The groups acknowledged concern about a sharp increase in youth use of such products, but said Gottlieb’s reaction has amounted to “regulatory panic and significant government overreach.” It said FDA’s plans to curb youth vaping would hurt adults and should be subjected to cost-benefit analyses.
“Private sector initiative and sound public policy should not be held hostage by prohibitionist impulses,” the letter said.
But Gottlieb shows no sign of backing down. In an interview Sunday, he said that while the FDA supports the role of e-cigarettes in helping adults quit smoking, “it’s now clear that widespread and sometimes reckless marketing of these products has come at the expense of addicting a new generation of kids on tobacco.”
He repeated a threat that if youth vaping continues to rise sharply, he may order flavored e-cigarettes off the market. “This entire debate will shift to ask whether these products should be swept from the market entirely” — until they go through a rigorous premarket review, he said.
Gottlieb has long been a proponent of using e-cigarettes to help adults stop smoking. But over the past year, as data showed a surge in adolescent vaping, he warned that e-cigarette use among minors is “an epidemic.” He moved to curb sales to minors — partly out of concern that some would end up smoking regular cigarettes.
In November, Gottlieb announced plans to sharply restrict the sale of most flavored e-cigarettes in convenience stores. Those restrictions will come in a guidance issued in the next few months. At a hearing last month, Gottlieb warned that e-cigarette companies face “an existential threat” if youth vaping continues to rise sharply.
Gottlieb’s actions have been praised by many vaping critics, including some congressional Democrats and public-health advocates. But they have also been faulted as too weak by some tobacco-control groups that want flavored e-cigarettes banned — and as too tough by industry supporters. That tension highlights the difficult balancing act facing regulators wrestling with e-cigarettes and other tobacco issues.
The letter to the White House is not the first tobacco-related criticism from conservatives. Just last week, in remarks on the Senate floor, Sen. Richard Burr (R.-N.C.), slammed a plan by Gottlieb to ban menthol cigarettes, saying it would reduce adults’ consumer choices and state and local revenue.
The clash is occurring as the debate heats up over the harms and benefits of e-cigarettes, with studies being touted by both sides.
Last week, a large trial published in the New England Journal of Medicine and led by British researchers showed people trying to quit cigarettes were almost twice as likely to succeed if they used e-cigarettes instead of conventional nicotine-replacement therapies such as patches and gum.
But an accompanying editorial urged physicians to be cautious about recommending e-cigarettes. It noted that 80 percent of the study participants were still using the devices at the end of a year, while just 9 percent of the other group were using nicotine-replacement products. That raises concerns about the long-term effects of vaping and nicotine addiction, they said.
Another study published last week found that young people who use e-cigarettes are more likely to try regular cigarettes. The association was especially strong for “low-risk youth” who typically would be less likely to smoke, according to the study published in the journal JAMA Network Open. Other studies have raised concerns about whether flavors used in e-cigarettes can hurt lung function.
Shortly after becoming FDA commissioner in 2017, Gottlieb had eased regulations on e-cigarettes, winning widespread applause from the industry. But after government data showed that vaping increased 78 percent among high schoolers last year, he said his priority was to curtail youth use of e-cigarettes.
Last November, he proposed that most flavored e-cigarette products be sold only in stores that did not admit minors or have a separate adult-only section — moves that he said were tantamount to a ban in convenience stores. Menthol, mint and tobacco flavors were not included. He also announced plans to bans to prohibit the sale of flavored cigars and menthol cigarettes.