FDA to expand public education campaign to focus on prevention of youth e-cigarette use

FDAToday, the U.S. Food and Drug Administration announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids. The agency plans to expand its "The Real Cost" public education campaign to include messaging to teens about the dangers of using these products this fall while developing a full-scale campaign to launch in 2018. These efforts are part of the agency's new comprehensive plan for tobacco and nicotine regulation, as well as ongoing efforts to educate youth about, and protect them from, the dangers associated with using all tobacco products. It is the first time the FDA will be utilizing public health education to specifically target youth use of e-cigarettes or other ENDS.

"While we pursue a policy that focuses on addressing the role that nicotine plays in keeping smokers addicted to combustible cigarettes, and to help move those who cannot quit nicotine altogether onto less harmful products, we will also continue to work vigorously to keep all tobacco products out of the hands of kids," said FDA Commissioner Scott Gottlieb, M.D. "Educating youth about the dangers of tobacco products has been a cornerstone of our efforts to reduce the harms caused by these products. Including e-cigarettes and other ENDS products in our prevention work not only makes sense, it reflects the troubling reality that they are the most commonly-used tobacco product among youth."

More than 2 million middle and high school students were current users of e-cigarettes and other ENDS in 2016. Data also show about half of all middle and high school students who were current tobacco users also used two or more tobacco products last year. This use by children and teens is especially concerning because of evidence that youth exposure to nicotine affects the developing brain and may rewire it to be more susceptible to nicotine addiction in the future.

The FDA's recently announced plan puts nicotine and the issue of addiction at the center of the agency's efforts. This policy aims to strike a careful balance between the regulation of all tobacco products, and the opportunity to encourage development of innovative tobacco products that may be less dangerous than combustible cigarettes. But, importantly, the approach also continues to focus on the need to reduce the access and appeal of all tobacco products to youth, including e-cigarettes and other ENDS, and maintains all of the existing regulations that currently apply to these products.

To re-double efforts to address the concerning youth use of these products, the FDA will capitalize on its already well-known "The Real Cost" campaign this fall by releasing new digital materials that are targeted to youth and focused on ENDS. This will include online videos to educate kids about the dangers of using e-cigarettes or other ENDS. Among the messages that will be part of the campaign is the potential for nicotine to rewire a teen's brain and create cravings that can lead to addiction. At the same time, the agency also is undertaking an effort to shape a new, full-scale campaign that is exclusively focused on youth use of ENDS. The FDA plans to launch this new, more extensive content in 2018.

Since its launch in February 2014, the FDA's "The Real Cost" campaign has proven to be successful, with a recent evaluation concluding that the campaign prevented nearly 350,000 youth aged 11 to 18 nationwide from initiating smoking from 2014 to 2016. With nearly 2,500 youth under the age of 18 in the United States trying their first cigarette each day, youth tobacco prevention campaigns remain essential to protecting public health.

The campaign is just one component of the agency's efforts to restrict youth access, limit youth appeal and reduce toxic exposure to youth from all tobacco products. The FDA continues to enforce important existing regulations specifically aimed at addressing youth access to ENDS and other newly-regulated products, including banning the sale of tobacco products to youth under age 18, requiring age verification by photo ID, and prohibiting free samples. Since August 2016, the FDA has issued over 6,400 warning letters to brick and mortar and online retailers for selling newly-regulated tobacco products such as e-cigarettes to minors.

As previously announced, the FDA also is exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive with an intense focus on youth. In particular, the agency is pursuing product standards for ENDS that would address known risks. This could include measures on battery safety, flavors/designs that appeal to youth, child-resistant packaging, and product labeling to prevent accidental child exposure to liquid nicotine. The FDA also intends to seek public comment on the role that flavors in tobacco products play in attracting youth. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS, including restrictions on how products may be sold and advertised, to further reduce youth exposure and access to these products.

"The FDA has a multi-pronged effort to protect kids from using any nicotine-containing product, including e-cigarettes," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. "As we continue to learn more about these products and their relationship to youth, the agency will be better prepared to help address the issue of youth use through science-based educational efforts and regulatory policies that will ultimately pay the greatest dividends in reducing tobacco-related disease and death."

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

Most Popular Now

Cannabis extract helps reset brain function in psy…

Research from King's College London has found that a single dose of the cannabis extract cannabidiol can help reduce brain function abnormalities seen in people with psyc...

For first time in 40 years, cure for acute leukemi…

Acute myeloid leukemia is one of the most aggressive cancers. While other cancers have benefitted from new treatments, there has been no encouraging news for most leukemi...

New cancer treatment uses enzymes to boost immune …

Researchers at The University of Texas at Austin have developed a new approach to treating cancer using enzyme therapy. The enzyme, PEG-KYNase, does not directly kill can...

Bayer accelerates six new startups

Changing the experience of health: that's the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year. The young companies fr...

Novartis receives European Commission approval of …

Novartis today announced that the European Commission (EC) has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pe...

Shire completes sale of oncology franchise

Shire plc (LSE: SHP, NASDAQ: SHPG) announces today that it has completed the sale of its Oncology franchise to Servier S.A.S. for $2.4 billion. The franchise includes the...

Antioxidant reduces risk for second heart attack, …

Doctors have long known that in the months after a heart attack or stroke, patients are more likely to have another attack or stroke. Now, a paper in the Journal of the A...

Novartis to divest the Sandoz US dermatology busin…

Novartis today announced it has agreed to sell selected portions of its Sandoz US portfolio, specifically the Sandoz US dermatology business and generic US oral solids po...

New tablet production facility in Ingelheim: Cente…

Boehringer Ingelheim held a groundbreaking ceremony for the construction of a new production facility for innovative drugs. This new Solids Launch facility will focus on ...

SOLAR-1 trial of Novartis investigational alpha-sp…

Novartis today announced the global Phase III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint s...

Tezepelumab granted Breakthrough Therapy Designati…

AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab...

Pfizer terminates domagrozumab (PF-06252616) clini…

Pfizer Inc. (NYSE: PFE) announced that it is terminating two ongoing clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrop...