E-cigarette companies that the FDA has already threatened for appealing to teens may land in more hot water with new campaigns that target older adults, say public health advocates and House Democrats.
After the FDA told them to stop pitching in a way that attracted teens, Juul and other companies have begun flooding television, radio and print media with ads that tout their potential to help adults quit traditional cigarettes. But they don’t have the data to back up such claims, say researchers, and the new ads might confuse teens even more.
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With FDA and congressional threats looming, public health advocates say manufacturers are overselling their potential in an effort to preserve a market for their products.
First they created an epidemic of use by youth, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, and now they’ve “swung the pendulum all the way to the point that they are making unapproved health claims.”
Few argue that vaping is as dangerous as traditional smoking — e-cigarettes were ostensibly invented to move smokers off more dangerous products, notes Thomas Houston, a longtime tobacco control advisor and fellow at the American Academy of Family Physicians. But most vaping manufacturers arrived on the scene with fruity flavors and flashy ads that attracted teens, driving a social media phenomenon and a new verb—to “Juul.”
That led the FDA to seize documents during a surprise inspection of Juul’s offices last year and threaten broader flavor bans and retail restrictions to curb teen use. Former FDA Commissioner Scott Gottlieb said increasing teen use could lead to a ban on some of the products.
But the industry’s response, making ambitious claims aimed at adults, isn’t winning fans either.
House Energy and Commerce Chairman Frank Pallone and Rep. Donna Shalala — HHS secretary under President Bill Clinton — introduced a bill Tuesday that would significantly restrict e-cigarette advertising, along with flavored vapors and online sales.
FDA announced plans in March to expand its anti-vaping marketing campaign beyond teen-centric locations to mainstream airwaves and ad pages. Government efforts to describe “the real cost” of nicotine addiction could soon sit next to Juul ads.
Juul’s this year started an extensive “make the switch” campaign featuring somber testimonials from former smokers — who are noticeably older than the millennials featured in the colorful 2015 ads that originally landed the company in hot water with the FDA.
“They clearly are testing where FDA is going to draw the line here,” said Marc Scheineson, a partner at Alston & Bird and former legal counsel for the agency.
Early evidence indicates that vaping can help traditional smokers quit, but researchers see many caveats. The most comprehensive study, published in New England Journal of Medicine earlier this year, found that when smokers who wanted to quit were randomly assigned to weekly therapy paired with vaping or traditional cessation products like nicotine gum and patches, the vapers were twice as likely to still be off cigarettes a year later.
But the vast majority of those former smokers were still vaping at the one-year mark. That shows that e-cigarettes are not really made to be a cessation product, especially when they don’t come attached to health programs or scaled-down nicotine levels, says Bonnie Halpern-Felsher, a Stanford researcher who focuses on childhood psychology.
It might seem like a small distinction, but the impact of long-term vaping is still unknown, even if it is less dangerous than smoking. Gottlieb told House lawmakers in March that vapor intake could be linked to seizures. Early data in mice suggests it could also cause lung damage.
There’s also a world of regulatory red tape tied to the difference. Claims of switching and cessation may appear synonymous to consumers, but cessation claims require an FDA stamp of approval based on years of data. The agency said it plans to “closely scrutinize” all claims, which leaves e-cigarette makers in fuzzy territory for their marketing.
A Juul spokesperson told POLITICO that the company’s research program includes 70,000 participants in ongoing studies to measure the effectiveness of Juul products, including flavor pods, at switching smokers and keeping them off cigarettes for up to a year.
The company is focused on preparing for its FDA submission as a tobacco product — with an August 2021 deadline — and not as a smoking cessation treatment.
In the meantime, ads touting Juul’s capacity to lure smokers off cigarettes could help prolong what Gottlieb dubbed a teen vaping epidemic, says Halpern-Felsher. “Youth are getting the message that these are safe for cessation, which gives them the idea that they are therefore safe and OK [for them] to use.
“We’re totally talking out of different ends of our mouths to these poor kids,” she said.
Some former smokers and public health advocates, however, say harsher approaches to e-cigarette regulation, like banning flavored products and ads, would just keep people on traditional tobacco. As FDA commissioner, Gottlieb talked frequently about keeping the “off-ramp” open for adult smokers while narrowing the on-ramp for teens to get hooked on nicotine.
His successor, acting Commissioner Ned Sharpless, alluded to the challenges Tuesday in an all-hands meeting. He told staff it’s vital to keep studying e-cigarette usage trends and to make regulatory decisions that keep teens from getting hooked on them.
“We simply won’t tolerate misleading marketing or selling tobacco products to children,” Sharpless said.