In October, the Food and Drug Law Institute (FDLI), Washington, D.C., held the Tobacco and Nicotine Products Regulation and Policy Conference. This two-day conference brought together a diverse group of stakeholders, including public health advocates, trade associations, researchers, manufacturers, lawyers, consumer interest groups, entrepreneurs and governmental agencies. Notably, leadership from the Food and Drug Administration’s Center for Tobacco Products (CTP) presented and participated throughout the conference.
Bret Koplow, CTP’s acting director, provided the keynote address. In his remarks, Koplow said CTP “recognized e-cigarettes, nicotine pouches, heated tobacco products and snus for their potential beneficial use for current tobacco users, predicated on recognition of a continuum of risk among different tobacco products, with combustible tobacco products generally posing the highest risk. While cessation is best, an adult smoker willing to switch to a lower risk authorized tobacco product needn't entirely relinquish tobacco in order to lower his or her risk.”
Koplow also provided insights into the FDA’s Premarket Tobacco Application (PMTA) process. “Over the past five years, FDA reviewed over 26 million applications, the vast majority for e-cigarette products…in this year alone, we reduced the backlog of pending applications by approximately 60%,” Koplow said. He went on to add that “CTP has learned valuable lessons from reviewing millions of applications, which have led to exploring streamlined approaches that maintain high standards while improving efficiency. Recently, CTP launched a nicotine pouch pilot program, which aims to streamline the review process for pre-market tobacco product applications.”
During the conference, the National Association of Tobacco Outlets, (NATO) participated in a panel with John Verbeten, CTP’s director office of compliance and enforcement. In the panel, we discussed strategies for addressing unauthorized nicotine products, including increasing enforcement activities and providing collaborative solutions throughout the supply chain.
In all, FDA’s CTP leadership provided insights into their work and strategies to address key issues surrounding the tobacco and nicotine industry. Many attendees left the conference with optimism that CTP will stay engaged by providing increased communication and transparency with its stakeholders. Further, it is likely that meaningful action will occur in the near future with more PMTA decisions and continued enforcement against unauthorized nicotine products.
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