FDA restricts all flavored e-cigarettes; moves to ban menthol

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Nov. 15, 2018 / 3:12 PM GMT

By Maggie Fox

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 strictly limit sales of flavored e-cigarettes to youths.

The FDA’s long-deliberated moves are driven by startling 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.

“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 went further than what had been telegraphed. He said he would use the agency’s power to try to stop all in-person sales of flavored e-cigarettes in outlets that allow entry to people of all ages, and to restrict online sales.

He said he was also starting the bureaucratic process for banning menthol and mint 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.”

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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.

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. Gottlieb said it seems clear that e-cigarettes can be used by smokers as a safer alternative to burnt tobacco, but he said it’s also clear that teenagers who vape often go on to smoke combustible cigarettes, also.

“(A)ny policy accommodation to advance the innovations that could present an alternative to smoking – particularly as it relates to e-cigarettes – cannot, and will not, come at the expense of addicting a generation of children on nicotine through these same delivery vehicles,” Gottlieb said.

“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.

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.

“Responsible manufacturers certainly don’t need to wait for the FDA to finalize these policies to act. They can stop certain marketing and sales practices—the ones we believe are part of the youth access and youth appeal problem—right now,” he said.

Some companies, including Altria’s Blu and Juul, said they were doing so.

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 thought their marketing is completely directed at kids. It’s hard to imagine a product more appealing to kids.”