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FDA asks e-cigarette giants to help regulate themselves

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It’s time for e-cigarette companies to step up, FDA says — but isn’t that the FDA’s job?

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Illustration by Alex Castro / The Verge

Leading e-cigarette companies have admitted in meetings with the Food and Drug Administration that vape flavorings appeal to kids, and suggested ways that the agency could regulate those products, according to an FDA statement today. But public health experts say not to expect the industry to come up with useful ways to police itself.

After years of public health officials warning that young people were using e-cigarettes in alarming numbers, the FDA is crafting regulations to prevent kids and teens from vaping. And as part of the process, the FDA has asked the five leading e-cigarette brands to come up with plans to combat youth vaping. “Everyone involved in this market has a shared responsibility to address this public health crisis,” FDA commissioner Scott Gottlieb said in today’s statement, explicitly telling the e-cigarette industry to “step up.”

But Desmond Jenson, an attorney with the Public Health Law Center at the Mitchell Hamline School of Law, is concerned that means the vape industry is getting too much input into how the FDA should regulate them. “Anybody who believes that the e-cigarette companies could come up with a plan to effectively regulate themselves should talk to me, because I have a bridge I would love to sell them,” he says.

In response, a spokesperson for the FDA points to language in today’s statement: “We will continue to seek public input from a diverse set of stakeholders, including public health advocates and the manufacturers and retailers affected by these policies.”

The manufacturers had a similar response. “We believe it will take industry and regulators working together to restrict youth access,” Victoria Davis, a spokesperson for Juul, says in an email.

As part of this scramble to regulate e-cigarettes, the FDA has been meeting with the companies making up the vast majority of the vape market: Altria Group, Inc.; Juul Labs, Inc.; Reynolds American Inc.; Fontem Ventures; and Japan Tobacco International USA Inc. Juul’s name is familiar — the others are behind vape brands like MarkTen, Vuse, blu, and Logic. “Each of these companies market products that recently had been sold illegally to minors,” the FDA says. And all except Juul also have ties to traditional tobacco products.

The FDA’s statement did not say who said what about flavors in the meetings, and FDA spokesperson Michael Felberbaum didn’t clarify. The statement only said, “The companies acknowledged the role that flavored e-cigarette products play in appealing to kids, as well as the role that flavored e-cigarettes can also play in helping adult smokers quit.”

Of the companies named in the statement, only James Campbell, spokesperson for Fontem Ventures (the company behind blu), specifically addressed flavor discussions with the FDA. “We discussed the importance of (suitably-named) vapor flavours in attracting and retaining of adult smokers to the vapor category – and we also committed to making sure the naming conventions for e-liquids were appropriate and did not appeal directly to minors,” Campbell said in an email.

To be clear, the jury’s still out on the role that flavors play in helping adults quit smoking, but previous studies have shown that flavors can attract young people to using tobacco products and vapes. “It’s very clear if you’re going to do a cost-benefit analysis that flavors are more harmful than helpful,” Jenson says. “It’s been clear for a long time — it’s why Congress prohibited flavors in cigarettes.”

The companies came up with a few proposals for how the FDA could regulate them. The agency could require more stringent age-verification for kid-friendly flavors, for example — although the statement didn’t specify what that would mean. Campbell, speaking for Fontem, says online sales from blu.com already require an adult ID and credit card. “In addition we could implement age verification if we connect the device to a smartphone app and we raised that possibility with the FDA,” he says. Victoria Davis from Juul said only that the company will outline its plans in the proposal the company intends to submit to the FDA shortly.

The FDA also floated the more drastic move of pulling certain kid-friendly products off the shelves altogether until the FDA has had a chance to review the companies’ applications for FDA authorization. Altria is already making moves to do so, saying in a letter to the FDA last week that it would pull its flavored (except tobacco, mint, and menthol flavors) and pod-based products from the market — for now. For Altria, the move isn’t as risky as it would be for a company like Juul, because Altria also makes traditional tobacco products like Marlboro, CNBC reports.

Another problem is young adults buying vapes for their underage friends. In its statement, the FDA says that some e-cigarette companies suggested combatting that by upping the legal age for purchasing tobacco to 21. But the FDA is prohibited from raising the federal minimum beyond age 18, which would take an act of Congress. “What do you think the odds are that a bill is going to reach the President’s desk in the near future?” Jenson says. “I bet it’s pretty close to zero.”

Instead, he says that if these companies were serious about raising the minimum age, they would support local and state pushes to do so. “The e-cigarette companies are not going to propose anything that loses significant amounts of money for them,” Jenson says. “Then you’re facing a lawsuit from your shareholders. These companies have no incentive to do the right thing.”