Tuesday, 20 November, 2018

FDA puts e-cigarette companies on notice over teen access

FDA puts e-cig makers on notice US government considers ban on flavored e-cigarettes over youth 'epidemic'
Gustavo Carr | 13 September, 2018, 20:00

American health officials threatened to ban flavoured e-cigarettes, warning of a teenage vaping "epidemic".

Juul and four other manufacturers, which Gottlieb said control 97% of the market, are now required to provide plans to mitigate youth sales within 60 days or face potential criminal or civil action. "We fully support and advocate for both legislation prohibiting sales of vaping products to minors and the ongoing FDA enforcement action against retailers selling e-vapor and other tobacco products to minors", the company said.

It will also "re-visit" the policy it announced previous year, which gave e-cigarette companies more time to apply for regulatory approval. Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid.

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.

It reserved its strongest action for the manufacturers themselves. But Gottlieb says sales have soared, especially to teens, who can quickly become addicted to nicotine. He said the problem had reached "epidemic proportion".

"I use the word epidemic with great care. E-cigs have become an nearly ubiquitous - and unsafe - trend among teens", added Gottlieb.

"The disturbing and accelerating trajectory of use we're seeing in youth and the resulting path to addiction must end", Gottlieb told agency staffers and reporters. It's simply not tolerable. The products being targeted are: Juul, MarkTen by the Altria Group, the maker of Malboro cigarettes in the US, Blu by Fontem Ventures, Vuse, by British American Tobacco, the company that makes Camel cigarettes, and a device called Logic.

In July 2017, the FDA said it was considering lowering nicotine levels in traditional cigarettes. JUUL pods, which can be bought in fruit or candy flavors, contain the same amount of nicotine as a pack of cigarettes.

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FDA Commissioner Scott Gottlieb has said that e-cigarettes, while still harmful, may be effective for adults who want to give up cigarette smoking, which kills nearly half a million Americans each year. But when it comes to minors, he said, even e-cigarettes should be off limits.

"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said at a press briefing.

He said the vaping industry had not taken prior warnings seriously. Nearly 12% of high school students and 3% of middle school students reported using e-cigarettes in the prior 30 days.

In April the agency launched a Youth Tobacco Prevention Plan, created to address some of the known public health risks, such as flavors, that contribute to adolescent use of e-cigarettes.

"Let me be clear: Everything is on the table", said Gottlieb.

And teenagers can expect to hear from the FDA in a new national campaign next week.

Produced by San Francisco-based Juul Labs Inc., Juul devices resemble a USB thumb drive and have become popular among students.