Published: Fri, September 14, 2018
Health Care | By Oscar Goodwin

FDA takes action against e-cigarette epidemic among youth

FDA takes action against e-cigarette epidemic among youth

USA health officials today said teenage use of e-cigarette has reached "epidemic" levels and are calling on the industry to address the problem.

FDA Commissioner Scott Gottlieb announced the plan Wednesday, saying the agency is giving the manufacturers of Juul, Vuse, MarkTen, Blu, and Logic-which make up more than 97% of the United States e-cigarette market-60 days to submit their plans, USA Today reports. It's simply not tolerable.

Popular e-cigarette makers like JUUL now have 60 days to submit a plan to the FDA detailing how they will prevent teens from using their products.

State health department officials continue to be anxious about JUUL, a device that looks like a flash drive, which they say dominates more than 70 percent of the e-cigarette market. The agency extended that reach to other tobacco products, including e-cigarettes, in August 2016 and allowed those products that were already on the market to continue sales while preparing an application for FDA clearance.

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"If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency", the FDA said in a press release.

"Let me be clear: Everything is on the table, including all our civil and criminal enforcement tools", Gottlieb said in a speech at FDA headquarters in Washington, D.C.

"Given the market's overarching concerns about Juul's impact on cigarettes, especially Marlboro, we think a potential "ban" on Juul would be positive for MO", Herzog wrote.

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.

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

"I've been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends", Gottlieb said. On Wednesday, it announced "historic action" against more than 1,300 retailers who illegally sold Juul and other e-cigarettes to minors during a crack down on retailers this summer.

"We're committed to the comprehensive approach to address addiction to nicotine that we announced previous year". But this "fundamental turning point" will produce results only if the agency follows through by requiring all manufacturers to immediately undergo pre-market review at the FDA, he added. "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".

Gottlieb noted that the FDA continues to support the availability of products to help adult smokers quit, but 'that work can't come at the expense of kids, ' he said. Big tobacco has yet to find a productive way to meaningfully compete against Juul, making the FDA's move a positive for the companies, according to Cowen analyst Vivien Azer. A government-commissioned report in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes.

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"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.

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