All right. Like Dr. Rosner said, a very timely topic and kind of serendipitous in some ways that this was scheduled previously, and then it was bumped to today. And with all the recent news, certainly vaping and e-cigarettes are a public health concern. 

So we're privileged today to have Gary Ewart, Drew Harris, and Chris Holstege here to give a multi-disciplinary discussion on this topic. I'll give a brief introduction, because we have a lot of information to get to you. Gary Ewart is the chief of Advocacy & Government Relations for the American Thoracic Society. He's worked in the Washington, DC office since 1995. 

And his primary issues there include clean air, climate change, environmental health, tobacco control, and the Medicare coding, billing, and regulation. Dr. Chris Holstege is the chief of medical toxicology at UVA and is a professor of both emergency medicine and pediatrics. He also is the director of the Elson Student Health Center at UVA and medical director of the Blue Ridge Poison Control. 

And so his expertise in the toxicology of this topic is important. And then Drew Harris is assistant professor of the Pulmonary and Critical Care Medicine. He's been at UVA since 2017, after completing his Pulmonary Critical Care Fellowship at Yale, where he was a chief fellow. 

And here, he's the director of the adult asthma program, the medical director of the Stone Mountain Black Lung Program in Jonesville, Virginia, is the founder and medical director of the Common Cause legal aid, a multi-disciplinary approach to understanding social determinants of health, and also is the director of our internal medicine department's community partner elective that's starting this year. So join me in welcoming all three of these guys for what proves to be a very interesting discussion. 

[APPLAUSE] 

Thanks for that introduction, Sumner. Happy to be here. I'm happy to have this especially timely lecture, which we did plan six months ago. And it's been a challenge trying to keep up with what seems like every five minutes. Even on our walk here, Gary was telling me the email he just got from the FDA, which changed his perspective to this talk. 

So it's been every few minutes. We're updating our slides. And hopefully, we'll get a lot to cover. So I'm going to dive in. We have no real disclosures. Gary wanted me to say that he's a full-time employee of the American Thoracic Society. And his views are his views alone and may not reflect those of the ATS. 

We have four objectives. The first is to get you all to appreciate that vaping is a diverse and rapidly changing field, and it's hard to study. After that, we'll talk some about epidemiology, then look at some of the health hazards associated with vaping, and finish up with some policy implications. 

So vaping comes in all different shapes and sizes. And regardless of what you are vaping, they basically have three parts to each of them, the first of which is a battery. And the battery is a lithium battery like you have in your cell phone. And it can range in how much volts it puts out, usually somewhere between 3 and 6 volts. 

The more volts you have, the more power you can generate. The more puff you can generate, the more nicotine. The more flavors you get, the warmer the vape is. In addition to that, there's something called an atomizer. And this is usually a metal coil and a wick. 

So it takes some of the liquid-- moves it and to heat it up on this coil. And the resistance of the atomizer depends on what metal is used. So if you have a lower resistance, more current goes through, more heat, more vapor, more nicotine. And the final component is the liquid. 

And we're going to talk about what's in the liquid in a second. But the liquid can either be filled yourself at home with a bigger bottle of liquid that you add into a reusable cartridge or you can buy pre-filled cartridges. And there are multiple generations of these products. And I brought some to pass around in a second. 

But the top left is called a cigalike. This is the first-generation product. It looks like a cigarette. They're often disposable. The tip lights up like the end of a cigarette will light up. Usually, these aren't really that popular anymore, mostly because you get less nicotine from them, and less of a drag, and less of a puff that would mimic a real cigarette. 

That's what this industry started out as. This middle product is the second generation. It's called a vape pen. The big black part is the battery. It can unscrew from the clear plastic part. You can feel the liquid up in there. And that smaller black part on the top right is the mouthpiece. 

And then the bottom right is the third-generation product, which is often called a mod. It's much more customizable, bigger battery. You can adjust the voltage. You can adjust the resistance in the atomizer. So I have an example of a third-generation product, which-- play around with. 

But don't press this button, because that will activate the heating. And it is charged. And this is an example of some of the liquids that you can fill it with, which looks like it was made in somebody's basement. But this is a commercially available product. So I'm going to have you all pass that one around. 

Feel free to play with it. And you can open it up. Then the fourth-generation product is something you all have probably heard of, which is called a Juul. And this is a little bit slicker. I'm going to pass this around as well. It has a couple of different components. 

The first is the device itself. And it plugs into a USB port, which just plugs directly into your USB and is magnetic. So you charge it like that. And it comes with pre-filled pods that you can insert in there. And the pods contain about 0.7 milliliters of liquid. 

And in that, it uses about 200 puffs to finish one of those liquids. It's supposed to mimic about one pack of cigarettes. I want to talk about that more in a second. So I wanted to also touch about what's in the liquids themselves. And there's typically three components. 

There's nicotine, there's flavoring chemicals, and there's solvents. And sometimes there's also some contaminants. I'm going to talk through each of these different components. The first is nicotine. So in that Juul packet, there's 0.7 milliliters. And the amount of nicotine in that 0.7 milliliters can range, depending on which product you buy. 

An average would be something like 24 milligrams per milliliter. And so if you smoked an entire one of those cartridges, it would be about 24 milligrams, which is about what you get in a pack of cigarettes. To compare one cigarette is about 1 milligram of nicotine. 

So we know that nicotine is bad for developing brains, lots of long-term structural and functional changes that can affect the growth of cells in multiple parts of the brains-- affects memory, attention, executive function. Folks who are exposed to higher amounts of nicotine when they're young get higher rates of ADHD, worse impulse control. 

And we know this is addictive. And the challenge for us-- or one of the many challenges here is, what do we do when we have the 15-year-old that's now addicted to nicotine? How do you get them off that nicotine? And if vaping is not the answer to get them off, there's not a lot of data to help guide us here. 

