Statement by FDA Commissioner Scott Gottlieb, M.D., on new evidence showing increasing use of



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SILVER SPRING, Md., Feb. 11 2019 / PRNewswire / – The US Centers for Disease Control and Prevention (CDC) today released additional data from our joint national FDA / CDC 2018 youth smoking survey. These data are reminiscent of initial findings that we shared last fall indicating a widespread increase in the use of e-cigarettes among young people, prompting the FDA to take a series of increasingly stringent regulatory measures as part of its plan. prevention of smoking among young people. We move these actions forward and engage in new steps. The epidemic use of electronic cigarettes in children is one of the biggest public health problems that the FDA is currently facing.

According to data released today, about 4.9 million college and high school students were current users (used within the last 30 days) of one type of tobacco product in 2018 , up from 3.6 million in 2017. This increase is due to an alarming surge in the use of the electronic cigarette. More than 3.6 million middle and high school students were current users (in the last 30 days) of the electronic cigarette in 2018, a dramatic increase of more than 1.5 million. students in one year. The authors of the study suggest – as the FDA also noted during the initial release of these data in the fall – that the increase in e-cigarette consumption over the past year is likely due to recent popularity certain types of electronic products. cigarettes, such as JUUL. In addition, youth who use electronic cigarettes also use them more frequently and use flavored products more often than last year. Many young consumers of tobacco products also use several products. Of the current tobacco users, about two in five (1.68 million) and one in three (270,000) students used at least two tobacco products in 2018. The most common combination of tobacco products was electronic cigarettes. and conventional cigarettes among college and high school students.

Similarly, data from the National Institutes of Health's recent Monitoring the Future study revealed similar trends: between 2017 and 2018, the current use of e-cigarettes (over the past 30 days) would have increased by 6 6% to 10.4% for Grade 8 students; 13.1% to 21.7% among Grade 10 students; and 16.6% to 26.7% among Grade 12 students. In other words, more than a quarter of the 12th American sorters use e-cigarettes, exposing them to the harmful effects of nicotine and other chemicals and exposing them to the risk of transitioning to other tobacco products.

These risks were further reinforced by recent research published in the JAMA Network Open, which showed that, compared to non-users, young people who use e-cigarettes are more likely to switch to conventional cigarettes – risking their entire lives to smoke and hence, smoking – attributable diseases and erasing the reductions in smoking rates among young people we have achieved in America. The bottom line is that children who use electronic cigarettes are not children "who would have smoked cigarettes". Rather the opposite. As a society, we have made great progress in stigmatizing the use of cigarettes in children. Children who use electronic cigarettes are children who have rejected conventional cigarettes, but do not see the same stigma badociated with their use. But now, after being exposed to nicotine through the electronic cigarette, they will be more likely to smoke. I will not allow a generation of children to become addicted to nicotine through the electronic cigarette. We need to prevent young people's trends in e-cigarette consumption from growing and we will take all necessary measures to prevent these children from becoming future smokers.

Based on a growing body of evidence, I am concerned that youth trends will continue in 2019, forcing us to make tough decisions about the regulatory status of e-cigarettes. The signs we see are not encouraging. They highlight the continued growth in the use of these products by young people. No child should use tobacco or nicotine-containing products. We will continue to take steps to investigate the root causes of this increase in e-cigarette use among youth and to put an end to these trends, in particular, by ensuring that these products are sold to make them less accessible and less attractive. youth. However, if these trends in youth use continue, we will be forced to consider regulatory measures that may limit, if not prevent, current adult smokers from having the same level of access to these products that they use now. I recognize that such a move could have significant consequences for adult smokers. The FDA has repeatedly stated our collective view that electronic cigarettes could be a promising tool to help currently dependent adult smokers quit smoking. But, with the staggering data on youth trends, we are struggling to preserve these opportunities for adults while battling the youth epidemic. I will not just allow their sale to be at the expense of a generation of nicotine kids.

Over the past year, to address this growing use among children, the FDA has taken a strong law enforcement stance, including a number of measures to combat the illegal sale of electronic cigarettes in Canada. young people through its law enforcement efforts. online stores; and measures to target businesses involved in child-friendly marketing that increase the attractiveness of these products for youth. I have also appealed to the companies responsible for many of these products and met with senior executives from five of the largest manufacturers of electronic cigarette products. In addition, last week, I sent letters to the CEOs of Altria Group Inc. and JUUL Labs Inc. asking them to meet with them to discuss their concerns that they did not seem fully attached to their written promises regarding the steps followed. to take to prevent young people from using their products.

Just last week, the FDA stepped up its case against some local Walgreens and Circle K stores for repeatedly selling tobacco products to minors by filing a complaint to prohibit both stores from selling tobacco products. tobacco for 30 days. As part of this effort, we are also writing to the management of several major national retail chains to determine if there is a problem at the company level. related to the non-compliance of their stores and to warn them that the FDA plans to do so. Additional means of applying the scale of the company to combat violent tobacco sales to young people, which also include the illegal sale of electronic cigarettes to children. Last fall, we reached a historic milestone with a total of one million tobacco retailer inspections since our launch in 2010. To commemorate this event, we are sending letters to governors and agencies across the country for thanking them for the work they have done to support our efforts to protect young people – and reminding them of the need to remain vigilant to ensure that retailers do not sell tobacco products to minors.

