FDA Gets Tough on Juul, Other E-Cigarette Makers

Alicia Farmer
September 13, 2018

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 U.S. e-cigarette market-60 days to submit their plans, USA Today reports.

The FDA set a 60-day deadline for five major tobacco manufacturers to provide a plan for mitigating youth sales, or the agency will pull them out of the market.

Today's announcement is part of a series of product standards the agency will roll out as part of their Youth Tobacco Prevention Plan, which they launched earlier this year.

"The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end", FDA chief Scott Gottlieb said.

According to the Campaign for Tobacco-Free Kids' president Matthew Myers, the FDA has made a crucial step toward curtailing youth use of e-cigarettes. "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". "Hindsight, and the data now available to us, reveal these trends". The FDA's delay on that requirement has allowed the industry to flourish with little oversight.

USA health officials are sounding the alarm about teenage use of e-cigarettes, calling the problem an "epidemic" and ordering manufacturers to reverse the trend or risk having their flavored vaping products pulled from the market. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping.

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. The FDA said more than 2 million middle school and high school students used e-cigarettes in 2017.

It will also "re-visit" the policy it announced past year, which gave e-cigarette companies more time to apply for regulatory approval.

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Shares of Big Tobacco companies surged in trading Wednesday.

Watch Altria and British American Tobacco trade in real time here.

Fontem Ventures, makers of blu, issued a similar statement.

Gottlieb called the action the largest coordinated enforcement effort in the agency's history. Short of that, he suggests the FDA might force companies to stop offering e-liquid flavors that appeal to minors, which are an important factor in quit attempts by adult smokers.

As part of its plan of action to address the epidemic, the FDA also sent more than 1,300 warning letters to stores for the illegal sale of e-cigarettes to minors and issued another 131 civil money penalties to stores that continued to violate the restrictions on sales to minors.

The FDA is in the process of rolling out a sweeping anti-smoking initiative created to make it easier for smokers to quit by cutting the nicotine levels in regular cigarettes. The agency had for decades had no power to regulate cigarettes or other tobacco products, but Congress passed a law in 2009 giving FDA limited power to do so. Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid.

On Wednesday, Gottlieb criticized e-cigarette companies' handling of the underage use problem, saying they approached it as "a public relations challenge rather than seriously considering their legal obligations".

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