Welcome. My name is Jamie Mancuso. I'm the moderator for this session entitled Combating the Youth Vaping Epidemic. I'm going to start with the learning objectives for today's session listed on the slide here. After a few minutes introducing the session and our distinguished speakers, the bulk of the session, around 45 minutes, will consist of remarks from all three presenters. During this time, we'll invite you to comment or ask questions in the chat. We'll then turn to the chat and hold an open conversation with the audience for about 15 minutes, or as much as time allows. I'll then wrap up with a few closing comments before we adjourn. I'll introduce all three presenters now. First up is Dr. Brenna Van Frank, Senior Medical Officer in the Office on Smoking and Health at the CDC. Next is Dr. Amoye Emoisali, a Lieutenant Commander in the United States Public Health Service. She's a medical officer in the medical branch of the Division of Individual Health Sciences within the Office of the Science, Center for Tobacco Products at FDA. And third and final presenter is Ms. Allison Kulas, a Campaign Manager for the FDA Center for Tobacco Products, The Real Cost Ends Campaign. Our plan is for each presenter to speak for about 10 to 20 minutes each, and then to hold an open discussion around your responses and questions for about 15 minutes. Now, please join me in welcoming Dr. Van Frank to the stage. Hi, and welcome. I hope that you're enjoying the conference so far, and I'm really happy to welcome you to this session. Apologies for the brief delay. We've had some technical difficulties behind scenes, and so we're getting our PowerPoints all lined up. But as that PowerPoint presentation is loading, my job is really today to kick things off a bit by getting everybody up to speed on the what, the who, and the why of e-cigarette use. We're going to start off with the what, and then move to who. There we go. Then move to who, and then we're going to talk about impact, and then wrap up with some implications and actions. So, what is an e-cigarette exactly? I think it's really important when we talk about these products to understand that not all e-cigarettes are the same. It's a really large and diverse class of products, and when you're talking about the products, you really need to understand two main things. First, the device and what that device is, and second, what's in the device. So, let's start with the device itself. This is the basic anatomy of an e-cigarette. It's pretty consistent across the product class. Each of these products generally has a power source, which is sometimes rechargeable and sometimes not, a heating element, which converts the liquid into an aerosol, and then a cartridge or a pod or a tank, some space in there where the liquid is held while it's being aerosolized. So, there's four different generations of e-cigarette devices. The first generation of products, which you see on the far left, really came into the U.S. market in about 2007. They're also called cig-a-likes, and that's because they're like a cigarette in shape and feel and disposability. So, they're intended to be used once and then just thrown away. The second generation products are also called pens. They have a rechargeable battery, and they're refillable. So, you buy a cartridge, and then you can put that cartridge in the pen. Third generation products are also called tanks or mods because they have a tank system that can be refilled with a separately purchased e-liquid or something that you make, and it also is modifiable. So, hence the mod piece. The device can be taken apart, and then the elements inside modify to do things like, for example, increase the voltage on the heating element, which increases the temperature at which the liquid is aerosolized, which can actually change the back-end chemistry of what happens when things are aerosolized, which can have some health implications. Fourth generation products are also called pod mods. These devices can look like everyday items, USB drives, highlighters. I think I saw one once that looked like a cartoon character. They are filled with a pod, a cartridge, or a refill solution, and they may or may not be modifiable. You may be most familiar with this generation because the first of the fourth generation on the market was Juul. It's not the only one anymore. There are a lot of Juul cousins, essentially, and so lots of different versions of this device. The other thing to know about fourth generation products is that the nicotine formulation they contain is called a nicotine salt. It's different than the nicotine formulation in other generations, and we'll talk more about that in just a second. You know more about devices now. Let's talk about what can these devices contain. I think the important thing to realize is that most e-cigarette products sold contain nicotine. I'm showing you 2015 sales data here, but this analysis was redone with 2017 sales data with really similar results. I think this is really important to understand, especially when we're talking about youth use, is because kids don't generally get this. They don't necessarily understand there is nicotine in the device that they're using, and they might think that they're really only using liquid flavor. Now, the nicotine content becomes really important when we're talking about youth use because of health implications of nicotine, which we'll talk about in a little bit. Okay, so I alluded to this earlier, but the new player in the market is nicotine salt. This came in around 2017 to the market, and it's contained in fourth generation devices like Juul and Sweren, but it's also becoming more and more prevalent in the general marketplace. To understand nicotine salt, I need you to sort of harken back to high school chemistry and the pH scale. The nicotine in cigarettes and in earlier generations of e-cigarettes is freebase nicotine. Freebase formulations increase the rapid penetration into the central nervous system, but that rapid penetration comes at a cost. Freebase nicotine is harsh. It has a really basic pH, and it hurts going in. What nicotine salt does is you take freebase nicotine and you add benzoic acid to it, and that pulls the pH down. This makes the formulation less harsh, which makes it easier for high levels of nicotine to be inhaled without pain and more easily. Honestly, that sort of combination of high levels of nicotine that don't hurt going in, for a kid that's