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US FDA targets e-cigarettes over 'epidemic' of underage use

14 September 2018

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.

Although e-cigarettes can potentially help adults quit smoking regular cigarettes and other smoked tobacco products, the CDC warns they are not safe for youth, young adults, pregnant women or adults that don't use tobacco products.

"The disturbing and accelerating trajectory of use we're seeing in youth and the resulting path to addiction must end", Scott Gottlieb, head of the Food and Drug Administration (FDA), said. It's simply not tolerable.

The FDA extended an Obama era deadline that would have required e-cigarettes on the market by 2016 to be reviewed starting this year. But, the group added, that will only be the case if the FDA acts quickly to ban e-cigarettes that have not yet been reviewed by the agency, requires all e-cigarettes to submit to immediate FDA review, and forces the manufacturers "that have fueled this epidemic" to change their marketing and sales practices.

Health advocates have anxious about the popularity of vaping products among kids and the potential impact on smoking rates in the future.

Juul is the clear leader among e-cigarette brands, with $454 million in sales over the 12 months ending in February, according to the Wells Fargo report, which cited market data from the research firm Nielsen.

"This use by children and teens is especially concerning to the FDA because the developing adolescent brain is particularly vulnerable to nicotine addiction", a statement from the FDA says. "Hindsight, and the knowledge now available to us, present these traits".

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In June, a government survey found teen vaping seemed to be holding steady previous year. Juul takes up almost 71 percent of the entire e-cig market with its USB sized device that comes with single inserts containing the same amount of nicotine as an entire pack of cigarettes.

The FDA noted that, over the past few years, e-cigarettes have become the most commonly used tobacco product by youth.

"The reason why we are in this business is for harm reduction because we have seen so many that have smoked for years", Hutsell said.

"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", the company said in a statement.

Most of the violations found in the undercover blitz, conducted from June through August, were for the illicit sale of Vuse, Blu, JUUL, MarkTen XL and Logic e-cigarette products, according to the FDA. Companies whose products are pulled from shelves will have to prove a net positive public health benefit before sales can resume.

However, there is little consensus about how to regulate the industry. But it's not clear how quickly the decision could be reversed.

Shares of Big Tobacco companies surged in trading Wednesday. Philip Morris International jumped as well. But it added that "appropriate flavors play an important role in helping adult smokers switch", spokeswoman Victoria Davis said.

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Originally, the FDA welcomed vaping, thinking it would help traditional smokers kick the habit.

Officials said the move against more than 1,300 retailers was the largest coordinated enforcement action in the agency's history.

"The FDA should immediately move to regulate flavored e-cigarettes, instead of waiting until 2022, as it is now planning to do", Bloomberg said in a statement.

"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes". Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid.

If these companies fail to comply, the agency said it would consider requiring them to stop selling flavored tobacco products, which critics say appeal more to young smokers.

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

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US FDA targets e-cigarettes over 'epidemic' of underage use