Policy

FDA Threatens to Stop Sales of Flavored E-Cigarettes

Agency gives companies 60 days to present strategy to curb youth use

The FDA wants e-cigarette manufacturers to take steps to curb youth use or “face regulatory consequences.” (Matt Cardy/Getty Images file photo)

The Food and Drug Administration on Wednesday announced it may force e-cigarette manufacturers to stop selling flavored products, citing what Commissioner Scott Gottlieb called an “epidemic” of youth use.

Five companies, including JUUL Labs, Inc., maker of the popular, USB-drive shaped device with nicotine flavors, will have 60 days to give the FDA a strategy on how they will curb youth use — “or face regulatory consequences,” Gottlieb said.

Gottlieb suggested several steps the manufacturers might take to curtail youth use: revising sales and marketing practices, policing retailers who sell to kids, or removing flavored products from the market until the FDA reviews product applications that are due in 2022.

If they don’t, the FDA might compel them. “We’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market,” Gottlieb said in a speech at FDA headquarters.

If the FDA isn’t happy with the responses, it will reconsider whether it will continue to allow those e-cigarette products on the market before the companies file applications with the FDA. Under regulations finalized in 2016, manufacturers of e-cigarettes and liquid nicotine products that fuel the devices were supposed to file applications to the FDA by August of this year.

Last summer, the FDA delayed the application deadline, in an attempt to provide more clarity to manufacturers trying to navigate the process. Products introduced before the 2016 regulations took effect can stay on the market until the application deadline.

On Tuesday, Gottlieb said the FDA could just as easily change its approach. “We wanted to give the e-cig industry time to come into compliance while we wrote the guidance and regulations to better define and explain how the new products would meet those application requirements,” he said, citing the potential that the products have to help adult smokers switch from dangerous traditional tobacco products.

“But our public health mandate to prevent youth addiction has forced us to now revisit this element of our overall plan,” he added.

Gottlieb said that around 97 percent of the products on the market were from the five brands it is now targeting: JUUL, Vuse, Blu, MarkTen and Logic.

JUUL said in a statement that it “will work proactively with FDA in response to its request. We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”

In addition to its challenge to manufacturers, the FDA also announced it had fined around 130 retailers who were caught selling e-cigarettes to underage individuals and sent nearly 1,200 more warning letters to other retailers.

Next week, the FDA will launch a campaign to warn young people about the danger of nicotine use.

Gottlieb said e-cigarettes have the potential to help adult smokers, but also said the industry’s lack of action on youth use could lead to fewer choices for adults who want to purchase e-cigarettes.

“I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends,” he said. “In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products.”

Members of Congress, particularly Democrats, have been pressuring the FDA to address the trends in young people’s use of e-cigarettes, and Wednesday’s announcement was met with praise by lawmakers such as Illinois Democratic Sen. Richard J. Durbin, a long-time anti-smoking advocate.

Others, however, urged the FDA to go further and make good on its threat to limit flavors.

“This step still falls short, since it fails to impose regulatory teeth. FDA has the legal power — but needs the will — to stop the spread of flavored e-cigarettes by removing them from the market,” Connecticut Democratic Sen. Richard Blumenthal said in a statement.

In his speech, Gottlieb argued that the Trump administration’s delay of application deadlines from 2018 to 2022 would not have changed where things currently stand, since the products would have still been on the market for most of this year.

Chris Hansen, president of the American Cancer Society Cancer Action Network, lamented the delay, as well as the years it took for the FDA to implement regulations following the 2009 law that provided it with new powers.

“Because of numerous rule-making delays and a seeming reluctance to fully assert its authority, FDA for years has repeatedly missed opportunities to keep tobacco products out of the hands of our children and we have seen e-cigarette use among youth hit epidemic levels,” Hansen said.

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