Amid a nationwide vaping crisis, flavored e-cigarettes will soon be ordered off the shelves and won’t be available until manufacturers gain federal approval — which could take a year or longer, the White House said on Wednesday.
“This would have the effect . . . of severely curtailing access to flavored e-cigarette products, which we believe drive childhood use, and will help us get a handle on this alarming and concerning trend,” acting FDA Commissioner Ned Sharpless told reporters in the Oval Office along with President Trump and Health and Human Services Secretary Alex Azar.
The announcement comes as at least six people have died from vaping and another 450 people across the country have fallen ill with mystery lung issues, according to the Centers for Disease Control and Prevention. It also comes in response to the growing problem of children, at least 5 million nationwide, using e-cigarettes regularly, according to HHS data.
The manufacturers of vaping products have come under sharp criticism for allegedly marketing to teens in the kid-friendly flavors they offer and for claiming e-cigs are a safe alternative to smoking. Vape flavors include bubble gum and mint.
Government officials are playing catchup because the Food and Drug Administration didn’t get the authority to regulate e-cigarettes until August 2016.
Under President Barack Obama, enforcement was delayed with the hope traditional smokers could use e-cigs to kick their tobacco habit with what seemed like a less-harmful means of nicotine delivery, Azar explained. By the time the FDA got involved, the market was already flooded with options, none of which had seen federal oversight or testing.
The agency set a May 2020 deadline for existing products to apply for FDA approval but is moving the deadline up amid public pressure and growing concerns over the unexplained illnesses.
“It’ll take several weeks for us to put out the final guidance that would announce all the parameters around the enforcement policy. And then there will likely be about a 30-day delayed effective date,” Azar said. “At that point, all flavored e-cigarettes, other than tobacco flavor, would have to be removed from the market.”
No companies have federal approval from the FDA yet, and none has applied. The application and approval process could take a year or more, an administration source said. The May 2020 deadline stands for tobacco-flavored e-cigs.
As part of the application, the FDA will examine how e-cigarettes are marketed, their possible public-health risks, the impact they could have on people’s behavior, and their ingredients.
Additionalreporting by NikkiSchwab andLorena Mongelli