naive to nicotine, is like the perfect bad package and can set you up for addiction. Of course, e-cigarette devices don't only contain nicotine. Nicotine e-liquid is a mixture of a variety of different substances that includes humectants for aerosolization, some flavorants. E-liquids can also be cannabinoid-based. There are cannabinoid e-liquids that can contain CBD or THC or sometimes synthetic cannabinoids. I think it's important to understand that because we have more and more data now that shows that marijuana use in e-cigarettes in youth has been increasing in recent years. Then there's also evidence that e-cigarettes can be hacked or modified to deliver illicit drugs, including synthetic cannabinoids, meth, ecstasy, cocaine, heroin, fentanyl, and a variety of other substances. All right. Now you know the what. Let's talk about the who. Since our focus today is on youth, let's start with this. In 2018, youth e-cigarette use was rising high enough and fast enough that the US Surgeon General declared an epidemic and called for immediate action to protect the health of the nation's young people. This is the data that spurred that call for action. You can see here in the red line, the prevalence trend over time for high school student current use of e-cigarettes was just taking off between 2017 and 2018 and then into 2019. You can also see that in 2020, we're actually seeing a statistically significant decline in the use of both e-cigarettes, any tobacco use, and then cigars and smokeless tobacco. Good news, but the numbers are still incredibly high. About one in five high school students reported current e-cigarette use in 2020. Those who currently use, about 40 percent are using them daily or nearly daily. Then you can see here that the middle school prevalence patterns are similar, albeit somewhat lower for products across the board. What are they using? I told you that device type is important to understand. Primarily, they're using fourth generation products, those pre-filled pods and cartridges, the ones that have nicotine salt in them. You can see that there's a shifting happening. Between 2019 in the light blue bar and 2020 in the dark blue bar, there's this large surge in the use of disposable products, almost a thousand percent increase among high school students. While Juul and its cousins are still the most common device type that's being used among kids, we're starting to see some shifts in product use behaviors. We've talked about what, and we've talked about who, but why? Why are kids using these products? There's really three key factors to consider when we're talking about youth initiation. Advertising, flavors, and nicotine. As a metaphor, advertising leads the horse to water, flavors get it to drink, and then nicotine keeps it coming back for more. We've talked about the nicotine piece a bit, and we're going to revisit that again, but let's talk about the other two elements first. First, advertising. Nearly 70% of students report exposure to e-cigarette advertising, and they're seeing these ads in all kinds of places. Retail has the largest presence, followed closely by internet, and then print media, and then even TV and streaming services. They're being exposed to these products. As far as flavors go, most youth who say they use e-cigarettes report using some kind of flavored product. That prevalence has increased in recent years, and you can see that it's high in both high school and middle school students. The most commonly used flavors are fruit, mint, menthol, and candy, so all really kid-friendly flavors. You know about what, and you know about who, and you know a little bit about why, so let's talk about the so what. I think it's important when we have conversations about e-cigarettes to acknowledge that there is a lot of current debate about e-cigarettes, about their potential benefits, the potential harms, the public health impact of the products, and we could have honestly a whole extra hour, hour and a half on that topic by itself. It's also important to acknowledge that the science here regarding the long-term health effects of these products is really still unmasking, but since we're really here today to talk about youth and e-cigarettes, let's focus specifically on that. I think that everyone would agree that no youth should initiate tobacco use because there's no safe tobacco product. They all carry a risk, so let's talk about what those risks are for kids, and we'll start with nicotine. So I had mentioned before, you know, nicotine is really important when we're talking about youth use of tobacco products, and ultimately that's because nicotine is not a harmless substance. Nicotine poses unique dangers to young people. It can harm the brain development, which we know continues until about the age of 25 through all of that prefrontal cortex myelination, and we know that nicotine can harm the parts of the brain that control attention, learning, mood, impulse control, and nicotine can also prime the adolescent brain for addiction to other substances. There's also substantial evidence that e-cigarette use in youth and young adults increases the risk of using combustible cigarettes. Of course, we all know the health consequences of combustible cigarettes, and so that poses a danger as well. In addition to the nicotine, there's also a variety of chemical constituents in the e-cigarette aerosol, so there's constituents in the liquid that we talked about, but remember there's a chemistry that happens when that liquid is heated and then aerosolized. So we know that aerosol can contain harmful and potentially harmful substances like volatile organic compounds, ultrafine particles that can penetrate deep into the lungs, carcinogens, heavy metals, and other chemicals that have been linked to adverse health outcomes. So we do know that e-cigarette aerosol is not harmless. And of course, any discussion of the health effects of e-cigarettes in youth has to include at least a brief discussion of EVALI. So the EVALI outbreak, as you probably remember, occurred in the summer and fall of 2019. There were about 2,800 cases, 68 deaths, and cases peaked in September of 2019 and then declined over time. Most cases were aged 18 to 24, the median age was 24 with a range of 13 to 85, and about 76% of the cases were under 35 years old. Now, most of those cases were linked to THC-containing e-cigarette or vaping products, and ultimately vitamin E acetate was identified as