The head of the Food and Drug Administration said Wednesday that teenage use of flavored electronic cigarettes has become “an epidemic” and ordered the five biggest manufacturers to say within 60 days how they will address it or face removal of their products from the market.
FDA Commissioner Scott Gottlieb sent letters to the companies that control 97 percent of the e-cigarette market. He said manufacturers have paid lip service to previous entreaties to halt sales to teens.
“I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends,” he said in a statement. “In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products.”
Health officials in Massachusetts, which has been in the forefront of efforts to combat teen use of e-cigarettes and other tobacco products, welcomed the crackdown.
“We know that these products contain nicotine, which is addictive,” said Dr. Monica Bharel, the Massachusetts public health commissioner. “The developing adolescent brain is especially vulnerable to nicotine addiction.”
Massachusetts Attorney General Maura Healey raised similar concerns about e-cigarettes in July, when she said her office was investigating one of the biggest makers, San Francisco-based JUUL Labs Inc., for alleged sales to minors. While teen cigarette use has hit a record low, she said, “ ‘juuling’ and vaping have become an epidemic in our schools, with products that seem targeted to get young people hooked on nicotine.”
Battery-powered e-cigarettes heat a liquid containing nicotine into vapors that are inhaled. Although vaping may be safer than a traditional cigarette and may help some adults quit smoking, Gottlieb said, the nicotine is still addictive.
The products, sold in flavors like cucumber, mango, and mint and packaged in devices as small as a thumb drive, have become ubiquitous despite being harmful to the developing brain, he said. Schools around the country have struggled to deal with the explosion of vaping on their campuses.
“It’s reached nothing short of an epidemic proportion of growth,” Gottlieb said. “The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products.”
The FDA sent letters to JUUL, R.J. Reynolds Vapor Co.’s Vuse, Altria Group’s MarkTen, Imperial Brands’s blu, and Japan Tobacco’s Logic devices.
JUUL Labs said in a statement that it was “committed to preventing underage use of our product” and will work with the FDA to keep it out of the hands of young people.
Altria also said it takes the issue seriously.
“We strongly believe kids shouldn’t use any tobacco products and take a number of steps to prevent kids from getting access to all tobacco products,’’ Altria spokesman David Sutton said in a statement.
Nearly half of Massachusetts high school students have tried e-cigarettes at least once, and nearly one-quarter reported in surveys that they had used them in the past 30 days — a rate nine times higher than adults, according to the latest statewide data.
In addition to confronting makers of e-cigarettes, the FDA is also targeting stores that illegally sell them to minors. It sent warning letters to 1,100 retailers, including 7-Eleven stores, Shell gas stations, and Walgreens. It issued 131 fines to stores that allegedly violated the restriction on sales to minors.
Gottlieb called the effort the largest coordinated tobacco compliance effort in the agency’s history. In the mid 1990s, the Clinton administration approved regulations to crack down on teenage smoking and officially classify nicotine as an addictive drug; much of that effort was later struck down in the courts, which said the FDA lacked authority. In 2009, Congress gave the FDA authority to regulate tobacco products.
In downtown Boston, the longtime manager of a 7-Eleven franchise store on State Street, said he was aware of the FDA’s concerns but that he and his 11 sales clerks never sell tobacco-related products to anyone under 21. 7-Eleven’s policy, he said, is to ask for the identification of anyone who looks 30 or younger — even if they only want to buy a lighter.
“I’ve never sold to a minor,” said the manager, who asked not to be identified because he didn’t want to get in trouble with the parent company. His store sells devices marketed by the five e-cigarette makers that received letters from the FDA.
In July, Governor Charlie Baker signed a bill that raises the legal age to buy any tobacco product statewide from 18 to 21, including e-cigarettes. The law goes into effect in January.
The state Department of Public Health has launched a public information campaign to educate parents of middle- and school-aged children about the dangers of vaping, with advertisements on public transit, online, on billboards, and through social media channels.
Overall, tobacco use is down among teenagers across the country, according to the 2017 National Youth Tobacco Survey, which was released by the federal government in June.
Fewer than 3 million high school students used any tobacco product in 2017 compared with nearly 3.7 million in 2011, the survey said. Some 670,000 middle-school students used a tobacco product in 2017 compared with 870,000 in 2011.
E-cigarettes are the most commonly used tobacco product among middle- and high-school students, said the survey. About 2.1 million students said they used electronic cigarettes, compared with 1.4 million who smoked traditional cigarettes. Of those students who used tobacco, many reported also using e-cigarettes.
An 18-year-old sophomore at Clark University in Worcester told the Globe she has no trouble buying a four-pack of JUUL pods containing nicotine for about $16 at a gas station near campus, even though Worcester has set the legal age at 21.
She said JUUL e-cigarettes are addictive but better than the ones she used to smoke.
“I would rather have a JUUL and use it occasionally than smoke cigarettes at the rate I used to,” said the student, who asked not to be identified. “There’s a super-high nicotine content in JUUL pods, but it’s not all the tar and the disgusting fillers that are in cigarettes.”
Dr. Michael B. Siegel, a professor and tobacco researcher at the Boston University School of Public Health, said he supports enforcing laws against youth vaping but worries that a potential ban on flavored e-cigarettes could imperil millions of adult former smokers who have relied on them to quit. Without flavors, e-cigarettes will taste like tobacco.
“It’s going to be a constant reminder every time they vape about how much they enjoy that tobacco,” Siegel said. “The most likely thing that will happen is they’ll revert back to smoking.” And smoking is deadly, while vaping, although addictive, “isn’t killing anyone,” he said.
While the FDA crackdown focused on retail sales, the agency said it was also taking a hard look at manufacturers’ Internet stores. The websites of all the manufacturers ask users if they are 21 or older. But the FDA is looking at whether websites are being used to make straw purchases of devices that are then resold to minors.
“If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify,” Gottlieb said.
Clarification: This story was updated on Sept. 14 to include a statement from Altria Group, the maker of MarkTen e-cigarettes. The Globe had not received the statement in time for the Sept. 13 print edition.