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FDA's ban on some flavored e-cigarettes draws skepticism from both sides

FILE - In this Aug. 28, 2019, file photo, a man exhales while smoking an e-cigarette in Portland, Maine. (AP Photo/Robert F. Bukaty, File)
FILE - In this Aug. 28, 2019, file photo, a man exhales while smoking an e-cigarette in Portland, Maine. (AP Photo/Robert F. Bukaty, File)
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A ban on most flavored vaping products announced by the Trump administration Thursday has left few on either side of the contentious policy dispute satisfied as the president attempts to navigate a compromise between the demands of public health advocates and the needs of a growing American industry.

“We have to protect the children. We have to protect the families,” President Donald Trump told reporters before a New Year’s Eve celebration at Mar-a-Lago Tuesday night. “At the same time, we have a very big industry. It’s become a very big industry. We’re going to take care of the industry.”

Though Trump first raised the prospect of banning all flavored e-cigarettes in September amid a spate of vaping-related illnesses across the country, the administration settled on a narrower approach. In addition to raising the minimum age to purchase tobacco and e-cigarette products to 21 as part of a year-end spending bill, the White House is now targeting vaping products believed to be most popular with adolescent and teen users.

Under the new guidance, the Food and Drug Administration will ban e-cigarette pods formulated to taste like fruit or mint, exempting tobacco and menthol flavors that are much less popular among teens. The ban, which takes effect in 30 days, also will not affect open-tank vaping devices that allow users to customize flavors, which are commonly found in vape shops and typically not used by children and teens.

President Trump indicated Tuesday he is hopeful the ban will be short-lived for many products. E-cigarette makers already faced a May deadline to submit all products for FDA review, and those that can demonstrate a benefit to public health will be permitted to remain on the market.

“People have died from this,” Trump said. “They’ve died from vaping. We think we understand why. But we’re doing a very exhaustive examination, and hopefully everything will be back on the market very, very shortly.”

According to the Centers for Disease Control and Prevention, vaping-related lung injuries left more than 2,500 people hospitalized in the United States in 2019, and 55 people have died from illnesses. However, most of the known cases appear to have involved black market cannabis products containing vitamin E acetate, not the commercial nicotine e-cigarettes impacted by the new ban.

Anti-smoking groups were disappointed by an FDA action they feel does not go far enough to curb teen vaping and falls short of what President Trump previously proposed. Robin Koval, CEO and president of the Truth Initiative, dismissed it as "a complete gift to the tobacco and vaping industries."

“Rather than clear the market of all flavored e-cigarettes, as the Administration promised to do in September, the new policy allows menthol flavored e-cigarettes and flavored liquids in every imaginable flavor to remain widely available — and kids no doubt will be able to get their hands on them,” Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.

Meredith Berkman, co-founder of Parents Against Vaping e-Cigarettes, welcomed the Trump administration’s interest in the issue but lamented exemptions that could undermine the president’s stated goal of stopping underage vaping.

“Obviously, we think this is a huge loss for children and families and a huge win for the industry and a huge mistake by the administration,” she said. “Leaving menthol out of the mix is an invitation to what we already know will happen, which is that all the youth will migrate to menthol.”

After leading e-cigarette maker Juul Labs voluntarily pulled its fruit flavors from stores in 2018, many users simply shifted from mango to mint. If mint is outlawed but menthol is still on the shelves, many expect teens who want to vape will quickly learn to like menthol.

Berkman, who attended a White House summit on vaping with President Trump in November, suggested political pressure from the industry drove the administration to scale back its plans. Industry groups and anti-regulation conservatives have warned Trump banning all flavored e-cigarettes could anger his base heading into an election year.

“It really did seem the president cared and wanted to protect kids,” she said. “What the administration has done is caved to the lobbying voices that created this ‘We Vape, We Vote’ campaign that preyed on administration fears there would be huge political repercussions.”

Some advocates were also troubled by the president overtly considering the health of the vaping industry alongside the health of the American public.

“The comments from the White House on the necessity of protecting the vape/tobacco industry are wrong-headed in the extreme,” said Chris Bostic, policy director for Action on Smoking and Health. “There is no win-win possibility for the industry and public health. The goals are entirely incongruous.”

Proponents of vaping were not entirely satisfied with the FDA guidance either. Gregory Conley, president of the American Vaping Association, credited e-cigarette users and vape shop owners for achieving a “partial victory,” but he cautioned the move could still push some former smokers back to cigarettes.

“Not every adult ex-smoker who currently uses NJOY or Vuse will switch over to open systems or be satisfied with a tobacco or menthol flavor; some of them will return to smoking,” he said. “The cavalier attitude of some activist groups and federal health officials to the potential of ex-smokers going back to Marlboros is deeply disappointing.”

In addition, Conley pointed to the looming May deadline to comply with Obama-era FDA rules as a bigger challenge for the industry.

“This move will allow thousands of small businesses to remain open, but short-term exemptions will mean little without long-term reforms at the FDA,” he said.

The Consumer Advocates for Smoke-free Alternatives Association applauded the FDA for revising its plan in response to public input, but it also urged additional changes before May.

“While this guidance for sales of certain flavored vapor products could otherwise be a step toward a workable compromise for the industry and a large segment of vaping consumers, the May 12, 2020 deadline for pre-market applications is still an existential threat to the entire category,” the CASAA said in a statement Thursday.

