MEG TIRRELL: Let's talk about tobacco. So you have announced plans to try to limit the nicotine levels in combustible cigarettes to minimally addictive or nonaddictive levels. You've also said you're going to look at flavors like menthol. You got sued yesterday, though, by several public health groups saying you didn't move fast enough, the FDA didn't move fast enough and has delayed rules on e-cigarettes and cigars and that kids will be exposed to them for longer and potentially get addicted. How are you looking at that?
SCOTT GOTTLIEB: Well, I'm not going to address the specific litigation. But when we announced this plan earlier, late last year, the idea was to put nicotine at the center of our regulatory efforts and, to your point, go through a process to try to regulate nicotine levels in combustible cigarettes, combustible tobacco, to minimally and nonaddictive levels to try to transition smokers more quickly off of combustible tobacco onto reduced-risk products or to quit altogether. But, you know, we know that there are going to be adult smokers who still want to get access to satisfying levels of nicotine, and if we're going to render cigarettes minimally or nonaddictive, where are they going to get access to nicotine? Obviously the most advantageous route is to go to an OTC nicotine replacement product. But --
MEG TIRRELL: Over-the-counter?
SCOTT GOTTLIEB: Over-the-counter product like a patch or a gum. But we do see an opportunity from things like e-cigarettes and other electronic nicotine delivery systems potentially being a viable vehicle for adults who want to access nicotine. But those products need to be put through a series of appropriate regulatory gates. When I came into the agency, none of the foundational regulations that needed to be in place in order to properly regulate e-cigarettes were in place, and the only way for us to get those regulations in place was to implement the delay and the application deadlines, because all of these companies had applications due to the agency within a year. Well, we got those rules in place, and that's, in fact, what we're doing. At the very time that I am trying to take nicotine out of combustible tobacco, I don't want to be sweeping the market of products that could provide an alternative to smokers who want to get access to nicotine. One of the things we're doing right now is looking very actively at could we bring an e-cigarette through the over-the-counter pathway, which would give us many more tools to look at both safety and benefit, to study whether or not an e-cigarette actually does promote smoking cessation, and also gives us many more tools to study the toxicology associated with it and see what effects it might have on the lungs. We're going to be putting out two guidance documents sometime soon, probably this summer. One's going to address specifically how to study the toxicology associated with an e-cigarette, so the pulmonary tox associated with the use of an e-cigarette if you want to bring it through the new drug approval pathway and try to sell it as an over-the-counter product. We're also looking at what additional endpoints we might allow for products that want to get smoking cessation or maybe even smoking reduction claims as an over-the-counter nicotine replacement therapy. Because we do want to open up the marketplace towards more opportunities to get nicotine sold as a pharmaceutical product for smokers who want to either reduce their smoking or preferably quit altogether. I think all of these elements are important. People like certain parts of what we're doing, don't like certain parts of what we're doing. I think the people who sued us waited until we got out all the parts that they liked, and then one day later sued us on the parts they didn't like. But, you know, this is -- to me, this is a comprehensive package and I think if you're in favor of trying to get adult smokers to more rapidly quit smoking, you can't just turn a blind eye to the fact that there's still going to be adults who want to get access to nicotine, and there needs to be products available to safely do that. Now, all that said, I will just close by saying we are deeply concerned around the youth access. We see what's happening with Juul. We see what's happening with the other e-cigarette products where you see a lot of youth initiation on those products. That's why we're going to address things like favors. That's why you're going to see us take some enforcement actions very soon against some products that we think are being inappropriately marketed to kids. And we'll continue to push on that very hard because no child should be using any tobacco product.
MEG TIRRELL: Was the FDA dragging its feet before you got there on this issue?
SCOTT GOTTLIEB: I think you're dealing with -- with the Tobacco Center and Tobacco Control Act, you're dealing with a relatively new piece of legislation and a new center. And I think that they had to make decisions about which regulations they promulgated and couldn't do everything. And so it's true when I got to the agency, certain foundational regulations that I think we need to provide a firm regulatory context to evaluate these products weren't in place. It's not that they were dragging their feet. I think they had to make different decisions about what they did first. And there was some unfinished business. But that's not because anyone had dropped the ball. It's because it's a new center and it doesn't have, you know, 100 years of history like our drug center and all the regulations in place, you know, clearly codified.
CNBC EXCLUSIVE: CNBC’S MEG TIRRELL INTERVIEWS FDA COMMISSIONER SCOTT GOTTLIEB FROM CNBC’S HEALTHY RETURNS CONFERENCE TODAY