NEW YORK -- As with his presentation at the NATO Show, Mitch Zeller’s appearance at the Smoke-Free Alternatives Trade Association (SFATA) Conference centered on the concept of a continuum of risk when it comes to nicotine and tobacco products. The director of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) went so far as to say the pro-vaping attendees were “preaching to the choir” when they called for a change in rhetoric for the debate over electronic cigarettes.
Attendee Bonnie Herzog, Wells Fargo’s senior tobacco analyst, said that Zeller agreed the societal debate needs to focus on “issues that really matter,” like the role e-cigs could potentially play in harm reduction. The current e-cig/vaping debate has zeroed in on issues like youth usage, flavors and marketing. Though Herzog acknowledged these points are “undoubtedly very important,” she expressed concerns that they are “diverting attention from the bigger-picture issues.”
“Encouragingly, Director Zeller underscored the importance of ‘opening up the dialogue’ across various stakeholders in the nicotine space, suggesting to us that he and the agency remain committed to using science and data to shape regulation while recognizing the nicotine continuum of risk, which is consistent with his previous comments,” she continued in a research note.
Besides recognizing the need to reframe the debate over e-cigs and nicotine as a whole, Zeller went on to discuss how the FDA might play a part in such efforts. Zeller said the agency has “taken seriously” the public comments submitted from smaller vaping manufacturers that might not have the resources of larger tobacco companies. Additionally, Zeller expanded upon a point he brought up at the NATO Show, stating that the CTP is currently exploring the role of “therapeutic nicotine” with other FDA “centers” (specifically the Center for Drug Evaluation and Research and Center for Devices and Radiological Health).
“We remain cautiously optimistic that the FDA ‘gets it’ with regards to a nicotine risk continuum that will ultimately be reflected in regulation,” wrote Herzog. “We remain bullish on vapor long-term, but near-term, we’re more cautious given increased uncertainty.”
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