"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.