Despite the fact that they can not legally be sold to anyone under 18, e-cigarettes - hand-held vaporizers that create aerosols from liquids typically packed with nicotine and other chemicals, often including flavorings - are now the most popular tobacco product among high school students, recent federal data shows.
The FDA is giving the five top-selling e-cigarette brands - Juul, Vuse, MarkTen XL, Blu and Logic - 60 days to provide plans for how they will mitigate sales to minors.
The FDA is alarmed that, according to the National Youth Tobacco Survey (NYTS), "more than 2 million middle and high school students were current users of e-cigarettes in 2017".
The FDA also plans to revisit its policy that extended the dates for manufacturers of certain flavored e-cigarettes to apply for premarket authorization. That could lead to removal of some major flavored e-cigarette brands, including the popular products made by Juul Labs Inc., if they do not address the issue to the agency's satisfaction.
"We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger", said FDA Commissioner Scott Gottlieb in a statement. E-cigs deliver lower toxin levels than regular cigarettes, but users can inhale more of the addictive stimulant nicotine.
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"We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people", he added.
What's more, e-cigarette liquids like Juul pods contain high concentrations of nicotine. Shares of cigarette and e-cigarette maker Altria Group also rose more than 6 percent, while Philip Morris International shares were up 4 percent.
In a release, the FDA said it's taking "historic action" against companies that it believes promotes use and addiction of their products to young vapers. Companies whose products are pulled from shelves will have to prove a net positive public health benefit before sales can resume.
Gottlieb noted that the FDA continues to support the availability of products to help adult smokers quit, but 'that work can't come at the expense of kids, ' he said.
Gottlieb warned action may require companies to change their sales and marketing practices; stop distributing products to retailers who sell to kids; and remove "some or all of their flavored e-cig products from the market".
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Shares of Altria, the maker of Marlboro cigarettes in the USA, rose as much as 5.3 percent to $62.60 in NY, the biggest intraday gain in eight years. Gottlieb would be on much firmer ethical ground if he took the opposite position: In trying to stop teenagers from vaping, we won't deny adult smokers access to products that could save their lives.
"We're announcing the largest ever coordinated initiative against violative sales in the history of the FDA". Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid.
"In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products, and as they did, these risks have mounted", Gottlieb said.
"We're especially focused on the flavored e-cigarettes", said Gottlieb.
"I'm here to tell them today that this prior approach is over", he said.
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