And as we will soon talk about, we are, as the media has phrased it, creating a generation of young people addicted to nicotine at this point. Some of the products-- or some of the drugs that we use for adults to get people off, like Chantix in the adult world, are not shown to be effective in those who are less than 18 years old. 

So in the liquid we have nicotine. We also have flavors. There are thousands of different flavors that are often youth appealing in fruit flavors or desert flavors. And it's concerning what are some of the chemicals that are in these flavors. Some of the ones we're most concerned about is diacetyl, which in the pulmonary world, we're all very familiar with in an outbreak of interstitial lung disease. 

And microwave popcorn workers with a butter flavor was inhaled by a lot of workers who developed what's later been called popcorn lung. We know this is toxic to inhale. And we know that there are many companies who say that their products don't contain diacetyl. But when it's tested in a lab, it's not run by that company. 

This chemical is actually found in the flavors. In addition to diacetyl, there's lots of other chemicals. You could pick any number of different flavors and give you some data about it. There was a JAMA article from this week that looked at mint and menthol flavors that shows very high levels of a carcinogen that's also renal toxic. 

So in the liquid, we have nicotine. We have flavors. And the last thing we have are solvents. Solvents basically keep everything together. The two most common ones are propylene glycol and glycerine. And if you read about these things, they are Generally Recognized As Safe, or GRAS, by the FDA, which makes some people feel OK about it. 

But the FDA indication for GRAS is largely due to things that are eaten and not inhaled. And so nobody really knows the long-term safety of these solvents. And there's emerging data to show that if you heat these solvents up, the degradation products can be toxic. 

So if you heat up propylene glycol, you can end up with things like formaldehyde, which is a carcinogen. And if you heat up glycerine, you can end up with acrolein, which is an airway irritant. So that's the components of what's in most liquids. 

And I wanted to pivot a little bit and talk about vaping cannabis, which if you've read anything about the vaping-associated pulmonary illness that's come out in the last few months, a lot of it has been implicated in cannabis. And so I wanted to talk some about that. 

So cannabis or marijuana is a flour. And to get it into a liquid form to use in a vape device, you usually have to process it first-- usually involves some degree of heat, some degree of pressure to form either a hash oil, or to get the THC itself out into a liquid, or to vape CBD as well. 

It is not well studied. I'm going to talk about why that is in a second. But there's one study in JAMA from last year that compared folks who vaped cannabis to smoking cannabis. And if you vape cannabis, you have much higher levels of blood THC concentrations, greater psychomotor impairment, and greater cognitive dysfunction. 

One of the things that is attractive to young people in vaping is doing it sort of secretly or covertly. And there is something called zero vaping, which essentially is you take a puff of your vape and you try to exhale it in such a way that nobody can notice you doing it. 

So there's YouTube videos of people that will hold the whole Juul device in their hand. They'll take a puff. And they'll hold it in for a long enough period that when they breathe out, they don't breathe out any vapor. And so this is stealth vaping or zero vaping. 

And one thing that's attractive about vaping cannabis for folks who are young and don't want to be caught by their parents or their teachers is that the exhale is odorless. And so much different from-- if you were to smoke a joint, you would have a distinctive smell from smoking cannabis. 

There is one university in the country that's charged with growing all of the marijuana that can be studied with federal dollars, and that's the University of Mississippi. And so if the University of Mississippi isn't growing and processing their marijuana to have hash oil, which they aren't, then nobody using federal dollars is studying the effect of hash oil. 

And so this changed as of three weeks ago. The FDA is now realizing that this needs to be studied. And so there are 33 other institutions who have applications pending to grow, to then process it in different ways and to study the effects. And so that's one of the reasons why studying vaping cannabis is so challenging is because we're not studying all the products that people are using. 

But in addition to that, there is a huge, growing, emerging black market for cannabis vaping. I'm sure some of you all saw this article in The New York Times from last week, which was in Wisconsin. Two brothers had this huge black market industry where they had 10 or 15 employees. 

And they were producing 3,000 pods of THC per day, each of which were sold for 30 or $45 a pop. And they were buying empty cartridges either from Canada-- from Chinese factories or online on places like eBay or Alibaba. And they were filling it with THC liquid purchased in the US market. 

And one of the challenges here is with this being such a robust black market industry that people are out to make a profit, the THC liquid is expensive. They're going to cut the THC liquid with something cheaper to fill the products with. And so we're worried about what that is. 

And one of the things that's been implicated that Dr. Holstege will talk about in a moment is vitamin E acetate, which has been implicated in some of this vaping-associated pulmonary illness. So we've been taking smoking histories for decades. And we're all comfortable asking smokers about their pack year history. 

And I think something that probably no one in this room is entirely comfortable with is how to take a vaping history. And there isn't really a set guideline for how to do this yet. I'm sure one is coming. But some of the things we thought was important for us to convey to ask your patients is, what type of device are you using? And what type of liquid are you using? 

So are you putting nicotine in it? Are you putting cannabis in it? What flavors are you using? Is this something that you added after you bought it commercially? Did you get it just in a vape shop and didn't modify it at all? A lot of questions to want to know to figure out what type of potential toxic effects you could be having with this. 

And in addition to that, ask about vaping behaviors. And primarily, this is frequency of puffs. So how many times a day are you using-- are you vaping? How many puffs per session that you vape. Some people ask about how big the cloud of vape that you exhale is. 

I think it's hard to quantify that. But that's in some of the recommended guidelines. And ask about if someone is stealth or zero vaping. And now, that's important. Because if you're doing large breath holds, you're likely going to expose more of your lungs to more of these potential toxic particles. 

So I'm going to pivot next and talk some about the epidemiologic trends that are really unprecedented in e-cigarette use and talk about how it's really important for us to recognize this as health care providers. And this, again, is data from this week. And so this is data that looks at the percentage of 12th graders in each country that in the past 30 days have vaped something with nicotine in it. 

