FDA cracks down on e-cigs, noting use by youth more than doubled in a year, and proposes to ban menthol in cigarettes

Centers for Disease Control and Prevention graphic

By Melissa Patrick
Kentucky Health News

The U.S. Food and Drug Administration proposed Thursday to ban menthol-flavored cigarettes and cigars, and restrict the sales of some flavored electronic-cigarette liquids, some flavored cigars and the removal of e-cigarettes that are marketed to youth.

The proposals are aimed at curbing teen use of e-cigarettes and follow the release of data showing that teen use of these products increased 78 percent among high-school students and 48 percent among middle-school students in the past year.

The 2018 National Youth Tobacco Survey found that 3.6 million middle and high schools students are using e-cigarettes -- up from 1.5 million last year -- with more than 3 million, or 21 percent, of the students in high school and 570,000, or nearly 5 percent of them in middle school.

"It’s clear we have a problem with access to, and appeal of these products to kids, and we’re committed to utilizing the full range of our regulatory authorities to directly target the places kids are getting these products and address the role flavors and marketing are playing in youth initiation,” Dr. Scott Gottlieb, the FDA commissioner, said in a news release.

Explaining the menthol/mint ban, Gottlieb said it's not fair to create a market difference by limiting menthol and mint flavors in e-cigarettes when they are still allowed in combustible products.

The researchers attribute the surge in e-cigarette use to the popularity of the Juul and similar devices, because they resemble USB flash drives, allowing them to be used discreetly; have a high nicotine content; and come in kid-friendly flavors.

The new restrictions would require all vaping liquids flavored with anything other than tobacco, mint or menthol be sold only in stores that have strict age-checking practices. And if sold online, the flavored liquids must be sold under more stringent age verification rules, which will be forthcoming.

Gottlieb said the FDA would proceed with a proposed regulation banning flavored cigars, would issue a proposed rule to ban menthol cigarettes and cigars and will seek to remove any e-cig products that are marketed to youth, including those using cartoon or animated characters on the packaging.

Gottlieb said the package "reflects a careful balancing of public health considerations" between adults having access to a less harmful alternative than combustible cigarettes to quit smoking and preventing teen use. "But make no mistake," he warned. "If the policy changes that we have outlined don’t reverse this epidemic, and if the manufacturers don’t do their part to help advance this cause, I’ll explore additional actions."

Michigan Education Association photo

Juul Labs, which controls more than 70 percent of the market, announced earlier this week that, among other things, it will stop selling its mango, fruit, creme and cucumber pods in convenience stores and vape shops, and would shut down its social-media promotions and keep monitoring third-party accounts.

More bad news in youth tobacco survey

The jump in e-cigarette use supports the fears of health officials who have long been concerned that e-cig use by teens will reverse the declines in overall youth tobacco use. Multiple studies show that teens who use e-cigs are more likely to transition to cigarettes.

The youth tobacco survey found that in the last year, overall tobacco-product use among high-school students increased by 38 percent, rising to 27.1 percent from 19.6 percent, and among middle-school students by 29 percent, rising to 7.2 percent from 5.6 percent.

Not only is use of the products increasing, so is the frequency of use, which could indicate development of a habit that may be hard to stop. The survey found that the number of high-school students reporting they had used e-cigs on 20 or more of the past 30 days increased from 20 percent to nearly 28 percent in the past year.

More high school students reported having used flavored e-cigarettes in the past year; that figure rose to 68 percent from 61 percent. And current use of menthol- or mint-flavored e-cigs rose to 51.2 percent from 42.3 percent. Teens and young adults have told researchers that the flavors are the primary reason for their e-cig use.

Proposals spark debate

Gottlieb is getting some push-back from conservatives, but has held firm to his commitment to stop the teen use of these products.

“My former friends in the libertarian community who think this is emblematic of nanny-state government intervention and denying adults access to legal pleasures — I hope that when they sit and think about the data we’re seeing they’re willing to accept modest speed bumps in terms of the access adults will have to these products to hopefully close off the access of these products to kids,” Gottlieb told Paige Winfield Cunningham of The Washington Post.

In a detailed story in The Wall Street Journal about menthol products and "Big Tobacco," a spokesman for Reynolds American Inc., which makes Newport, the leading U.S. menthol brand, said banning menthols could possibly result in a legal battle, and a ban would also expand the underground market for these products, Jennifer Maloney and Tom McGinty report.

Matthew L. Myers, president for the Campaign for Tobacco Free Kids said in a news release that the menthol ban would "have a greater impact in reducing tobacco use by youth and the African-American community than any regulatory measure ever undertaken by the federal government."

But Myers argued that the FDA's e-cigarette proposal doesn't go far enough, because it stops short of banning many flavors that are highly popular with young people, noting that the menthol and mint flavors used by 51 percent of teen e-cig users will still be available.

"With these flavors still widely available, it is doubtful that this plan will stem the tide of youth e-cigarette use, and it will be critical for the FDA to quickly supplement the steps announced today," Myers said. "In addition, the Juul device itself and other e-cigarettes that deliver exceptionally high levels of nicotine will continue to be sold in convenience stores and gas stations."

Bonnie Hackbarth, a spokeswoman for the Foundation for a Healthy Kentucky, noted that the proposed regulatory changes can take years to implement and that there has already been "unnecessary delays" in the e-cigarette regulations, which have allowed new products to "flourish."

"We’re heartened by the FDA’s stepped-up enforcement and by what appears to be a clear-minded attempt to balance the absolute necessity of keeping tobacco products out of the hands of kids while allowing adults who smoke access to products that may help them quit tobacco completely," she said. "But we can’t wait two more years or even another six months, only to find that e-cig flavors and easy access have hooked millions more kids to a deadly habit."

Ben Chandler, president and CEO of the foundation, said, "Flavored cigarettes were banned in 2009 largely because the colorful packaging and names appealed to youth, which is the age most smoking habits are established. The explosive growth in teen use of Juul and other pod e-cigarettes in recent months, in conjunction with research showing that most youth try flavored e-cigarettes first . . . just proves the point. Flavors are a powerful tool in the tobacco business-model toolbox that relies on addicting new customers to stay in business. Unless and until it's proven that flavored e-cigs actually do help adult smokers quit, they shouldn't be allowed on the market."