Findings from the National Youth Tobacco Survey (NYTS) released by the U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) show that more than 3.6 million middle and high school students are or have been current (past 30 day) e-cigarette users in 2018.? This represents a dramatic increase of more than 1.5 million students since last year.

The National Youth Tobacco Survey is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students. The data for the 2018 NYTS were collected from March to May 2018.

Photo 1.0: Alex M. Azar II is the current Secretary of Health and Human Services (HSS)? Azar has spent his career working in both the public and private sectors, as an attorney and in senior leadership roles focused on advancing healthcare reform, research and innovation. From 2001 to 2007, Azar served at the U.S. Department of Health and Human Services ? first as its General Counsel (2001?2005) and then as Deputy Secretary. During his time as Deputy Secretary, Azar was involved in improving the department?s operations; advancing its emergency preparedness and response capabilities as well as its global health affairs activities; and helping oversee the rollout of the Medicare Part D prescription drug program. In 2007, Azar rejoined the private sector as senior vice president for corporate affairs and communications at Eli Lilly and Co. From 2012 to 2017, he served as president of Lilly USA LLC, the company?s largest affiliate.

Reversing decline
According to the results published in the agency’s Morbidity and Mortality Weekly Report, youth who use e-cigarettes also are using them more frequently and using flavored products more often than last year. The sharp rise in e-cigarette use has resulted in an increase in overall youth tobacco product use, reversing a decline seen in recent years, and is prompting a series of steps by the FDA to curb youth use trends.[1]

?These new data show that America faces an epidemic of youth e-cigarette use, which threatens to engulf a new generation in nicotine addiction,? noted HHS Secretary Alex Azar.

?By one measure, the rate of youth e-cigarette use almost doubled in the last year, which confirms the need for FDA?s ongoing policy proposals and enforcement actions. HHS?s work will continue to balance the need to prevent youth use of e-cigarettes with ensuring they are available as an off-ramp for adults who are trying to quit combustible cigarettes,? Azar added.

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Increase
According to the findings, the number of U.S. high school students who reported being current e-cigarette users increased 78% between 2017 and 2018 to 3.05 million (or 20.8%). Numbers among middle school students rose 48% to 570,000 (or 4.9%). The study authors suggest the rise in e-cigarette use in the last year is likely due to the recent popularity of certain types of e-cigarettes, such as JUUL. These products include ones that are cartridge-based, can be used discreetly because of their resemblance to slim USB flash drives, have a high nicotine content and come in appealing fruit and candy flavors.

Health risk
The increased popularity of e-cigarettes among youth raises a number of other health concerns: risk of addiction to nicotine early on in life; potential harm from nicotine exposure to the developing adolescent brain; and exposure to chemicals associated with adverse health effects. In addition, research shows that, compared with non-users, youth who use e-cigarettes are more likely to transition to conventional cigarettes ? risking a lifetime of addiction to smoking and resulting smoking-attributable disease.

The uptick in e-cigarette use has led overall tobacco product use to increase by 38% among high school students (to 27.1%) and by 29% among middle school students (to 7.2%) in the last year, reversing the positive decline seen over the last few years.

More frequent use
Additionally, the survey also shows that high school students who reported being current e-cigarette users also reported using the product more frequently. In the last year, the proportion of those using the product more regularly (on 20 or more of the past 30 days) increased from 20% to 27.7%, an alarming one-year rise.

Photo 2.0: Scott Gottlieb is the 23rd Commissioner of Food and Drugs (FDA). He is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner.

The 2018 NYTS also found that, among high school e-cigarette users, there was a significant increase in flavored e-cigarette use within the past year, from 60.9% to 67.8%. Research shows youth and young adults identify flavors as a primary reason for e-cigarette use. Additionally, there is evidence from the Population Assessment of Tobacco and Health (PATH) Study indicating youth who first tried a flavored tobacco product have a higher likelihood of current tobacco use compared to those who first tried an unflavored product.

