Sunday, September 22, 2019

Trump 'stunned' electronic cigarette industry with plan to ban almost all flavorings, The Washington Post reports

President Trump and first lady Melania Trump listened as
acting FDA Commissioner Ned Sharpless talks about a plan
to ban most flavored e-cigarettes. (Associated Press photo)
President Trump stunned the electronic-cigarette industry by saying the Food and Drug Administration would ban flavorings in e-cigarettes except for tobacco flavor, Laurie McGinley, Neena Satija, Josh Dawsey and Yasmeen Abutaleb report for The Washington Post.

"Juul Labs did everything in the power players’ handbook to cement its status in Washington," they write. "The Silicon Valley start-up worked to make friends in the nation’s capital. It hired senior White House officials wired into President Trump and the first family. It sent politically connected officials to the West Wing to extol its products. It spent big on lawmakers in both parties."

So, the Post reports, "The scope of the announcement stunned most of the industry, even big companies like Juul that have carefully nurtured relationships with policymakers to gain influence. But lately, those companies have also been undercut by a stream of reports about teen e-cigarette use and a mysterious lung illness tied to" use, perhaps misuse, of the devices.

Juul hasn't decided whether to challenge the proposed ban "on mint and menthol e-cigarettes, its two biggest moneymakers," the Post reports. "The company might argue to keep its menthol flavor on the market because it is legal in cigarettes and it wants to give smokers an alternative to menthol cigarettes, a Juul official said."

Their allies and consumers "were heartened by a Trump tweet Friday evening that suggested vaping might, in fact, be a good alternative to cigarettes, and the ban was simply to 'make sure this alternative is SAFE for ALL!' and to keep e-cigarettes out of the hands of children," the Post reports. "A senior White House official said the tweet reflected the president being told some supporters were upset by the ban, and did not signify a policy shift."

Not a spur-of-the-moment thing

"Despite its strong deregulatory approach, the Trump administration started focusing intensely on e-cigarettes a little more than a year ago when then-FDA Commissioner Scott Gottlieb saw data showing a 78 percent jump in high schoolers using e-cigarettes — a product ostensibly designed to help adult smokers quit cigarettes," the Post notes.

About the time he announced he would leave the job, Gottlieb accused Juul and its 35 percent owner, top combustible-cigarette maker Altria Group, "of reneging on commitments to quell teen use, according to people familiar with the discussions," the Post reveals. "He also said the companies were trying to undermine the FDA by going over his head to the White House, where the companies found a more sympathetic ear, they said."

As he left, Gottlieb proposed "sweeping sales restrictions — but not a ban," the Post notes. "Health and Human Services Secretary Alex Azar promised to continue the anti-youth-vaping agenda, suggesting officials might consider tougher action if youth vaping continued to increase. Then came a summer of devastating headlines about a mysterious vaping-related illness that had sickened 380 people in 36 states and resulted in seven deaths. Many of the victims used illicit marijuana products, according to health authorities and clinicians. But officials have not been able to unequivocally rule out nicotine products, giving vaping foes new ammunition to press their case for a crackdown."

Then first lady Melania Trump voiced concerns about e-cigarettes, and and presidential daughter Ivanka Trump also got involved, senior White House officials told the Post, which reports, "Some White House aides and political advisers were also concerned the vaping issue could become a 2020 campaign problem."

Matt Myers, president of Campaign for Tobacco-Free Kids, told the Post, “Juul has created more public outrage in a shorter period of time than any other company I can think of. When you prey on middle-class white kids, Republican or Democrat, you will make a lot of people angry.”

The stakes got higher when "Azar got new data right after Labor Day showing that 27.5 percent of high schoolers in 2019 said they had used e-cigarettes in the past 30 days, up from 20.8 percent the year before — the second big jump in two years," the Post reports. "The data also pointed to the surging popularity of mint and menthol e-cigarettes."

Trump's advisers gave him several options, "ranging from doing nothing to removing almost all vaping flavors from the marketplace," the Post reports. "The president, who had previously expressed no opinions about vaping, had also been reading stories about people dying from a mysterious lung disease, say White House officials. Faced with a perfect storm of worsening youth vaping numbers and fatal illnesses potentially related to vaping, he chose the toughest course."

The FDA has said its guidance would be published in several weeks and go into effect 30 days afterward. "Manufacturers could seek FDA approval to bring their products back to the marketplace, but it’s far from clear they would be successful," the Post says. "Those manufacturers had already faced a May 2020 deadline for such applications, which among other things would need to show whether the product would make it less likely adults would smoke regular cigarettes and not entice young people to start smoking. But under that earlier plan, companies could have kept their products on the market for some period of time while the agency weighed approval."

Only the big companies will be able to weather the storm if it continues, Michael Siegel, a professor of community health sciences at Boston University, told the Post. “Those are the only companies that are going to have the resources to put in the applications that are going to be required by the FDA. I’m sure that they’re already getting these applications together.”

Juul saw smaller companies cut into its market share after it "voluntarily stopped selling all flavors but mint, menthol and tobacco in retail outlets — and then watched as competitors and counterfeiters filled the void with their own sweet and fruity products," the Post reports. "Juul says it has been eager for a government crackdown on those products to level the playing field" and protect young people.

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