FDA wants e-cigarette makers to extinguish use by kids

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

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

The Food and Drug Administration (FDA) declared teen e-cigarette use an epidemic today, threatening to slap manufacturers including Juul with crushing fines if they don't present plans to curb sales to minors.

This is the latest in a series of steps the FDA is taking to limit children's use of e-cigarettes, which has "reached an epidemic proportion" in the U.S., FDA Commissioner Dr. Scott Gottlieb announced Wednesday.

But Gottlieb said in an address at FDA headquarters that he failed to predict the current "epidemic of addiction" among youth, mainly driven by flavored products.

"The vast majority of the violations were for the illegal sale of five e-cigarette products - Vuse, Blu, JUUL, MarkTen XL, and Logic".

"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.

The Vapor Technology Association, which says it represents over 600 vaping manufacturers and distributors, also supports limiting teen access, but added that the new actions by the FDA ventured "into risky territory" by not being in the best interest of public health. That initiative emerged from the agency's broader plan to regulate nicotine and tobacco, unveiled in July 2017, under the Family Smoking Prevention and Tobacco Control Act.

"We welcome FDA's action today and look forward to sharing our thoughts about how to prevent and reduce youth use, an issue we have focused on for decades", Altria spokesman George Parman said in a statement.


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. More than 2 million middle and high school students were users of e-cigarettes in 2017, according to the agency. Lisa Murkowski also asked the FDA to end delays. But spokeswoman Victoria Davis said "appropriate flavors play an important role in helping adult smokers switch". Instead, the agency gave extensions to new and existing vaping products, giving them until August 2022 to submit information to support their products' safety and efficacy as switching devices.

San Francisco-based Juul, which commands over 60 percent of the e-cigarette market, said it is working to prevent underage use of its products but added that flavors can help adult smokers quit cigarettes. "Hindsight, and the data now available to us, reveal these trends".

And some of the retailers that received warning letters are still advertising and selling these products, he said.

"In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products".

The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties.

To gain clearance to return to the market, the companies would have to show evidence that the benefits for adults who use e-cigarettes to stop smoking outweigh the risks associated with youth vaping, Bloomberg reported, citing Gottlieb's words that he is "disappointed in the actions the companies have taken" to try to address the problem.

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