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14 September 2018, 03:41 | Silvia Roy
The FDA Is Considering Pulling Some Flavored E-Cigarettes From the Market to Fight 'Epidemic' of Youth Vaping
The said that doesn't mean e-cigarettes are benign, and officials are anxious about vaping's impact on young people's brains.
'We won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products, ' Gottlieb said. "It be simply no longer tolerable".
"Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications", Gottlieb said.
Such a step would be a major blow to the e-cigarette companies - Juul, Vuse, Blu, Logic and MarkTen - which often feature cream and fruit flavorings in their products. The value of all sales reached $2.35 billion in 2016. It is considering restricting e-cigarette manufacturers from selling flavored nicotine liquid or making the products undergo an agency review. "We're going to have to take action".
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His comments came as the agency revealed it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette and vapor products to minors during "a nationwide, undercover blitz" of retail stores and online sites this summer. But spokeswoman Victoria Davis said "appropriate flavours play an important role in helping adult smokers switch".
Wednesday, the commissioner of the federal agency said it was investigating if flavored vaping products are risky for teens, and need to come off the market.
As of September 1, the FDA said it has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law, and initiated 18,560 civil money penalty cases in its checks of retail establishments selling tobacco products.
Manufacturers offer and market e-cigarette flavours that clearly appeal to minors, including candy and bubble gum flavours.
San Francisco-based Juul, which commands over 60 percent of the e-cigarette market, said it is working to prevent underage use of its products but added that flavors can help adult smokers quit cigarettes.
Gottlieb said the FDA recognized the impact this might have on adults trying to stop smoking, but said that emerging research on how flavored products encourage excessive use by young people shows action must be taken.
"E-cigs have become an nearly ubiquitous - and risky - trend among teens", Gottlieb said in a statement. "Hindsight, and the knowledge now available to us, present these traits". The company has more than two-thirds of the USA e-cigarette market, according to Nielsen data.
"The FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law", he said.
The Food and Drug Administration on Wednesday announced it may force e-cigarette manufacturers to stop selling flavored products, citing what Commissioner Scott Gottlieb called an "epidemic" of youth use. It was "the largest coordinated enforcement effort in the FDA's history", according to the agency.
E-cigarette makers argue the devices help adult smokers give up cigarettes - potentially saving them from related illnesses - by giving a nicotine fix without the smoke and smell of combustible cigarettes.
Wells Fargo analyst Bonnie Herzog said Juul is the brand "most at risk" from an FDA crackdown and that a potential ban on the company's products would boost Altria and other cigarette makers that also sell e-cigarettes.
The FDA has also been revamping its regulation on tobacco, including lowering the amount of nicotine in conventional cigarettes.
Bottles of flavor packets for e-cigarettes stand displayed in a tobacco shop in New York on June 23, 2015.
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