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FDA shakeup could stop e-cigarette regulations



Commission for Food and Drug Administration Scott Gottlieb's sudden dismissal yesterday has public experts worried that progress on e-cigarette regulations may stop, or even stop.

The news only comes a few days after Gottlieb has made a proposal for e-cigarette flavor restrictions to the White House, according to Axios. His dismissal – just like his agency was strengthening the regulations – is worrying for people tracking the future of tobacco control. "I don't think anyone knows for sure what this means," says Desmond Jenson, public health lawyer at Mitchell Hamline School of Law, in an email to The Verge . "It doesn't feel like it will be good news."

Gottlieb leaves a mixed legacy of tobacco regulations. Earlier in his time at the FDA, he delayed the deadline for when e-cigarette manufacturers had to apply for the agency's permission to stay on the market. The extended time the products could stay on shelves largely unregulated. But after Juul's headlines because of the growing popularity of the unit with underage vapers, the FDA began to increase the pressure on the e-cigarette industry to prevent the children from waking up. In November 2018, Gottlieb announced plans to limit the sale of nicotine juice in child-friendly flavors by banning them in stores without strict age restrictions.

During Gottlieb, the FDA has also taken early steps to ban menthol in traditional tobacco products. (Mentol is a flavoring agent known to entice children who have been specially marketed for color communities.) In July 2017, Gottlieb announced plans to cut the nicotine into cigarettes and started the long road to regulation in March 2018, but it has not has been considerable progress since. "Many of what Commissioner Gottlieb has done is to start the wheels that are moving on proposal, rather than putting some rules and regulations in place," said Micah Berman, public health professor at Ohio State University.

Now, Kathleen Hoke, a legal professor at the University of Maryland, suspects some progress on tobacco control and e-cigarette regulations may cease for months. "I don't expect anything to happen at this time – if ever," she says. "It's a bit of a fact that someone who expressed this kind of support to public health aspects of this problem is quickly gone."

The Public Health Community is disappointed But the tobacco industry can profit, according to an email from Bonnie Herzog, a financial analyst for Wells Fargo Securities, LLC first reported by Vox . "We believe his f ratification raises the question of whether the FDA will actually enforce tougher rules on youth e-cig use / access, cig nicotine boundaries and a cig menthol ban given he was the master of these initiatives, "Herzog says. On Tuesday night, the tobacco stocks already climbed.

The news could mean a challenge to wake up giant Juul, the goal of an FDA breakdown that included a surprise inspection of the company's headquarters. Just before the FDA announced its plans to limit the sale of sweetening wrap juice, Juul announced that it would cease delivering its tasty pods to brick and mortar stores. But after a big tobacco company, Altria used $ 12.8 billion to buy a 35 percent stake in Juul, and Gottlieb sent letters asking the companies to explain how their new alliance would affect their efforts to curb youth arms. Juul refused to comment on Gottlieb's departure.

E-cigarette company Blu did not make significant comment, but at least recognized Gottlieb's departure. "We look forward to continuing our constructive engagement with the FDA," spokesman James Campbell said in an email to The Verge . "We have great respect for both Commissioner Gottlieb and his team and recognize the ongoing challenge of balancing the public health potential of vapor products with the need to prevent youth access."

Corey Henry, spokesman for the tobacco company Philip Morris International, or PMI, applauded Gottlieb to raise awareness of "new, innovative, non-flammable products," he says in an email to The Verge . PMI is waiting for the FDA authorization to market a device called IQOS, which heats a stubby tube of tobacco instead of burning it. The FDA also assesses whether the company can claim that the product is less risky than traditional cigarettes. Henry says PMI cannot comment on the status of its applications with the FDA. But Wells Fargo analyst Herzog wrote that Gottlieb's resignation could have implications (positive, we hope) "for IQOS approval.

Gregory Conley, head of the American law firm Vaping Association, had a mixed reaction to Gottlieb's forthcoming departure, In a telephone conversation with The Verge, he praised Gottlieb to give e-cigarette manufacturers extra time to apply for FDA authorization to stay on the market. He says: "We are no closer to a coherent, achievable structure for these programs today than we were two years ago." He is concerned about how companies will face threatening regulatory deadlines without clear FDA guidance.

Hoke believes Gottliebs heritage may be a gradual progress towards gathering both extremes of the polarized conversation around vaping: "People who believe that you will be issued a weapon pen on earth and people who believe that you will burn on the stick h show you sell vapes, "she says. "I feel there was some progress towards the middle where rational politics can happen." Gottlieb's departure means slowing that momentum. That, she says, is the biggest loss.


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