US mulls ban on flavoured e-cigarettes amid youth 'epidemic'

FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’	 	 	 			File an e-cigarette

FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’ File an e-cigarette

Those five brands account for about 97% of the US e-cigarette market, the agency reported. And it highlighted e-cigarettes' role as a way for adult smokers to transition off cigarettes. Although these products were the subject of the agency's action in May, they are no longer being sold with the offending label no advertised by the companies that received the letters in May.

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

The Food and Drug Administration is looking to crack down on flavored e-cigarettes since the surge in teenage use of the products. A government-commissioned report in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes.

But FDA commissioner Scott Gottlieb says the agency did not predict an "epidemic of addiction" among youth, mainly driven by flavored products.

Shares of British American Tobacco, which owns the Vuse brand, closed up almost 6%, while shares of cigarette-maker Imperial Brands PLC, which owns Blu, rose more than 3%.

"We can not allow a whole new generation to become addicted to nicotine", he said. The companies insist that the flavors are critical to helping nicotine-addicted adult smokers switch from conventional cigarettes.

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. "Clearly the FDA knows who the industry culprits are in this epidemic and as such should exercise its full regulatory authority over these products rather than allow the industry to voluntarily self-correct". "It's now clear to me, that in closing the on-ramp to kids, we're going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs".

Dr Gottlieb acknowledged that the toughened approach would force "hard trade-offs" when it comes to promoting e-cigarettes to adults. 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.

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The FDA has given makers of e-cigarettes until 2022 to seek its approval for products that were on the market by August 2016. We welcome the opportunity to demonstrate, and work with the FDA to further strengthen, our youth access prevention policies and procedures.

The FDA has given five companies - Vuse, Blu, JuuL, MarkTen XL, and Logic- 60 days to come up with a plan to keep teenagers from using its devices and sent warning letters to 1,300 companies that it caught selling the device to minors.

At that time, Gottlieb said, the agency didn't foresee the "epidemic'"of adolescent use that has become one of the plan's biggest challenges".

At some level of the 60-day ready length, the FDA plans to overview the five companies' advertising and marketing and gross sales practices, with doable "boots on the ground inspections", Gottlieb said.

The appeal of e-cigarettes is that users are said to inhale far fewer toxins than cigarette smokers.

Now, Gottlieb is coordinating the largest scale initiative to enforce regulations against selling e-cigarettes to-date.

In the absence of such plans, Gottlieb vowed "to revisit the FDA's exercise of enforcement discretion for products now on the market".

The press released called on the FDA to immediately begin "requiring all e-cigarettes and other newly deemed tobacco products to go through the premarket review process required in the Tobacco Control Act, and removing all flavored tobacco products from the marketplace".

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