And you can see the trends are amazing. So in 2017, 11% of 12th graders were vaping. And that's as high as 27.5% this year. And so that's at least once in the past 30 days. When you look at who's using this daily, it's 12% of 12th graders in the US. 

So we are indeed creating a generation of people addicted to nicotine. And I put some data from other countries in there. But the data is much less robust in other countries. And so I'm focused primarily on the US. Here at UVA, we've also asked who's vaping. 

And we had a babysitter that was taking care of our kids last night. And I asked her about vaping. And I think she might not want to come back again, because I was kind of grilling her about whether or not she vaped or not, if anyone dabbed, which is like vaping marijuana. 

And she was not thrilled to answer that question. But when people are asked-- a lot of people that aren't asked by threatening parents will say that they are indeed vaping. And so 22% of undergrads at UVA are vaping. And folks in fraternities at a much higher percentage and much higher than those who are smoking traditional tobacco products. 

This is a CDC graph that shows what is preferred by high school students, which type of tobacco product. And you can see clearly that e-cigarettes far outpaced anything else, including cigarettes, or cigars, or hookah smoking. And so a lot of this trend is because of the rise of Juul. 

And Juuling is now a verb, meaning vaping a Juul product. And this was from a Boston Globe article earlier this year that said Juuling was maybe-- perhaps the most widespread phenomenon you've never heard of. This is a graph that's from 2018 that shows the percentage of market share for each of the major e-cigarette companies. 

And you can see Juul is the dashed line that starts out at the bottom in 2016 and is rising quickly in 2018. And I added on a publication that came out a year later that shows this trend really continued. And now, Juul is-- about 75% of the US market is people buying and vaping Juul products. So Juul is really outpacing everyone else here. 

And it's at least a big part of the trend-- an epidemiologic trend. Monitoring the Future is a organization that surveys high school students every year for the last 50 years to ask about substances and nicotine and tobacco products. And this is a quote that was in The New England Journal from folks who did this Monitoring the Future survey. 

And I'm going to just read it. "Put in historical context, the absolute increases in the prevalence of nicotine vaping among high school students between 2017 and 2018 are the largest ever recorded by Monitoring the Future in the 44 years that has continuously tracked dozens of substances." 

So this is really a striking statement about how rapid this has been taken up by high school students in the US. So why is this happening? And lots of people have asked this question. And there's many answers to the question. And this is data from the 2018 CDC Youth Tobacco Survey. 

The first reason is because it's trendy. If your friends are doing it, you're likely to do it. If your family members are doing it, you're likely to do it. The other are the flavors which we talked about, so the candy, dessert, fruit flavors are attractive to young people. 

And the third is that there's a belief that vaping is perhaps less harmful than other forms of tobacco, such as combustible cigarettes. And this survey was done before this vaping-associated pulmonary illness outbreak occurred. And so perhaps we'd get different numbers now. 

But at this point in this survey last year, 40% of people didn't even realize that they were vaping nicotine, on those who are using it, which is really astounding. So when thinking about other reasons why this happens, marketing and access clearly is a driver here. 

And so more than 3/4 of middle school and high school students have seen an e-cigarette commercial in the last month. And they're sold what seems like on every street corner. And one study found over 400 websites where you could purchase e-cigarettes, not all of which were you able to require age verification. 

And this is night and day from when I was a 16-year-old and had to run as fast as I could into the Chinese restaurant next to my parents' house to shove quarters in a vending machine as fast as I could to pull one of these knobs to grab the cigarette pack and run out before someone grabbed me. I mean, this is 400 websites where you can buy a non-age verified e-cigarette. 

I think it's really astounding. So I'm going to bring up my son, Reece, who is here today as a prop. And he does not know what question I'm about to ask him. Will you turn on your mic and make sure it works? All right. Turn around so you [AUDIO OUT] see everyone. I'm going to have Reece turn around and tell us what two cereals he sees up there. 

Cinnamon Toast Crunch. 

Talk in your mic, man. 

Cinnamon Toast Crunch. 

And? 

Froot Loops. 

Good. And do you think that these cereals are delicious or not delicious? 

Delicious. 

[LAUGHTER] 

And do you think that these cereals are mostly for kids or mostly for grown-ups? 

Mostly for kids. 

Good. And I didn't prep Reece on either of that. Thank you, man. You can turn your mic off and sit back down. 

[APPLAUSE] 

So those aren't cereals, right? So those look exactly like e-cigarette products. And it's clear that these are marketed to children. And if Reece is seven-- if in five years, he had to go into a big store and pick a product, I mean, there's no question that children are going to be the ones who are going after these products. 

And so this is part of the marketing that's been done by these companies, but it's much more sophisticated than that. And on social media, which largely engages our young and youth, the marketing campaigns involved getting social media influencers, which is something-- I didn't know what it was a year ago. 

But it's people who have hundreds of thousands of followers on Instagram who are paid to endorse products. And so this leads to young people trying to be like they're-- people they are influenced by. And you can see the trends on Twitter. Like the hashtag #juuling has exploded in the last couple years, mostly because of marketing campaigns that are designed to target young and youth. 

Isn't Juul owned by Altria Worldwide? 

Yeah. So a third of the company was bought for something like $15 billion. I mean, it's like a huge industry. So it's not just a problem of youth. There's almost 11 million US adults who use e-cigarettes. You can see the age breakdown here. It's largely in younger folks. But clearly, there are people in their 60s, 70s, 80s who are vaping. 

And I also wanted to touch on the cannabis vaping epidemiology. With the rise in nicotine vaping, there's been a parallel rise in cannabis vaping. The most recent study came out in North Carolina where they found about 10% of high school students had vaped cannabis in the past month, which is a lot. 

