FDA seeks halt to teen vaping ‘epidemic’

Food and Drug Administration Commissioner Scott Gottlieb has dramatically escalated his efforts to stop an “epidemic” of teenage vaping, announcing Wednesday a massive enforcement action against retailers for allegedly selling e-cigarettes to minors. He also warned manufacturers of a potential ban of flavored e-cigarette liquids.

Officials said the move against more than 1,300 retailers was the largest coordinated enforcement action in the agency’s history. The threatened ban, if carried out, would significantly upend the fastgrowing industry.

The latest data, not yet published, show a 75 percent increase in ecigarette 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 spike in teen use, emerging sales trends and concerns among parents and teachers convinced him that underage use of e-cigarettes has become a fullblown 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 sent almost 1,200 letters to brick-and-mortar stores and online retailers warning them that they could face penalties for selling e-cigarettes to people under 18. The agency also imposed fines — ranging from $279 to $11,182 — on 130 more establishments for repeated offenses.

Among stores targeted were Walgreens, Walmart, 7-Eleven, Circle K and Citgo and Exxon gas stations.

Also, notices sent Wednesday to five leading e-cigarette manufacturers, including San Franciscobased Juul Labs, demand that the companies submit plans within 60 days detailing ways to 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 in their products. Many publichealth groups believe such flavors entice young people to try the devices. The companies insist that the flavors are critical to helping nicotine-addicted adult smokers switch from conventional cigarettes.

Gottlieb’s action drew praise from a major tobaccocontrol organization, the Campaign for Tobacco-Free Kids.

“This is potentially the most important step FDA has taken to curtail youth use of e-cigarettes,” said the group’s president, Matthew Myers. But this “fundamental turning point” will produce results only if the agency follows through by requiring all manufacturers to immediately undergo pre-market review at the FDA, he added.

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 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,” an association statement said.

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 onramp 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 January report from the National Academies of Sciences, Engineering and Medicine found that while e-cigarettes are less harmful than conventional cigarettes, which produce multiple 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 he’s worried about the effects of nicotine in e-cigarettes on the developing brain.

“JUUL Labs will work proactively with FDA in response to its request,” a company spokeswoman said Wednesday. “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.

Much of the FDA’s sharp change in course is a result of the phenomenal success of Juul, which looks like a USB flash drive. In three years, it has captured about 70 percent of the e-cigarette market, according to Bloomberg. The FDA has pressed Juul in recent months for information about its marketing.

“Juul was a game changer,” Myers said in an interview. 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. Earlier 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 are restricted from other tobacco products.

“In closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults.” Dr. Scott Gottlieb, FDA commissioner