Today, the Food and Drug Administration (FDA) officially announced plans to limit the sale of sweet-flavored e-cigarette products in places where people under the age of 18 can freely shop. The agency will also take aim at flavored cigars and menthol-flavored cigarettes in an effort to keep kids from getting hooked on any products that contain nicotine.
This isn’t a complete ban on flavored e-cigarette products, and it’s weaker than the proposal that was teased last week before the FDA officially announced it. All e-liquids — in pods, bottles, and cigalikes — in traditional tobacco flavors, as well as mint and menthol, can stay on the shelves of convenience stores and gas stations. Stores can sell products in more kid-friendly flavors only if they don’t let in underage consumers, or if the products are placed in an age-restricted section where kids can’t see them, much less buy the merchandise. E-cigarette manufacturers can continue to sell their fruity- and dessert-flavored cartridges online, provided they have adequate age verification measures in place.
“That’s 1.5 million more students.”
The move is an effort to curb what FDA Commissioner Scott Gottlieb has been calling an epidemic of vaping. Today, the FDA and CDC revealed why: 3.6 million high school and middle school students are using e-cigarettes, according to long-awaited results from the National Youth Tobacco Survey that the FDA released today. “That’s 1.5 million more students using these products than the previous year,” Gottlieb says in a statement. For high school students, that’s a 78 percent spike compared to last year. For middle school students, it’s a 48 percent increase. The majority of these students report that they vape flavored products.
The appeal of flavored products isn’t new; previous research reports that flavor preferences drive vaping more for adolescents than for adults. “It’s the exact reason that flavored cigarettes were banned. We’re not reinventing anything here, we’ve already lived this,” says Meghan Morean, a psychology professor at Oberlin College who has studied the appeal of flavors. And a massive report from the National Academy of Sciences, Engineering, and Medicine suggests that kids who start vaping are more likely to try cigarettes than their peers.
This new report of skyrocketing vaping in high schools and middle schools has ignited a push for more regulation. “These increases must stop,” Gottlieb says. “I will not allow a generation of children to become addicted to nicotine through e-cigarettes.”
“These increases must stop.”
The restrictions announced today won’t go into effect immediately, although different components can unfold faster than others. Experts think that increased restrictions on the sale of flavored products will happen relatively quickly, because they wouldn’t technically involve changing existing regulations. Instead, the FDA will revisit an extension the agency gave to cigar and e-cigarette companies in 2017 that has allowed products that hit shelves between 2007 and 2016 to stay on the market without prior FDA authorization.
The original plan was that e-cigarette and cigar manufacturers had until 2018 to submit applications to keep new products on the market, and they could stay there for another year while the FDA reviewed those applications. But in 2017, the FDA extended that application deadline until 2021 for cigars, and 2022 for electronic cigarettes. And until those applications are in, there’s still a lot that the FDA doesn’t know about how these products are made and marketed.
That 2022 deadline will still be in place for the mint, menthol, and tobacco flavored products, Mitch Zeller, director of the FDA’s center for tobacco products, said in a press briefing. The changes the FDA is looking for would limit the sale of flavored e-cigarette products to in-person or online locations with strict age restrictions. “It doesn’t have to go through the formal rule-making process — it’s essentially something the FDA can just do,” says Micah Berman, an associate professor of public health and law at The Ohio State University.
“If it’s really urgent they sell unicorn puke e-liquids ... it better be an age restricted location.”
If manufacturers are caught continuing to sell fruity and dessert-flavored products in non-age restricted locations, they’ll have to pull them and wait for the FDA to authorize them for sale. “If it’s really urgent they sell unicorn puke e-liquids, and if they want to sell a product like that, it better be an age restricted location,” Zeller says. “If it’s not, and if we see it, that product is going to have to come off the market.”
The new policies would also ban the sale of what are considered “new” flavored cigar products that hit the market between 2007 and 2016 until the manufacturers apply for and receive FDA authorization. Young cigar smokers are more likely to use flavored products than adults, the FDA says, so the goal is to keep kids from getting started on cigars and nicotine in the first place.
The agency plans to give the market some time to transition — so all told, it could take months before we actually see these restrictions finalized. Still, in today’s statement, FDA Commissioner Gottlieb says that he hopes manufacturers won’t wait for that. Within the next 90 days, the agency wants to see manufacturers voluntarily take flavored vape products off shelves or websites where kids can access them.
“This is action that is long, long overdue.”
A comprehensive ban on all flavored cigars — even those that hit shelves before 2007 — as well as menthol-flavored cigarettes and cigars, will take a little longer. Those regulations will have to go through the FDA’s rule-making process, which will include a period of public comment and time to review those comments. “That rule-making process will still take a couple of years,” Berman says. “This is action that is long, long overdue.”
Public health officials, including a federal advisory committee, have long warned that menthol cigarettes are especially appealing to young people and have been disproportionately marketed to communities of color. In today’s statement, Gottlieb acknowledged that menthol cigarettes are, and have been, a problem: “I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes.”
On the e-cigarette side, today’s announcement is the culmination of months of back and forth between the FDA and major e-cigarette companies, including vaping giant Juul. In April, the agency asked Juul for information that might explain why the vape is so popular among teens. The FDA conducted a surprise inspection of the company’s San Francisco headquarters earlier this fall, and seized more than a thousand pages of documents.
In September, the agency gave Juul and the companies behind MarkTen, Vuse, Blu, and Logic e-cigarettes 60 days to come up with plans to keep their products out of teens’ mouths. Juul voluntarily announced its own plan on Tuesday. It included cutting its supply of fruity and dessert-flavored nicotine pods to brick-and-mortar stores, and vacating its Facebook and Instagram pages. (The accounts are still online and still have followers. They’re just empty.)
“Juul and FDA look like good guys.”
The back-to-back announcements from Juul and the FDA were savvy moves by the company that’s come under fire for its popularity among teens, and the agency that’s been criticized for under-regulating the e-cigarette industry. “Juul announces voluntary action to get good guy media coverage,” Kathleen Hoke, a law professor at the University of Maryland, tells The Verge in an email. Then when the FDA announces what Juul has already agreed to, she says, “Juul and FDA look like good guys.”
Still, the FDA’s restrictions are late and limited, Berman says. If the FDA had stuck with its original timeline for premarket review, “the FDA would be in a very different position.” As it stands, we’ve seen Juul take off since the agency extended the deadline, and it now dominates more than 70 percent of the market, according to CNBC. Youth vaping rates have continued to climb and there’s still a lot to learn about the long-term effects of vaping. “Because we don’t have premarket review, we still don’t have a whole lot of data about these products,” Berman says. “We don’t know what the companies know, and we’re not going to unless we start going through this process.”
“We’re wide-eyed about this.”
It’s hard to say what the effects of the ban will be over the long term, Morean says. It could play out in a few different ways. If the main driver of youth vaping is those sweet flavors, she says, “one option would be that we’ll see a dramatic decrease in the amount of kids who are up-taking these products.” But if the draw to vaping is really the device, like Juul, kids might just switch to the pods that are still on shelves. “Especially the cooling flavors, like mint or menthol, because we see kids are more likely to start using tobacco cigarettes that are menthol flavored,” Morean says.
That’s why Gottlieb put e-cigarette companies on notice, and if kids keep using menthol or mint-flavored pods, they’ll have to reconsider the policy. Going forward, Gottlieb is hopeful these steps will make a dent in the rise of youth vaping. “We’ll never eliminate any youth experimentation. We’re wide-eyed about this,” he said in a press briefing. “But levels of youth use and the growth in the youth use that we see simply are intolerable.”