Four Takeaways from FDA’s E-cig ‘Epidemic’ Statement

Big changes may be coming to the e-cigarette industry.

Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, released a long statement on Wednesday, Sept. 12, criticizing manufacturers of the tobacco alternative for their marketing practices, particularly in regards to teenagers.

Here are four takeaways from Gottlieb’s statement:

  1. An e-smoking ‘epidemic’?

Gottlieb used the word “epidemic” in describing the use of e-cigarettes by American teenagers.

He said:

“Unfortunately, I now have good reason to believe that it’s reached nothing short of an epidemic proportion of growth. I use the word epidemic with great care. E-cigs have become an almost ubiquitous – and dangerous – trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products.”

According to the Department of Health and Human Services, e-cigarette sales to high school students surged nearly 900 percent between 2011 and 2016. Like tobacco cigarettes, e-cig sales are restricted by law to people 18 and older.

  1. The war on e-cigs

The FDA is responding to the “epidemic,” according to Gottlieb, with “the largest ever coordinated initiative against violative sales in the history of the FDA.”

“This is the largest single enforcement action in agency history,” Gottlieb said. “It’s aimed at retail and online sales of e-cigarettes to minors.”

As part of this enforcement, the FDA sent more than 1,100 letters to stores who illegally sold e-cigs to minors and issued 131 fines to persistent violators.

The FDA also ordered the top five e-cig makers (who collectively account for more than 97 percent of the e-cig market) to produce within 60 days “robust plans” on how they will prevent minors from using their products.

“In the meantime,” Gottlieb said, “we’ll be investigating their marketing and sales practices, including with boots on the ground inspections. The FDA is going to continue to work to find out why so many kids are using and abusing these products.”

  1. A focus on flavors

The FDA is particularly concerned about the appeal of flavored e-cigs.

“We’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market,” Gottlieb said.

E-cigs are available in thousands of flavors. A 2016 National Institute of Drug Abuse study found that 66 percent of teens using e-cigs thought the devices contained only flavoring.

“We know that the flavors play an important role in driving the youth appeal,” said Gottlieb.

  1. A ‘minor’ priority

The FDA is willing to inconvenience legal e-cig smokers in order to protect minors.

“[This initiative] may create some obstacles for some adults who also enjoy e-cigs,” he said. “These are the hard trade-offs that we’re grappling with. But the youth risk is paramount.”

Gottlieb 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.”

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