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FDA Insight: Episode 12 – Transcript

>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the deputy commissioner for Medical and Scientific Affairs here at the FDA. Thank you for joining us for another great episode.

This week, we're discussing something called electronic nicotine delivery systems, but you may know them by another name, e-cigarettes or vapes. Joining me to discuss this very important issue is Mitch Zeller, the director of the Center for Tobacco Products here at the FDA.

Mitch, welcome to FDA Insight.

>> Mitch Zeller: Thanks so much, Anand. Great to be with you.

>> Anand Shah: Well, let's jump right in. We know that electronic nicotine delivery systems or ENDS are battery-operated devices that people use to inhale an aerosol, which typically contains nicotine flavorings and other chemicals. One of the biggest questions out there is whether vaping is less harmful than smoking cigarettes? Is it?

>> Mitch Zeller: Yeah. I wish there was a really simple black and white answer to that question. But the answer really comes down to the answer to two other questions, who is using the e-cigarette and how is it being used? E-cigarettes, while compared to cigarettes have far fewer harmful compounds in the vapor, are not safe. They are not risk free. And as you said, they contain nicotine. So, any use of e-cigarettes by a kid is bad for public health. There's the still developing adolescent brain. And there's evidence that a kid who never used any tobacco product who experiments with an e-cigarette is more likely to go on to try a combustible cigarette. So, any use of e-cigarettes by kids goes on the negative side of the ledger.

On the other hand, we still have more than 30 million addicted adult cigarette smokers. Almost all of whom are concerned about their health and have some interest in quitting. So, if a typical pack-a-day cigarette smoker could completely substitute all of his or her cigarettes with e-cigarettes, there's no question that that person, that hypothetical pack-a-day smoker, would be reducing their risk compared to continuing to smoke a pack of cigarettes every day.

The problem is in the real world, the majority of e-cigarette users who are adults continue to smoke cigarettes. They are the so-called dual users. They may be smoking fewer cigarettes per day than when they were only using cigarettes, but they're still smoking cigarettes most of them. And we don't know if there's any health benefit at a population or individual level for dual users. We do know that if you completely switch regardless of what the long term — the unknown long-term health consequences are of e-cigarettes, if you can completely switch from cigarettes to e-cigarettes, there's a good chance that you're significantly reducing exposure and risk. It's a long way of saying we can't say that vaping is safe. It really comes down to the answers to those two critical questions, who is using them and how are they being used?

>> Anand Shah: Mitch, speaking of youths and adolescence, I know that one priority for the FDA and public health has been preventing youth use of e-cigarettes and other ends. Why is vaping so appealing to youths?

>> Mitch Zeller: Yeah. This is this is really concerning to us because we know from research, quantitative research, qualitative research, kids know that cigarettes are harmful. We still have a massive public education campaign into fully communicating all of the harms of cigarette smoking. But when we started to look into the research a couple of years ago before mounting a very large multimedia prevention campaign aimed at kids at risk of vaping, what we learned from our research is that there are a lot of kids walking around thinking that e-cigarettes are harmless, that they think it's just some kind of harmless water vapor. And amazingly, there are a bunch of kids who don't even know that there's nicotine in e-cigarettes. So, we start behind the eight ball when it comes to public education, because there are these misperceptions that a lot of kids are walking around with thinking that e-cigarettes are harmless. So, part of our effort has to be to debunk those misperceptions.

And then there are other behavioral issues that we are very, very concerned about. There are products that are deliberately designed to be used in a discreet way to actually conceal the use of the product. We've had to issue warning letters against companies that are selling backpacks and hoodies that are deliberately designed to conceal the use of a vaping device. So, these products are easy to use. They're discreet. They're literally products in the marketplace designed to conceal the use of the product. And then when you add the — whatever the coolness factor is, because the technology is a sleek, up-to-date, cool technology, you have a product, especially with all the flavors that e-cigarettes are available, and that turned out to be very appealing to kids and are far and away the most popular category of tobacco products with kids.

>> Anand Shah: Mitch, you mentioned warning letters. Can you tell us a little bit about what a warning letter is and why do we as the FDA issue these?

>> Mitch Zeller: Sure. So, typically — and this goes for all of the centers. We — when we see a potential violation of law, we do our research and we send what is called a warning letter. And that's all it is. It is a letter that warns. It's actually legally not an enforcement action. But it puts the recipient of that letter on notice and usually gives them 15 business days to remedy or fix the problem.

