In an unusually candid letter, the Food and Drug Administration chief, Scott Gottlieb, announced on Wednesday that the agency could intensify its crackdown on e-cigarettes in the face of an “epidemic” of teen use — a trend that’s caught the agency off guard.
“I use the word epidemic with great care,” Gottlieb wrote. “E-cigs have become an almost ubiquitous — and dangerous — trend among teens.”
The verbose letter says the FDA is currently considering how to address the spiraling problem of youth vaping. Most surprisingly, Gottlieb said the agency could go as far as banning or curtailing access to and marketing of flavored e-cigarette products. The agency is also eyeing moving up the 2022 compliance deadline for the regulation of e-cigarette products that were on the market before 2016.
Why now? Gottlieb says the agency has new data on e-cigarette use in teens (presumably to be released soon) that suggests tough action is urgently needed. There have also been recent warnings from health researchers writing in the New England Journal of Medicine and other journals that e-cigarettes are more dangerous than many people currently realize.
This doesn’t mean e-cigarettes will go away anytime soon, though. In the letter, Gottlieb was clear that he’s committed to tobacco harm reduction and ensuring adult smokers who want to quit have access to e-cigarettes. But, he wrote, “in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”
“This is a very forthright message about the delicate balance in trying to pursue a harm reduction strategy for vaping products,” said University of Waterloo public health researcher David Hammond. Helping smokers quit while ensuring kids aren’t getting hooked on nicotine isn’t an easy balance to strike, he added. It’s something health regulators around the world are grappling with, and it’s shaping up to be one of Gottlieb’s greatest public health challenges.
Gottlieb’s harm reduction approach to e-cigarettes has been controversial because of the rise in teen vaping
Tobacco is still the leading cause of preventable death in the United States. And since his first days on the job, Gottlieb has struggled with how to address e-cigarettes in that context.
In July 2017, the FDA delayed the compliance deadline for the regulation of e-cigarette products to 2022. This gave the industry five more years to file public health applications that show that their products are safe alternatives to conventional cigarettes and that they weren’t unduly targeting minors.
Gottlieb positioned the delay as a way to give manufacturers time to get in step with the new laws while ensuring smokers had access to cigarette alternatives that could save their lives.
But some public health advocates viewed it another way: as a giveaway for the vaping industry, and a chance for e-cigarette makers to further expand their market share among kids at a time when e-cigarette use by teens has eclipsed conventional cigarette use.
“In this world, a delay of [five] years is a lifetime,” Matt Myers, president of the Campaign for Tobacco-Free Kids, told Vox last spring. “And the data seems to indicate this product is being used by kids all across the country.”
Meanwhile, the e-cigarette market has continued to grow. In 2017, the US market expanded by 40 percent, to $1.16 billion, with a lot of that growth driven by Juul, a leading vaping device that’s controversially appealing to youth. As of March, Juul made up more than half of all e-cigarette retail market sales in the US, according to Nielsen data. Considering it has only been on the market since 2015, and there are hundreds of other devices available to consumers, Juul’s market share is staggering.
More recently, the FDA has been taking action against Juul and teen e-cigarette use — but has stopped short of changing that compliance deadline. In April, the FDA took the unusual step of demanding Juul Labs submit documents about its marketing and research and what it knows about Juul use among young people. The move was part of the FDA’s new Youth Tobacco Prevention Plan.
In May, the agency followed up by sending requests for information to four other e-cigarette makers that also appear to be marketing to young people.
On Wednesday, the agency announced it has again sent warning letters to Juul Labs and the manufacturers of other vaping devices, giving them 60 days to come up with plans that minimize their products’ appeal to minors. It’s also warned more than 1,000 retailers that are illegally selling e-cigarettes to minors to stop.
“FDA is showing willingness to be flexible as the reality changes,” said David Liddell Ashley, a former director of the office of science in the Center for Tobacco Products at the FDA. “FDA, in general, is not an organization that changes directions rapidly. But they are realizing that in a rapidly changing market like e-cigarettes, they have to be able to adjust rapidly also.” But is FDA moving fast enough?