- Posted September 12, 2018
FDA Gets Tough on Juul, Other E-Cigarette Makers
Calling the use of electronic cigarettes a burgeoning epidemic among teens, the U.S Food and Drug Administration on Wednesday announced a crackdown on the sale of Juuls and other flavored e-cigarette devices to minors.
More than 1,200 warning letters and fines have been sent to retailers and five major e-cigarette manufacturers who illegally sold Juul devices, which look like computer flash drives, and other e-cigarette products to minors. The companies have 60 days to come up with plans to stop those sales or the FDA may consider a ban on the sale of all flavored e-cigarette products, the agency said.
"The disturbing and accelerating trajectory we're seeing in youth and the resulting path to addiction must end," FDA commissioner Dr. Scott Gottlieb said at a morning media briefing. "We're seriously considering a policy change that would lead to the removal of these flavored products from the market."
Manufacturers of the five top-selling national e-cigarette brands have received FDA warning letters, he said. All of these brands -- JUUL, Vuse, MarkTen, blu e-cigs, and Logic -- made up the majority of products sold illegally to minors, the agency said. The retailers targeted by the FDA include 7-Eleven stores, Circle K convenience shops and Shell gas stations.
In addition, the agency's plan includes a series of actions to stop youth use of tobacco products, especially e-cigarettes. More than 2 million middle and high school students were regular users of e-cigarettes last year, according to the FDA.
"Our youth tobacco prevention plan focuses on three key strategies," Gottlieb said. "First, preventing youth access to tobacco products. Second, curbing the marketing of tobacco products aimed at youth. And finally, educating teens about the dangers of using any tobacco-related products."
Although Gottlieb believes that e-cigarettes can help some adults quit smoking traditional cigarettes, he is concerned that e-cigarettes pose health risks, including the possibility of releasing nicotine at higher levels than conventional cigarettes, and may lead to nicotine addiction in teens.
Nicotine is not a benign chemical, Gottlieb said. The developing adolescent brain is particularly vulnerable to nicotine addiction, he noted.
"The FDA will not tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products," he said.
Gottlieb said that e-cigarette manufacturers have been given ample time to change their ways.
"I've been warning the e-cigarette industry for more than a year that they needed to do much more to stem these youth trends," 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, and as they did, these risks have mounted," Gottlieb said.
And some of the retailers that received warning letters are still advertising and selling these products, he said.
One manufacturer in the FDA's crosshairs, Juul Labs, said in a statement, "JUUL Labs will work proactively with FDA in response to its request. 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."
Fontem Ventures, makers of blu, issued a similar statement. "We fully support and advocate for both legislation prohibiting sales of vaping products to minors and the ongoing FDA enforcement action against retailers selling e-vapor and other tobacco products to minors," the company said.
But the FDA said it is also investigating whether e-cigarette manufacturers have introduced new products after Aug. 8, 2016, without premarket authorization.
The agency said it continues to check retail stores that sell tobacco, to ensure they are in compliance with federal laws.
The steps announced Wednesday are just the initial elements of these new efforts, Gottlieb said.
Manufacturers say they've changed from the days of Joe Camel, he said.
"But look at what's happening right now. On our watch, and on their watch. They must demonstrate that they're truly committed to keeping these new products out of the hands of kids, and they must find a way to reverse this trend," Gottlieb said.
Visit the U.S. National Institute on Drug Abuse for more on e-cigarettes.
SOURCES: Sept. 12, 2018, media briefing with Scott Gottlieb, M.D., commissioner, U.S. Food and Drug Administration; Sept. 12, 2018, statements, JUUL Labs, Fontem Ventures