Federal health officials also said they would pursue companies that promote any kind of vaping product to minors or fail to take steps to keep the items away from them.
The policy is a partial retreat from President Trump’s Sept. 11 plan, which would have “swept the market” of all flavors, except tobacco, that are used in all types of vaping products. That comprehensive ban set off intense lobbying by vape shops and vaping advocates, which ultimately led Trump to backtrack.
Health and Human Services Secretary Alex Azar described the new specifics Thursday as a “smart, targeted policy that protects our kids without creating unnecessary disruption.” During a conference call with reporters, he said the plan struck the right balance between preserving e-cigarettes as an option for adults trying to quit smoking conventional cigarettes while sharply reducing access by teens.
Azar said administration officials pulled back from the comprehensive ban after getting more information on youth usage, including numbers showing that menthol is much less popular among teens than mint and fruit flavors. Stephen Hahn, who recently became FDA commissioner, added that a new law raising the legal age for buying tobacco products to 21 also will help keep vaping items out of kids’ hands.
Officials said the flavored-pod restrictions were necessary because 2019 data showed more than 5 million students in middle and high school have used e-cigarettes within the past 30 days — and a majority reported using pod-based products. Juul Labs, which critics say helped spark the teen-vaping surge, has stopped selling most of its pod flavors.
An array of public health groups denounced the new policy, calling it a “lost opportunity” to get the youth vaping epidemic under control. Teen vapers, they said, would simply switch their flavor preference to menthol or try open-tank systems.
Democratic lawmakers also were critical. Sen. Patty Murray (Wash.), the ranking Democrat on the Senate Health, Education, Labor and Pensions Committee, blasted Hahn for siding with Trump and “and putting politics ahead of science, data, and public health.” He “has failed his first major test,” she said.
The FDA’s 30-day clock on most pod flavors begins once the government publishes the agency’s new guidance, which is likely to occur early next week. Companies that don’t pull targeted products could be subject to FDA “enforcement action,” including fines and the seizure of those products.
Products removed from the market next month could go back on sale at some point. Under a court-ordered deadline, marketing applications for all e-cigarette products must be submitted to the FDA by May 12. To date, e-cigarettes have not needed the FDA’s sign-off to be on the market; they instead have been sold under “enforcement discretion” followed by the agency.
Now companies will have to prove a product provides a net health benefit. Small manufacturers have said it will be hard for them to comply with the application process, which they describe as expensive and cumbersome.
Heather Janik, a spokeswoman for Hahn, said the FDA commissioner “stands by today’s data-driven announcement and the agency’s actions to prevent youth use of tobacco products" and “looks forward to working with members of Congress.”
Thursday’s announcement, which came two days after Trump talked about protecting both families and the e-cigarette industry, marks the end of a chaotic policymaking process that left both vaping supporters and public health groups wondering what would happen next.
In September, Trump said the FDA would ban all flavored e-cigarettes but tobacco — a sweeping effort that would have applied to both the closed-pod systems and the e-liquids used for open-tank systems.
But the news ignited a firestorm of protest among vape shop owners and advocates, prompting Brad Parscale, the president’s 2020 campaign manager, to privately warn the ban could cause job losses and hurt his reelection effort in battleground states. The White House put the plan on hold and began searching for a compromise.