FDA launches public education effort to prevent youth e-cigarette use: Advocacy group wants agency to speed up new requirements.

Abstract

A YouTube video shows images of teenagers engaging in typical teen activities: carrying skateboards, bowling, going out to eat, … and vaping. It concludes with the message, “Vaping can deliver nicotine to your brain, reprogramming you to crave more and more. Don't get hacked.” The digital media spot, which aired on multiple social media channels and other online sites last fall, is part of the new US Food and Drug Administration (FDA) campaign to discourage kids from using electronic cigarettes, or “e-cigarettes,” and other electronic nicotine delivery systems (ENDS). These devices may be called “vapes,” “vaporizers,” “vape pens,” “hookah pens,” or “e-pipes,” but they all involve a liquid that is heated into an aerosol that the user inhales. That liquid may contain nicotine, as well as flavorings, propylene glycol, vegetable glycerin, and other ingredients in varying quantities. The FDA is developing more public education ads targeting youth about the risks of e-cigarettes and other ENDS devices, and plans to roll out a full-scale campaign this fall. The effort is an extension of the agency's “Real Cost” campaign, launched in 2014 to educate youth about the dangers of smoking cigarettes, and shown to have prevented nearly 350,000 youth from 11 to 18 years of age nationwide from initiating the habit. Tobacco control advocates point to great success in reducing youth smoking rates. Cigarette smoking among high school students has fallen to an all-time low of 8% in 2016, a 72% decrease from 1999 levels according to the federal government's 2016 National Youth Tobacco Survey.1 “We believe we've made significant strides in driving down smoking and reaching an incredibly high level of awareness about the health consequences, and we wanted to apply that same strategy toward reducing teen e-cigarette use,” says Kathleen Crosby, director of the office of health communication and education at the FDA's Center for Tobacco Products. The data show that more than 2 million middle and high school students used e-cigarettes and other ENDS in 2016, and that approximately half of current users in this age group also used 2 or more tobacco products last year. Youth usage rates of ENDS have increased since the products came on the market. For example, from 2011 to 2015, e-cigarette use rose from 1.5% to 16% among high school students and from .6% to 5.3% among middle school students. And, although that 16% figure for high school students did decline to 11.3% in 2016 according to the 2016 National Youth Tobacco Survey, progress is far from over, notes Matthew Myers, president of the Campaign for Tobacco-Free Kids. He points out that 1 in 5 high school students still use some form of tobacco.1 “When it comes to kids, we don't think there's any safe level of tobacco use,” Crosby says. “No one understands the long-term consequences of teens starting to use ENDS now and what [those consequences] will mean for them.” A congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine issued in January 2018 finds that the long-term health effects of e-cigarettes are not yet clear.2 It goes on to conclude that among youth, who use these products at higher rates than do adults, “there is substantial evidence that e-cigarette use increases the risk of transitioning to smoking conventional cigarettes.” The study recommends more and better research on the short- and long-term health effects of e-cigarette use, as well as the devices' relationship to conventional smoking. In 2016, the FDA finalized a rule that gave the agency regulatory authority over all tobacco products, including e-cigarettes and other ENDS that meet the definition of a tobacco product. As a result, the FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of these devices. Among the requirements of that rule are the prohibition of sales to children under age 18, and the presence of warning labels on packaging. Advocacy groups like the Campaign for Tobacco-Free Kids laud these new measures, as well as current public education efforts from the FDA. However, they also believe that the agency should move faster to enforce certain elements of the new law, especially in regard to flavored e-cigarettes that appeal to kids. “Although we think it's a very good step to educate kids, parents, and teachers that these products are not harmless for kids, the campaign is not a substitute for effective regulation of e-cigarettes,” says Vince Willmore, vice president for communications at the Campaign for Tobacco-Free Kids. At issue, he says, is the FDA-sanctioned, extended timeline for companies to submit tobacco product review applications for the newly regulated e-cigarettes and ENDS on the market. The rule, which went into effect on August 8, 2016, gives companies until that same date in 2022 to submit applications. The deadline had previously been November 8, 2018, according to Willmore. “The delay allows these products to stay on the market,” he says. “And currently, e-cigarettes are sold in thousands of flavors like ‘gummy bear’ and ‘cotton candy’ that appeal to kids. We think that was a serious error by the FDA.” The FDA maintains that it needs time to explore clear measures of ways that tobacco companies might make products less toxic, and less appealing and addictive. One measure might be to develop standards to protect against public health risks and exposure to liquid nicotine. The agency further states in a news release that the aforementioned extended deadline “also will provide manufacturers additional time to develop higher quality, more complete applications.” The FDA plans to seek public input on approaches to regulating kid-appealing flavors in e-cigarettes and cigars, and it submitted a proposed rule on the issue to the federal Office of Management and Budget (OMB) in December 2017. (As of early February, the proposal was still pending review by the OMB according to FDA spokesperson Michael Felberbaum.) —Kathleen Crosby, FDA Center for Tobacco Products Carla Berg, PhD, a clinical psychologist and associate professor in the department of behavioral sciences and health education in the Rollins School of Public Health at Emory University in Atlanta, Georgia, has conducted research in e-cigarette use among young adults ages 18 to 25, and says the devices are still controversial among the tobacco control community. For instance, she points out, the effectiveness of e-cigarettes in helping smokers quit needs to be further researched. And smokers need to know that these devices are much less harmful than cigarettes. However, at the same time, young people need to be warned about the risks of initiating use of the products, she says. Toward that end, the FDA is meeting with focus groups of teenagers in 4 select cities this spring to gain input toward developing a more comprehensive e-cigarette public education campaign that will launch this fall, Crosby says. Although thorough evaluations of the campaign's impact will not occur until the following year, “The fact that we've had more than 1.5 million views on YouTube and a lot of questions from teens about the risks of ENDS on our social media channels sends a good sign,” she adds. “The biggest take home is that all of these harm reduction products are really complex, and so is the potential impact on the population,” says Dr. Berg. “It's really important that we consider the audience.”