FDA Chief to Keep Heat on E-Cigarette Makers as He Departs
Gottlieb said he had a contentious meeting last week with executives from Marlboro maker Altria Group and Juul Labs.
(Bloomberg) -- With weeks to go in his tenure atop the U.S. Food and Drug Administration, Scott Gottlieb squared off with two companies at the center of his efforts to halt a surge in teen vaping.
Gottlieb, who plans to leave his post April 5, said at an event in Washington that he had a contentious meeting last week with executives from Marlboro maker Altria Group Inc. and Juul Labs Inc. Late last year, Altria took a $12.8 billion stake in Juul, maker of a popular vaping device, at the same time that the companies had promised to increase efforts to keep kids from getting hooked on e-cigarettes. Miffed by the transaction, Gottlieb had summoned the companies to Washington to provide answers.
“The e-cigarette industry has been overly dismissive” of the risk that kids could become addicted to nicotine through e-cigarette use, Gottlieb said on Tuesday at the Brookings Institution. “We’re capturing an exploding epidemic right now.”
The FDA chief raised the possibility of temporarily pulling pod-based nicotine products off the market if youth vaping numbers continue to rise substantially. Sales could resume if manufacturers can show that their devices are geared toward adult cigarette smokers trying to quit, and not kids.
“It was a difficult meeting,” the commissioner said, noting that there was a “disconnect” between the companies’ priorities and those of health officials. He added that it appeared Altria’s decision to purchase a stake in Juul was purely a business decision and not driven by public health concerns.
Shares of Altria were up less than 1 percent to $56.03 in New York at 9:42 a.m. after closing Tuesday down 2.2 percent, the biggest drop since January.
Gottlieb’s remarks about the meeting shouldn’t have caught anyone off guard, said Stefanie Miller, an analyst at Height Capital Markets.
“There was virtually no chance in the current political universe that Gottlieb would leave a meeting with Altria and Juul Labs and feel reassured and positive about their activities over the past few months,” she wrote in a note to clients.
Altria and Juul didn’t specifically respond to Gottlieb’s characterization of the meeting. Both companies said they remain committed to combating underage use of e-cigarettes.
“The FDA is going to have to very carefully calculate its action against the entire category of pod-based products,” Gottlieb said. If the vaping products are pulled from the market, the FDA could allow the companies to resume selling them after a review. He said the agency is working on defining exactly what constitutes a pod-based product in case it needs to take such action.
Gottlieb also said the FDA’s proposed rule to cut nicotine in cigarettes to nonaddictive levels will likely be ready for review by the Trump administration this summer. Doing so could cause about 5 million adult smokers to quit smoking in the first year of adoption, the FDA has previously reported.
Miller was skeptical that the proposed rule would get through administrative review this year, saying “2024 is the absolute soonest we will see a final regulation to cap the amount of nicotine in cigarettes.”
Separately, San Francisco officials proposed legislation on Tuesday that would ban the sale of e-cigarettes in the city and prohibit companies like Juul from occupying city-owned property in the future, the San Francisco Chronicle reported.
Read more: Altria falls as San Francisco seeks e-cigarette ban
The FDA last week released a draft guideline on its much-anticipated plan to limit the sales of most flavored e-cigarettes. The proposal calls for enhancing enforcement against flavored e-cigarette sales in retail locations where a minor can enter at any time, such as a convenience store or gas station. The restrictions won’t apply to tobacco, mint or menthol-flavored e-cigarettes.
Gotlieb, who has taken heat from senators and industry-leaders over a plan to ban menthol cigarettes, declined to comment specifically on next steps for the initiative following his departure. But he he did say he thinks the long-term goal is to remove “characterizing flavors” from all tobacco products.
Health and Human Services Secretary Alex Azar told senators last week that there are complex legal issues surrounding banning menthol in cigarettes.
Ned Sharpless, the director of the National Cancer Institute, will serve as acting FDA commissioner when Gottlieb leaves his post.
--With assistance from Riley Griffin.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet, Timothy Annett
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