Washington • The Food and Drug Administration on Thursday launched a multipronged attack on the rising underage use of tobacco products, imposing sharp sales restrictions on flavored e-cigarettes and announcing plans to ban menthol cigarettes and flavored cigars.
The FDA says it will limit sales of many flavored e-cigarettes to bricks-and-mortar outlets that have either age-restricted entry or areas inside stores that are not accessible to people under 18. Such restrictions are tantamount to a ban for many convenience stores and gas stations but not for specialty vape and tobacco stores, said a top agency official. The FDA also will require stepped-up age verification for online sales.
The new limits reflect health experts' concerns that e-cigarette use could lead to nicotine addiction early in life and affect the developing adolescent brain and that some e-cigarette users will go on to smoke more dangerous regular cigarettes.
Perhaps even more significant than the e-cigarette steps are the FDA’s commitments to propose bans on menthol in cigarettes and cigars, as well as other flavors in cigars. Such prohibitions will require new regulations that could take years to go into effect, and could be derailed by opposition from the cigarette industry. If successful, though, the bans could have an especially significant impact on African American adults and youth, who smoke menthol cigarettes and flavored cigars at higher rates than other groups.
The tobacco blueprint was released by FDA Commissioner Scott Gottlieb as the government published new data showing a surge in e-cigarette use among minors. The 2018 National Youth Tobacco Survey, by the FDA and the Centers for Disease Control and Prevention, found that vaping had increased 78 percent among high school students since last year and almost 48 percent among middle schoolers; 3.6 million youngsters reported vaping at least once in the previous 30 days.
Especially concerning to officials was a sharp rise in regular use. Almost 28 percent of high school vapers said they used e-cigarettes at least 20 days a month, and most used flavored products.
“The bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes,” Gottlieb said in a statement. “We won’t let this pool of kids, a pool of future potential smokers, to continue to build.” He said the new policy was designed to get to the “core” of the issue — flavored nicotine products, often in fruity, sweet and creamy flavors, that appeal to kids. The restrictions do not affect mint, menthol and tobacco flavored e-cigarette products.
Gottlieb called on companies to remove the affected products within 90 days from stores that children can enter and from online sites that don't have adequate age-verification procedures.
The FDA's moves on menthol cigarettes and flavored cigars drew widespread praise even before they were officially announced. Its actions on e-cigarettes were more controversial. Public health experts called them a start but said they were not a comprehensive solution to the problem, while vaping advocates said they would hurt adult smokers using e-cigarettes to quit.
"The proposal to prohibit the sale of menthol cigarettes and flavored cigars has the potential to have a greater impact on youth tobacco use and tobacco use among African Americans than any regulatory measure every undertaken by the federal government," said Matt Myers, president of the Campaign for Tobacco-Free Kids. But he added that the e-cigarette actions "fall short of what's needed."
Robin Koval, chief executive of Truth Initiative, a tobacco-control group, also praised the planned bans, but said it was a mistake to exempt mint and menthol e-cigarettes from sales restrictions, given that data shows those flavors are becoming increasingly popular among high schoolers.
But Gottlieb insisted that the exclusion of mint and menthol reflected a "careful balancing" of concerns about youth and the needs of adult smokers using e-cigarettes to quite smoking. And he said he would consider restricting those flavors if youth use didn't decline.
Some critics raised the possibility that the agency could face a lawsuit by trying, in effect, to limit vaping product sales to certain types of stores.
"I don't think they know where the law allows the FDA to ban hundreds of thousands of stores from selling a legal product," said Lyle Beckwith, senior vice president of the National Association of Convenience Stores.
On the menthol issue, the 2009 tobacco-control act banned all flavors in traditional cigarettes except menthol; that was left for the FDA to tackle. But the agency never sought to bar menthol cigarettes, which over the years have been marketed heavily to African Americans. A big-selling menthol cigarette is Newport, by Reynolds American, a subsidiary of British American Tobacco.
Black organizations late Wednesday applauded the idea of a menthol ban, noting that almost 90 percent of African American smokers choose menthols. "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," said Delmonte Jefferson, executive director of the National African American Tobacco Prevention Network in a statement also signed by the National Urban League, the National Association for the Advancement of Colored People and other groups.
Gottlieb, in pursuing his tobacco strategy, is taking some flak from fellow conservatives. “The administration promised less regulation - without sacrificing protections,” said Jeff Stier, a senior fellow at the Consumer Choice Center. “So if the FDA fails to meet both objectives — by announcing a heavy-handed regulatory plan — President Trump should realize that the current leadership at the FDA is not equipped to implement the administration’s policy agenda.”
Health and Human Services Secretary Alex Azar signaled his support for the FDA. "We believe FDA's goals and policies strike the right public health balance in addressing the multifaceted challenge we have before us today," he said in a statement.
The FDA’s e-cigarette crackdown already has had an impact. Juul Labs, which accounts for more than 70 percent of e-cigarette retail sales and has been blamed by the FDA for much of the rise in underage use, announced this week that it would stop selling most of its flavored e-cigarette pods — specifically, mango, fruit, crème and cucumber — in 90,000 retail outlets, and enhance its online protections. The company also said it would halt its social media promotions of the products. And Altria said late last month it would stop selling its pod-based flavored e-cigarettes for now.
The e-cigarette sales restrictions cover e-liquids as well as cartridges and pods, the FDA said. But e-liquids already are sold primarily in adult vape and tobacco shops, officials said.
The plan outlined by Gottlieb on Thursday is a major revision of his July 2017 tobacco framework. That plan emphasized that nicotine-containing products represent a spectrum of risk, with regular cigarettes on the one end and vaping products and nicotine-replacement products on the other. As part of that, he endorsed cutting the nicotine in regular cigarettes to minimally addictive levels. And he gave e-cigarette manufacturers an extra four years to apply for FDA marketing authorization.
Health groups sued Gottlieb, arguing that the delay in e-cigarette regulation inadvertently contributed to the recent surge in youth vaping. The FDA chief disagreed, saying Juul would have been on the market in any case.