U.S. FDA sets temporary ban on some flavoured vaping products
The U.S. Food and Drug Administration said it would ban fruit and mint flavors that have been blamed for getting millions of children hooked on e-cigarettes, a months-in-the-making plan designed to curb an epidemic of underage vaping.
Under the new policy, companies that don’t cease the manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes other than tobacco or menthol within 30 days run the risk of being sanctioned by the FDA.
“Our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth,” said Health and Human Services Secretary Alex Azar in a statement.
The steps outlined Thursday will for now effectively remove from the market all cartridge-based flavored vaping products except those that taste like tobacco or menthol. Technically, no vaping products are on the market legally; the FDA has allowed some products to be sold with the aim of helping more adults quit smoking cigarettes, and all vaping devices must be submitted for approval by the agency by May.
The FDA said Thursday it will allow flavored e-liquids to continue to be sold for refillable open-tank devices commonly available in vape shops.
The exception for tank systems is partly the result of a concerted push by vaping advocates to protect a small but growing industry of small retailers that sell such devices. Easy-to-conceal cartridge-based devices, such as the sleek, flash-drive-like vaporizer made by Juul Labs Inc., have been more popular with teen users.
“Pod cartridge-based systems got us into this problem,” Azar said on a call with reporters on Thursday. “This is a balancing effort of public health.”
Health groups that had hoped for a policy in line with Azar’s September statements were critical of the plans. Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the administration only exposed kids to higher risk of addiction by creating a loophole that excludes menthol.
During a call among public-health groups on Thursday, Myers said the FDA’s policy will likely be insignificant in reversing an “unprecedented” explosion of youth use. “I don’t think we can overstate the significance of loopholes,” Myers said.
“Political pressure dictated this, not science,” Myers said. He also emphasized the potential for brands such as Suorin USA and SMOK, which allow users to buy and refill empty cartridges, to attract users who can’t buy Juul pods.
Along with Suorin, disposable vape brands like Puff Bar and Stig could pose an enforcement hurdle.
Pro-vaping groups resisted the idea that the FDA’s guidance favors the vaping industry. Vape shops may be safe for now, but it’s only a “partial victory” given a PMTA deadline that now stands to ban open-tank systems too, said Greg Conley, president of the American Vaping Association.
Former adult smokers, he said, will surely shoulder the burden from the flavor restrictions as they have less options to stay away from combustible cigarettes.
“The reality is that banning flavors in closed systems will result in more adults smoking,” said Conley in a statement. “The cavalier attitude of some activist groups and federal health officials to the potential of ex-smokers going back to Marlboros is deeply disappointing.”
The Trump administration has made curtailing teen nicotine use a public-health priority. In addition to the curbs on flavored vaping products, the president also signed into law a measure that raised the minimum age to buy tobacco products to 21 nationwide.
Tobacco stocks slumped on Thursday, with Marlboro maker Altria Group Inc. sliding as much as 1.7 per cent in afternoon trading. Altria also holds a large stake in Juul Labs.
The announcement marks the culmination of a polarizing saga that pitted public-health advocates against political operatives and divided big and small players in a still-emerging industry.
In September, Azar suggested that the Trump administration would remove almost all flavored vaping products from the marketplace. But after months of wrangling behind the scenes and in public, industry advocates appear to have convinced the White House that the more sweeping restrictions could cost thousands of Americans their jobs and be politically costly to the president.
Azar had initially proposed a far-reaching ban on all flavored vaping products with the exception of those that taste like tobacco. His plan would have kept many off store shelves pending their approval by the FDA.
But soon after that plan was announced in September, the Trump administration appeared to waver, in part out of concern that tough restrictions could alienate some of the president’s supporters. Pro-vaping groups closely aligned with conservative anti-tax lobbyists pushed Trump and his re-election campaign to take a cautious approach, arguing that thousands of jobs in key states could be at stake.
The delay in implementing the Azar proposal angered some lawmakers, as data showed rising e-cigarette use among teens, with vaping among high-school students soaring 143 per cent since 2017.
On Thursday, some lawmakers said the FDA’s new enforcement priorities for mint and other flavors didn’t go far enough.
“A public health epidemic of this magnitude requires bold, decisive action,” said Representative Frank Pallone, a New Jersey Democrat. “Unfortunately, the Trump Administration caved to industry lobbying pressure and decided to prioritize politics over people’s health.”
Separately, several states and cities moved to curb flavored vape products. Attempts to implement statewide bans in New York and Michigan were blocked in the courts, making Massachusetts the only state to enact such legislation. Despite pushback from small businesses, major cities including Los Angeles; San Francisco; New York; and St. Paul, Minnesota; were able to adopt their own flavor bans.
On Nov. 28, Trump held a meeting at the White House where e-cigarette makers, vaping advocates and public-health groups clashed over the potential curbs on flavors. Trump said afterward that he wanted to “do something for everybody, where everybody’s happy.”