The Trump administration is finalizing a ban on flavored e-cigarettes after the outbreak of a vaping-related illness that’s sickened 450 people and resulted in at least six deaths.
“We can’t allow people to get sick and we can’t have our youth be so affected,” President Donald Trump said during an Oval Office meeting with Health and Human Services Secretary Alex Azar and acting FDA Commissioner Ned Sharpless. “People are dying from vaping, so we’re looking at it very closely.”
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Democrats and increasing numbers of Republicans in Congress have pressed for flavor bans, age restrictions and other curbs on the sale of vaping products. They’ve urged the FDA to move faster to investigate and regulate e-cigarettes, which have been touted by manufacturers as a way to wean people from traditional cigarettes but have also led to what the FDA calls an “epidemic” of youth vaping of nicotine.
Public health officials haven’t established a firm cause for the vaping-related respiratory illnesses. Counterfeit or black-market vapes may be playing a role, but legal vapes haven’t been ruled out. Many of the cases have been linked to vaped forms of marijuana and its component, CBD.
Capitol Hill Democrats swiftly backed the administration’s move, calling it long overdue and further evidence that the growing e-cigarette market needs tight oversight. Democrats, led by Sen. Dick Durbin (D-Ill.), had harshly criticized the administration’s response to the respiratory illness, hammering the FDA for weeks over its delays in taking decisive action.
“It’s been clear for years that an epidemic of youth e-cigarette addiction was building,” said Sen. Jeff Merkley (D-Ore.). “It should never have taken multiple deaths and hundreds of cases of teenagers with lung disease.”
Inside the Trump administration, health officials have for months expressed concerns about the spread of e-cigarette use — and raised alarms about companies’ marketing claims and product safety well before reports of vaping-related illness first made waves last month.
Former FDA Commissioner Scott Gottlieb, who left the administration this spring, pushed an aggressive anti-smoking agenda with Azar’s backing, despite griping from some congressional Republicans who had lobbied for a more sympathetic approach to the vaping industry. Azar’s allies say he’s had a particularly strong interest in public health, including a deep skepticism of tobacco and e-cigarettes.
“[Azar] saw the work that Gottlieb was doing as very much part of his own legacy,” one person familiar with the situation said, adding that industry giant Juul’s attempts to curry favor with the Trump administration won over few officials at HHS.
Vaping industry groups were quick to condemn the administration’s move. The Vaping Industry Association said there was no indication that its members products were to blame for recent cases of lung illness, adding that flavored vaping products have been shown to be one of the most effective smoking cessation tools
“Barring flavors would be a public health travesty,” the group said in a statement.
The administration’s announcement came as preliminary findings from a national youth tobacco survey indicate a continued rise in vaping, especially non-tobacco flavors. HHS said preliminary data show that more than a quarter of high school students had used e-cigarettes in the past 30 days, and the overwhelming majority of youth e-cigarette users cited the use of popular fruit and menthol or mint flavors.
Mint and menthol were not covered by FDA restrictions announced last fall that limited sales of flavored vaping products in convenience stories and gas stations.
Azar said the administration within weeks would prioritize requirements subjecting flavored products, including mint and menthol, to pre-market reviews. The administration has been developing a rule requiring all e-cigarette makers to submit their products for review by May 2020 or pull them off the market.
Manufacturers would have to show the FDA administration that their products don’t pose a public health threat. They would also need to demonstrate why any flavored products should stay on the market. E-cigarette manufacturers that submit products for review can keep their products on the market for a year while the FDA evaluates them.
“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” Azar said.
The agency in March acknowledged that many flavored vapes would likely be discontinued in response to the looming regulatory deadline and sales restrictions.
Senate Finance Chairman Chuck Grassley (R-Iowa) on Wednesday endorsed the administration’s focus on vaping, but stopped short of backing a sweeping ban. Grassley has long expressed concern about presidents’ use of executive powers, preferring instead for Congress to pass legislation.
“I’m concerned about the rise in underage vaping and the ability for devices to be tampered with in ways that might be especially hazardous to users’ health,” he said, adding that he’s already discussed the issue with members of his panel. “It’s something we’re looking into in the Finance Committee.”