The latest data, not yet published, show a 75 percent increase in e-cigarette use among high school students this year, compared with 2017. The FDA declined to publicly release the numbers, but people familiar with them said they were preliminary data from the National Youth Tobacco Survey, on which the agency and the Centers for Disease Control and Prevention collaborate.
In a speech to FDA employees, Gottlieb said that rapid growth in teen use, emerging sales trends and concerns among parents and teachers convinced him that underage use of e-cigarettes has become a full-blown crisis that must be forcefully addressed. “The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end,” he said.
In its enforcement action, the FDA recently sent almost 1,200 letters to brick-and-mortar stores and online retailers warning them that they could face penalties for allegedly selling e-cigarettes to people younger than 18. The agency also imposed fines — ranging from $279 to $11,182 — on an additional 130 establishments for repeated offenses.
Among those targeted were locations of Walgreens, Walmart, 7-Eleven, Circle K, and Citgo and Exxon gas stations.
Even more significant, notices sent on Wednesday morning demand that five leading e-cigarette manufacturers, including San Francisco-based Juul Labs, submit plans within 60 days detailing ways to sharply curb sales to underage consumers. If the blueprints don’t promise to “substantially reverse” the youth-use trend, Gottlieb said, the agency will consider steps that could lead to the temporary or permanent removal of flavored products from the market.
Such a step would be a major blow to the e-cigarette companies — Juul, Vuse, Blu, Logic and MarkTen — which often feature cream and fruit flavorings such as mango, melon and “cherry crush” in their products. Many public-health groups believe such flavors entice young people to try vaping. The companies insist that the flavors are critical to helping nicotine-addicted adult smokers switch from conventional cigarettes.
Gottlieb’s announcement drew quick praise from major anti-tobacco organizations.
“This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. It will be a “fundamental turning point,” he added, though only if the agency formally requires all manufacturers to comply and to immediately undergo pre-market review.
Robin Koval, chief executive of Truth Initiative, urged fast follow-up to rein in the e-cigarette makers and cautioned against any promises of voluntary action. “There’s no track record for this industry being able to police themselves on a voluntary basis,” she said.
The commissioner has repeatedly agreed that e-cigarettes can be an effective tool for adults trying to quit smoking, so his harsh words for the industry on Wednesday were all the more remarkable.
The Vapor Technology Association, a nonprofit group with more than 600 industry members, called the move “a giant step backwards” that it blamed in part on “hysterical public health groups.”
“By threatening an industry — and technology that millions of adult smokers are successfully using to reduce or quit smoking deadly cigarettes — FDA is venturing into dangerous territory,” a statement from the association said.
In his remarks to FDA staffers, Gottlieb acknowledged that some adults might get hurt by a crackdown on flavored e-cigarettes. But “the youth risk is paramount,” he said. “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.”
A National Academies of Sciences, Engineering and Medicine report in January found that while e-cigarettes are far less harmful than conventional cigarettes, which produce a raft of toxic substances when burned, they still pose health risks. And though the devices may help adults quit smoking, the report said evidence shows their use increases the risk of young people eventually moving to traditional cigarettes.
Gottlieb echoed those concerns, saying that he was worried about the effects of nicotine in e-cigarettes on the developing brain and that a proportion of teenagers who use the devices will end up on regular cigarettes.
Kevin Burns, chief executive of Juul Labs, said Wednesday that the company "will work proactively with FDA in response to its request. . . . We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people."
Altria, which owns MarkTen, said in a statement that it welcomed the FDA's action and looked forward "to sharing our thoughts about how to prevent and reduce youth use, an issue we have focused on for decades. We strongly believe kids shouldn't use any tobacco products."
The FDA’s regulation of tobacco products has long been marked by twists and turns and lengthy debate. In 2009, the Tobacco Control Act gave the agency authority over cigarettes and smokeless tobacco. In 2016, the agency “deemed” that products such as e-cigarettes also were under its jurisdiction and told companies to file applications to market their products by August 2018. Sales were allowed to continue in the interim.
A few months after being sworn in as commissioner last year, Gottlieb announced a new comprehensive tobacco framework. It included plans to reduce nicotine in conventional cigarettes to nonaddictive levels. And it highlighted e-cigarettes’ role as a way for adult smokers to transition off cigarettes.
Gottlieb used “enforcement discretion” to extend the deadline for e-cigarette makers’ marketing applications until 2022, saying both the agency and the industry needed more time to prepare. The delay was denounced by public-health groups, which have sued to restore the tighter timeline.
The agency remains committed to the tobacco framework, Gottlieb told staffers Wednesday, but he acknowledged that it “didn’t predict what I now believe is an epidemic of e-cigarette use among teenagers.”
One possible remedy, he said in an interview, would be to revoke the application delay for cartridge-based e-cigarettes, the most common type used by young people. That would block manufacturers from selling the flavored devices without explicit FDA authorization — a move that could force some products off the market, temporarily or permanently.
As part of Gottlieb’s announcement, the FDA also said that it is investigating whether some e-cigarette companies introduced new products after Aug. 8, 2016, without getting the required authorization from the agency. That could mean the products are on the market illegally.
Much of the FDA’s sharp change in course is a result of the phenomenal success of the Juul vaping device, which looks like a USB flash drive. In just three years, it has captured about 70 percent of the e-cigarette market, according to a Wells Fargo analysis of Nielsen sales data. The FDA has pressed Juul in recent months for information about its marketing.
“Juul was a game changer,” Myers said. He listed three reasons the company became so successful: It figured out how to deliver high levels of nicotine in a way that wasn’t harsh; it packaged the product in a streamlined, clever way; and it developed a social media and advertising campaign that made a Juul e-cigarette “cool and hip.”
The company has stressed that the device was created for adults who want to transition from regular cigarettes. This year, as criticism of the company mounted, it committed $30 million over the next three years for independent research, youth and parent education and community engagement. It also announced a new social media policy that features adult smokers — not models — and their stories of switching to Juul.
Still, Myers said, there’s “no way to put that genie back in the bottle” with youth use. “Now that Juul has shown how to market to adolescents and young adults, others are using the same marketing tactics.”
Flavors other than menthol have been banned since 2009 in regular cigarettes to reduce their appeal to young people. No flavors currently are restricted from other tobacco products.