Faced with a proliferation of new electronic cigarettes and a sharp rise in teen vaping, the US Food and Drug Administration on Friday sent letters to 21 electronic cigarette manufacturers seeking information to assess whether the products are being marketed illegally.
An FDA rule banned the sale of new e-cigarette products after August 2016 without regulatory approval.
In September, Reuters reported that startups and big tobacco firms launched more than a dozen new high-nicotine e-cigarette products mimicking the popular Juul devices after the FDA imposed the deadline.
The agency on Friday sent letters to companies including Reynolds American Inc, a unit of British American Tobacco Plc , which makes the Vuse Alto device, asking for evidence that the products were on the market before the August 2016 cutoff date.
Proper Approval
FDA Commissioner Scott Gottlieb said the agency "will not allow the proliferation of e-cigarettes" being sold without proper approval and "will take swift action when companies are skirting the law."
The agency also sent letters to Fontem Ventures, a unit of Imperial Brands Plc, seeking information about its myblu e-cigarettes, as well as smaller companies including Kandypens, Myle Vapor and VGOD.
If the FDA determines the e-cigarettes were introduced after the August 2016 deadline, companies could face fines or have their products seized from store shelves. Gottlieb said the agency was concerned about sweet flavors in several of the products, which he said are “one of the principal drivers of the youth appeal of e-cigarettes.”
Customer Base
The FDA has faced increased pressure to act as the sleek Juul e-cigarettes have reportedly surged in popularity among U.S. teenagers.
Juul Labs Inc's share of the e-cigarette market rose to more than 70% now, up from 13.6% in early 2017, according to a Wells Fargo analysis of Nielsen retail data that does not include online sales.
Juul sales grew more than sevenfold between 2016 and 2017, from 2.2 million to 16.2 million devices sold last year, according to data from the U.S. Centers for Disease Control and Prevention. Many high schools have resorted to locking bathrooms – jokingly called "Juul rooms" by students.
The Juul design mimics a flash drive - with plug-in cartridges of concentrated nicotine juice. It is far more compact than earlier vaping devices and produces less vapor, making it easy to use without being detected - an attribute some health advocates say attracts teenagers.
Juul was on the market before the August 2016 FDA deadline, but other companies have introduced a slew of new copycat devices after the cutoff date without regulatory consequences.
Anti-smoking advocates including the Campaign for Tobacco-Free Kids complained about the Juul lookalikes in an August letter to the FDA, saying the agency had failed to assert its authority over companies that had "evaded the review process."
Crackdown
The FDA has recently cracked down on what it calls an "epidemic" of youth e-cigarette use, threatening last month to ban Juul and four other leading e-cigarette products unless their makers take steps to prevent use by minors.
Earlier this month, the agency said it seized more than a thousand pages of documents from Juul Labs about its own sales and marketing practices after a surprise inspection.
In a statement at the time, Juul Chief Executive Kevin Burns said the meeting was constructive and transparent, adding that the company wants "to be part of the solution in preventing underage use."
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