Beyond enforcement and social responsibility, we are committed to making significant policy changes. In particular, I announced in November the new measures proposed to protect young people by preventing access to flavored tobacco products, including e-cigarettes. This policy framework will both address the worrying trend of e-cigarette use among youth and advance historical declines in children's rates of cigarette consumption in recent years. This framework reflects a doubling of the FDA's efforts to protect children from all products containing nicotine. It also reflects a very careful balance between stages of public health to allow adults to transition to non-combustible products; and our solemn mandate to make nicotine products less accessible and less appealing to children. In other words – a balance between closing the access ramp so that children become addicted to nicotine via combustible and noncombustible products, while maintaining the adult access ramp in their homes. allowing access to potentially less harmful forms of nicotine administration for adult smokers who wish to transition away from smoking tobacco products.

Evidence shows that minors are particularly attracted to flavored electronic cigarette products and that young people have access to them, both at traditional retailers and retailers. Bearing this in mind, we are reviewing our compliance policy whereby some electronic cigarettes, including flavored electronic cigarettes, remained on the market until 2022, with manufacturers submitting applications for authorization. prior to commercialization. In particular, as I announced on November 15, 2018, the FDA is reviewing the pre-market smoking product approval authorization policy for all e-cigarette products. flavored products other than tobacco, mint and menthol, sold in physical premises where 18 years of age are permitted. For example, this would include electronic cigarettes or electronic products such as nicotine delivery systems (ENDS), such as e-liquids, cartridge-based systems and cigalikes, in such fruit and candy flavors. as cherry, vanilla, cream, tropical, melon and others. . In addition, we will seek to limit the sale of applicable flavored ENDS products sold online without an advanced age verification process.

We will provide more information on these policies soon. If data continues to show upward trends in youth smoking, we will continue to refine our policies as needed, taking additional steps to strengthen our response.

More recently, we have begun efforts to deepen the discussion and understand how we can help children who are already addicted to nicotine in electronic cigarettes who quit smoking. This includes holding a public hearing to discuss efforts to eliminate youth e-cigarettes and other tobacco products, with a focus on the potential role of pharmacotherapies in smoking cessation and on smoking cessation. problems affecting the development of such therapies in young people. Already, I've heard too many troubling stories from teen parents, pediatricians and young people themselves about the effects of this epidemic. The stories clearly show that for many young users of e-cigarettes, addiction has already taken root.

We also launched the youth e-cigarette prevention campaign "The Real Cost" – a new comprehensive effort targeting nearly 10.7 million young people aged 12 to 17 who have used or are willing to use electronic cigarettes. try. The new campaign features powerful ads on popular digital and social media sites for teens, as well as posters featuring e-cigarette prevention messages in high schools across the country. The new e-cigarette prevention effort stems from the FDA's first youth tobacco prevention campaign, "The Real Cost", launched in 2014 to reduce teen smoking. In its first two years, the youth smoking prevention campaign prevented nearly 350,000 teens from starting to smoke and saved more than $ 31 billion for youth, their families, and their families. society in general by reducing smoking-related costs such as costly, early loss of life. medical care, lost wages, decreased productivity and increased disability. The success of the "Real Cost" campaign suggests that our other tobacco prevention campaigns, including our campaign on the use of e-cigarettes by young people, can build on this success as we strive to reduce the number of children using tobacco.

As part of the e-cigarette prevention campaign for youth, we also partnered with Scholastic to expand the distribution of youth electronic cigarette prevention posters to all private and public high schools. United States and have published new resources for doctors, youth groups, churches, and local public health agencies, and others on the dangers of using electronic cigarettes by young people. In addition, our work with Scholastic to provide educators with resources to help them interact with students on the use of the electronic cigarette has reached more than 2.7 million students until the end of the year. now. We also received very positive feedback from teachers on the usefulness of these resources. Vaping remains a major problem in some schools, but teachers report that vaping on campus has declined after using these resources on the dangers of using electronic cigarettes by young people.

Although these efforts are a good start, we recognize that they are not enough. It's an explosive epidemic. We will continue to bring the full scope of our regulatory tools against this growing public health crisis. We are considering new steps for 2019.

In the future, the FDA has planned a number of actions and we will have more to say about these actions and others very soon. We continue to intensify our enforcement actions by conducting a sustained campaign to monitor, sanction and prevent the sale of e-cigarettes to minors at retail outlets, including manufacturers' internet windows. The agency is also exploring ways to use repressive tools, both civil and criminal, to target potentially violent sales and marketing practices of manufacturers and retailers. We are also investigating counterfeit electronic cigarettes. In addition to our meeting with Altria and JUUL, we also plan to meet with state attorneys general to discuss how they can help combat the use of e-cigarettes by young people in their states. We are also exploring partnership opportunities with other partners to explore opportunities to work together around these common goals. These are just some of the additional steps we take.

The numbers are clear: we see an increase in e-cigarettes consumption by young people at the epidemic level, which threatens the progress we have made to reduce youth smoking. These trends require aggressive, sometimes unprecedented, action by regulators, public health officials, manufacturers, retailers and others to address this troubling issue. Our commitment to curbing the epidemic of e-cigarette use among young people has not been lifted, but we know that all parties need to do more.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.

For more information:

FDA Youth Smoking Prevention Plan

Youth Tobacco Use: Results from the National Youth Smoking Survey

Media requests: Michael Felberbaum, 240-402-9548; [email protected]
Consumer Inquiries: 888-INFO-FDA

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SOURCE US Food and Drug Administration

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