?We?ve been aware of these data for several months and are pursuing a robust set of new policies to address this epidemic level of e-cigarette use by kids. This spike in use threatens to stall or reverse the substantial public health gains we?ve made by reducing tobacco use overall, and especially among children,” FDA Commissioner Scott Gottlieb, MD said.

“It?s clear we have a problem with access to, and appeal of these products to kids, and we?re committed to utilizing the full range of our regulatory authorities to directly target the places kids are getting these products and address the role flavors and marketing are playing in youth initiation,? he added.

?We still believe that non-combustible forms of nicotine delivery, such as e-cigarettes, may be less harmful alternatives for currently addicted adult smokers who still seek nicotine. And we want to keep this option open for adults as the evidence develops to inform their use by adult smokers. But as we?ve said before, we will not allow that opportunity to come at the expense of addicting a whole new generation of kids to nicotine. We must close the on-ramp of nicotine addiction for kids even if it risks narrowing the off-ramp from smoking for adults. These are the hard trade-offs we must take to keep these products out of the hands of kids and confront this troubling epidemic,? Gottlieb concluded.

Alarming rise
The alarming rise in use of e-cigarettes products and the threat of a new generation of young people becoming addicted to nicotine prompted the FDA and CDC to release latest data earlier than usual so as to encourage e-cigarette companies and retailers, state, county and local health departments, public health organizations, and parents and educators to act immediately to curtail this crisis. The FDA and CDC plan to release the remaining data on usage rates of other tobacco products in early 2019.

?The markedly accelerating rate of e-cigarette use among U.S. youth within the past year is a cause for grave concern,? said CDC Director Robert R. Redfield, M.D. ?E-cigarette use is unsafe among youth, and it?s critical that we implement proven strategies to protect our Nation?s youth from this preventable health risk.?

Social media and beyond
Tailoring social media, digital resources and web content for parents, teachers, coaches, and other youth influencers, CDC provides states and communities with accurate, actionable, and up-to-date science and information about the risks of e-cigarettes to young people. For example, CDC has a number of online resources explaining the risks of e-cigarettes for youth and ways to prevent youth from using e-cigarettes or to help them stop.

In addition to the steps the FDA announced, the agency has taken a series of actions over the past several months to target the illegal sales of e-cigarettes to youth, as well as to target companies engaged in kid-friendly marketing that increases the appeal of these products to youth.

These actions cover, in particular, the FDA recently announced a series of critical enforcement actions that included issuing more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer?the largest coordinated enforcement effort in the FDA?s history. Moving forward, the FDA is indefinitely stepping up enforcement actions with a sustained campaign to monitor, penalize and prevent e-cigarette sales to minors in retail locations, including manufacturers? internet storefronts. The agency is exploring action under both its civil and criminal enforcement tools to target potentially violative sales and marketing practices by manufacturers as well as retailers.

Widespread youth access
The agency also issued letters in September to five major e-cigarette manufacturers that produce JUUL, Vuse, MarkTen, blu e-cigs and Logic, which, combined, comprise more than 97% of the market share for closed-system e-cigarette products. These letters asked the companies to submit to the FDA within 60 days plans describing how each firm will address the widespread youth access and use of its products. The FDA recently met with these companies to discuss not only the potential steps they would take to restrict youth access to, and appeal of, these products, but also the measures they think the FDA and other policy-makers can take to reverse the trends in youth use of e-cigarettes.

Campaign
The agency also launched ?The Real Cost? Youth E-Cigarette Prevention Campaign. This new, comprehensive effort targets nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. The new campaign features hard-hitting advertising on digital and social media sites popular among teens, as well as posters with e-cigarette prevention messages in high schools across the nation. The FDA also recently announced a public hearing, to be held on December 5, 2018, to discuss efforts to eliminate youth e-cigarette use, with a focus on the potential role of drug therapies to support cessation among youth, and the issues impacting the development of such therapies for children.

Photo 3.0: Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center and chair of the AACR’s Tobacco and Cancer Subcommittee.