And you can see at the bottom bullet point-- 10th graders in the US. The trends in 2017-- 9% had vaped cannabis in the past month. And in 2018, 14% had vaped cannabis. So next, I'm going to touch briefly about toxicity before I turn it over to Chris. 

But I wanted to start off by mentioning a few things. One is that we know combustible cigarettes kill people. Everyone in this room knows that. There's tons of ingredients, tons of toxic chemicals, carcinogens, carbon monoxide, tar. We know that. What is also perhaps less well known is that long-term cigarette smoke is more toxic than e-cigarette aerosols. 

And there's lots of studies that look at this. And so this is a graph that shows the ratio between combustible or traditional cigarettes and e-cigarettes. And you can see there is nine times more formaldehyde in emissions from a combustible cigarette compared to an e-cigarette. 

And there's 450 times more acetaldehyde in combustible cigarettes compared to a e-cigarette and so on. And so I think there's no doubt that the long-term effects of smoking are terrible, putting aside this vaping-associated pulmonary illness, which Chris will talk about in a second. 

But because of that data, there are many countries, including and most importantly the UK, that think electronic cigarettes could be a harm reduction tool that could be useful in smoking cessation. And their statements from the Royal College of Physicians, which is the UK-- they say things like e-cigarettes appear to be effective when used by smokers as an aide to quit smoking. 

And you can be a doctor and write a prescription for e-cigarettes in the UK, which you certainly can't do here. The ATS has responded to this statement in a letter to Congress a couple years ago, which basically cites what still is the case today, that there's really little data that supports e-cigarettes for smoking cessation. The studies that are out there are small with lots of methodologic flaws. 

And some trials even show no benefit. And so there's not been much of a push to encourage e-cigarette use as a smoking cessation project program here. The Royal College of Physicians also says things like the health-- the hazards to health arising from vapor inhalation from e-cigarettes is unlikely to exceed 5% of the harm from smoking tobacco. 

And phrased another way, e-cigarettes are 95% safer than regular cigarettes, which is something that lots of people cite when they talk about why they're vaping. And it's important to know that this statement was based entirely on expert opinion, not based on data. 

And since this expert opinion came out, which was 2014, there's been a whole slew of evidence, including this vaping-associated pulmonary illness, which sort of makes us think that perhaps this is not as safe as we once thought it was, especially with the rise in youth epidemic of using these products, which we now see. 

So clearly, long-term smoke is much more toxic than e-cigarette aerosol over the long term. But that doesn't mean that e-cigarettes are a healthy choice. And with that, I wanted to turn it over to Chris. And he'll focus on the toxic effects of these products. 

[APPLAUSE] 

Slides are-- great. I'm going to be brief, because I want to give time for Brian. It's a complex topic right now. So it's not just the chemicals that we're finding in these products. And there's a tremendous variety of chemicals that are being found in. 

There's the products of combustion, too, as these products are being heated. I think that's what's really challenging for us as we're looking at this and as we're seeing this outbreak right now. I appreciate Drew and Brian inviting me on to come speak. And just realize, as you saw in the epidemiologic data, the risk to our youth is tremendous right now. 

Moving forward, the data's pretty damning as things-- as we're seeing this explosion. If you look at the lung illnesses right now, this is growing, as you know, in leaps and bounds-- 380 cases, 6 deaths that now have gone to 8 deaths and over 500 cases. The case definition is here-- vaping and dabbing during the 90 days before symptom onset. 

Chest infiltrate, absence of infection on initial work-up, no evidence of alternative causes, cardiac rheumatologic, et cetera. If you look at some of the things that have been reported out there, some of the original reports-- median age around 19 years of age, which isn't a surprise, right? 

Based on the epidemiologic data on who's using this right now, 32% are less than 18 years of age, 83% are Caucasian and rare for them to have other illnesses such as asthma. And there's not a geographic clustering, which is interesting. Because even right now, we're seeing some outbreaks in some other areas where people are making substances with geographic clustering. 

For those of you haven't heard, there's a V8 product right now. It's a male enhancer that's causing hypoglycemia. Because it's someone in their van that's making this, going to stores and actually selling this to them, not knowing that there's actually sulfonylureas in that product. So there's some interesting things that are ongoing right now. 

If you look at what are in some of these products, certainly nicotine, which we know the youth doesn't realize. And that's going to be problematic for the developing brain. If you look at some of the other products that are out there, where they're looking at marijuana products and what has marijuana in, there's a combination of products. 

And then we also have CBD oil. And Michelle Peace did some work at VCU, pulling the CBD oils off the market and actually found that they had dextromethorphan in it-- had synthetic cannabinoids in them as well as other chemicals. So all bets are off, even if they state what they are taking. 

If you look at some of the data that's out there in regards to some of the cohorts and how they're presenting, this gives you a little breakdown of what their presenting signs and symptoms are. Not common are rhinorrhea, sneezing, congestion. Certainly, their vital signs are showing that they're in distress. 

They are having leukocytosis-- but these are all non-specific, and that's why it's hard to pick up these cases-- as well as some nausea, vomiting, and then bilateral infiltrates, which you'd expect if there's a toxin or something that's being inhaled and affecting both lungs. Just some of the things that have been reported out there from 19 cases. 

And from Henry's study in The New England Journal of Medicine was some of the patterns on CT scan and other imaging. But certainly, giant cell interstitial pneumonitis has been talked about in these cases. At the University of Virginia-- and, Drew, you can probably attest to this a bit, too, on what cases have been here. And any comments on this? 

Yeah. So I surveyed, informally, the pulmonary faculty here. And a bunch of people replied. And if we followed just the actual case definitions for the CDC, we really have two patients that met the case definition. One was Dr. Sturek, who's in the back, who had a case in 2017. 

It was kind of before this real epidemic started. And the second case was this summer of someone who added CBD oil to their Juul products, somehow figured out how to get the oil into this already pre-packaged product. A couple other patients maybe met the case definition. 

