Abstract
In recent weeks, the FDA has taken steps to address underage use of e-cigarettes: The agency has identified and warned retailers selling to minors, issued warning letters to companies selling e-cigarette cartridges in adolescent-appealing packaging, and requested information from e-cigarette companies. The steps are part of the FDA's ongoing effort to prevent middle- and high-school students from using e-cigarette products.
In recent weeks, the FDA has taken steps to limit the use of electronic cigarettes (e-cigarettes) among adolescents—cracking down on retailers selling to minors, warning companies about packaging that appeals to children, and requesting information from device manufacturers.
“The basic public health concern is that no kid should be initiating on any nicotine-containing product,” says Mitchell Zeller, JD, director of the FDA's Center for Tobacco Products.
According to the Centers for Disease Control and Prevention, e-cigarettes—which vaporize a nicotine-containing liquid that is then inhaled—are popular among adolescents. Moreover, usage is climbing—in 2011, 0.6% of middle schoolers and 1.5% of high schoolers had tried an e-cigarette in the past 30 days, compared with 4.3% and 11.3%, respectively, in 2016.
The FDA is particularly concerned about JUUL e-cigarettes and similarly designed devices. “These products look like USB sticks, have very high levels of nicotine, and because of the way the products are designed, apparently can be used much more discreetly,” Zeller says.
Since March, the FDA has issued 40 warning letters to retailers caught selling JUUL products to minors, and in April, the agency started an enforcement blitz to identify additional retailers illegally selling e-cigarettes. The FDA also issued warning letters to companies selling e-cigarette cartridges in packaging that resembles products appealing to children, such as juice boxes. The letters inform companies they have violated federal statutes and give them 15 days to explain how they will remedy the violations. In addition, the agency sent letters to JUUL Labs and five other e-cigarette makers demanding product information.
“A big part of the ‘document demand’ is for research that they've done—research on every aspect of the potential health effects and behavioral consequences of using the product,” Zeller says.
In response, JUUL Labs announced a strategy to combat underage use that includes research and education. The company and proponents of e-cigarettes maintain that the devices are less harmful than conventional cigarettes and may aid in smoking cessation.
However, others say the FDA's efforts are insufficient, particularly after the agency last year extended the application deadline for review of e-cigarettes on the market as of August 2016 from 2018 until 2022.
“What we have seen is some initial action from FDA, but certainly not the type of action that's necessary to address the problem,” says Erika Sward of the American Lung Association, one of several groups suing the FDA over the extension. The groups also wrote to the FDA, outlining concerns about JUUL products. “It really gets back to the idea that none of these products have gone through premarket review and are sitting on the market indefinitely.”
Zeller emphasizes that the extension must be considered within the context of all tobacco and nicotine regulations, which focus on the conventional cigarette as “the fundamental public health problem.”
Moreover, with more time to understand the science of e-cigarettes and put “rules of the road” in place for manufacturers, Zeller thinks the review process will be more efficient and transparent. He says he hopes the agency's recent actions make it clear that every other aspect of the statutory requirements remains in effect—and will be enforced.
Jennifer Grandis, MD, of the University of California, San Francisco, and the American Association for Cancer Research's Tobacco and Cancer Subcommittee, considers the FDA's recent actions to be “moving in the right direction.” However, she notes that although data is lacking on e-cigarettes, decades of data show the harm caused by other tobacco products.
“Now we have a new actor, and the actor has a new costume, and new flavors; it's a different kind of delivery device, but there's no reason to expect it won't be damaging,” she says. Resources must be devoted to generating data, particularly from animal models, about potential harms. Until then, “at the very, very least, these products absolutely have to be banned from falling into the hands of people who are not adults.” –Catherine Caruso
