The FDA is giving the five top-selling e-cigarette brands - Juul Labs Inc., Vuse, MarkTen XL, Blu, and Logic - 60 days to provide plans for how they will mitigate sales to minors.
Juul said in a statement that the company is committed to preventing underage use of its product, and that it will work with the FDA to keep its merchandise out of the hands of minors.
The FDA is calling the use of e-cigarettes by young people an epidemic. "E-cigs non-public changed into an almost ubiquitous - and unhealthy - pattern among young of us".
Last month, Gottlieb told our sources that the FDA was weighing the benefits of flavored e-cigarettes in helping adults quit smoking against the risk to young people who become addicted to tobacco through vaping.
Popular e-cigarette makers like JUUL now have 60 days to submit a plan to the FDA detailing how they will prevent teens from using their products. The agency may also ban sales of some flavored e-cigarette products, which Gottlieb says are particularly appealing to underage users, and consider shortening a grace period that now gives e-cigarette companies until 2022 to apply for FDA approval.
According to the FDA, e-cigarettes have become the most common tobacco product used by teens in the past two years.
The latest data, not yet published, show a 75 percent increase in e-cigarette use among high school students this year, compared with 2017.
The plan focuses on reducing access and appeal of e-cigarette products.
It marks a shift in the agency's tone on e-cigarettes.
Dr. Gottlieb said he believes that certain flavors make the products appealing to teens.
Considering the Trump administration's fixation on deregulation without regard to the potentially harmful impact of loosened protections on such niceties as clean air, land or water, or even human health, it's something of a pleasant surprise to find at least one area in which federal authorities are standing up for the public interest and challenging private industry.
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"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes", Juul said in a statement.
There will also be regulations about making health claims about vaping, a ban on candy and dessert flavouring and more control over who can access the products.
While the health risks for e-cigarette smoking are still being conducted, there are decades worth of studies on traditional cigarettes highlighting the terrible side effects of smoking.
The FDA has warned both makers and sellers of e-cigarettes about it's intentions, sending letters to some 1,100 retailers including 7-Eleven, Walgreens, Circle-K and Shell gas stations warning that the products need to be kept away from minors.
Gottlieb said e-cigarettes have the potential to help adult smokers, but also said the industry's lack of action on youth use could lead to fewer choices for adults who want to purchase e-cigarettes. The FDA is now developing a survey to determine what percentage of youth vapers are using Juul products, Gottlieb said.
"We've gone a long way toward curbing smoking in society, and then something like the e-cigarette comes along and we are essentially normalizing smoking again", said Phillips.
The FDA has also been revamping its regulation on tobacco, including lowering the amount of nicotine in conventional cigarettes.
Gottlieb called the action the largest coordinated enforcement effort in the agency's history. She said the enforcement is necessary - in particular, for a certain brand of e-cigarettes called "Juul".
Kelli Cogan says her 15-year-old son was able to get free Juul cartridges online last year by using his father's name and birth name and having them shipped to a different address.
Millennials and hipsters beware, big government wants to come for your e-cigarettes if teenagers do not stop using them.