Statement on the measures taken by the agency to combat the youth vape epidemic and a judicial decision on the filing deadlines for certain tobacco products, including e-cigarettes

At the end of last week, a judge of the US Federal Court of Maryland issued a ruling that required manufacturers and importers of electronic cigarettes and other electronic nicotine delivery systems (ENDS) and certain other tobacco products. such as cigars, pipe tobacco and narghile. submit applications for their products currently marketed to the agency within 10 months.

This court decision comes at a time when, like many others, I am extremely concerned about the growing consumption of electronic cigarettes among young people in our country and in particular the potential they have for becoming traditional smokers. We can not allow the next generation of young people to become addicted to nicotine because of e-cigarettes. I am only too aware of the heavy toll of public health on tobacco products. As someone who has dedicated my life to reducing the burden of public health and the suffering caused by cancer, the importance of preventing youth addiction to nicotine sounds particularly good in my mind.

The FDA is ready to speed up the review of electronic cigarettes and other new tobacco products. And we remain committed to tackling the vaping epidemic among young people using all available regulatory tools. We will continue to take strong measures to ensure that e-cigarettes and other tobacco products are not marketed or sold to children. We will continue to expand our very successful education efforts, such as the "The Real Cost" campaign, to educate youth about the dangers of using tobacco products, including e-cigarettes. And we will continue to implement the necessary policies to ensure that American children do not end up with e-cigarettes and all tobacco products.

Our ongoing monitoring of e-cigarettes and other ENDS products is critical to our public health mission and, in particular, to protecting children from the dangers of nicotine and tobacco-related illnesses and deaths. The judge's decision promptly encourages the agency to receive and review applications to assess the public health benefits and harms of a product and to ensure that any product authorized for marketing is appropriate for the protection of health public. It is important to note that the judge acknowledged the agency's work to provide a clear framework and guidance to companies seeking to market e-cigarette and ENDS products as they prepare their applications.

Let's be clear with the tobacco industry: Responsible manufacturers certainly do not need to wait 10 months to act. We have outlined our recommendations on what the FDA hopes to include in e-cigarette pre-commercialization applications. We have also provided a number of resources to help the industry present its proposals for other products and assist the agency in fulfilling its public health mandate. We encourage the industry to use these resources now as a guide for their submissions to the agency.

In addition, we will continue to take decisive action to address the e-cigarette epidemic among youth through compliance, awareness and enforcement. The agency remains particularly committed to finalizing the compliance policy we proposed in March to limit youth access to flavored tobacco products such as electronic cigarettes and cigars as soon as possible. The development of the compliance policy is one of the most critical public health measures that the FDA can take to curb the vaping of young people and combat the use of youth-flavored cigars.

Later this month, we will also launch our first TV commercials on e-cigarette prevention, as part of the e-cigarette prevention campaign for young people, called "The Real Cost," on the dangers of e-cigarettes. use of the electronic cigarette. As we approach the first anniversary of the campaign, we also plan to distribute new posters for US high schools early in the new school year and develop educational materials for colleges across the country. This public education effort was launched in September 2018 with compelling commercials on digital and social media sites, as well as posters with e-cigarette prevention messages in high schools across the country, targeting 10.7 million young people aged 12 to 17. have used electronic cigarettes or are willing to try them.

In addition to the work of the public education campaign to combat this growing use among children, we have taken a number of steps to combat the illegal sale of e-cigarettes to young people, as well as other actions aimed at target child-friendly marketing that increases consumer appeal. these products to youth.

From April 2018 to April 2019, the FDA sent over 3,950 warning letters and more than 665 monetary penalties (fines) to physical sellers and online retailers for illegal sales of electronic cigarettes and cigarettes. Other ENDS products, including e-liquids. to minors. The FDA has also taken action – often in collaboration with the Federal Trade Commission – against more than 15 companies for selling e-liquids that look like child-friendly foods, such as juice boxes, cereals and sweets; and sent warning letters to four companies that manufacture, advertise and offer for sale or distribution several flavored e-liquid products in the event of a violation of the online publications by social media influencers on behalf of each company, including including non-compliance with the required nicotine warning. The FDA also continues to investigate counterfeit electronic cigarette products and determine whether companies are introducing new electronic cigarettes in violation of pre-market authorization requirements.

We have also undertaken 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 and a separate science workshop to discuss efforts to eliminate the use of e-cigarettes by youth and other tobacco products, with a focus on the potential role of pharmacotherapies in the fight against smoking cessation and the problems that affect their development. therapies for young people.

While some ENDS products may be promising to help addicted adult smokers switch from fuel tobacco to a potentially less harmful form of nicotine, these products – like all tobacco products – are at risk and should not be used by children . Years of progress in tackling youth smoking – to prevent long-term nicotine addiction – are now threatened by an epidemic of electronic cigarette use by children. We must also prevent young people in our country from using dangerous burned tobacco products like cigars. As part of our youth smoking prevention plan, we will maintain our energy and focus on the use of our authority to prevent children from getting their hands on tobacco products, by putting a special focus on the threat of youth vaping.

The FDA, an agency of the US Department of Health and Social 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, food supplements, products emitting electronic radiation and the regulation of tobacco products.

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