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The FDA cracks down on menthol cigarettes and flavored cigars

The agency stopped short of a ban on flavored e-cigarettes that had been expected.

FDA Examines Menthol Cigarettes, With Possible Ban In Sight
Researchers have long known menthol cigarettes are more attractive to youth and harder to quit than regular cigarettes.
Photo by Joe Raedle/Getty Images

With e-cigarette use now epidemic among teens, and cigarettes still the leading cause of preventable death in the United States, the Food and Drug Administration announced on Thursday a series of moves meant to drive young people away from tobacco products.

The agency said it’s working to ban menthol cigarettes and flavored cigars from the market, as well as restrict the sales of flavored e-cigarettes in stores and online — though it wouldn’t outright ban vape flavors in brick-and-mortar retailers, a move that was widely anticipated after leaked reports from FDA over the last week.

The menthol ban will require new regulation, and it will take years to go into effect. But it would have a greater health impact: Researchers have long known menthol cigarettes are more attractive to youth and harder to quit than regular cigarettes. They’ve also been heavily marketed at — and are especially popular among — black smokers.

“I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” FDA Commissioner Scott Gottlieb said in a statement Thursday. “Moreover, I believe that menthol products disproportionately and adversely affect underserved communities.”

The new e-cigarette restrictions FDA is pursuing will allow retailers to continue selling flavored vape products, but in age-restricted, zoned-off areas. For products sold online, the agency also wants to heighten age verification requirements.

These changes fall short of the ban on flavored cartridge-based e-cigarettes in thousands of convenience stores and gas stations across the US that many anticipated. According to the New York Times, the agency backed off pursuing such a ban because it lacked the legal authority and would have wound up in “protracted court battles.”

The crackdown is a response new data showing a 78 percent increase in the use of vaping devices among high schools since 2017, as well as evidence that teens are quickly adopting products like Juul, a vape device that burns pods with flavors like Creme Brûlée.

“These increases must stop,” Gottlieb said. “And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes.”

By trying to curtail access to vape, cigar, and cigarette products that appeal to youth, the FDA is aiming to drive down vaping and smoking rates in minors without adding any barriers for established smokers who want to move to vaping. But with teen vaping already widespread in America, that might be easier said than done. And some think the agency hasn’t gone far enough.

Gottlieb’s e-cigarettes restrictions follow the rise in teen vaping

Tobacco remains a major killer in the US. Yet, when the FDA banned flavor claims on regular cigarettes, Congress exempted menthol in 2009, to the dismay of health advocates. So the proposed changes may close the cigarette gap, and also remove flavored cigars from the market, but make mint and menthol e-cigarettes relatively easily available.

“This reflects a careful balancing of public health considerations,” Gottlieb said Thursday. “Among all [e-cigarette] users, data suggests that mint- and menthol-flavored [electronic nicotine products] are more popular with adults than with kids.”

Since his first days on the job, Gottlieb has struggled with how to strike this balance between curbing the uptake of e-cigarettes in minors while also helping smokers quit.

In July 2017, the FDA delayed the compliance deadline for the regulation of e-cigarette products to 2022. This gave the industry five more years to file public health applications that show that their products are safe alternatives to conventional cigarettes and that they weren’t unduly targeting minors.

Gottlieb positioned the delay as a way to give manufacturers time to get in step with the new laws while ensuring smokers had access to cigarette alternatives that could save their lives. But some public health advocates viewed it another way: as a giveaway for the vaping industry, and a chance for e-cigarette makers to further expand their market share among kids at a time when e-cigarette use by teens has eclipsed conventional cigarette use.

“In this world, a delay of [five] years is a lifetime,” Matt Myers, president of the Campaign for Tobacco-Free Kids, told Vox last spring. “And the data seems to indicate this product is being used by kids all across the country.”

For these reasons, health groups sued the FDA over the delay and sent a letter to Gottlieb asking the FDA to begin regulating e-cigarette products like other cigarettes immediately.

In 2017, the e-cigarette market grew by 40 percent. Juul has been driving a big portion of that growth.

Meanwhile, the e-cigarette market has continued to grow. In 2017, the US market expanded by 40 percent, to $1.16 billion, with a lot of that growth driven by Juul.

As of March, Juul made up more than half of all e-cigarette retail market sales in the US, according to Nielsen data. Considering it has only been on the market since 2015, and there are hundreds of other devices available to consumers, Juul’s market share is staggering.

More recently, the FDA has been taking action against Juul and teen e-cigarette use — but has stopped short of changing the compliance deadline. In April, the FDA took the unusual step of demanding Juul Labs submit documents about its marketing and research and what it knows about Juul use among young people. The move was part of the FDA’s new Youth Tobacco Prevention Plan.

In May, the agency followed up by sending requests for information to four other e-cigarette makers that also appear to be marketing to young people.

Last September, FDA announced it has again sent warning letters to Juul Labs and the manufacturers of other vaping devices, giving them 60 days to come up with plans that minimize their products’ appeal to minors. It’s also warned more than 1,000 retailers accused of illegally selling e-cigarettes to minors to stop.

Juul Labs, the maker of Juul, this week appeared to be preempting the FDA’s crackdown, with an announcement it would stop selling its fruit and dessert-flavored products in more than 90,000 brick-and-mortar retail stores, and halt its marketing on Facebook and Instagram.

Gottlieb called on other manufacturers to take similar voluntary measures. “They can stop certain marketing and sales practices — the ones we believe are part of the youth access and youth appeal problem — right now,” he said.

But some wish the FDA would go further. “The mass marketing of cigarettes, a highly sophisticated, addictive and defective nicotine delivery device that kills over 7 million people globally every year, is an abuse of corporate power and a human rights violation,” said Laurent Huber, Executive Director of ASH, the anti-tobacco non-profit. “Banning menthol is a step in the right direction, but it is time to go one step further and phase cigarettes out of the market to prevent millions of unnecessary deaths.”

“My sense is that the pro-vaping crowd will be happy because the restrictions on [e-cigarettes] seem to be fairly light, and the restrictions on combustibles fairly severe but will take years, if ever,” said Michael Eriksen, dean of the school of public health at Georgia State University and a former director of the Centers for Disease Control and Prevention’s Office on Smoking and Health.

Allowing adult-only access areas is not that different from what the FDA was doing before, said David Liddell Ashley, the previous director of the office of science in the Center for Tobacco Products at FDA. “I do not think it will completely solve the likely increase in cigarette smoking, which will result from the use of e-cigarettes by youth.”

That would require a number of extra steps — like engineering products so they’re less addictive and cracking down on marketing. And the FDA has stalled on both these fronts.

For more on Juul and e-cigarettes, read our explainer, listen to the May 3, 2018, episode of Today, Explained, and watch our Vox video here.