The U.S. Food and Drug Administration announced Thursday a series of policies to attack what it calls "the epidemic use of electronic cigarettes and nicotine addiction among kids."
It imposed sharp restrictions on where most flavored e-cigarette products can be sold, and announced plans to ban flavored cigars and menthol cigarettes. The use of all three products has been on the rise among youth.
In the last year, e-cigarette use has jumped 78 percent among high school students, according to new data from the National Youth Tobacco Survey released Thursday. More than 3.6 million middle and high school students currently use e-cigarettes, most of which have flavors like candy, vanilla, and fruit. And more than a quarter of youths use the product daily.
Many parents, advocates, and health officials worry these products will start children on the path to becoming regular smokers. Research shows 90 percent of adult smokers started smoking before the age of 18, and 95 percent by the age of 21.
"I will not allow a generation of children to become addicted to nicotine through e-cigarettes," Commissioner Scott Gottlieb said in a statement. "We won't let this pool of kids, a pool of future potential smokers, of future disease and death, continue to build. We'll take whatever action is necessary to stop these trends from continuing."
Sales of most flavored e-cigarettes will be limited to stores that sell only to customers over the age of 18, or areas of stores that have age-restricted entry. Gottlieb called on companies that cannot adhere to the restrictions to remove the products within 90 days.
The move aims to decrease the number of young people buying these items from convenience stores and gas stations. Nearly a quarter of all attempts by minors to purchase tobacco in Philadelphia in 2015 were successful.
"For too long, flavored cigars and menthol cigarettes have been the on-ramp to smoking for teenagers in Philadelphia. Prohibiting these flavored products would be a major advance in the battle against the nation's biggest killer, tobacco," said Philadelphia Health Commissioner Thomas Farley. "We also support FDA's proposed actions to protect teens from the marketing of flavored e-cigarettes."
Convenience store owners questioned the fairness of the policy, suggesting it imposed additional burdens on only select types of retail outlets. "Sound regulation should ensure that e-cigarettes are sold responsibly and that the market is a level playing field," said Lyle Beckwith, senior vice president of government relations for the National Association of Convenience Stores. Many vape shops already impose an age limit for customers, so they would not be affected by the new rule.
In addition to the regulations for brick-and-mortar stores, the FDA will also require websites that sell e-cigarettes to use stricter methods to verify buyers' ages.
The new restrictions will not apply to menthol, mint, or tobacco-flavored e-cigarettes for now. Gottlieb said these products can help adults who use conventional cigarettes quit smoking, though evidence is limited. He stressed that the new regulations seek to balance protecting children with giving adult smokers access to products that may help them go smoke-free.
Thursday's announcement came after months of efforts by the agency to curb youth vaping. E-cigarettes — which look nothing like conventional cigarettes — have become wildly popular with teens. They produce tiny vapor puffs from pods that contain flavored nicotine fluid. The most popular brand, Juul, is designed to look like a thumb drive, can be charged on laptop computers, and can be easily hidden in a shirtsleeve.
In September, the FDA demanded that e-cigarette manufacturers produce a plan to restrict sales to minors, and imposed a deadline that passed last weekend. Juul Labs, which accounts for nearly 70 percent of e-cigarette sales, announced this week it would stop selling most of its flavored products in retail stores. Another company, Altria, said late last month it would stop selling its pod-based flavored e-cigarettes for now.
The FDA also announced plans to target flavored cigars and menthol cigarettes. The agency is starting the process to ban both products.
Flavors, including menthol, candy, and fruit, help mask the harshness of tobacco and can make it easier for youths to start smoking. One study found two-thirds of teenagers who had smoked a cigar used a flavored one their first time.
The tobacco industry has long fought to protect menthol cigarettes, and several companies made it clear they'd fight both proposed bans.
The National Association of Tobacco Outlets said it shares the FDA's concerns about youth smoking, but bans would have "unintended consequences," shifting items to the black market. The group advocated enforcement of current laws instead. "Education and compliance with the law are the keys to achieving the goal of helping to prevent underage access," said Thomas Briant, executive director of the association.
Others questioned the evidence behind the proposed bans. Altria Group, which makes Marlboro cigarettes and Black & Mild cigars, said in a statement, "We continue to believe that a total ban on menthol cigarettes or flavored cigars would be an extreme measure not supported by the science and evidence."
Yet research shows menthol cigarettes can actually be more difficult to quit than non-flavored cigarettes.
Health advocates, who have pushed for a ban on menthol cigarettes for years, applauded the move as a key step toward reducing racial health disparities. National data show 70 percent of African American youth smokers choose menthol cigarettes, compared to just over half of young white smokers. Flavored cigars are also especially popular among African American youth.
"If adopted, these two proposals will 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," Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a statement.
Flavored cigars and smaller cigarillos are a particular concern in Philadelphia, where their use has doubled in recent years, even as cigarette use fell. The use of cigars has tripled among African American youth in the city. Earlier this year, City Council proposed banning flavored cigars and cigarillos, but the measure failed after the state prevented individual cities from enacting new tobacco restrictions.
Gottlieb said the new policies represent a start, and the FDA is open to enacting more restrictions in the future.
"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," he said.