Vaping lobbyists and industry groups had sought to highlight the economic and political cost of the sort of broad ban on flavored e-cigarettes Trump initially floated in September. The Vapor Technology Association circulated an economic analysis that concluded a ban on flavored vapor products would shut down most of the nation’s 13,480 independent vape shops and result in the loss of more than 150,000 jobs in the vaping industry.

The association also cited an October poll of adult e-cigarette consumers in battleground states that found 99% of respondents opposed a ban on all flavored products and 83% claimed they were likely to decide their vote solely on this issue. Specifically, nearly three-quarters said they would be less likely to vote for President Trump in 2020 if his administration banned flavored vapes.

This is not a new policy challenge, but it has become more urgent in the last few years as millions of youths say they have tried vaping. According to The New York Times, the FDA has struggled with how aggressively to regulate e-cigarettes since they first hit the market over a decade ago.

In 2009, the agency attempted to label vaping products illegal drug devices, but the industry successfully challenged that position in court, leaving officials with more limited tools to address them under the Tobacco Control Act. As a result, vaping devices and products spread rapidly for years without much FDA oversight.

In the final year of President Barack Obama’s administration, officials considered a full ban on flavored e-cigarettes, but the administration backed off under intense lobbying pressure. The Los Angeles Times reported senior officials determined after meetings with more than 100 tobacco lobbyists and small business advocates in 46 days that the economic impact on vape shops would outweigh the health benefits of a ban.

Watered-down e-cigarette regulations announced by the Obama administration in 2016 were still denounced by the vaping industry and its supporters as unbearably onerous. The Trump administration initially delayed the deadline for e-cigarette companies to prove their health benefits to the FDA until 2021, but a judge overturned that decision and set the May 2020 deadline.

In the meantime, teen e-cigarette use has skyrocketed, with many experts and advocates placing blame on the appeal of flavored vaping products. In the absence of aggressive federal action, several states have stepped in to impose bans, but they have encountered legal challenges as well. Last week, the Michigan Supreme Court declined to temporarily reinstate a ban on flavored vaping products issued by Gov. Gretchen Whitmer until a pending lawsuit over the policy is resolved.

Recent research underscores the danger posed by youth vaping, but experts are less united on what to do about it. Researchers at the University of Michigan found the number of e-cigarette users who started vaping at age 14 or younger has tripled in the last five years. Authors of the study, published in the American Journal of Public Health, believe the perception that e-cigarettes are safer and less addictive than traditional tobacco products contributed to that trend.

Additional research published in the Journal of Pediatric Nursing last fall backs up that assessment. University of Buffalo researchers found teens who vape often consider e-cigarettes to be safe and most have never smoked regular cigarettes. Many respondents said they had older siblings who successfully used e-cigarettes to quit smoking.

Last month, a team of public health experts argued in the journal Science that bans on vaping products could do more harm than good. The availability of legal flavored vapes provides health benefits for many adult smokers, and cutting off access to those products could steer adult and teen users to more dangerous black market materials.

“It is crucial to identify the source of serious lung injuries and closely monitor and regulate the vaping industry – including how it markets its products to young people,” co-author James Curran, dean of the Rollins School of Public Health at Emory University, said at the time. “But the evidence so far supports continuing to allow nicotine vaping as a harm-reduction alternative to smoking, which remains the largest preventable cause of death and disability in our country.”

A survey of adult smokers published in Substance Use & Misuse in July raised similar concerns that a ban could prove counterproductive. About 22% of respondents said they would likely increase their use of tobacco cigarettes and reduce use of e-cigarettes if regulations limited the customizability of vaping devices, and 17% said they would smoke tobacco more if flavors of e-cigarettes were limited to menthol and tobacco.

There are conflicting opinions on how important flavored vapes are to underage e-cigarette users, but the flavors are clearly a factor. A study published in the Journal of the American Medical Association in November found mint was the most popular flavor among high school users in 2019, and researchers also found teens who use flavored e-cigarettes are more likely to become regular vape users.

However, vaping advocates point to findings in the CDC’s 2019 National Youth Tobacco Survey that curiosity and use by friends or family are stronger motivators for teens’ decision to try vapes than the availability of flavored materials. They also note the survey showed smoking of cigarettes by high schoolers has dropped significantly as e-cigarette use has risen.

An October study of peer-reviewed scientific literature on e-cigarette use in British Medical Journal Open concluded that the availability of non-menthol flavored products decreases the perception that vaping is harmful and increases the willingness of youths and young adults to try vaping. The research also indicated flavored e-cigarettes greatly increase the appeal of vaping for adults and suggested the role of flavored vapes in smoking cessation among adults is uncertain.

Adam Goldstein, one of the authors of that study and director of tobacco intervention programs at the University of North Carolina School of Medicine, called the FDA’s partial ban “a good start” but suggested more research will be needed to determine if other steps should be taken.

“At least for non-menthol flavors, there’s direct evidence of how they influence kids’ attitudes and use behaviors for vaping, so there’s every reason to believe a ban on those will have an impact,” he said. “The question is, will that be enough or will there need to be additional bans and restrictions?”

According to Goldstein, the exemption for menthol and tobacco flavors is consistent with the FDA allowing the sale of regular combustible cigarettes with those flavors and with research indicating they are less appealing to teens. If that changes when those are the only flavors left, as some public health advocates fear, that stance may need to be reevaluated.

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“What they’re trying to do is significantly and drastically decline youth use but not impact adult use of vaping that is moving to less combustibles,” he said. “If there’s not dramatic declines in youth use or youths transfer their use from non-menthol flavors to menthol and tobacco flavors, there’s every justification for that additional banning too.”

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