playing a significant role in the outbreak. So it was found in product samples, it was found in bronchial alveolar lavage samples from case patients, and so really a strong link from EVALI to VEA. And since we're on the topic of EVALI and we're really primarily here talking about youth e-cigarette use, I want to ensure that I'm providing some clarity in distinguishing these two really important public health issues. It's important to not conflate them. They're interrelated, but they're distinct. Now, the youth e-cigarette epidemic primarily affects youth who use nicotine-containing products that are obtained from formal sources, so retail environments. In contrast, the EVALI outbreak primarily affected young adults who use THC-containing products obtained by informal sources, so friends, family, online dealers, and other types of informal places. It's important to really distinguish here because while the EVALI outbreak has largely subsided, the youth e-cigarette epidemic is still of significant concern and there's still much work to be done in that space. So what do we do? Well, tobacco cessation, or excuse me, tobacco control has really always approached this from two, from both ends, prevention and cessation. Now, I want to talk about cessation first because tobacco cessation has been a huge challenge in kids less than 18 for years. We have been fighting this for years, and largely because the evidence has been and truly remains sparse on how we treat tobacco use disorder in children. It's challenged even further by this new and diverse tobacco product landscape. Now, there are some promising practices and a handful of initiatives that I'm showing you here that are really building evaluation evidence as we speak. There are some really smart people continuing this really important work. But in the meantime, I would suggest to you that we need to move together, public health and healthcare, as rapidly as we can to respond to this crisis. We need more evidence on what works to treat kids with nicotine dependence and on better ways for rapid clinical assessment of dependence. And while we're working on all of that, we need a way to move forward now so that we can help kids who currently use quit. And while we're working on all of that and building out the evidence to help kids who already use tobacco products to quit, we need to put equal effort into helping kids who don't use now not even start. So to that end, we can take what we know works for tobacco control and prevention, price strategies, smoke-free policies, cessation, mass media campaigns, this tobacco control vaccine, if you will, and contemporize it to move with the tobacco product landscape. It's not a new idea. This was first proposed by the Surgeon General in the 2016 report on youth use of e-cigarettes. So here's the idea. So we can expand price and tax policies to include e-cigarettes as those states shown in here in blue have done. We can incorporate e-cigarettes into smoke-free policies and make those policies product agnostic of all tobacco products. We can include e-cigarettes in mass media campaigns, particularly those that are targeting youth. And we can extend treatment for and explore research on treating novel tobacco product use. There are also other things we can do like restrict youth access to products in retail settings, license retailers, regulate marketing that's likely to attract youth. These are all population level measures that we know work to curb tobacco use, youth tobacco use initiation. We just have to keep moving with the times and contemporize our approaches. So what I would ask is that you keep this conversation going. If you're in public health, keep fighting the good fight by partnering with communities, with health systems, with educators, raise awareness, contemporize our tobacco prevention approaches, and really keep supporting those communities that are at disproportionate risk. If you're in healthcare, talk to your young patients about tobacco use. Ask them what they're using, what devices, what's in the devices. Offer them treatment and then follow up. Prevention is really critical and tobacco use in this population, any tobacco use is an urgent clinical issue. We all have the skills and resources to make a difference in these young lives. So the bottom line here is that everybody has a role in addressing youth tobacco use. So let's keep fighting this good fight together. Thanks. My apologies for not unmuting. Good afternoon. I am Lieutenant Commander Amoye Amoiseli. I am a medical officer in the Center for Tobacco Products at the FDA. I have no conflicts to disclose. Today, I am presenting on behalf of Dr. Bao Guang Wang Trends and Characteristics of Poisoning Exposure Cases Involving E-Cigarettes in the United States from 2010. This is the outline of the presentation. Previous studies have reported trends in poisoning exposure cases involving e-cigarettes and e-liquids among children and the general population, with data as recent as April 2017. E-cigarette use has increased dramatically, as we've just heard, among youth in the US since 2011. And e-cigarette products have been evolving, and new products have been on the US market, as previously described. The objective of this study was to describe trends and characteristics of poisoning exposure cases involving e-cigarettes and e-liquids, which are termed as e-cigarette exposure cases in the United States from 2010 to 2018. We used data from the National Poison Data System, or NPDS, which is owned and managed by the American Association of Poison Control Centers, or AAPCC. It contains information on poisoning exposure cases in humans and animals. We analyzed data on human cases involving e-cigarettes or e-liquids only between 2010 and 2018. We included closed cases only, meaning investigations of these cases had already been completed. And we excluded cases involving more than one substance other than e-cigarettes or e-liquids to separate the effects due to other substances. We also excluded cases that were confirmed non-exposures, or for which a clinical effect was determined to be unrelated to an e-cigarette or e-liquid. Now, let's take a look at what we found. So this figure shows the trends in the number of e-cigarette-related exposure cases between 2010 and 2017. And you can see, overall indicated by the blue line, the number of cases peaked in 2014, then declined in 2015, 2016, and 2017. We observed similar trends among