FDA Moves to Restrict Flavored E-Cig Sales, Ban Menthol Cigarettes

THURSDAY, Nov. 15, 2018 (HealthDay News) -- The U.S. Food and Drug Administration said Thursday it will take steps to limit or ban access to flavored e-cigarettes, menthol cigarettes and flavored cigars.

The move against flavored e-cigarettes stops short of the full ban that had been expected from the agency. Instead, sales of these products -- thought to be especially alluring to teens -- will only be allowed in stores within special closed-off areas made inaccessible to minors, The New York Times reported.

More unexpected was the FDA's proposed ban on menthol cigarettes and flavored cigars, products which have long been thought to disproportionately harm the health of black Americans.

The menthol ban still has regulatory hurdles to overcome, so removal of those products from the market could take two years, the Times noted.

Still, the move would come as a huge blow to the tobacco industry, since menthols make up more than a third of the cigarette market.

All three moves are aimed at curbing uptake of vaped and smoked nicotine by the young. More than 3.6 million Americans under the age of 18 now vape, the agency noted.

The announcements come after the leading vape maker, Juul Labs, announced Tuesday that it would voluntarily withdraw most flavors of its hugely popular vaping product from the marketplace.

Juul, which controls 70 percent of the e-cigarette market, has come under increasing pressure to do something about the surging popularity of its vaping devices among youth.

In a statement released Tuesday, Juul CEO Kevin Burns said, "Our intent was never to have youth use Juul. But intent is not enough. The numbers are what matter, and the numbers tell us underage use of e-cigarettes is a problem."

And in a statement released Thursday, FDA Commissioner Dr. Scott Gottlieb noted that "almost all adult smokers started smoking when they were kids. Today, we significantly advance our efforts to combat youth access and appeal with proposals that firmly and directly address the core of the epidemic: flavors."

Nevertheless, the decision to restrict but not ban flavored e-cigarettes came as a surprise, since leaked documents had suggested a full FDA ban was imminent. In the end, the complex legalities of imposing a ban may have meant drawn-out court battles, something the FDA may have wanted to avoid, legal experts told the Times.

Instead, Gottlieb said that within the next three months, e-cigarette manufacturers should remove the products from "where kids can access them and from online sites that do not have sufficiently robust age-verification procedures."

Anti-smoking advocates expressed some disappointment at the FDA's announcement, however.

"We commend the FDA for recognizing the grave threat posed by electronic cigarettes on our children, and for imposing restrictions on manufacturers," Nancy Brown, CEO of the American Heart Association, said in a statement.

"With e-cigarette use having jumped by 78 percent among high school students and 48 percent among middle school students, the need for action is urgent," she added. "But limiting the sale of e-cigarettes is not enough -- the FDA should also remove flavored e-cigarettes from the market and prohibit companies from marketing their products in ways that appeal to kids."

And Matt Myers, president of Campaign for Tobacco-Free Kids, wondered to the Times, "Does this mean a simple curtain with a sign like we used to see at the entrance to the pornography section of video stores?"

Lyle Beckwith, a spokesman for the National Association of Convenience Stores, said his group "will be reviewing the regulation and advising our members accordingly" as to how to best implement the new rules.

He noted that, according to his teenaged son, most minors already get their flavor pods from older youth, not convenience stores.

The FDA first began its crackdown on flavored e-cigarettes earlier this year, as the number of teens using the products reached epidemic proportions, the Times reported. By far, the leading vaping product is made by Juul, whose e-cigarette devices resemble small computer flash drives. Use of Juul has skyrocketed among teens over the past year.

Flavored versions of e-cigarettes -- including chicken and waffles, rocket Popsicle and "unicorn milk" -- have boosted sales among the young even further, experts contend.

"The availability of flavors in e-cigarettes is one of the top reasons that middle and high school students cite as their motivation for using e-cigarettes," said Patricia Folan, director of the Center for Tobacco Control at Northwell Health in Great Neck, N.Y. "Young people are more likely to try flavored e-cigarettes and consider them less harmful than tobacco-flavored e-cigarettes."

The vaping industry has countered that flavored e-cigarettes actually provide a potential health benefit, helping to encourage tobacco smokers to quit.

"Flavors are important for switching," Dr. Moira Gilchrist, a scientist with Philip Morris International, said during a visit to Washington in October for an FDA public meeting. Phillip Morris hopes to market its IQOS heat-not-burn device in the United States in tobacco and menthol flavors.

"The focus should be on what is the right thing to do for the 40 million men and women in the United States who would otherwise continue to smoke cigarettes," she said.

As for the ban on menthol cigarettes and flavored cigars -- both highly favored by black Americans -- challenges lie ahead. The U.S. tobacco industry has long fought hard against such a ban. But health advocates were heartened by the news.

"Studies show that menthol cigarettes increase initiation, especially among youth," Brown noted. "Menthol also has a disproportionate impact on minorities including African-Americans, who favor menthol cigarettes and find them more difficult to successfully quit."

Delmonte Jefferson, executive director of the National African American Tobacco Prevention Network, told the Times, "While we're saddened by the number of lives lost and new smokers addicted over the past decade, we're pleased that the FDA is moving in this direction."

The group also praised the agency for taking on flavored cigars.

"Little cigars like Black & Milds and Swisher Sweets are heavily marketed to African Americans and are often cheaper in our neighborhoods," said LaTroya Hester, a spokesman for the network. "A lot of young, black kids don't know that cigarillos are just as dangerous, so hopefully this will send that message. This is a huge step in protecting their health. It's about time our young people are prioritized."

More information

The U.S. National Institute on Drug Abuse has more about e-cigarettes.