"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.
Gottlieb says the five largest e-cigarette manufacturers will have 60 days to produce plans to immediately reverse underage use of their products. The FDA said more than two million middle school and high school students used e-cigarettes past year.
Despite this extensive plan, some of the unelected bureaucrats at the FDA would still like to ban flavored e-cigarette products. The "epidemic" perceived by the FDA is mainly an epidemic of e-cigarette experimentation, and even that trend seems to have reversed, judging from the latest NYTS results. Many public-health groups believe such flavors entice young people to try the devices.
And specifically the agency announced that it's issuing more than 1,300 warning letters and fines against convenience stores, gas stations and other outlets that the FDA discovered were illegally selling e-cigarettes to kids during an undercover blitz over the summer.
The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit.
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.
JUUL, a private company that doesn't make cigarettes; Logic, which is owned by the Japan Tobacco International, and R. J. Reynolds Vapor Company's Vuse said they plan to work with the FDA.
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San Francisco-based Juul, which commands over 60 percent of the e-cigarette market, said it is working to prevent underage use of its products but added that flavors can help adult smokers quit cigarettes.
To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes in order to stop smoking traditional cigarettes outweigh the risks associated with youth vaping.
"E-cigs have become an nearly ubiquitous - and unsafe - trend among teens", Gottlieb said in a statement. Hindsight, and the data now available to us, reveal these trends. It was "the largest coordinated enforcement effort in the FDA's history", according to the agency.
In the US, about 12 percent of high school students use e-cigarettes at least once a month, the US Centers for Disease Control and Protection estimated in 2017.
Supermarket, drug and mass retail and fuel locations cited in the FDA action - primarily with warnings - included Coborn's, Dillons, Dollar General, Food Lion, Fred Meyer, Fred's, Fry's, H-E-B, Hannaford, Harps, Hy-Vee, Jewel-Osco, Kroger, Meijer, Publix, Rite Aid, Safeway, Smith's, Walgreens and Walmart.
US health officials on Wednesday declared the teen use of e-cigarettes an epidemic and issued more than 1,300 warning letters and fines to entities related to the sale and marketing of e-cigarettes to minors.
Budding research on e-cigarettes also suggests that these flavors contain terpenes that may be more damaging to the lungs than other flavors are. As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of burning tobacco. The FDA said more than 2 million middle school and high school students used e-cigarettes in 2017.
Bottles of flavor packets for e-cigarettes stand displayed in a tobacco shop in New York on June 23, 2015.