children under five years old, indicated by the red line, and other age groups. And what happened between 2014 and 2017 is that 18 states enacted laws requiring child-resistant packaging for liquid nicotine containers. And the Child Nicotine Poisoning Prevention Act of 2015 was signed into law and became effective by July 2016. Now, did this decline continue into 2018? Nope. Hmm. Let's see. OK. So this figure shows that the overall number of cases increased by 25%, as seen by the blue line, from 2017 to 2018. The largest one-year increase in number of cases occurred among young children under five years old, as seen by the red line. The increases in the number of cases coincided with the sharp increase in e-cigarette use prevalence among youth in 2017 to 2018 and skyrocketing increase in sales of e-cigarette products in 2017 to 2018. The question then became, did the number of cases with more serious medical outcomes also increase in 2017 to 2018? This figure shows that the trends in the number of e-cigarette-related exposure cases with moderate and major medical outcomes between 2010 and 2018. As you can see, the number of cases increased by nearly 30% from 2017 to 2018, a similar pattern to what we saw on the previous slide. And what about cases among teens and young adults? This figure shows the trend in the number of e-cigarette exposure cases with moderate and major medical outcomes between 2010 and 2018 by age now. As you can see, the patterns are similar to what we saw earlier, with the number of cases doubled among adolescents, indicated by the purple line, and more than doubled among young adults, as indicated by the blue line. When we looked at the characteristics of all e-cigarette-related exposure cases, we found that approximately 2 3rds of the cases were children under 5, and about one in every seven cases was a teenager or young adult. This slide shows the distribution of level of care at health care facilities, or HCF. And what I want to point out is that about 1 3rd of cases received medical attention, as indicated by the yellow, red, and some of the dark blue areas. Overall, there were 283 patients who were admitted to the hospital, including 99 patients who were admitted to critical care units, and 130 patients who were admitted to non-critical care units. This slide shows the distribution of medical outcomes of e-cigarette-related poisoning exposure cases. More than 1 3rd had no symptoms. About 1 5th of the cases had minor symptoms with self-limited symptoms. About 3% of the cases had more pronounced and prolonged symptoms, but were not life-threatening. And 24 cases, or 0.1%, developed life-threatening symptoms. There were two fatality cases, unfortunately. One was a one-year-old child who died of accidental ingestion of e-liquid in 2014, and the other was a 29-year-old who intravenously injected e-liquid, according to a suicide note left by this individual. In summary, the number of e-cigarette exposure cases peaked in 2014 to 2015, followed by declines in 2015 to 2017, then increased sharply in 2018. The number of e-cigarette exposure cases with moderate and major medical outcomes increased sharply among adolescents aged 12 to 17 years and young adults aged 18 to 24 years. The one-year sharp increase coincided with the increase in youth e-cigarette use and skyrocketing sales in some e-cigarette products. Overall, children less than five years old accounted for more than 2 thirds of e-cigarette-related poisoning exposure cases. Adolescents and young adults were also at risk. An up note and more recent data that are not shown on the slides, in 2019, the trends in the number of e-cigarette exposure cases reported to poison control centers continued to increase, but followed by a decrease in 2020. And these changes coincided with increased prevalence of current e-cigarette use among U.S. high school and middle school students in 2019, as Brenna had previously described, and the subsequent decrease of current e-cigarette use among U.S. high school and middle school students in 2020. And increased poison exposure cases among young children correlated with the increased prevalence of ENDS use in 2019. In 2020, despite the decrease in prevalence of current e-cigarette use, the number of ENDS-related poisoning exposure cases in 2020 was actually higher than in 2018. And the characteristics of e-cigarette exposure cases reported to poison control centers were similar to that described in 2019, or prior to 2019. So in conclusion, findings from this study underscore the importance of continued surveillance of e-cigarette exposure cases, may inform efforts to prevent e-cigarette exposures focusing on young children, adolescents, and young adults, and may inform programs for educating the public about the potential danger of e-cigarettes. For more information or any questions, please contact Dr. Wang at her email address. Thank you. Nope, we're gonna scroll through these. And if I can have the next slide deck, please. Thank you very much. So hello again, everyone. This presentation is about ENDS-associated seizure and neurologic adverse experiences from December, 2010 through March, 2021. Safety reporting portal. So in 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, which established a center for tobacco products at the FDA. And this act provided FDA with authority over a number of regulatory and surveillance activities of tobacco products, which are listed here, including post-market surveillance and adverse event reporting. Therefore, we at FDA want to know about health problems or quality problems associated with tobacco products. Adverse experiences, or AEs, can be reported to our Secure Safety Reporting Portal, or SRP for short. Though FDA had compiled AE reports since 1988, the SRP was launched in 2014 as an online portal to help streamline the process of reporting safety concerns to the FDA. And it's a major tool in the surveillance of tobacco-related AEs. The homepage of the SRP is seen here on the left, and on the right, you can see the tobacco product page that's contained within the SRP. The SRP is for reporting new or worsened medical conditions, health or safety problems occurring in human users and non-users of tobacco products. Examples of health problems include seizures, any new diagnoses or worsened symptoms, burns or other injuries, toxic or allergic reactions, adverse events related to animals or pets, and more. Product problems are also reported