The agency said 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, whose resignation as commissioner will take effect next month. He has said 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 would 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 guidance also bans flavored cigars that were introduced after 2007 — although that is a small subset of the total number of flavored cigars on the market.
Tobacco-control advocates said the policy fell short. “This will fail to solve the e-cigarette epidemic,” said Erika Sward, a spokeswoman 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.”
Myers criticized the guidelines for largely exempting e-cigarettes with mint, menthol and tobacco flavors, noting that data shows those products are used by more than half of teen vapers.
On the other side, Liz Mair, a spokeswoman for Vapers United, said the group was pleased the FDA was requiring age-verification measures, but was concerned there was “insufficient clarity” about how flavored vapor products should be “sequestered” from minors in brick-and-mortar stores. Without clearer language, she said, retailers might overcorrect in restricting access, making it harder for adult smokers to obtain e-cigarettes.
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 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.”
Anti-tobacco groups doubt the agency will be able to take aggressive steps to curb vaping after Gottlieb leaves, however. National Cancer Institute Director Norman “Ned” Sharpless, who will become acting commissioner, is enthusiastic about anti-tobacco initiatives. But his acting status could make it difficult to push contentious changes. It’s not clear who will be the permanent commissioner — or even whether there will be one. The administration said that a search is underway.
The draft guidance released Wednesday, which is expected to be finalized after a 30-day public comment period, largely reverses the agency’s enforcement policy for flavored e-cigarette products. E-cigarettes are allowed on the market under “enforcement discretion” — meaning they have not been approved but the agency is not moving against them.
Under the new vaping guidelines, the FDA is revoking that discretion for all e-cigarettes products, but saying it will prioritize enforcement actions for those sold in ways that allow minors to get access to them.
Such guidelines, even when finalized, are not legally binding but companies are expected to adhere to them to avoid conflicts with the FDA. However, the companies and other retail interests could challenge the policy in court.
Once e-cigarette companies submit their applications to the FDA by August 2021, they’ll have to show that their products are appropriate for the “protection of public health,” including that they do not encourage teens to start vaping. Public health advocates say it would be difficult for many of the e-cigarettes on the market to meet that standard.
The dominant player in the youth vaping market, Juul Labs, stopped selling most of its flavored pods at retailers in November and also beefed-up age-verification for its online sales.