E-cigarette use is an 'epidemic', FDA chief says

14 September, 2018, 02:02 | Author: Veronica Peterson
  • US government considers ban on flavored e-cigarettes over youth 'epidemic'

"I believe certain flavors are one of the principal drivers of the youth appeal of these products", Gottlieb said.

"We're announcing the largest ever coordinated initiative against violative sales in the history of the FDA".

"We're especially focused on the flavored e-cigarettes".

Gottlieb announced the agency sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that continued to violate the restrictions on sales to minors.

"Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications", Gottlieb said. They comprise more than 97 percent of the US market for e-cigarettes.

The FDA also warned e-cigarette companies that they have 60 days to show they can keep their products away from kids or risk being taken off store shelves.

"Unfortunately, I now have good reason to believe that it's reached nothing short of an epidemic proportion of growth", FDA Commissioner Scott Gottleib said in a briefing.

"Even though a 2017 BPS Youth Risk Behavior Survey shows the overall percentage of district students who reported using electronic cigarettes declined by 9 percent, we are always concerned about students engaging in risky behaviors", BPS said in an April letter to the community.

In a speech to FDA employees, Gottlieb said that rapid spike in teen use, emerging sales trends and concerns among parents and teachers convinced him that underage use of e-cigarettes has become a full-blown crisis that must be forcefully addressed.

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"The disturbing and accelerating trajectory of use we're seeing in youth and the resulting path to addiction must end", Gottlieb told agency staffers and reporters. It's simply not tolerable.

While e-cigarettes are thought to be less harmful than regular cigarettes, it's still unclear of the impact of long-term use. That could lead to removal of some major flavored e-cigarette brands, including the popular products made by Juul Labs Inc., if they do not address the issue to the agency's satisfaction.

"If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify", said Gottlieb.

"Anything that slows down Juul market share is a positive and this is what we think we will see in all possible outcomes around the "60-day" action", Jefferies analyst Owen Bennett said in reference to the 60-day window the FDA is giving manufacturers to submit their plans.

"We can not allow a whole new generation to become addicted to nicotine", he said.

Lee said after 40 years of smoking cigarettes and several failed attempts to quit, it was vaping that helped him finally accomplish his goal. According to the NYTS, the incidence of past-month smoking among high school students fell from 15.8 percent in 2011 to 7.6 percent in 2017.

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".

"Let me be clear: Everything is on the table", said Gottlieb.

And teenagers can expect to hear from the FDA in a new national campaign next week. "And as far as the liquids we carry, we do not pick up brands that have the potential to appeal to children, because we have that responsibility", said Hutsell.

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