I started March of last year, there were some inherited priorities that required my attention and the attention of the center before we could get to more forward-looking strategic opportunities and priorities," he said during a Warner Series webinar hosted by The Legacy Foundation.
Unsurprisingly, those established priorities included tackling the hefty issues of substantial equivalence, menthol and deeming regulations.
"That really occupied a lot of my time through spring and summer of last year," said Zeller.
Last fall, however, Zeller and his counterparts at the CTP received an unexpected opportunity to take the time needed to evaluate what the center's priorities should be moving forward.
"One of the side benefits of the government shutdown is because [CTP is] an entirely user-fee operation, we came to work every day when others legally couldn't," he said. "This gave us time to focus on a deeper dive on strategic opportunities, looking at where we can have the greatest positive impact on public health over the next few years."
While there were many questions on the issues of substantial equivalence, menthol and deeming, Zeller first wanted to take the opportunity to publically discuss these new priorities of the CTP.
He outlined five strategic priorities going forward, which included:
- Product Standards: "We are working on a strategy to issue product standards," he said, defining product standards as a provision in the law that gives FDA the power to ban or restrict the allowable levels of compounds, ingredients and substances in tobacco products. "Specifically, we are supporting the research and exploring potential product standards in three areas: addiction, toxicity and appeal."
- Nicotine Policies: "It's time that all of us start looking at nicotine differently," Zeller said, repeating his commitment to a continuum of risk. "We need to recognize that there is a continuum of nicotine delivery products. It's not the nicotine that kills half of all long-term smokers, it's the delivery mechanism. We have to recognize some of these realities and figure out how they can impact regulatory policies." As such, Zeller said the CTP was working on finalizing deeming regulations, developing jurisdictional policies for nicotine containing products across the FDA (whether it be tobacco products, medicinal products or delivery devices), and exploring options related to expedited pre-market policies based upon principles of relative risk.
- Pre-and-Post Market Controls: "The ability to put in pre-and-post market controls is fundamental to our role as regulators," Zeller said. "Historically, in an unregulated marketplace, nobody stood between the products and the consumer. We are the regulatory gatekeeper armed with the regulatory science to drive policy. We now stand between the products and the end user." Upcoming actions might include rules and guidances for substantial equivalence, pre-market tobacco applications, modified risk tobacco product applications, tobacco products manufacturing practices or something as mundane as validated analytical test methods.
- Compliance and Enforcement: "We are a regulatory agency with law enforcement responsibilities," Zeller continued. "We have inspection, investigation, monitoring and review activities that go a long way to informing how we're going to enforce and ensure compliance with the law. The CTP has already built a very robust state compliance check in 48 states and intend to have compliance and enforcement presence in every state and territory going forward." Zeller also acknowledged the issues of compliance and enforcement with tribal lands and said the FDA was "working long and hard on this."
- Public Education: "Our focus is on the most at-risk and vulnerable out there, identifying 40% of youths who are particularly at risk," Zeller said, noting that the Real Cost campaign launched in February was aimed at the "general market" of all 12- to-17-year olds. "But there are complimentary campaigns coming in the next year or two aimed at multicultural, rural, and LGBT youth."
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