FDA puts e-cigarette companies on notice over teen access

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The vast majority of the manufacturer offenders are Vuse, Blu, JUUL, MarkTen XL and Logic, the FDA said.

But on Wednesday, when FDA commissioner Scott Gottlieb warned e-cigarette makers on new regulation if they do not work to control to the accelerating trajectory of flavored e-cigarette usage among youths, Big Tobacco stocks skyrocketed.

The U.S. Food and Drug Administration recently sent more than 1,300 warning letters and fined U.S. retailers for selling e-cigarette products to minors.

"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", JUUL CEO Kevin Burns said in a statement.

"Nicotine can be harmful to the still-developing brain of an adolescent", said Mitchell Zeller, the Director of the FDA Center for Tobacco Products.

Under Wednesday's announcement, the five largest e-cigarette manufacturers will have 60 days to produce plans to reverse underage use of their products. The FDA received congressional approval to regulate e-cigarettes in August 2016, although it's trying to ease regulation to help stop cigarette smoking among adults. He listed three reasons the company became so successful: It figured out how to deliver high levels of nicotine in a way that wasn't harsh; it packaged the product in a streamlined, clever way; and it developed a social media and advertising campaign that made a Juul e-cigarette "cool and hip".

"The way that e-cigarettes are marketed, they are really are marketed to naive users of tobacco products and they're also marketed to younger people", Kirshenbaum said.

In his remarks to FDA staffers, Gottlieb acknowledged that some adults might get hurt by a crackdown on flavored e-cigarettes.

The FDA's moves come as the booming e-cig company Juul has been flagged by doctors, researchers and non-profits for health risks and deceptive marketing to attract minors.

[The FDA's approach] calls to mind the predictably lazy federal approach to firearms regulation: Rather than do the hard work of running down street dealers and straw buyers, the ATF and the anti-gun lobby concentrate their efforts on firearms makers and licensed gun dealers, because it is easier to police the law-abiding than it is to police criminals.

Gottlieb said the agency could also target "cartridge-based products" such as the USB-sized Juul, which is favored by teens and sold in convenience stores.

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"I use the word epidemic with great care", Gottlieb said.

According to the FDA, e-cigarettes have become the most common tobacco product used by teens in the past two years.

In addition, the FDA on Wednesday issued 12 warning letters to online retailers for selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies. Altria Group Inc. and British American Tobacco Plc had the biggest one-day percentage gain in about a decade.

If the plans fall short, the FDA could block sales of the products by enforcing a requirement that companies provide detailed safety and health data about their products before marketing them.

The companies say they are working with the FDA to prevent young people from using their devices.

"I believe certain flavors are one of the principal drivers of the youth appeal of these products", Gottlieb said.

The Campaign for Tobacco-Free Kids said the steps announced by Gottlieb "have the potential to make a fundamental difference".

According to the company's website, the mission of JUUL products is to improve the lives of the world's 1 billion adult smokers.

The commissioner said flavors play a key role in peaking teen interest.

"I'm here to tell them today that this prior approach is over", he said.

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