FDA Ban On E-Cigarette Flavors: A Showdown Between Protecting Kids And Reducing Harm


In this Wednesday, April 5, 2017, file photo, Dr. Scott Gottlieb speaks during his confirmation hearing before a Senate committee, in Washington, as President Donald Trump’s nominee to head the Food and Drug Administration. (AP Photo/J. Scott Applewhite, File)ASSOCIATED PRESS

Look for an article tomorrow sharing what public health experts think about the new FDA regulations and other ways to decrease teen use of e-cigarettes.

The US Food and Drug Administration has announced measures to drastically cut back on flavorings used in e-cigarettes, heightening the tension that already exists between proponents of e-cigarettes as tools for harm reduction and public health researchers who claim e-cigarettes are a pathway leading teens to start using traditional cigarettes.

“Any policy accommodation to advance the innovations that could present an alternative to smoking – particularly as it relates to e-cigarettes – cannot, and will not, come at the expense of addicting a generation of children to nicotine through these same delivery vehicles,” Gottlieb said in an FDA statement. “This simply will not happen. I will take whatever steps I must to prevent this.”

The measures are part of several that have been anticipated since the Washington Post reported on the expected changes last week.

What Are The New Rules?

The FDA is restricting all flavors of e-cigarettes—except menthol, mint and tobacco flavors—to be sold only in person at locations not accessible by those under age 18. These refers to all flavored products for electronic nicotine delivery systems (ENDS), including “e-liquids, cartridge-based systems and cigalikes.”

These products can still be sold in 18-and-up vaping shops, and menthol, mint and tobacco-flavored (or non-flavored) e-cigarettes can still be sold in any location cigarettes are sold. However, flavorings also cannot be sold online “without heightened age verification processes,” the details of which still need to be developed.

Gottlieb also proposed banning all flavors in cigars, including products previously exempt from restrictions through grandfathering, and continuing the process of banning sales of menthol cigarettes. Flavored cigars and menthol cigarettes are more popular among youth, and menthol cigarettes are particularly popular among black teens, contributing to the racial disparities in tobacco addiction.

Gottlieb’s Track Record with E-Cigarette Regulation

Gottlieb may have seemed an unlikely ally for public health folks wishing for greater e-cigarette regulation. He previously served on the board of a North Carolina vaping company and has previously expressed support for e-cigarettes, even when he introduced a comprehensive plan for addressing tobacco and nicotine use in July 2017.

Then and now, Gottlieb said he continued to believe in the “potential for innovative, less harmful products that can efficiently deliver satisfying levels of nicotine to adults who want them,” including “new technologies like electronic nicotine delivery systems (ENDS) as an alternative to cigarettes for adults who still seek access to satisfying levels of nicotine, without all the deadly effects of combustion.”

But his interpretation of recent data appears to have dampened his enthusiasm. Declines in teen smoking over the past several decades seemed to show steady progress, even as teens’ interest in e-cigarettes began climbing. Then came the 2018 National Youth Tobacco Survey (NYTS), published today by the FDA and the Centers for Disease Control and Prevention. The report’s numbers “shock my conscience,” Gottlieb said.

They show that e-cigarette use has increased 78% in high schoolers and 48% in middle schoolers, resulting in 3.6 million adolescents currently using e-cigarettes—1.5 million more than last year. More than one in four of these teens use e-cigarettes regularly, at least 20 days in the past month. Further, about two out of three teens use flavored e-cigarettes.

In his statement, Gottlieb’s tone is half defensive, half apologetic: it seems clear he wanted to see reductions in teen vaping through the various programs and measures FDA has already deployed before moving to restrict flavorings.

“I told the manufacturers of e-cigarettes that the youth use of their products was an existential threat to this innovation,” Gottlieb said. “And we weren’t quiet about our concerns. And yet these deeply disturbing trends continued to build.”

