Dr. Scott Gottlieb, the former FDA Commissioner, gave an interview to CNBC host Meg Tierrel at the Health Returns conference which primarily focused on several issues related to the FDA's approach to vaping under his leadership.
Gottlieb was asked about a ruling made by a federal judge last week stating the FDA needed to move more quickly in regards to regulating e-cigarettes saying the slow pace was "an abdication of FDA statutory responsibilities", alluding to the "deeming rule" and delaying of the PMTA deadline for vape products until 2022, even though the process was moved up in March.
PMTA is an acronym for Premarket Tobacco Application, an agency term for the process that companies go through to get their product approved for market sale, a long expensive process. The PMTA process for the IQOS, the heat not burn device from Philip Morris tobacco took at least two years and millions of dollars for the just the one product. The FDA has indicated it would require a separate PMTA for each vape device, vape juice flavor (including for each nicotine level and again if any ingredients change.
I was saying when I was there was that the 2019 National Youth Tobacco Survey data, which is going to be coming out sometime in the end of July or early August, if that shows another sharp uptick in the use of the pod-based e-cigarette products, I think the agency had to consider sweeping the market of those products.
Gottlieb went on to say, "[W]e were looking to move towards pulling those products [pods] in earlier anyway. Now, whether or not this judge's ruling provided the impetus for the agency to go ahead and do that now as opposed to waiting"
When asked about the balance the FDA took on e-cigarettes focusing on helping currently addicted smokers:
We struck the wrong balance, and the epidemic of youth use caught us all by surprise. I mean, one of the worst days of my time at the Agency was when the head of my tobacco center, on August 30th, 2018, came in my office and presented the data from the 2018 National Youth Tobacco Survey showing a 78% increase in the rate of use among high school teens. I remember it vividly.
I still think the policy of doing that, while trying to open up avenues not just for e-cigarettes to be potentially useful alternatives to currently addicted adult smokers, but also nicotine replacement therapies, which we also tried to expand the market for, is a sound policy. Now, the question is: How do you make the e-cigarettes available without them becoming vehicles by which kids become addicted? It's really just one sponsor that now has that problem and has driven a lot of youth use. And the other thing I would say is that the open-tank vaping systems, which actually have better data showing that they help currently addicted adult smokers quit, don't have the same youth use problem. The kids aren't going out and buying these big open-tank systems that are rather expensive. They're buying the cheap, disposable pod-based systems and, particularly, one brand of that system.
The open-tank systems, Gottlieb is referring to are the larger subohm tanks and box mod style vape kits, saying these type of vape devices don't appeal as much to the youth as the vape pods which are smaller, inexpensive and typically have much higher nicotine content.
[D]ata shows that adults who do switch to e-cigarettes, a lot of them will experiment with the pod-based product and then go on to buy the open-tank system. So, if you eliminate the pod-based products, you're eliminating that easy access point for the adult to try it and then decide it's something better than smoking. So, you don't want to do that from a public health standpoint. That's the balancing we were trying to engage in. But at some point, you have to say there's so much youth use of those products, any redeeming public health value that they would have is foreclosed by that youth use.
If you eliminate the pod-based products, you're eliminating that easy access point for the adult to try it and then decide it's something better than smoking
These sort of statements follow a history of previous statements made by the former Commissioner about "narrowing the off-ramp" for adult smokers to attempt to prevent teens from becoming addicted to nicotine.