FDA Commissioner Scott Gottlieb, who has called teenage use an
"epidemic," issued the draft guidelines during his final weeks as
head of the agency, after a surprise resignation announcement last
week.
The proposal would allow traditional retailers such as convenience
stores to sell tobacco, mint and menthol e-cigarettes, which the FDA
says are more popular among adults than minors. But other flavors
could only be sold in stores or online when strong age-verification
protocols are in place.
In an interview on Wednesday, Gottlieb said the new guidelines give
the agency flexibility to further restrict sales if youth use trends
continue.
The agency is paying close attention to "pod-based" e-cigarettes
such as the ones popularized by Juul Labs Inc, he said. Those
devices use pre-filled, flavored nicotine cartridges and have been
especially popular among U.S. high school students.
"The FDA did this in a fashion that's going to allow us to put in
place additional restrictions if the youth rates continue to grow,"
Gottlieb said. "It allows us to very quickly adjust our policy
further."
Under the proposal, makers of e-cigarette products would have to
submit a formal application to the FDA by August 2021 in order to
keep selling them, a year earlier than previously proposed.
Shares of tobacco companies Altria Group Inc and Philip Morris
International Inc, which have been pressured by recent news of
rising regulatory scrutiny into e-cigarettes, initially fell on the
news before edging higher.
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Gottlieb had said in November that the agency planned more
restrictions on flavored e-cigarettes.
Juul and Altria, which took a 35 percent stake in Juul last
December, said on Wednesday they supported the FDA's efforts to
combat underage use. Juul announced its own plans in November for
stricter age-verification requirements online and in retail stores.
Public health and anti-smoking groups said the agency's plan falls
short of what is needed to curb underage e-cigarette use.
"A public health crisis of this magnitude demands faster and more
forceful action than the steps announced by the FDA," Matthew Myers,
president of the Campaign for Tobacco-Free Kids, said in a
statement.
Data released in November by the FDA and the U.S. Centers for
Disease Control and Prevention showed a 78 percent increase in high
school students who reported using e-cigarettes in the last 30 days,
compared with the prior year.
The draft guidelines are expected to be finalized within the next
three months, following a public comment period.
(Reporting by Chris Kirkham in Los Angeles and Manas Mishra in
Bengaluru; Editing by James Emmanuel and Richard Chang)
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