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 The FDA said last month it was considering a ban on flavored
e-cigarettes from Juul and others as the agency grapples with an
"epidemic" of youth e-cigarette use that threatens to create a new
generation of nicotine addicts.
Retail sales of Juul grew more than seven-fold from 2016 to 2017,
according to a study by the U.S. Centers for Disease Control and
Prevention (CDC). By December, Juul comprised nearly 1 in 3
e-cigarette sales nationally, it said. The CDC study of retail sales
did not include online sales or sales at “vape shops.”
Juul has about 72 percent of the U.S. market for e-cigarette sales,
according to Wells Fargo.
"Juuling," along with "vaping," has become a common term for
e-cigarette use by teenagers on social media and at U.S. high
schools. E-cigarettes vaporize a liquid that contains nicotine, the
addictive stimulant that gives smokers a rush.
The inspection, completed on Friday, followed a request in April for
documents that would help the agency better understand the high
rates of use and appeal among youth of Juul products.
The FDA also said it conducted inspections of several of Juul's
contract manufacturing units earlier this year.
"We've now released over 50,000 pages of documents to the FDA since
April that support our public statements," Juul Chief Executive
Officer Kevin Burns said in a statement, adding the meeting with the
regulator was constructive and transparent.
"We want to be part of the solution in preventing underage use, and
we believe it will take industry and regulators working together to
restrict youth access".
The FDA's regulation of e-cigarettes has come under the spotlight as
Juul's popularity surged.
U.S. Senators Dick Durbin and Lisa Murkowski in a letter on Tuesday
urged the FDA to immediately ban child-friendly e-cigarette
flavorings and restrict online sales of nicotine products.
“While it remains unclear whether e-cigarettes can actually help
adults quit smoking cigarettes, it is abundantly clear that tobacco
companies are developing and marketing e-cigarette flavors that
appeal to, and addict, children,” the senators wrote.
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In July, Durbin, a Democrat, and Murkowski, a Republican, introduced
legislation that would place restrictions on e-cigarette flavorings
that appeal to children like gummy bear, chocolate cupcake and tutti
fruitti.
Along with the Juul phenomenon, a new wave of lower-priced Juul
knockoffs are showing up at convenience stores, vape shops and
online, despite an FDA rule that banned the sale of new e-cigarettes
after August 2016 without regulatory approval.
Startups and major tobacco firms have launched more than a dozen new
high-nicotine devices with Juul-like designs since the FDA imposed
the deadline, according to a Reuters review of the companies' online
advertisements, social media posts and public statements.
Shares of tobacco companies, including Philip Morris <PM.N>, Altria
<MO.N>, British American Tobacco <BATS.L> and Imperial Brands <IMB.L>,
jumped after the FDA announcement.
Juul's flash-drive-like device is recharged via a USB port. The
device comes with cartridges, or pods, of nicotine-based liquids in
flavors like mango, creme and mint — that critics say appeal to
minors.
The newest liquid blends from Juul and its imitators - called
"nicotine salts" in the industry - contain a compound called benzoic
acid, which lowers the pH level of the liquid.
That reduction allows users to take in more nicotine without a
bitter taste, according to the U.S. Centers for Disease Control and
Prevention (CDC).
(Reporting by Tamara Mathias and Ankur Banerjee in Bengaluru and
Yasmeen Abutaleb in Washington; Editing by Maju Samuel and Sriraj
Kalluvila)
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