One is now a patient who has not had an infection work-up, which is part of that case definition. And the second one had a bunch of confounding illnesses like a bacterial pneumonia. So it's hard to know for sure. But I think now that we all have our eyes open for this, we're probably going to diagnose it more. 

And part of it is also looking back retrospectively on some of these cases, too, as people are starting to realize that maybe some of the cases they've had in the past are actually related to the vaping. And I find even with some of the clinicians that I'm working with, it's not something that's on the screening tools, right? 

As you're looking at it with vaping being one. [INAUDIBLE] having to look at lipid-laden macrophages, which gets interesting in some of those chemicals that are being used out there. It gives you a little bit of a breakdown on what percentages are out there in regards to Oil Red O staining not attributed to exogenous lipoid material aspiration. 

None had low attenuation infiltrates on [INAUDIBLE] scan-- looks clinical. Significance wasn't clear on these cases. The big question was vitamin E acetate is to blame. So this is the one thing that was linked to the cases that were being reported. They found 10 of the 18 THC samples tested by the FDA. 

And nearly all the THC products tested by the New York State Health Department lab had vitamin E acetate in. The question is, what role was this playing? Not found in any of the nicotine products used by those with it. And so it gets interesting. They're starting to hone in on different potential sources that are out there, but it's not clear. 

It also gets confusing, because the question also comes. What about the products of combustion? What is the heat that is occurring with these products? And what is being formed from these? Flavorings, oils, contaminants. As Drew did a nice job of presenting, a lot of the people who are out there right now-- the youth 

think these just have flavorings-- don't even realize that there's nicotine that's in them. 

Or is it a combination that's causing this? But when you're getting those flavorings, what happens when those get heated? And what is being formed? And that's being studied right now. And then the surveillance systems are well established. 

And what you may not know is certainly the state is following this very closely. Michelle Peace, and others, and the forensics units, and the Division of Consolidated Labs are following this and pulling products from the market to try and see if there's consistencies with them as we were looking for cases. 

And we actually are having weekly meetings on this currently with Virginia Department of Health. And the surveillance systems are actually being enhanced in that rate. And I think that's also going to find more of these cases and also a better look at some of these products with wrapper detection. 

So CDC is recommending clinicians to report cases of it as quickly as possible. And that's part of the reason why we're here today. The other thing that comes up is certainly you have injury from explosion. And I appreciate Drew putting this slide in, who did a lot of work on these slides. 

But realize that there has also been other problems that have not been anticipated from these vaping devices that aren't always just lung related. With all these flavors-- again, lots of flavors that are out there, some of which are toxic. And there's certainly an epidemiologic crisis for our youth right now. 

You think the University Virginia students. And why is a toxicologist working with University of Virginia students? It's because of these issues right now. We have epidemiologists who are following with them. But to have 21% of them the last month using these products is a pretty amazing number. 

And it's really a question. Is it just the youth? And it's not. And we certainly know it's the adults, too. And so this is going to be a challenging time for us with trying to sort this out. And this isn't the end of it right now with all the chemicals that we're seeing. And the people are making their own homemade solutions, too. So with that, Brian. 

Thank you. So I'm Gary Ewart. I'm staff for the American Thoracic Society. Just as a quick background, the American Thoracic Society is a medical professional organization of about 15,000 members dedicated to prevention, treatment, cure of respiratory illness, critical care, injury, and sleep disorder methods. 

In the interest of time, I'm just going to blow through these slides. I am a lobbyist. So I've been working on policy issues for about 25 years and been working around the e-cigarette issue for probably last seven or eight years. So my goal today is to talk to you about what's going on. 

So let's start with where it kind of started. In 1994, during the Clinton administration, then David Kessler, the commissioner of FDA, proposed a rule that would regulate all tobacco products as medical devices. It was the findings at the time that the industry had-- knew of the pharmacological effects of nicotine and had manipulated them, which in the opinion of Dr. Kessler meant the standard of medical device. 

That was challenged in court in 1996. The court said only Congress has the power to-- has to expressly give that authority to FDA. FDA cannot assume that power. Fast forward over a decade. Congress in 2009 passes the Family Smoking Prevention and Tobacco Control Act. 

That gives FDA the authority to regulate tobacco products. What are those authorities? Granted immediately to FDA was the authority to regulate all cigarettes, including the manufacture, ingredients, nicotine levels, marketing, advertising, labeling, any health claims. 

The legislation immediately banned all flavored cigarettes except for menthol. It also established a timeline for FDA to issue graphic warning labels for cigarettes. It banned terms such as low, and light, and low tar. And it gave the FDA authority to deem their authority over other tobacco products via the issue of a regulation. 

Also in the legislation was an important date-- February 15, 2007. Any product that was on the market prior to that date was considered a grandfathered product. Any new product entering the market after that date either had to prove that it was substantially equivalent to a product that was already on the market or it was considered a new product and would have to go through FDA's review as a new product. 

And these new products would only be approved by FDA if their entrance into the market would improve public health. There were some limits in this legislation. FDA cannot ban tobacco products. FDA can limit the nicotine content, but it cannot reduce it or require it to be reduced to zero. 

FDA cannot raise the federal age of purchase of tobacco products. And while this wasn't addressed in legislation, only Congress has the power to raise federal excise taxes. So FDA does not have that power. So fast forward. We're going back in 2009. So FDA just has this authority. And e-cigarette starts to enter the market. 

So at the time, two companies, Smoking Everywhere and NJOY e-cigarettes, were importing these products from China. FDA claimed that these are medical products. The e-cigarettes are medical devices and said that FDA has the authority to regulate these as medical devices and therefore take action to block their importation. 

Understandably, the e-cigarettes industry took FDA to court. In the case Sottera versus FDA, the court said that FDA had overstepped its authority and must regulate e-cigarette products as tobacco products. They cannot be regulated as medical products. The FDA appealed that decision. 