to SRP, such as overheating, fires or explosions, damaged or defective products, strange tastes or smells, foreign material in the product. Product problems may or may not cause an injury or health problem. CTPs, Tobacco Product Surveillance Team, or TPST, is an interdisciplinary group of which I'm a member. TPST is an interdisciplinary group of which I'm a member that monitors data received through the SRP. Major TPST functions include receiving, reviewing, analyzing, coding, and responding to AE reports, and building and revising the SRP tobacco questionnaires. The data analysis shared in this presentation was performed by TPST using our database. TPST has seen an overall increase in the number of voluntary AE reports over the last decade. Since 2009, the majority of reports have been associated with electronic nicotine delivery systems, or ENDS. This slide reflects the various product types associated with health or product problems as reported by consumers or concerned citizens and healthcare professionals in voluntary AE reports per calendar year since 2016. This was the year when all tobacco products came under regulation by CTP. And here, you can see the number of reports received by FDA for each product type by year. It is important to keep in mind that data reported to the SRP are voluntary. There is no under-reporting of AEs. Reporting rates and content may be influenced by a variety of factors such as FDA outreach activities, regulatory actions, market withdrawals or recalls, and other publicly available information about tobacco product problems. Use and exposure information for specific tobacco products may not be well characterized, and one cannot calculate incidence, estimate risk, or compare products from these data. Experiences reported may not have a causal relationship to product exposure and may be affected by selection or recollection bias. Even though there are limitations, these data can provide important safety information, particularly for newer or novel tobacco products. As the data are from voluntary reporting, much of the data are low-quality. Some reports are from healthcare providers while others are lay reporters, and some of the lay reporters receive medical attention and some do not. Few reports have follow-up information or provide additional details on medical workups or outcomes. Finally, there is a range of average time between the occurrence of the event and when the experience was reported. It could be a couple of days. It could be a couple of years. With these limitations in mind, I will now share background information and data on neurological adverse experiences reported to the SRP, including seizures. And first, some background information on seizures. About 5% to 10% of people will have a seizure in their lifetime. There's about 25 different types of seizures, which may be classified by the International League Against Epilepsy Seizure Classification System, seen here. Acute nicotine intoxication can cause nausea, vomiting, headache, tremors, seizure, central nervous system depression, coma, and can even lead to death from respiratory paralysis. A study in mice and rats also showed that high doses of nicotine elicited seizures by activated neurons in the amygdala via nicotinic acetylcholine receptors. In late 2018, CTP received three cases in which the reporter attributed seizures to ends use among young people. In addition, 28 other reported cases of seizures were identified in the American Association of Poison Control Centers, which you heard about in the prior presentation. Between CTP and AAPCC, by late 2018, there were 35 reported cases of seizures that had been identified among both new and experienced ENDS users. And two-thirds of these seizures had occurred among youth or young adults. In most cases, the specific ENDS device was not specified. After additional cases were subsequently reported, the decision was made to issue a public announcement with a concurrent statement released by the FDA commissioner in April, 2019. FDA did not state that the e-cigarettes were causing the seizures, but made a call for further reports of any adverse experiences that individuals attributed to ENDS use. This announcement was shared by mainstream news media coverage. The same day as the public announcement, there were 12 additional reports submitted to SRP and 73 reports were received that same week. And through March 1st, 2021, FDA has received 308 reports. The following data are a summary of ENDS-associated seizure reports submitted to CTP from December 10th, or 2010, through March, 2021. There were a total of three reports submitted to CTP from December 10, 2010 through March 2021. There were a total of 308 affected individuals, of which 300 were ENDS users and 8 were non-users. Of the ENDS users, 266 reported seizures. The majority of reports were from youth and young adults between ages 13 to 24, although the onset of epilepsy has been demonstrated to peak at younger ages. 61% of those affected were male and 39% were female. The vast majority identified as white and most identified as non-Hispanic. E-cigarettes use appears to be less common in the Latino population. There were other health sequelae that were reported along with seizures, including concussions, broken bones, and mechanical ventilation, among others. Some seizures occurred during potentially life-threatening situations, such as while driving, being in or around water, or on the stairs. Although we have received a couple hundred reports of seizures attributed to ENDS use, this is still a very small number and no conclusions can be drawn and no causality can be implicated. More data are needed to determine whether any associations exist between the use of ENDS products and incidents of seizures or other serious neurological sequelae, and if so, then any underlying causes. It is important that healthcare providers ask about ENDS use, especially when evaluating neurological symptoms for which the etiology is unclear. The cause of reported seizures is unknown, but given the pro-convulsant effects of nicotine, it is possible that high nicotine content in ENDS products may lead to inhaled nicotine toxicity. Until the public's reports of seizures associated with ENDS use, nicotine-related seizures are most often associated with cases of liquid nicotine ingestion. The predominance of seizures reported in youth and young adults may reflect the demographics of ENDS use, and multiple