WASHINGTON -- Last week, the U.S. Food & Drug Administration's (FDA) Center for Tobacco Products (CTP) hosted a webinar during which CTP director Mitch Zeller addressed a variety of tobacco-related topics covering everything from premium cigars to menthol regulations and substantial equivalence approvals (Read the complete story here). Electronic cigarettes and other potentially reduced risk products were by far the most discussed issue of the day, however. Zeller even suggested this stunning evolution of tobacco and nicotine delivery products played a role in his decision to return to the FDA.
"There's something going on driven in part by consumer demand--especially smokers who have concerns about the health risks," he said. "They certainly seem to be open to getting their nicotine through other ways than cigarettes. We started with a much more straightforward marketplace for tobacco products when I started. Now we have cigarette companies in the practice of selling smokeless, e-cigs, nicotine rubs, nicotine gels and dissolvables."
With the FDA's proposed deeming regulations reportedly being reviewed by the Office of Management and Budget (OMB), Zeller couldn't say much on how the agency might oversee products like e-cigarettes; however, he repeatedly acknowledged a continuum of risk when it comes to how the public consumes nicotine.
"It is not the nicotine that kills half of all long-term cigarette smokers," said Zeller. "The nicotine creates and sustains the addictions, but it's not the nicotine that kills people."
"Different tobacco products deliver nicotine in different ways," he continued. "Certain products pose more risk to the individuals than others. What is the best we can do to help currently addicted smokers, especially those who would not intentionally quit?"
It seemed to be a positive indication for e-cigarettes, especially with many individuals sharing personal experiences of how e-cigs helped them quit smoking. Though these stories are inspiring, Zeller was quick to point out that rulemaking must consider many different factors.
"We can't make policy simply on the information of some people who had a good experience with any of the newer products," he said. "The law requires us to have a scientific handle on all the net population impact."
Zeller added that the agency is currently seeking out information on e-cigarettes from the scientific community to better understand just that. Specifically, the FDA wants a grip on who is using products like e-cigarettes and how they are being used--with a focus on the net population health impact of different usage behaviors, including those who use e-cigs as a cessation device, those who use both e-cigarettes and combustible cigarettes and whether or not there are people who use e-cigarettes as a pathway to initiate or re-initiate combustible cigarette use.
With so many issues to tackle for such a new--and evolving--line of products, coming up with lasting, science-based regulations has been a challenge.
"There are lots of questions on e-cigs and their place on the risk continuum," Zeller said. "It's complicated."
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