FDA cracking down on sales of e-cigarettes to kids
FDA cracking down on sales of e-cigarettes to kids
The FDA Is Considering Pulling Some Flavored E-Cigarettes From the Market to Fight 'Epidemic' of Youth Vaping
16 September, 2018, 15:30
The FDA has given five companies - Vuse, Blu, JuuL, MarkTen XL, and Logic- 60 days to come up with a plan to keep teenagers from using its devices and sent warning letters to 1,300 companies that it caught selling the device to minors.
Juul Labs, which controls about 70% of the market, said in its order that "acceptable flavors" play a job in adults changing their smoking habits, but added that they "are committed to combating underage employ of our product, and we want to be allotment of the resolution in preserving e-cigarettes out of the hands of children".
"I now have good reason to believe that it's reached nothing short of an epidemic proportion of growth", Gottlieb said.
"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said in an interview.
The FDA stated that although e-cigarettes can potentially help adult smokers move away from traditional cigarettes, that effort can't come at the expense of a whole new generation becoming addicted to nicotine.
In response to a nationwide undercover investigation of brick-and-mortar and online stores over the summer, the FDA levied civil fines ranging from $279 to $11,182 on e-cigarette retailers found to have sold their products to minors and issued more than 1,300 warning letters.
During the 60-day waiting period, the FDA plans to investigate the five companies' marketing and sales practices, with possible "boots on the ground inspections", Gottlieb said.
In the absence of such plans, Gottlieb vowed "to revisit the FDA's exercise of enforcement discretion for products now on the market". Of the 3.6 million middle and high school students who said in 2017 they were tobacco product users, 2.1 million used e-cigarettes, Bloomberg reports, citing CDC stats.
The FDA extended an Obama era deadline that would have required e-cigarettes on the market by 2016 to be reviewed starting this year.
But Gottlieb acknowledged Wednesday that the agency failed to predict an "epidemic of addiction" among youth, mainly driven by flavored products.
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It's bad for business when regulators target one of your fastest-growing products - unless they also go after a competitor working to put you out of business.
While applauding the FDA for today's actions, some said the agency should increase its efforts to protect the nation's youth from the dangers of vaping.
Budding research on e-cigarettes also suggests that these flavors contain terpenes that may be more damaging to the lungs than other flavors are. "I think education is the answer to fixing the problem, just like how we have educated young people about alcohol and other tobacco products over the years", Delaney said. Under the circumstances, that makes the rise in e-cigarette use by teens a legitimate "epidemic", which is exactly how the FDA is describing it.
Next week, the FDA will launch a campaign to warn young people about the danger of nicotine use.
"We're now actively evaluating how we'd implement such a policy", Gottlieb said.
Juul CEO Kevin Burns has said restricting flavors "will negatively impact current adult smokers" who want to switch from smoking to vaping.
Almost a decade ago, President Obama signed major legislation that granted the the power to regulate the manufacturing, marketing and sale of tobacco products while banning candy and fruit-flavored cigarettes that were seen as attractive to youths. And the agency says this is the largest coordinated enforcement action the FDA's ever taken.
"Nicotine can be harmful to the still-developing brain of an adolescent", said Mitchell Zeller, the Director of the FDA Center for Tobacco Products.
- Products created to help adults kick the habit may be encouraging addiction in kids.
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