FDA Gets Tough on Juul, Other E-Cigarette Makers

US government considers ban on flavored e-cigarettes over youth 'epidemic'

Food and Drug Administration Commissioner Scott Gottlieb declared teen vaping an epidemic yesterday and vowed to do all he could to stop the nefarious devices from ending up in their hands. That is not true of the doses in e-cigarettes, she said.

"But we are not going to let e-cigarettes be an on-ramp for our youth to get addicted to nicotine and transition potentially into combustible tobacco - not going to happen". "The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. It be simply no longer tolerable".

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

They typically contain nicotine, and sometimes flavorings like fruit, mint or chocolate. With its attack on vaping, the FDA is coming to the aid of Big Tobacco, whose main product, to which vaping provides an attractive alternative, kills millions of Americans.

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". Hindsight, and the data now available to us, reveal these trends.

She says people will always find a way around the regulations but she believes that more education of students, teachers and parents can reduce teen vaping. Some experts were cautious about the results, however.

The FDA also issued 12 warning letters to other online retailers "selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies". The study will take three years.

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To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes in order to stop smoking traditional cigarettes outweigh the risks associated with youth vaping. The FDA should also be moving to remove all flavored tobacco products from the market - unless a manufacturer shows that they help adults switch completely from cigarettes and do not attract youth - which is clearly not the case for the most popular products now on the market.

In addition to JUUL, 4 other vape companies face the FDA's ultimatum: Vuse, Blue, Markten XL, and Logic (who collectively make up 97% of the USA e-cig market). New laws that should come into place soon will allow nicotine but regulate its use. But it's not clear how quickly the decision could be reversed.

The latest Youth Tobacco Use survey said almost 1 in 5 high school students and 1 in 18 middle school students reported using a tobacco product a year ago, compared with almost 1 in 4 high school students and 1 in 13 middle school students in 2011. And in fact, the FDA's announced a plan to basically slash the amount of nicotine in cigarettes to try to wean more Americans off tobacco cigarettes. Philip Morris International jumped as well.

The company said in a statement that "appropriate flavors" help adult smokers switch, while adding it will work with the FDA "to keep e-cigarettes out of the hands of young people".

The agency sent more than 1,100 warning letters and 131 fines to retailers it said illegally sold JUUL and other e-cigarette products to minors during a nationwide undercover sting including brick-and-mortar and online stores this summer. "Thousands of small-business vape shops across America do not engage in irresponsible marketing practices and don't even sell the products being targeted by the FDA with threatening letters", said Gregory Conley, president of the American Vaping Assn., a nonprofit organization that advocates for what it calls sensible regulation.

The FDA is trying to set up a framework for regulating e-cigarettes. It also announced a new social media policy that features adult smokers - not models - and their stories of switching to Juul.

The risks associated with vaping are trivial compared with the risks associated with smoking cigarettes. He said in June tobacco companies "better step up and step up soon" but he didn't divulge what consequences the industry could face - until now. Today's effort notches up that action, becoming, said Gottlieb, the "largest ever coordinated initiative against violative sales in the history of the FDA".

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