WASHINGTON -- The Food and Drug Administration issued a much-anticipated policy on Wednesday designed to restrict how and where flavored e-cigarettes are sold -- an effort to combat what the agency's commissioner has called "an epidemic" of underage vaping.
The initiative, a top priority of departing FDA Commissioner Scott Gottlieb, would limit sales of fruity and kid-friendly vaping products to stores that bar minors or have separate adult-only sections. And it says online sellers must tighten age verification and curb bulk sales.
The agency said that companies that violate those conditions would be subject to FDA enforcement actions -- including having their products ordered off the market.
Gottlieb also moved up by one year -- to August 2021 -- the deadline for flavored e-cigarette companies to submit product applications for FDA approval to remain on the market. The sales restrictions and new deadline would apply to a vast array of e-cigarette products, including those offered in flavors such as cherry, bubble gum and cotton candy.
"We're exceedingly concerned about the spike in the use of these products," said Gottlieb, who last week announced he would resign as commissioner next month. The agency chief has said that the new policy would make it very difficult for convenience stores and gas stations to continue to sell the specified flavors and predicted that some flavored products will no longer be sold.
The new policy would not apply to mint, menthol and tobacco flavors unless those products were being sold in a way that targeted minors, the agency said. E-cigarette advocates say those products are most often used by adult smokers trying to quit, but anti-tobacco groups are skeptical of the claim, saying there isn't data to support it.
The new policy was issued as a draft guidance and is similar to the plan Gottlieb outlined in November to combat youth vaping.
Tobacco-control advocates said the policy fell short. "This will fail to solve the e-cigarette epidemic," said Erika Sward, a spokesman for the American Lung Association. "The FDA is continuing to kick the can down the road rather than doing what it will ultimately take to end this epidemic -- removing all flavored tobacco products from the market."
Matthew Myers, president of the Campaign for Tobacco-Free Kids, said Gottlieb deserves credit for focusing attention on the epidemic of e-cigarette use by children. But the "FDA's proposed actions don't match his strong words," he said. "A public health crisis of this magnitude demands faster and more forceful action than the steps announced by the FDA."
He criticized the guidelines for largely exempting e-cigarettes with mint, menthol and tobacco flavors, noting that data show those products are used by more than half of teen vapers.
On the other side, Liz Mair, a spokesman for Vapers United, said that while the group was pleased that the FDA was requiring age-verification measures, it was concerned that there was "insufficient clarity" about how flavored vapor products should be "sequestered" from minors in brick-and-mortar stores. Without clearer language, retailers might overcorrect in restricting access, making it harder for adult smokers to obtain e-cigarettes, Mair said.
FreedomWorks, a libertarian group, said it would fight the new policy and faulted the FDA for going after products that other "developed nations have embraced as less-harmful alternatives" to conventional cigarettes.
The latest vaping effort represents a tougher stance than the lenient one Gottlieb adopted soon after becoming commissioner nearly two years ago. At that time, he delayed, from 2018 to 2022, the deadline for e-cigarette makers to submit product applications to the FDA. That's the deadline he's moving to 2021.
Gottlieb started retooling his approach late last summer when federal data showed vaping increased 78 percent among high schoolers between 2017 and 2018. The increase was due in large part to the popularity of Juul Labs' devices that pack a potent dose of nicotine in liquid-filled pods. The commissioner declared youth vaping an epidemic in September and first outlined the sales restrictions two months later.
Gottlieb said Wednesday that he's worried that youth e-cigarette use is still increasing. If the next round of federal data shows another jump, he said, the FDA may have to look at taking further steps, including banning flavored pods for e-cigarettes. That would occur after his departure, but he said the administration "is committed to the effort."
A Section on 03/14/2019