In our cases, it means that e-cigarettes, which are not lawfully on the market, that the products that are the subject of warning letters would need to be removed from the market. And the companies that get these warning letters usually have 15 business days to tell us what their plan is to remedy the problem. But whenever we send a warning letter, it's because we are prepared to follow up with legal action if we have to, if a company doesn't follow what has been requested in the warning letter. And that legal action for tobacco products can be seeking what are known as civil money penalties in court or seeking an injunction or a seizure.

>> Anand Shah: Mitch, let's go back to youths and adolescence. The 2020 National Youth Tobacco Survey numbers were just released. Can you share about those findings and what they mean for public health?

>> Mitch Zeller: Yeah, happy to. I mean, there's — for the first time in a number of years, there's good news in the 2020 National Youth Tobacco Survey results. There was a significant decline in middle school and high school use of e-cigarettes. And use is defined as any use within the past 30 days of when the young person was asked the question, so a significant decline. In 2019, there were 5.4 million middle and high school-aged kids who were currently cigarette users. And in 2020, that number went down by 1.8 million to 3.6 million. So, that's the good news.

The bad news is, it's still 3.6 million, which is a shockingly high number. And that was the number of kids using e-cigarettes in 2018. So, great that there's a decline, there are still far too many kids that are current users of e-cigarettes. And then there were other results that came out in the 2020 National Youth Tobacco Survey that are very disturbing. There are more kids than ever who are frequent users. And a frequent user is a kid who used on 20 or more of the past 30 days. And more kids than ever that were daily users of e-cigarettes. And then the other finding that is a finding of concern is compared to 2019, a significant increase in the percentage of kids who were e-cigarette users who used flavored, disposable e-cigarette products. A 1,000 percent increase from 2019 for high school kids and a 400 percent increase for middle school kids. So, a mixed bag of good positive results overall in terms of prevalence, but these other findings that are very disturbing and worthy of our attention.

>> Anand Shah: So, Mitch, it sounds like there's some good news but also some real ongoing concerns. You know, what has FDA done to educate youth about the potential dangers of e-cigarettes as well as prevent minors access to these products?

>> Mitch Zeller: The Center for Tobacco Products is looking at the programmatic work of all of our offices to battle this ongoing public health crisis when it comes to kids use of e-cigarettes. So, our Office of Compliance and Enforcement has been working hard. And this is even during the pandemic, we had to shut down physical inspections of manufacturing facilities and retailers. But we have been able to continue all of our monitoring and surveillance online and advertising and marketing. And we continue, unfortunately, to have to issue warning letters to companies just based upon that monitoring and surveillance during the pandemic when there's evidence that e-cigarettes are being targeted or marketed to kids. So, that kind of compliance and enforcement activity continues.

But you also asked about public education. We've had a major public education campaign underway since September of 2018 using the brand that we created back in 2014, called The Real Cost. And the thinking behind that brand is we have a way with our research to communicate to kids the real cost of using any of the tobacco products that are the subject of these various campaigns. And The Real Cost youth e-cigarette prevention campaign has a major investment in TV, social media, internet. We can — when kids were in school, we had a way to target kids on high school grounds so that when they were on their phones at lunch or at recess and they were going on the web, we could shoot prevention messages to their devices while they were on high school grounds.

We have partnered with scholastic and we have gotten materials into the hands of a million and a half middle school and high school teachers and administrators and partnering with students against destructive decisions. We have gotten snarky posters into the bathrooms of every single public and private high school in the country. And we will continue to refresh all of these efforts. And while we are heartened by the reduction in the number of kids who are current e-cigarette users, 3.6 million kids being current e-cigarette users is 3.6 million too many. And so, all of these efforts, compliance, enforcement, public education, and research will continue.

>> Anand Shah: That's great. And to share with our listeners some additional good news. This week has been an important milestone for the agency in how we protect the public health. Mitch, can you explain the significance of the recent September 9th deadline to the regulation of e-cigarettes in the United States?

>> Mitch Zeller: Sure. I think that one of the bedrock, one of the hallmark consumer protection features of the Food, Drug, and Cosmetic Act and the work that FDA does across the board, whether it's foods, drugs, medical devices, biologics, and now tobacco, is the principle of pre-market review of new products, that companies don't get to decide what new products to put on the market. They have to submit an application to FDA on a pre-market basis and the scientists at FDA make the decision on a case by case basis whether a new product should come to market or not.