And it was not overturned. So the court of appeals has affirmed that all e-cigarettes must be regulated as tobacco products. So we jump from 2009 to 2016. After several years, FDA finally issues a rule that says, we now exert our authority to regulate all other tobacco products beyond cigarettes. 

So FDA can now regulate e-cigarettes, hookahs, cigars, smokeless, and any novel nicotine product that is put out by the industry and further establishes a deadline that of August 2018, that any product that-- every tobacco product has to do one of three things. 

One, prove that they were on the market prior to February 15, 2007. Two, if they weren't-- can't prove that, they have to prove that they are substantially equivalent to one of those products that was on the market. And if they can't meet either of those thresholds, then they have to submit a PMTA, which is a Premarket Tobacco Application. 

So that is a review process vaguely similar to a drug review process. Not unexpectedly, the industry filed several lawsuits, both the cigar industry saying they shouldn't be covered, the traditional cigar or hand-rolled cigars saying they shouldn't be covered. 

And the e-cigarette saying that FDA exerted its authority. All these cases are still under review. But I think it highly likely that the courts will support FDA's authority to regulate these products. If you may recall in one of the opening slides that Dr. Harris provided, there was a-- the views expressed are mine and not necessarily the ATS. 

And that's largely because of this single slide. So there's a picture of former Commissioner Scott Gottlieb. I intentionally chose a picture that looks vaguely like a Bond villain. Because if there is one person who I think is responsible or partially responsible for the mess we're in, it's Dr. Gottlieb. 

So Dr. Gottlieb-- in addition to being a physician prior to becoming the commissioner of FDA, served on the board of Kure, a vape company. And there's a little quote from them, where they believe that Kure's mission was to bring the passion-- or excuse me-- the passion and art of vaping to everyday consumer. 

So he was on the board in 2016, still had financial interests in this company in 2017 when he was nominated for the position of commissioner of FDA. So what did he do as commissioner of FDA? You may recall from the earlier slide, August 2018, all companies had to submit review of their products to FDA. Scott Gottlieb in 2017 extended those deadlines for e-cigarette products from August 2018 to August 2022. 

He made a similar extension of August 18 to August 21 for cigar products. It was believed or stated by Dr. Gottlieb at the time. This additional time was needed by both FDA to establish the standards at which these products would be reviewed and for the companies to collect the information they needed to meet the FDA scrutiny for these products. 

I would say a skeptical thinker, me, would say this delay was intentionally used by the industry to further expand their market share. In 2018, Dr. Gottlieb and FDA issued three advance notice of proposed rule-making. Now, I'm going to sort of geek out on policy stuff. 

Advance notice of proposed rule-making is essentially a trial balloon. It is not an actual proposed rule. It is often used as a way to delay action on important issues by saying, here's what we're thinking about. There were three advance notice of proposed rule-making. 

One, to create a low nicotine cigarette proposal. The second, whether we should regulate cigars at all. And the third was, how should we regulate flavors? Now, the regulation of cigars and the regulation of tobacco flavors had already been largely addressed in the 2016 Deeming Rule that was issued during the Obama administration. 

The [AUDIO OUT] nicotine cigarette proposal is probably worth its own entire presentation. But I'll say one thing. If you create low nicotine cigarettes and there are nicotine addicted people who are looking for nicotine, what's the product they're going to migrate to? E-cigarettes. 

So things start to go wrong. So last year, November 2018, data shows a 70% increase in youth e-cigarette use. Now, a little context is necessary in that, in that in 2015 to 2016, there actually was a substantial drop. And then 2016 to 2017 showed a small increase. 

So I believe a charitable view of this data could be that the FDA felt the problem really wasn't growing. And we're sort of surprised when this data came out in 2018. Once this data is out, obviously, FDA has a problem they have to respond to. 

Dr. Gottlieb announces the following proposals that they intend to move forward with, accelerating the e-cigarette review date by one year. So we went from 2018 to 2022 to 2021, limiting the sales of e-cigarette flavored products, except menthol and mint to online only and only allowing brick-and-mortar sales of mint and menthol. 

The exclusion of mint and menthol was to allow adult smokers who are looking for switching products to still have a product that they are familiar with. He was going to create enhanced verification for online sales of all the other products and would also-- announced his intent to move forward with a ban of menthol cigarettes and a ban of most candy flavored cigars. 

What was interesting, though-- this was essentially a press release and was never followed up with a specific-- either guidance or proposed rule. And then in March in 2019, Dr. Gottlieb resigns as commissioner of FDA. Simultaneous to the announcement of the delay on this, the ATS and the American Academy of Pediatrics sued FDA for what we felt was their inappropriate and illegal delay of these review deadlines. 

Initially, the court felt that FDA was going to be responsive and put this case in abeyance. And then a couple months ago, changed their mind and actually agreed with the American Academy of Pediatrics and accelerated by one additional year the deadlines that FDA has to meet for these review of these cigarette products. 

And then more things go wrong. And that's kind of where we are today. So as Dr. Harris mentioned earlier, this has been a somewhat frustrating slide deck to put together. Because it's only a slight exaggeration to say every time I go to The Washington Post or to the website, there's-- new data are making me update this slide. 

So this is a very fast-moving topic. So we're at about over 500 cases of CDC confirmed vape-associated pulmonary injury. Seven, now eight confirmed deaths. And we have our first confirmed death in Canada. So what has been the response? So on September 11, the Trump administration issued that they going to take action on this. 

And they said they are going to clear the market of flavored cigarettes. Secretary of HHS Alex Azar said-- thanks the president for his unqualified support of this critical public health initiative. And while they said it would take several weeks for them to issue guidance on this, they expect there to be a 30-day effective date, and that these products would be off the market. 

