12 September 2018:
By: Anna Edney
The U.S. government signaled that it is prepared to adopt a tougher stance on electronic cigarettes in order to stem an epidemic of use by teens and children, after taking a more cautious approach last year.
The Food and Drug Administration told five major e-cigarette manufacturers on Wednesday to address youth use of their products in the next 60 days or the agency could require them to stop selling flavored tobacco pods that appeal to children.
The move is part of a campaign by regulators to limit sales to minors of new cigarette-smoking alternatives, which officials say still contain addictive nicotine and can have negative effects on brain development. FDA Commissioner Scott Gottlieb said that data the agency would soon release showed a “substantial increase” in youth vaping over the past year.
The FDA had attempted to ease regulations on the e-cigarette industry last year as a way to encourage development of more products that could help adults quit smoking. But critics of the agency had said that it didn’t do enough to prevent kids from using products like Juul, a pocket-sized device that resembles a USB drive and has become popular with students.
Health and Human Services Secretary Alex Azar said in an interview at Bloomberg’s office in New York that the FDA has his “complete, undivided support,” and that, as a father, the effort has personal urgency.
“I have teens, and I get to hear anecdotally what’s going on in the schools in terms of access to Juul and other products,” Azar said. “We are extremely concerned about this and we’re not going to permit it.”
“By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission,” Juul said in an e-mailed statement. Altria said it looks forward to sharing its thoughts with the FDA on “an issue we’ve focused on for decades.” Fontem said it would continue to work with regulators.
Gottlieb recently began to ask whether the use of Juul and other similar products by kids is overshadowing any benefit to adult smokers using the devices to help them quit cigarettes. He said in June tobacco companies “better step up and step up soon,” but he didn’t divulge what consequences the industry could face until now.
In July 2017, the FDA said it was considering lowering nicotine levels in cigarettes. In addition, the agency pushed back until 2022 a deadline for electronic-cigarette companies to submit applications to the FDA. Gottlieb said at the time he was trying to ease the regulatory pathway for products that are potentially less harmful sources of nicotine than smoking.
“I have grown increasingly concerned around what we see as rising youth use in these products, and I’m disappointed in the actions the companies have taken to try to address this,” Gottlieb said in an interview this week.
The Truth Initiative, a tobacco-control group based in Washington, is pleased with the FDA’s move, but it wants the agency to immediately pull flavored e-cigarettes from the market, said Chief Executive Officer Robin Koval.
“The circumstances have changed and we’re glad to see them reacting in the real world,” Koval said about the FDA. “Organizations like ours have been saying for quite some time now that products like Juul are a risk.”
Like the Truth Initiative, Senator Richard Blumenthal, a Democrat from Connecticut, said in a statement Wednesday that the FDA should remove flavored e-cigarettes from the market immediately. Another Democrat who often weighs in on tobacco issues, Senator Dick Durbin of Illinois, thanked the FDA for taking an “important step.”
Despite the setback dealt to big tobacco companies’ nascent electronic-cigarette business, shares of the companies rallied. Cigarette smoking has been falling in the U.S. for decades, but former smokers who vape could be pushed to return to traditional cigarettes if flavored e-cigarettes are no longer available.
Altria, which makes Marlboro cigarettes in the U.S., gained 6.7 percent in New York trading, the biggest advance for the stock in nearly 10 years. U.S.-traded shares of British American, the maker of Camel cigarettes, climbed 6 percent, also the biggest gain in almost 10 years.
Nevertheless, regulators made clear that the intent behind the proposed new restrictions on alternative tobacco devices was to drive smoking rates as low as possible, by closing off an enticing entry point for children.
“We are committed to getting people off of combustible tobacco,” Azar said. “We just simply cannot allow the e-cigarettes to be a vehicle for kids getting addicted on nicotine products and then potentially waking up years from now that that’s become an on-ramp for combustibles and a whole other generation hooked on combustible just as we’re seeing improvement in adult consumption rates.”