LEILA FADEL, HOST:
The FDA, for the first time, has approved the sale and the marketing of fruit-flavored electronic cigarettes. The Wall Street Journal reports that President Trump called FDA Commissioner Marty Makary over the weekend and urged him to approve the products. Mitch Zeller is here to explain the science and the process behind this. He led the FDA tobacco regulation efforts for nearly a decade until 2022. Good morning, and welcome to the program.
MITCH ZELLER: Thanks, Leila. Thanks for having me.
FADEL: Mitch, let's start with the science. The FDA previously granted permission only for e-cigarettes flavored like tobacco or menthol. What's the basis of this new decision?
ZELLER: Basis for the new decision is at least some evidence of benefit, that there's a certain number of current addicted cigarette smokers who in the real world would switch to this new product that has flavors that are appealing to kids. But the other critical component is the presence of what's called age-gating technology, technology that's built into the e-cigarette device that, in theory, would prevent a young person from being able to use the product, even if they got their hands on it. And my understanding is the way that it works is the adult that purchases the product has to go through some proof of age experience on an app. And then each time the e-cigarette is going to be used, it has to be in close proximity to the adult's iPhone or Android.
So this might not make it completely impossible for a kid to use it if they had both the device and the iPhone. But my understanding of the technology is that this is pretty strong prevention so that the people that shouldn't be using it won't use it. And then, coupled with the evidence of benefit, that's my understanding of the basis for allowing these products on the market.
FADEL: OK. Let's get to the process here, though. I mean, if the president interjected himself into this decision, like the reporting indicates, what does it say to you about the independence of the agency and its reliance on science?
ZELLER: I've worked on FDA issues since 1982. And the independence of this part of what FDA does, science-based review of applications - whether it's e-cigarettes, human drugs, animal drugs, food additives - that really needs to be held sacrosanct. If the reporting is accurate that the experts at my former center concluded that it was appropriate to market this product, and they were then overruled by the political leadership of FDA, who in turn was then called onto the carpet and told to change his mind by the president of the United States, to me, that constitutes politicization of a process that politics should play no part in.
The job of the regulator, looking at these applications, is like an umpire in baseball. You call balls and strikes. Someone is going to be unhappy for sure, but you follow the science and you follow the law. And that's what my former center did. And then the whole thing became very political. That undermines faith and trust in government and in science.
FADEL: And what would that mean, then, if the public loses trust in the regulators?
ZELLER: I think that the worst thing that could happen, since we still have just under 30 million adults who smoke, almost all of whom are addicted, if this is now a product that the experts at FDA have said, look, if you're concerned about your health and you're interested in trying to get off of cigarettes, give this a try - if this were to undermine their faith in the scientific process, that would be a public health shame.
FADEL: That's Mitch Zeller, former director of the FDA Center for Tobacco Products. Thank you so much for your time and your insights.
ZELLER: Thank you.
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