The challenge for us with e-cigarettes is up until 2016, we didn't have jurisdiction over e-cigarettes, so the products were already on the market. When we finally gained jurisdiction over them starting in August of 2016, we had to deal with the pragmatic issue of, "Okay, there are literally thousands and thousands of these products on the market lacking pre-market review and authorization as required by the Family Smoking Prevention and Tobacco Control Act." So, we permitted those products to remain on the market under an exercise of what is known as enforcement discretion.

While September 9th was the day of reckoning for the industry, because that was the deadline consistent with a court order from July of last year where for any currently marketed e-cigarette or other categories of newly regulated or newly deemed products because that includes cigars — certain cigars, pipes, hookah. If you're still on the market, you have to get an application into us by September 9th. And September 9th has come and gone, we've gotten lots of applications. We still haven't tallied up all the applications that have come in as of this date. But now the system is working the way Congress envisioned, which is the applications are in. We will begin scientific review. And then we will make an assessment on a case by case basis as to whether those products should remain on the market.

And equally importantly, if there are products on the market that did not get their applications in, then those will become candidates for enforcement priorities and enforcement actions down the road.

>> Anand Shah: Great. Focusing here on the patient and consumer, every time I speak with my patients who smoke, I provide them with resources for quitting tobacco use, but it's not easy. There are a ton of resources out there. For those who are listening today and want to quit, what options do you suggest?

>> Mitch Zeller: We have mounted our own campaign aimed at health-concerned cigarette smokers who made a quit attempt within the last 12 months. The campaign is called Every Try Counts. And think about that message, every try counts. What we're trying to convey with a very positive branding is we know how hard it is to quit. We know that if you're concerned about your health and you made a quit attempt within the last 12 months and you're still smoking, well that's probably not the first quit attempt you made. You've probably made half a dozen, dozen, two dozen quit attempts over the course of the many years that you may have been smoking. Every single quit attempt helps, even if you wind up lapsing and relapsing to smoking. Because we know that statistically, every subsequent attempt that you make puts you that much closer to the attempt that will enable you to succeed. And all of that is captured in the brand that we've created called Every Try Counts.

And there is a website, everytrycounts.gov, that has tons of resources for health-concerned smokers, the friends, and loved ones of health-concerned smokers. We know it is really hard to quit. And we know that for many smokers, it takes multiple quit attempts before they finally succeed. We also know that because so many smokers have tried and not been successful over the years that they are walking around with not just an addiction to a deadly product, but additional shame and guilt because they really want to be cigarette-free. But because they are so addicted to the cigarette and because they have tried so many times unsuccessfully to quit, they're walking around with that additional level of shame and guilt. And part of our message is to celebrate the quit attempt itself and to acknowledge how hard it is to quit.

The cigarette is deliberately designed to create and sustain addiction. This has all emerged from previously secret internal tobacco industry documents. This is a remarkably efficient drug-delivery device. The nicotine in a cigarette gets from the lips of the smoker through the bodily systems and up into the brain to feed what are known as nicotinic receptors within 10 seconds. It is a remarkably efficient drug-delivery device. And because the cigarette delivers the nicotine in less than 10 seconds, that's why it's so hard to quit.

That smoker that we see outside in the cold in the wind in the rain smoking is smoking to stave off the symptoms of withdrawal. And the symptoms of withdrawal start with a signal that the brain is sending to the rest of the body saying, "I need my next dose of nicotine and if I don't get it, the body is not going to be feeling very good." And it's a long way of saying that's why it is so hard to quit. And so, smokers, friends, and loved ones who want to go to that website, everytrycounts.gov, can see all kinds of resources about FDA-approved drugs both prescription and over-the-counter that can help you quit. Access to and links to counseling services because we know that if you combine the use of an FDA approved medication with any form of counseling, you can greatly increase your chances of successfully quitting. And we just want to be there to celebrate the quit attempt and to support the smoker who is going to make that next attempt to become cigarette-free.

>> Anand Shah: That's great. And speaking of quitting, we have to wrap up this episode of FDA Insight. Mitch, thank you for taking the time to join us this week for this very special and timely conversation. And many thanks to you and your team at CTP for all that you do every day to protect the public health.

>> Mitch Zeller: Thanks so much, Anand. I really appreciate it.

>> Anand Shah: Thank you. In future episodes, we'll be discussing more topics including nutrition in women's health. As always, we'll be providing you insight, in plain language, to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app such as Apple Podcasts, Google Podcasts, and others. Thanks for listening.

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