other causes that are yet to be undefined may contribute to seizures attributed to ENDS use. For instance, many ENDS users use multiple products, and there's a large overlap with cannabis, particularly with e-cigarette devices. Also, younger ENDS users are more likely to get ENDS from alternative sources, such as friends or pop-up shops, and these products may be less reliable and may contain other contaminant ingredients. Overall, the long-term clinical implications of seizures after ENDS use are unknown. And so, remember, that's why we want to hear from you as physicians and clinicians about any adverse events that may be attributed to ENDS use, so we can better characterize any potential adverse events or health effects associated with vaping. I would like to thank my colleagues at CTP. Thank you. Thanks. And next, we wanted to turn your attention to what FDA is doing for our mass health communication youth e-cigarette prevention campaign, the real cost. So we are tackling youth e-cigarette use prevention using our standard models of the real cost. So, as teen e-cigarette use has increased, there has been the increased importance to counteract it with our large-scale national media campaigns. These are things that we know are demonstrated effective after years and years of research, including the model that we used to develop the real cost, which was our first cigarette prevention campaign. And so, the proven strategy is really being used to address now the rise of youth e-cigarette use. So, since the fall of 2018, we have released a suite of e-cigarette prevention messages. And they're mass media, which includes TV, online, radio, social media, and digital platforms, really targeting our teens where they are. And additionally, in 2019, the campaign created posters that were distributed through all high schools to be displayed in the high school bathrooms across the country. So our campaigns are really grounded in that behavior change theory. And so, we're measuring at every level throughout our campaign's progress. And so, we're looking first at the level of ad awareness and receptivity, really understanding the audience exposure to our messages and recall of campaign messages. And additionally, we're looking at the reactions to and the perceptions of the campaign messages. And so, those are our short-term outcomes, that ad recall and ad awareness. And then we're looking next to if we're changing those knowledge, attitudes, and beliefs around the campaign messages. And then finally, we eventually hope to change tobacco use intentions and behaviors. So we're looking at their intention to use tobacco, as well as the initiation and progression to establish tobacco use. And we understand that all of these things are impacted by a number of environmental factors, like Dr. Van Frank had talked about the tobacco control vaccine. And so, all of those things are happening in other campaigns at other state and local levels are all interacting with our campaign, but we try to really evaluate what is attributable change just to our campaigns, so we can better understand how youth are viewing our ads and if they're understanding the messages that we're sharing. So we go through rigorous amounts of research to develop and produce our ads. Our campaign messages go through the following process. We start out with qualitative research. So we just ended some additional focus groups, but for every new set of campaign messages, we go through focus groups, talking directly with the teams that are either susceptible to already experimenting with or current e-cigarette users. So we really want to know with our target audience, what they're thinking about our new campaign concepts and messages. And then we'll, from there, we'll kind of take those most successful, most promising messages that they want to hear about, and we go into production. And then after production, we'll go through another round of research with our target audience called copy testing. So we show them the produced spot and look for the understanding of the campaign messages and testing to see if there are any unintended consequences from our ads. And then we'll eventually launch the campaign across all of those media channels. So we wanted to talk a little bit through our research lens with teens to understand this addiction that we're seeing. And so what we're starting to hear is that they actually see that addiction as a bad thing. So in previous research, teens were really dismissive of addiction, saying that they're addicted to a lot of things like hamburgers. But now they're really starting to believe that addiction to vaping is a consequence. And so they're seeing those emotional costs that come from e-cigarette use. But they really do still want to hear those strong harmful health consequences messages. They also acknowledge that addiction is emotional. It's not just physical. So for some teens, vaping is the consistent part of their daily life. And they don't like when it's disrupted or suddenly limited. So we have one quote here from a focus group, an ENDS experimenter who was in that older 15 to 17 age range and said, I remember one time before a cheer competition, this girl had a panic attack. And she said she needed her device. I need my device. We all ran to the bathroom right before we went on so she could hit it. So they're starting to see this in either themselves or their friends and really understand what the signs of addiction are looking like. They also mentioned that they would understand people who would fiend for a hit of an e-cigarette. And they acknowledge they've seen that negative behavior like irritability, that irrational anxiety about losing access to either e-cigarette devices. So like if they're going on a weekend trip with their parents, or if they're just really nervous, because those relationships with their parents are really important for teens of this generation. And so they're not, we've heard some that are, you know, it's not necessarily that I'll ruin that relationship with my parents, because that is a really big concern for them. But also that they would just get the device taken away and they couldn't handle that. And so that was a really big sign of addiction for some of them. So for our campaign, we are constantly hyper-targeting our campaign messages to effectively reach those 12 to 17 year olds, looking at those media passion points, understanding what's going on in the teens world, where