The extremely popular company Juul was particularly targeted by the FDA in their calls for voluntary industry action on reducing teen e-cigarette use. And following the Washington Post’s announcement last week that more FDA restrictions were coming, Juul, a $16 billion company, announced Tuesday that it would stop selling its flavored e-cigarette pods in retail stores, the popular mango, fruit, crème and cucumber flavorings that account for nearly half (45%) their retail sales, according to the New York Times.

Gottlieb noted that only 1 percent of cigarette smokers started smoking after turning age 26, and he’s trying “to strike a careful public health balance between our imperative to enable the opportunities to transition to non-combustible products to be available for adults and our solemn mandate to make nicotine products less accessible and less appealing to children.”

That’s a balance wrought with tension: adults who use electronic nicotine/tobacco products say that flavors—the same characteristic that public health officials claim attracts kids to e-cigarettes—are what make e-cigarettes attractive for adults hoping to reduce harm by replacing combustible cigarettes.

What Does The Evidence Show?

Everyone agrees teen e-cigarette use, or vaping, has increased, and nearly everyone agrees that’s a problem. (Some believe teens are switching from traditional cigarettes to e-cigarettes, which may not necessarily be a problem.)

Gottlieb noted a growing body of evidence suggesting that teens who try e-cigarettes are more likely to try traditional combustible cigarettes later. Early studies in this area have been problematic, using small populations and/or cross-sectional study designs (single-time surveys) that aren’t able to establish whether one thing causes another.

But more recent studies have had more robust study designs, and they do seem to point toward a higher risk of starting to smoke regular cigarettes after becoming addicted to nicotine through e-cigarette products.

E-cigarette advocates question that data, regularly poking holes—sometimes valid and sometimes stretching—into that research. They point to research suggesting that e-cigarettes are a less harmful alternative to traditional cigarettes that can help people quit smoking and therefore reduce harm in those with nicotine dependence.

Again, that research is not clear-cut either. The US public health community seems divided—though it’s difficult to say how much or how many necessarily fall strongly on one side or another—over the harm reduction benefits of e-cigarettes. But in the United Kingdom, the Royal College of Physicians has come out firmly supportive of e-cigarettes as a harm reduction strategy for current smokers.

What Do Advocates Say?

As one might expect, there are advocacy organizations are on opposite sides of the debate, though they all agree that youth should not be able to easily purchase vaping products.

“No youth should vape, and there is room for more rigorous enforcement to ensure youth are not accessing these products,” said Greg Conley, president of the American Vaping Association, a nonprofit that “advocates for rational regulations of vaping products” and receives funding from “vaping product manufacturers and retailers,” according to Conley. But Conley believes Gottlieb has gone too far.

“Not every town has a vape shop, meaning that for many adults, it will be much easier to pick up a pack of Marlboros or Camels — or even an unrestricted cherry-flavored cigar — at a local convenience store than it will be to make the switch to a vaping product that can truly help smokers break their desire for cigarettes,” Conley said.

But the American Academy of Pediatrics (AAP) and public health organizations like Public Health Solutions, in New York City, are pleased with the latest FDA moves—and want to see more.

“We’re making progress but we need to see more being done,” said Lisa David, president and CEO of Public Health Solutions. David thinks online age verification is not stringent enough, and she wants to see the FDA use pricing to reduce youth use.

“Young people are much more sensitive to price increases than adults, and making the price of e-cigarettes comparable to cigarettes is a critical next step,” David said. “If we don’t approach this issue with an aggressive strategy now, e-cigarettes will continue to hook a new generation of smokers on nicotine.”

The AAP agrees: “Even with new sales restrictions announced today by FDA preventing flavored e-cigarettes from being sold at certain brick and mortar storefronts, teens will still find ways to access them,” AAP President Colleen Kraft, MD, said in a statement. “E-cigarette products that appeal to children have no business in the marketplace, period. FDA must take stronger action to protect young people.”

Look for an article tomorrow sharing what public health experts think about the new FDA regulations and other ways to decrease teen use of e-cigarettes.

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