“Our aim is to make sure no kid can access a fruity flavor product in a convenience store,” FDA Commissioner Scott Gottlieb said. He added that stores that want to sell fruit-flavored e-cigarette products "need to age-restrict completely or have a separate room that is age-verified. A curtain or a partition won’t cut it.” Agency officials said they believe that vape and tobacco shops will not have trouble complying.
The new sales restrictions 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. The agency also said it will go after products marketed to children — through the use of cartoon characters, for example.
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 large 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 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, while calling 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. 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.
The FDA’s moves on menthol cigarettes and flavored cigars drew widespread praise. But its actions on e-cigarettes were more controversial. Public health experts and Democratic lawmakers lauded the vaping moves as a first step but said they didn’t go far enough. For example, Sen. Richard Durbin (D-Ill.) said the agency was finally “moving in the right direction” on e-cigarettes but called on Gottlieb to immediately ban all kid-friendly flavors. Meanwhile, Sen. Ron Johnson (R-Wis.), endorsing the view of many vaping advocates, said that the FDA effort could hurt adult smokers who use e-cigarettes to try to quit regular cigarettes.
"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 ever undertaken by the federal government,” said Matt Myers, president of the Campaign for Tobacco-Free Kids. But, he said, the e-cigarette actions “fall short of what’s needed.” In particular, he said, he is worried that some convenience stores will continue to sell the flavored e-cigarettes “by creating an ineffective artificial barrier.”
Robin Koval, chief executive of Truth Initiative, a tobacco-control group, also praised the planned menthol and cigar bans but said it was a mistake to exempt mint and menthol e-cigarettes from the planned sales restrictions, given that data shows those flavors are becoming increasingly popular among high schoolers. Public health groups want a ban on all flavored cigarettes, at least until manufacturers can prove the items benefit public health.
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 exempted flavors if youth use didn’t decline.
Lyle Beckwith, senior vice president of NACS, which represents convenience stores, said his group would review the proposal carefully but that “sound regulation should ensure that e-cigarettes are sold responsibly and that the market is a level playing field.” He also said that any ban on menthol cigarettes would simply shift sales of those products to the black market.
The 2009 tobacco-control act banned all flavors in traditional cigarettes except menthol; the law left that to the FDA. Part of the reason that menthol was left out of the law was because of a split in the black community. For years, the tobacco industry has donated money to black interests such as the Congressional Black Caucus Foundation and marketed heavily to African Americans. But FDA, while long debating a menthol ban, never proposed one.
Black organizations applauded 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. The statement also was signed by the National Urban League, the National Association for the Advancement of Colored People and other groups.
In a statement, the R.J. Reynolds Tobacco company, which makes the nation’s best-selling menthol cigarette, Newport, said research does not support differing regulations for menthol and non-menthol cigarettes and hinted at the possibility of a lawsuit.
“Any regulation of menthol in cigarettes must be done through the established comprehensive rulemaking process and must be based on a thorough review of the science while considering the unintended consequences of any rule,” the company said. “Failing to do so would mean any such action would not withstand judicial review.”
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." But Gottlieb’s boss, Health and Human Services Secretary Alex Azar signaled his support for the FDA 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. Agency officials said those items already are sold primarily in adult vape and tobacco shops. But vaping advocates said the items are popular at truck stops, and could be affected.
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.