they want to be, what things they're watching, how they're using and consuming media these days, because it is changing rapidly and we need to keep up with it. So we've actually had over 10.5 billion teen impressions. So how many impressions, how many eyes on our messaging since our campaign launched. We are on streaming platforms, we're on the traditional linear broadcast TV and cable. We are on their mobile devices when they're on social media or listening to online music. And then we're also integrating into the gaming that they, that's a huge passion point for them. So we're developing mini games so that if they want to play or get freebies in their own game that they went to play, they can play our mini game, learn about the toxic metals that are in these and then get our messages and get free points in their media. So it's really, you know, partnering with those custom placements that we can really reach them where they are. And then we also have now launched our season two in partnership with Awesomeness TV doing teen true stories, my vaping mistake. And so you can go to YouTube and view these teen stories. We have long form videos that can run up to four minutes as well as some, some cut down ads that are really peer to peer driven. And so these have seen really promising results of having teens who have overcome their e-cigarette addiction, talk to peers and really understand kind of what they were going through and how their life has changed for the better because they've overcome their addiction. And so these stories are really relatable with teens and young adults. This is something that has worked phenomenally well with adult smokers and we're really pleased that it is actually also seeing some promising results for our teen e-cigarette users. And so, so far we've had nearly 3.6 billion teen views in 16 months of the two seasons. And we really engaged with teen audiences with more than almost a million likes and over 132,000 shares and comments. They're engaging with our messages and talking about how it relates back to them. And we do see time and time again that we see the majority of youth are exposed to our campaign and they are receptive to our messages. They see FDA is the real cost as a trusted messenger. And we've also seen a change in youth perception that e-cigarettes, they used to really think that they were just those flavors. They were completely harmless. And we're now really tracking to see that change in those knowledge, attitudes, and beliefs. And they're showing that greater understanding that e-cigarette use could lead to serious consequences. And we do partner with NCI because teen cessation is a really important part. So we get them to think about their behaviors. They're kind of wondering, am I addicted? Am I seeing myself in this ad and in this kind of space? And then we link our campaign messages with the National Cancer Institute smoke-free teens. And so they have developed e-cigarette cessation content, which gives that comprehensive behavioral health techniques to deal with cravings, navigate peer pressure, prepare to quit. And we see that they're actually spending a lot of time on these pages, over four minutes on how to quit vaping, four minutes on acquiring tips for managing stress and anxiety, and over five minutes on managing that nicotine withdrawal. So I think we just have a little bit of time for questions, but thank you very much for attending our sessions. We're really happy to talk with everybody. Thanks to all three of our presenters for these great talks on youth vaping. We've been given a few extra minutes by ACPM in thanks for your attention and staying with us throughout our technical difficulties at the beginning. So we've been authorized to go till 1.55 or 13.55 for you military types out there. So I'd like to just kick it off with a question. I think I'm going to ask Dr. Van Frank first, but others can also opine. There's a number of questions in the chat, and I'm going to sort of combine them into one. And it's about the effectiveness of policies and regulations. So for example, the Tobacco 21 banning flavors and the like, what's the evidence? How's that playing out in terms of reducing and preventing youth vaping? Over. Sure. I can take a first stab at that, and then we'll defer to my FDA colleagues who are in the regulatory space, so where CDC is certainly not. But what I would say is that the passage of the federal minimum sale age of 21, I think was a victory for tobacco prevention and control. The intention is to really try to pull tobacco products out of schools, quite honestly. High school students can be 18 years old when they're seniors. And so pulling that minimum legal sale age can certainly help with some of that. The evaluation of that policy, you know, it's still being implemented in states. That didn't go into effect until, I always get my years mixed up, pandemic brain is what I call it. But in 2019, December, and so the evaluation of that on a national scale is certainly starting to ramp up. We do have state examples of states that had passed T21 policies prior to the federal legislation. And so evaluation in places like Hawaii showing promising results. So all really good news from a policy standpoint there. Flavors, also very promising. There again are state examples, local examples, where flavors are being pulled for a variety of tobacco products. FDA just made an announcement a couple of weeks ago, maybe it was just last week, again, pandemic brain, on its intention to pull menthol and flavored cigars off the market. And a lot of that is, you know, there's a strong evidence base in terms of flavors and initiation for tobacco amongst youth. And so the intention here is really to get the tobacco out of the hands of kids. But I'll defer to my FDA colleagues if they have anything more to say from a regulation standpoint. Yeah, I think you covered it. CDC's work with states and locals really gives us a lot of information. And then we're just continually looking at those National Youth Tobacco Survey data to really track over time the impacts on youth and behaviors. Absolutely. And we did see, as you mentioned, from NYTS survey data that there was a decline in the current e-cigarette use among both high school and middle school students, which, again, is a great win. Still high, but we're going in the right direction. But we're still trying to evaluate at this point in time exactly what are the causes