As part of the agency?s comprehensive plan on tobacco product and nicotine regulation, the FDA also issued an advance notice of proposed rule-making in March to seek public comment on the role that flavors in tobacco products, including e-cigarettes, play in attracting youth. Additionally, the agency plans to explore additional restrictions on the sale and promotion of e-cigarettes to further reduce youth exposure and access to these appealing products.

American Association for Cancer Research
?Preventing youth addiction to nicotine is paramount, and we strongly encourage our policymakers in Congress and at the FDA to build on [their] actions to stop teenagers from getting hooked on e-cigarettes. Ultimately, we hope our policymakers will go even further, banning the sale of e-cigarettes in retail stores and gas stations,? said Margaret Foti, PhD, MD, Chief Executive Officer of the American Association for Cancer Research.

?Nicotine, which is a major ingredient in e-cigarettes, is a highly addictive substance, and much is unknown about the health impacts of medium- and long-term e-cigarette use,? said Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center and chair of the AACR’s Tobacco and Cancer Subcommittee.

?The AACR shares the FDA?s goal of preventing a new generation from becoming addicted to nicotine, and we remain committed to continuing to work with the FDA and Congress to prevent e-cigarettes from being used by children and non-smokers,? Herbst concluded.

The members of the AACR?s Tobacco and Cancer Subcommittee, chaired by Herbst, have been advocating for additional peer-reviewed research on the use and composition of these products and for additional regulatory actions to keep tobacco products away from children.

?Youth use of e-cigarettes is a major health care problem and the AACR stands ready to support the FDA in its efforts to prevent kids from using these products,? said current AACR President Elizabeth M. Jaffee, MD, deputy director of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University. ?While we recognize the potential concern about restricting access to alternatives for adults who are trying to quit smoking, we believe these measures by the FDA are necessary during this time of skyrocketing use of e-cigarettes by youth.?

Reference
[1] Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA. Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students ? United States, 2011?2018. MMWR Morb Mortal Wkly Rep 2018;67:1276?1277. DOI: http://dx.doi.org/10.15585/mmwr.mm6745a5.


Last Editorial Review: November 17, 2018

Featured Image: Young woman smokes an electronic cigarette outdoors. Courtesy: 2018 ? Fotolia. Used with permission. Photo 1.0: Alex M. Azar II is the current Secretary of Health and Human Services (HSS)? Azar has spent his career working in both the public and private sectors, as an attorney and in senior leadership roles focused on advancing healthcare reform, research and innovation. From 2001 to 2007, Azar served at the U.S. Department of Health and Human Services ? first as its General Counsel (2001?2005) and then as Deputy Secretary. During his time as Deputy Secretary, Azar was involved in improving the department?s operations; advancing its emergency preparedness and response capabilities as well as its global health affairs activities; and helping oversee the rollout of the Medicare Part D prescription drug program. In 2007, Azar rejoined the private sector as senior vice president for corporate affairs and communications at Eli Lilly and Co. From 2012 to 2017, he served as president of Lilly USA LLC, the company?s largest affiliate.? Courtesy: ? 2010 ? 2018 Health and Human Services (HSS).? Used with permission.?Photo 2.0: Scott Gottlieb, MD, is the 23rd Commissioner of Food and Drugs (FDA). He is a physician, medical policy expert, and public health advocate who previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a senior advisor to the FDA Commissioner. Courtesy: ? 2010 ? 2018 Food and Drug Administration – FDA.? Used with permission.?Photo 3.0: Roy S. Herbst, MD, PhD, Chief of Medical Oncology at the Yale Cancer Center and Smilow Cancer Hospital in New Haven, CT. Herbst, is a principal investigator on the Stand Up To Cancer ? American Cancer Society Lung Cancer Dream Team.? He is also chair of the American Association for Cancer Research’s (AACR) Tobacco and Cancer Subcommittee. Courtesy: ? 2010 ? 2018 AACR/Stand Up to Cancer.? Used with permission.

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