The Food and Drug Administration announced two major attacks on the tobacco industry Thursday, saying it will start the process to ban menthol in cigarettes and limit sales of flavored e-cigarettes to youths.
The FDA's long-deliberated moves are driven by new figures from the Centers for Disease Control and Prevention showing a 78 percent increase in vaping by high school students, with 3.6 million high school and middle school students now using e-cigarettes.
Calling the numbers “astonishing," FDA commissioner Dr. Scott Gottlieb said he was stepping up his agency’s actions to curb youth vaping.
"Among high school students, current e-cigarette use increased from 1.5 percent in 2011 to 20.8 percent in 2018,'' the CDC report reads.
“These data shock my conscience: From 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students,” Gottlieb said.
He said he would speed up FDA action to limit sales of flavored electronic cigarette products to underage users, both in stores and online, and said he was starting the process to ban menthol in cigarettes.
The FDA’s plans had been widely leaked last week but Gottlieb’s announcement has changed somewhat since then. He said he would use the agency’s power to try to force outlets to sequester sales of vaping products to keep them away from teens and children.
"We're not telling the retail stores you can't sell them," Gottlieb said. "If the establishments want to continue to sell these fruity flavored products, they're going to have to put into place measures that will make sure they are not going to get into the hands of kids," Gottlieb told NBC News.
He said he was also starting the bureaucratic process for banning menthol in all combustible cigarettes, and to ban flavors in cigars. This is a longer-term process and one likely to be fought every step of the way by the tobacco industry, which has succeeded for years in protecting menthol products from regulation.
"More than half (54 percent) of youth smokers ages 12-17 use menthol cigarettes, compared to less than one-third of smokers ages 35 and older," Gottlieb said. "We will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars," he added.
Anti-smoking advocates praised the moves, while questioning how easy it would be to enforce them. For one thing, vape products are sold in a variety of outlets, said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “It’s a loophole big enough for a truck to go through,” Myers told NBC News.
“(Gottlieb) doesn’t define age-restricted, in-person locations. For this to have any effect, that has got to be a very vigorous definition.”
Gottlieb told NBC that measures might include a curtained-off section where vapes are sold. Online sales will need age verification protocols, he said.
Groups such as the Campaign for Tobacco-Free Kids said the FDA has moved far too slowly to limit teen vaping. “I don’t think there is any question that the last six-plus years the FDA has failed to take the action necessary to prevent this from happening,” Myers said.
The American Academy of Pediatrics also called on the FDA to do more.
“Even with new sales restrictions announced today by FDA preventing flavored e-cigarettes from being sold at certain brick and mortar storefronts, teens will still find ways to access them. E-cigarette products that appeal to children have no business in the marketplace, period," the group's president, Dr. Colleen Kraft, said in a statement.
Myers had more praise for the decision to finally start the process of banning menthol in cigarettes and flavored cigars, something advocates have been demanding for years.
“Overall, the proposal on menthol cigarettes and on flavored cigars has the potential to make an enormous public health impact,” Myers said. “The combined impact of those two proposals would reduce tobacco use and deaths from tobacco use more than anything FDA has done to date.”
Menthol products are favorites of teenagers. “More than 50 percent of the kids in this country who smoke start on and use menthol cigarettes,” he said. “Many of the others use flavored cigars.”
The NAACP welcomed the proposed menthol ban. "For decades, data have shown that the tobacco industry has successfully and intentionally marketed mentholated cigarettes to African Americans and particularly African American women as 'replacement smokers' (and) that menthol smokers have a harder time quitting smoking," the organization said in a statement.
Several studies have shown that teenagers who vape often go on to smoke combustible cigarettes.
“We know that teens using these products who were not smokers in the first place are four times more likely to go on to smoke cigarettes,” said Robin Koval, CEO of the Truth Initiative, a foundation started to battle smoking.
Health and Human Services Secretary Alex Azar said it seems clear that e-cigarettes can be used by adult smokers as a safer alternative to burnt tobacco. "But in trying to build this off-ramp from a deadly addiction, we cannot let e-cigarettes become an on-ramp for kids to enter a lifetime of nicotine addiction and tobacco use," Azar said.
Virtually all smokers start before the age of 21, so stopping teen smoking is key to reducing tobacco deaths. According to the CDC, smoking kills more than 480,000 people a year in the U.S. “On average, smokers die 10 years earlier than nonsmokers,” the CDC says.
Gottlieb said the FDA would not as yet limit menthol and mint flavors in electronic cigarette products because he did not want to make menthol cigarettes an appealing alternative once vape products are harder for kids to get.
Tobacco companies signaled they would fight efforts to ban menthol.
"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," Altria, which makes a range of tobacco products, said in a statement. "We expect that establishing product standards on menthol cigarettes and flavored cigars will be a multi-year, deliberative process, and we will be fully engaged throughout."
Some companies, including Altria, Blu and Juul, said they were already working to limit underage sales.
Myers was skeptical of the announcements by Juul, especially. The company got widespread media coverage of its announcements this week that it would limit sales of flavored products and stop social media campaigns.
“Juul is smart enough to try to use FDA actions to falsely create an impression of it as a caring, responsible company,” he said.
Juul now dominates the e-cigarette market with its small, sleek, pod-based product that delivers a far heftier dose of addictive nicotine than other vape devices.
“Having used social media to gain market dominance among young people, Juul can step back now because it no longer needs to pay for social media. Its young, addicted customers are doing it for them. It’s stunning to me,” Myers said.
“It is so completely out of the Big Tobacco playbook it is unbelievable,” he added.
Juul’s sales are close to $1 billion and the company is valued at $15 billion.
“They started out saying they never wanted to market to kids even though their marketing is completely directed at kids. It’s hard to imagine a product more appealing to kids.”
And Koval worried about relying on voluntary actions by companies. "Depending on the tobacco industry and the retail trade is not enough," she said. "They need to get rid of all the flavors. They need to ban online sales. We need real marketing restrictions for e-cigarettes."
The vaping industry says its flavors are meant to appeal to adults but anti-tobacco advocates, medical groups and even politicians reject this argument. "It’s ludicrous to think flavors like bubble gum, cotton candy, or tutti frutti are meant for adults," senators Dick Durbin, an Illinois Democrat, and Lisa Murkowski, an Alaska Republican, said in a joint statement.
"E-cigarette companies want to hook another generation of Americans onto a deadly and addictive product so they have a customer for life. These flavors are the key to their callous business strategy, and they have no business being sold on the market."