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15-Jul-2019

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on the agency's actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

SILVER SPRING, Md., July 15, 2019 /PRNewswire/ -- Late last week, a U.S. District Court judge in Maryland issued a decision that, among other things, requires makers and importers of e-cigarettes and other electronic nicotine delivery systems (ENDS) and certain other tobacco products like cigars, pipe tobacco and hookah to submit applications for their currently marketed products to the agency within 10 months.

This court decision comes at a time when I, like many others, are tremendously concerned about the rising use of e-cigarettes among our nation's youth and especially the potential for them to become traditional cigarette smokers. We cannot allow the next generation of young people to become addicted to nicotine because of e-cigarettes. I am all too aware of the staggering toll inflicted on the public health by tobacco products. As someone who has dedicated my life to reducing the public health burden and suffering caused by cancer, the importance of preventing youth addiction to nicotine rings especially true to me.

The FDA stands ready to accelerate the review of e-cigarettes and other new tobacco products. And we remain committed to tackling the epidemic of youth vaping using all available regulatory tools at our disposal. We will continue to take vigorous enforcement actions aimed at ensuring e-cigarettes and other tobacco products aren't being marketed to, or sold to, kids. We will continue expanding our highly successful education efforts, such as "The Real Cost" campaign, to educate youth about the dangers of using tobacco products, including e-cigarettes. And we will continue to implement the policies necessary to keep e-cigarettes and all tobacco products out of the hands of America's kids.

Our ongoing oversight of e-cigarettes and other ENDS products is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death. The judge's decision sets a rapid pace for the agency to receive and review applications to evaluate the public health benefits and harms of a product and ensure that any product authorized for marketing is appropriate for the protection of public health. Importantly, the judge recognized the agency's work to provide a framework and clear guidance for companies seeking to market e-cigarette and ENDS products as they prepare their product applications.

Let me be clear with the tobacco industry: responsible manufacturers certainly don't need to wait 10 months to act. We've outlined our recommendations for what the FDA expects to be included in e-cigarette premarket applications and have provided a number of other resources to aid industry in their submissions for other products and assist the agency in fulfilling its public health mandate. We encourage industry to use these resources now as a guide for their submissions to the agency.

Additionally, we will continue to take decisive action to address and mitigate the epidemic of youth e-cigarette use through compliance, education and enforcement. Notably, the agency remains committed to finalizing the compliance policy we proposed in March to limit youth access to flavored tobacco products like e-cigarettes and cigars as quickly as possible. Finalizing the compliance policy is one of the most critical public health steps that the FDA can take to curb youth vaping and address youth use of flavored cigars.

Later this month, we'll also be launching our first e-cigarette prevention TV advertisements educating kids about the dangers of e-cigarette use as part of "The Real Cost" Youth E-Cigarette Prevention Campaign. As we approach the campaign's one-year anniversary, we are also planning to distribute new posters for U.S. high schools for the start of the new school year and are also developing educational materials for middle schools across the country. This public education effort launched in September 2018 with hard-hitting advertising on digital and social media sites, as well as posters with e-cigarette prevention messages displayed in high schools across the nation, targeting nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them.

In addition to the public education campaign's work to address this growing use among kids, we've taken a number of actions to combat the illegal sales of e-cigarettes to youth, and other actions to target kid-friendly marketing that increases the appeal of these products to youth.

From April 2018 through April 2019, the FDA issued more than 3,950 warning letters and more than 665 civil money penalties (fines) to brick-and-mortar and online retailers for illegal sales of e-cigarettes and other ENDS products, including e-liquids, to minors. The FDA also took actions – many in conjunction with the Federal Trade Commission – against more than 15 firms for selling e-liquids that resemble kid-friendly foods, such as juice boxes, cereal and candy; and issued warning letters to four firms that manufacture, advertise and offer for sale or distribution several flavored e-liquid products for violations related to online posts by social media influencers on each company's behalf, including failure to include the required nicotine warning statement. The FDA also continues to investigate counterfeit e-cigarette products, as well as whether companies are introducing new e-cigarettes in violation of premarket authorization requirements.

We've also undertaken efforts to further the discussion and understanding around how we can help those kids who are already addicted to the nicotine in e-cigarettes quit. This includes holding a public hearing and a separate scientific workshop to discuss efforts to eliminate youth e-cigarette use as well as other tobacco product use, with a focus on the potential role of drug therapies to support cessation and the issues impacting the development of such therapies for youth.

While certain ENDS products may hold some promise in helping addicted adult smokers transition away from combustible tobacco to a potentially less harmful form of nicotine delivery, these products – like all tobacco products – pose risk, and should not be used by kids. Years of progress to combat youth use of tobacco – to prevent lifetimes of addiction to nicotine – is now threatened by an epidemic of e-cigarette use by kids. We must also keep our nation's youth from using dangerous combusted tobacco products like cigars. As part of our Youth Tobacco Prevention Plan, we will maintain our energy and focus on using our authorities forcefully to prevent kids from getting their hands on tobacco products, with a particular emphasis on the threat of youth vaping.

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.

Media Inquiries: Michael Felberbaum, 240-402-9548, michael.felberbaum@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

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SOURCE U.S. Food and Drug Administration

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on the agency's actions to tackle the epidemic of youth vaping and court ruling on application submission deadlines for certain tobacco products, including e-cigarettes

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Last Updated: 15-Jul-2019