Kind of sounds like a ban, right? Well, clearing the market is not really a regulatory phrase or a legal phrase. There's a little bit of wiggle room in there. And then two days later, the president issues a statement that could be perceived as money in the water in saying, "While I like vaping alternative to cigarettes, we need to make sure this alternative is safe for all. Let's get the counterfeits off the market and keep young children from vaping." 

I don't want to read too much into that. But most of the discussion up to this really hadn't focused around counterfeits. It had been just on the generic product itself and the role that marijuana additives may have played in this. So I am curious to see how this moves forward and whether the policy is evolving to go from the broader ban that seemed to be expressed by the administration to something more targeted. 

I've spoke with several colleagues who said that this is just Trump's attempt to pacify the e-cigarette market, and that we shouldn't read too much into this. We'll see. So what is the American Thoracic Society position on e-cigarettes? ATS believes strongly and has articulated for seven, eight years now. The FDA should ban characterizing flavors in all cigarettes. 

If FDA chooses not to ban these flavors, all flavors should have to go through a pre-market testing with a special attention on those flavorings that have either known or suspected toxicity. There should be full disclosure of e-cigarette ingredients, require graphic warning labels on e-cigarette products, regulation of the explicit and implied health claims related to e-cigarette products, regulation of the nicotine level in e-cigarette products. 

And again, separate from FDA's authority, we should equalize the taxes on e-cigarettes, similar to e-cigarettes. There's a huge discrepancy in both federal and state excise taxes compared to combustible cigarettes and e-cigarettes. So what's next? In the coming weeks, we expect that the FDA will issue final guidance on how they are going to implement the 2016 Deeming Rule, and that it will remove non-tobacco flavored products from the US market. 

And after this is issued, it'll have a 30-day effective date. And it will require all e-cigarette products to submit their products for review by FDA. HHS Secretary Alex Azar has also said if they see a migration of kids from flavored products to tobacco flavored products, FDA may take further action. 

And we may see further issues of rules from FDA on the regulation and sales of these products. Just yesterday, The Washington Post reported that FDA is opening a criminal investigation into the supply chain of development of e-cigarette refillables. Now, what's important to note in this is that this may temporarily remove flavors from the market. 

But it does leave the possibility that FDA could review and approve future products that have flavorings. So as you're thinking about this, I would encourage you not to think of this as a ban, as more of a temporary removal and potentially a door being still open at FDA to have flavored e-cigarette products on the market. So what's the industry response? 

Predictably, the industry is very concerned. Juul has stated very public that they are going to fight to preserve at least mint and menthol flavors. The Vape Association was on Capitol Hill just this week to try to essentially urge a quid pro quo will support Tobacco 21 universal purchase on all tobacco products as federal legislation if you don't go after flavored products. 

I'm sure they weren't quite as crassly making that statement as I just did, but that's essentially the message they're getting out there. The small business community has also been reaching out heavily to the administration, telling them, don't do this. And whatever FDA does-- good, bad, or otherwise, we know it'll be challenged in court. 

So what will likely be challenged in court? Does anyone know what a tobacco flavored e-cigarette product really is? We're so far removed when we get to an e-cigarette that the leaf almost doesn't exist anymore. How can you define and how can you enforce what a tobacco flavored product is? The flip side of that is true. What is a characterizing flavor? 

In sort of layman's terms, that means you put enough cherry flavoring in the product that it tastes like cherry. What happens if you sort of scale back the flavor and then it no longer is identifiably tastes as cherry, but it still has a smooth taste or pleasant taste? Those are issues that I guarantee will be tried to be addressed by FDA and will be challenged in court. 

So if you believe e-cigarettes are products, and are a problem, and should be acted on, what can you do? Well, first, contact your member of Congress and tell them to do nothing. We are very aware that Congress may enact legislation that will either slow, weaken, or delay FDA's response. So that would be step one. 

Step two, congratulate the White House for their announcement of doing something on this and encourage them to follow through their activity. I would also encourage you-- for those who are in social media-- to state your strong support for FDA's need to act decisively and quickly on this issue. 

And then there are a couple other things that are moving on-- you might want to consider. There are two open rules out there. One is a list of potentially hazardous substances in tobacco products that FDA is seeking public comment on through October 4. 

Currently missing from that list are a lot of the flavoring agents that have known or suspected respiratory toxicity. The ATS will be commenting on this, but this is a bit of a volume game. So if there's a large number of comments from the community, that will have impact with the FDA as well. 

FDA also has open for public comment the graphic warning label on combustible cigarette products. And that comment period closes October 15. So about near the end of my presentation. Things I could have spoken about, but didn't and would be happy to answer any questions on-- why are menthol cigarettes still on the market? 

Why are candy flavored cigars still on the market? How does the interaction between the Tobacco 21 bill and the e-cigarette impact the state of play now? And what is the correct ICD-10-CM code for e-cigarettes? Anyone have a guess on that? We can get to that in questions. So with that, I thank you for your attention-- would happily take any questions. 

[APPLAUSE] 

If you have a question, please wait for a microphone, so all can hear. Any questions? 

Question on the policy side of things. How are the e-cigarette companies getting around the tobacco legislation on advertising? I'm seeing on TV-- e-cigarette advertisements. And I thought kind of regular cigarette advertising was banned. 

It is not legally banned. There is essentially an agreement between the federal government in the US that the tobacco industry would not-- or pardon me. You are correct. There is legislation that made that. But it was specific to combustible tobacco products. The e-cigarette industry believes that they are different from this. There's been a long argument in the tobacco control community on whether we take the e-cigarette industry to court over what we believe is a violation of the spirit of this legislation. 

The challenge we have is the court has migrated in their belief in corporate rights significantly, that we're afraid if we were to challenge this in court, we would lose. And not only lose e-cigarettes, but it would open up the door for other tobacco products to advertise on TV. So we're aware of it. We're concerned by it. But we are fearful that if we go that route, we'll have more to lose than to gain. 