or what are the reasons behind that decline. We would like to say that we have some inklings, but we're still really doing some research into that. So I can't wait to see what publications and the literature show in the next few months and a couple of years. Oh, that sounds great. Yeah, there's been a little bit of talk in the chat about the effectiveness of different policies as well as media campaigns. I think, Alison, Ms. Kulas, you talked a little bit about that. It sounds like the jury is still out and we're gonna be seeing those data come forward in the next months to years as well. Is that right, for media campaigns? Yeah, we've been evaluating the campaigns since the inception of the PACA. So we're actually in a second round of evaluation going into follow-up four of the same pod of teens and young adults to really kind of understand those changes. And so follow-up four evaluation will be taking place later this summer. And then we'll just be continually evaluating our effectiveness. So stay tuned, because hopefully we will be able to release and publish some information based on these results. I do also wanna chime in that, when we're talking about policies and policies and we're talking about policies and policy approaches to prevention and tobacco prevention and control, what we're talking about is not just one thing that's gonna solve it, right? When you talk about the tobacco control vaccine for a reason, and that's because all of those components together are evidence-based, and we know to work at least in situations where cigarettes are the most commonly used product, which they are still in adults and used different now, but it's no one of those is the silver bullet, right? It's that comprehensive approach. You have to pull in all of these policies and approaches together to be able to really have that big impact. Great, thanks to all for your responses. There's a number of additional questions about the tension with harm reduction and what role e-cigarettes and ENDS may have in particularly closed populations like the military or colleges. Do you have any thoughts on the use of e-cigarettes for harm reduction? Sure, like I said, that could be an hour and a half conversation, right? An hour and a half presentation in and of itself. And I think the frame that I like to use when we're talking about and debating the public health benefit versus the public health harms and sort of the net public health impact of products like these, I like to frame it up as thinking about a weighing, if you will. So adult cessation potentially on one side, youth initiation on the other side, and really sort of amassing the evidence either way to really have a better sense of what's the net public health impact. I think everyone agrees that youth initiation is something that is incredibly concerning. No tobacco product is risk-free and no youth should be using these products. No nicotine-naive youth should be using these products. The evidence for cessation in adults who have tried to quit cigarettes with evidence-based therapies in the past is still burgeoning, right? We're still gaining more and more information in that space. I think the bottom line for physicians is that e-cigarettes are not an FDA-approved cessation aid. And we have evidence-based therapy that we know works. So while the evidence is still gathering, as a clinician, my sense is let's try with the stuff we know that works and actually use it. I've seen a lot, and I'm in my practice as well, I'm guilty of this, of trying once, the patient, it doesn't work for them, they didn't like the gum, they didn't chew it right, the patch gave them nightmares, whatever it was, the patient sort of falls off the radar and that's it, right? And you don't necessarily come back to that with them until next year or the year after that. We would never do that with someone who had high blood pressure or diabetes. Oh, sorry, you had a trial of a hypertension medication, a blood pressure lowering medication, didn't work, we'll try again next year. So we would never do that, right? So one of the things that I think is really important is that we've got to use the tools that we have, the evidence-based tools that we have, and give them a real-world try with counseling and medication together. I'm curious what Oye thinks from her clinical standpoint as well. That you said, Dr. Van Frank, and I myself as an internist and having been a primary care physician for three years, absolutely think that we need to put more effort and more focus as clinicians into assisting our patients with known FDA-approved cessation medications or therapies that are used for tobacco cessation. And as you mentioned earlier, when we're talking about e-cigarettes from the regulatory standpoint, as a medical officer at FDA, we're thinking about when we're evaluating an application, is this product appropriate for the protection of public health? And we're trying to make that determination, but at the same time, there are a lot of unknown factors that we still don't know. So for instance, as a medical officer, people will ask, well, what are the long-term health consequences of e-cigarette use? And we don't really know that at this point in time because they're relatively new when you compare them to products such as combustible cigarettes, which have been around for decades. For vaping, we have some ideas about what we've seen in some studies or potentially short-term consequences, but we haven't seen long-term health effects over the course of decades because they haven't been out for that long. So we're taking all of these things to consideration, making regulatory decisions, but I think that in the absence of that evidence, we do have evidence for cessation products and to definitely use what we have seen to work for some people. Great, thanks for your thoughtful responses on that. There's lots of other great questions in the chat, but we're at the end of our time. So I wanna thank all of our presenters today for a great talk. I really enjoyed it. I hope you did too. And I'm gonna let you guys go on and take a break before your next session. Thanks for your time. Thank you.

Combating the Youth Vaping Epidemic

youth vaping

e-cigarette devices

generations of e-cigarette devices

nicotine content

health risks

poisoning exposure cases

increase in cases

seizures after e-cigarette use

FDA

youth e-cigarette prevention campaign

harmful effects of e-cigarette use