For Immediate Release: June 07, 2018 Statement From:

We’re encouraged by declines in overall youth tobacco use over the last several years reflected in the 2017 National Youth Tobacco Survey. Protecting our nation’s youth from the dangers of tobacco products is among the U.S. Food and Drug Administration’s most important responsibilities and we’re taking aggressive steps to make sure all tobacco products aren’t being marketed to, sold to, or used by kids. These efforts are a cornerstone of our comprehensive plan announced last summer. They are also the focus of our Youth Tobacco Prevention Plan announced in April. We’re actively examining a policy to prevent future generations from becoming addicted in the first place by rendering cigarettes minimally or non-addictive and taking every opportunity to disrupt the cycle of successive generations of nicotine and tobacco addiction.

While fewer youth are using cigarettes and other combustible tobacco products, we must do more to address the disturbingly high number of youth who are using e-cigarettes and vaping products. We must not lose sight of the fact that for the past several years, e-cigarettes have been the most commonly used tobacco product among both middle and high school students and a total of 2.1 million youth used e-cigarettes in 2017.

These figures are particularly concerning because youth exposure to nicotine — whether it comes from a cigarette or an e-cigarette — affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future. And while there was no change in e-cigarette use from 2016 to 2017 among high school-aged teens, it’s too soon to tell whether this represents a leveling off, following a steep decline from 2015 to 2016. But this bears watching.

Our work to protect youth from dangers of nicotine and tobacco products is first-and-foremost focused on making sure e-cigarettes — or any other tobacco products — aren’t getting into kids’ hands in the first place. That’s why as part of our Youth Tobacco Prevention Plan we conducted a nationwide blitz of brick-and-mortar and online retailers in April that led to warning letters to businesses that sold JUUL brand products to minors. We’re also planning to conduct additional nationwide blitzes in the near future as part of our sustained enforcement efforts to reduce tobacco product sales to minors. Additionally, we issued numerous warning letters — many in partnership with the Federal Trade Commission — to manufacturers, distributors and retailers for selling e-liquids used in e-cigarettes with false or misleading labeling and/or advertising that cause them to resemble kid-friendly food products such as juice boxes, candy or cookies, and some of them with cartoon-like imagery. These efforts are the start of a sustained campaign to address sales to minors.

As we work to address youth use of, and access to, these novel nicotine-delivery products, we’re also taking a hard look at whether certain design features and product marketing practices are fueling the youth use. To that end, we’ve required JUUL Labs Inc. and the manufacturers/importers of several other similar products to provide critical information for us to further examine marketing practices and the youth use and appeal of these types of products. We’ll explore all of our regulatory options, including enforcement actions, based on what we learn from this information. We’re also adding JUUL as a specific e-cigarette example in future tobacco use surveys to ensure we’re accurately capturing patterns of youth use of e-cigarette products.

In addition, we’ve been conducting focus groups with teens across the country about e-cigarettes to hear directly from young people to best inform our public education efforts about the dangers of youth tobacco use. And we know our compelling, science-based campaigns are having a meaningful impact through powerful messages that raise awareness, shift beliefs and ultimately save lives by changing behaviors. “The Real Cost” campaign has already helped prevent nearly 350,000 kids from smoking cigarettes since it launched in 2014. Capitalizing on that success, we expanded the campaign last fall with messages focused on preventing youth use of e-cigarettes. Later this year, we’ll be launching a full-scale campaign focused on youth use of e-cigarettes. We’ve had a lot of success with our campaigns in the past. And we expect that this new public effort will impact youth use of e-cigs in the same manner that our campaigns have impacted children’s use of combustible tobacco products.

Along with these efforts, we’re continuing to advance our framework for the regulation of products like e-cigarettes through our premarket review process to address youth initiation. Additionally, we’re exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive — with an intense focus on deterring youth use and exposure. This could include measures on flavors/designs that appeal to youth, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine. We also plan to explore additional restrictions on the sale and promotion of electronic nicotine delivery systems to further reduce youth exposure and access to these products.

E-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them. We are working hard to develop a pathway to put products like e-cigarettes through an appropriate series of regulatory gates to properly evaluate them as an alternative for adults who still want to get access to satisfying levels of nicotine, without all the risks associated with lighting tobacco on fire. And we will continue to encourage the development of potentially less harmful forms of nicotine delivery for currently addicted adult smokers. That also includes the development of medicinal nicotine products.

But these public health opportunities are put at risk if all we do is hook another generation of kids on nicotine and tobacco products through alternatives like e-cigarettes. Ultimately we need to make every effort to prevent youth tobacco use. This responsibility falls on all of us, including the companies that develop and market these products, the retailers selling them, and the online venues that help to fuel the teen popularity of, and access to, these products. We’re going to hold industry participants responsible for actions that promote youth addiction. There’s no acceptable number of children using tobacco products. We’ll take every opportunity to protect kids and significantly reduce tobacco-related disease and death.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Inquiries Media: Michael Felberbaum 240-402-9548 Consumer: 888-INFO-FDA

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