Thank you. 

Hi, there. So I just want to have a quick question, is that there's three different issues going on. I said on number one, we're still accumulating data on patients as to what's the long-term effect. And eventually, the original tobacco litigation in the '60s and '70s-- there's always this counter-science that's continually pushing back. 

And there was a lot of debate and the fight for about 15, 20 years to get that pushed through in a finishing line. So question number one is that I think what we're experiencing is that this device that you can put whatever you want to put in. And people are starting to put these things in there. And that's causing these issues. 

And we have to somehow present it in a very convincing way that the device itself is a risk. Not just what's in it, but the device is available as a freestanding-- something to deliver a toxic material. So in that aspect, Philip Morris and Altria has been making that heat, not burn. So all this previous one is heat and combustible. So we're talking about all those things [INAUDIBLE] and all this happening that's toxic. 

[INAUDIBLE] family as well as patient herself. 

But that was not me. 

Just issues of going to hospice in the next few days after her visit to [INAUDIBLE] in North Carolina. 

So do you know in terms of the ATS? And so I know the FDA just approved that device like three months ago. 

It is the first product to go through the pre-market-- 

In US? 

Yes. 

So I know for sure that Philip Morris and Altria is going to start saying that while now we have just heat, it's not combusted, so it's much safer. So none of these is going to happen. It's going to come out from their side, I think. Because they've been trying to build that up for some time in Europe. So do we have any like-- considered [INAUDIBLE] to how to counter these? 

There's going to be counter-science and false sciences coming out of this. And how do we-- because they're going to continue this R&D. And that has been a problematic aspect of this dealing with the tobacco industry early on. So any of-- that it's happening at a national level? 

So I agree with you. We should always be concerned about the next step of the tobacco industry. And IQOS is clearly one of the next steps the tobacco industry is looking at. However, I think in the grand scheme of thing, getting FDA to actually use the regulatory authority that they have over all products is the best first step. 

So what has been frustrating for me, and it was probably obvious in the presentation, the ATS both worked hard as did many public health organizations. So I don't want to pretend this was just the ATS effort. But we worked hard to get the initial legislation passed in 2009. 

We hammered FDA hard to actually get them to deem authority over all tobacco products. We've actually been involved in the court cases trying to prevent the court from scaling back that authority. And in the case of e-cigarettes and cigars, FDA has yet to effectively use that authority. 

And that's largely why we're in this situation right now. So I agree with you. We need to be worried about IQOS. But the most effective way to get IQOS addressed is to have FDA effectively using their authority over a wide range of tobacco products, which will include IQOS. So we're focused on that right now. 

A little curious about states where marijuana is legal and a lot of marijuana [AUDIO OUT] I guess that's still referred to. [AUDIO OUT] 

Short answer is I don't know. Obviously, there's sort of counter-trends going on where I think the American public is very concerned about e-cigarettes and the impact it's having on our youth, while at the same time, it's taking a more embracing, liberalizing attitude towards marijuana use. How these two trends are going to intersect-- anyone's guess right now. 

I have a question-- more at home question with UVA. I was impressed by the numbers of our undergrads who are using vaping and e-cigarettes with 20% in the general population, but even higher to 50% in the fraternity population. How are you counseling that group in particular to lower their e-cigarette use? 

Because it seems like a big part of this message is we understand that there is a potential for harm based on the cases nationally. But counseling the youth population of a potential for harm doesn't tend to change behavior very well. And so I'm more interested in, what particular approach are you taking? 

So very challenging right now, right? If you look at the data that occurred in 1940s with tobacco-- cigarettes-- very similar to what we're seeing right now, right? A huge explosion of use-- youth. It's also a weird conundrum. Because you have youth that are really worried about chemicals in the environment, what they're eating and such, yet they have no problem with vaping. 

So trying to educate them is going to be a challenge. The collegiate students-- and part of the reason for the epidemiologic data-- you're seeing from Monitoring the Future, the University of Michigan study. That's been going on for a long time. We're actually inheriting this here, right? 

There are about 21-- over 20. That's around 25% now-- high school seniors. Ours is similar. And then the question is, how do you educate that actually there may be harm when the data is still not there for the long term or short term? This is the first time we've got the attention of them, because of the short-term or the acute lung injury. 

And that's getting out by the Office of Health Promotion. And all the universities are doing that. I talked to the School Nurse Association for the state. They're desperate for help in this, because it's so prevalent in the high schools. And how do they educate on this? 

One other thought, too. Just as we're talking about the regulatory, we're having challenges also in the toxicology realm. The United Nations Office of Drug and Crime five years ago said for the first time in its history since the 1960s, they've completely lost control of the drug trade, because it's a world market, right? 

These chemicals are coming in under other brand names. And the internet-- they're talking to each other as to what they're trying to get. So it's going to be a really interesting history of regulation. How much can we control some of these products and as we have the legalization of marijuana, too? 

Because it may say, for example, CBD oils, as I alluded to with Michelle Peace. But what's in it is completely something different. So these students think they're informed. They think they know what they're getting when, in fact, they have no idea what they're putting in their bodies-- the chemicals and things. 

That's why this investigation is so difficult trying to track down, because people are making these fluids up. And so it's really a challenging time for us and looking at closely, too, that we're going to be seeing epidemiologic-- it's just a really interesting time in the toxicology realm. It's going to be full of challenges. 

I would say from a policy point of view, alluding to what Dr. Harris mentioned, is there are no FDA-approved treatments for nicotine cessation in adolescence. So one of the policy steps we need to take in addition to getting FDA to move more aggressively on regulation of e-cigarettes-- we also need to work more aggressively with both the research community and FDA to develop and prove more effective smoking cessation or nicotine cessation products across all age groups, but with a special focus on the adolescent market. 

Thank you all so much for being here.