The Trump administration on Thursday announced plans to bar sales of flavored e-cigarette cartridges, except for menthol and tobacco flavors.
"The United States has never seen an epidemic of substance use arise as quickly as our current epidemic of youth use of e-cigarettes," Health and Human Services Secretary Alex Azar said in a statement about the change, which goes into effect in 30 days.
The FDA released its statement announcing the new policy on Thursday, saying the move was not a "ban" but an announcement prioritizing the agency's law enforcement powers against tobacco products. The agency "has attempted to balance the public health concerns," the statement said.
The move would exclude refillable vaporizer liquid flavors also sold in vape shops. Unlike the cartridges, which are commonly used in e-cigarette devices like Juul, the exempt liquids are used in vaping devices that come with a refillable reservoir tank.
The partial flavor "enforcement policy" comes as a retreat from the president first saying he would ban all flavored vapes in early September. Last month, Trump signed the federal spending bill that raised the age to buy both tobacco cigarettes and e-cigarettes to 21, up from 18 nationwide. That age increase covers flavored nicotine liquids sold to refill larger vaporizers, which are exempted from the new ban.
“We’re going to protect our families, we’re going to protect our children, and we’re going to protect the industry," said President Donald Trump on New Year's Eve. "People have died from this."
In November, survey results reported by the Journal of the American Medical Association suggested that more than 1 in 4 high school students (more than 5 million teens nationwide) now use flavored e-cigarettes monthly, a significant increase from last year that alarmed public health officials. Mint was the most popular flavor among high school students, according to the surveys, followed by mango.
In October, the e-cigarette giant Juul announced the suspension of US sales of mango, creme, fruit, and cucumber flavors, but not mint and menthol flavors. The company added mint to its suspended list in November, following the release of the JAMA results about teens' use of flavored e-cigarettes. Fifty-nine percent of the students surveyed reported using Juul, by far the leading brand used among high schoolers.
Much of the furor over e-cigarettes has sprung from a nationwide outbreak of vaping-related lung injuries that peaked in September, now at more than 2,500 cases nationwide, with at least 55 deaths. Although those cases largely appear to be related to vaping of illicit THC-containing liquids in refillable devices, pressure has increased on public officials to stem use among teens of e-cigarettes amid the outbreak.
At a November face-off between cigarette firms and public health officials, Trump expressed worry that a full flavor ban would drive both kids and adults to the illicit market and lead to more deaths. The FDA's top tobacco official, Mitch Zeller, had suggested in December that legally the administration couldn't exempt vape shops from a ban in congressional testimony. On Thursday, he told reporters "the immediate actions are expected to have minimal impact on vape shops" in a telephone briefing for reporters on the announcement.
The newly announced ban and its exemptions, discussed this week by Trump and administration officials ahead of its official release, displeased both sides of the debate over banning flavored vapes.
E-cigarette advocates called the Trump administration's announcement only a partial victory. In May, the FDA will require shops to prove the exempted flavored liquids pass a costly public health review process to remain on the market.
"President Trump will get the blame if America's vape shops are forced to close their doors in May," American Vaping Association President Gregory Conley told BuzzFeed News in an email.
On the phone briefing, Zeller said the agency would "facilitate" public health review of vape shop liquids — Juul has already submitted materials for review — but the agency faced a court-ordered May 12 deadline for such reviews.
Conley also argued that the ban could drive former smokers back to cigarettes. More than 10 million US adults vape e-cigarettes regularly, while more than 34 million smoke cigarettes.
"The reality is that banning flavors in closed systems [cartridges] will result in more adults smoking," Conley said. A study released on Monday suggested that users of refillable tank vaporizers are more than twice as likely to relapse to tobacco cigarettes than e-cigarette smokers are.
Public health experts decried the ban's exemptions for menthol flavors and refillable tank liquids, with a coalition of health organizations such as the American Heart Association and Parents Against Vaping E-Cigs protesting the announcement on Thursday as a capitulation to the tobacco industry.
"This isn't solving the problem — it's prolonging it," the American Lung Association's Erika Sward told BuzzFeed News. "Keeping menthol-flavored cartridges and flavors sold in vape shops on the market will keep kids addicted."
In September, the CDC's Anne Schuchat had testified at a House of Representatives hearing that a ban that didn't include menthol would be ineffective.
"I am deeply disappointed that President Trump ignored the advice of medical experts," said Rep. Raja Krishnamoorthi of Illinois, the chair of the subcommittee Schuchat testified to, in a statement to BuzzFeed News.
Roughly 1 million high school students are daily e-cigarette users physically dependent on nicotine, surveys suggest. They are likely to just switch to menthol cartridges or start using refillable bubble-gum liquids bought at a vape shop, Sward said, rather than quitting nicotine cold turkey because of the partial ban.
"It is disappointing to see that this is the industry policy that they have put forward when this should be about kids' health."
This post has been updated with comment from the FDA's Mitch Zeller, the American Lung Association's Erika Sward, and Rep. Raja Krishnamoorthi.