More than 2 million middle-school and high-school students used e-cigarettes in 2017. And the agency says if these companies don't prove that they're doing this within 60 days, they might pull flavored e-cigarettes off the market. "I use the word epidemic with great care". "The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end", he said.
The agency has so far issued fines to 131 retailers, ranging from $279 to $11,182.
The FDA also plans to revisit its policy that extended the dates for manufacturers of certain flavored e-cigarettes to apply for premarket authorization. E-cigarette sales have threatened Big Tobacco companies. Short of that, he suggests the FDA might force companies to stop offering e-liquid flavors that appeal to minors, which are an important factor in quit attempts by adult smokers.
E-cigarettes were the most commonly used nicotine/tobacco product among young people previous year, with 2 million middle and high school students reporting use. If the companies do not respond to the agency's satisfaction, the FDA said, it will consider removing their products from stores. Many researchers say the devices are less risky than traditional, combustible cigarettes because they don't contain tobacco's cancer-causing ingredients.
However, he added: "The youth risk is paramount". "It's aimed at retail and online sales of e-cigarettes to minors".
Dr Gottlieb said the agency plans to launch a national campaign to raise awareness of the risks to teens, as it sees signs that the number of users is increasing.
"The FDA has at its disposal both civil and criminal remedies to address demonstrated violations of the law", he said.
"We're announcing the largest ever coordinated initiative against violative sales in the history of the FDA". In 2009, the Tobacco Control Act gave the agency authority over cigarettes and smokeless tobacco. Sales were allowed to continue in the interim.
Following Wednesday's announcement, tobacco stocks surged then pared some of those gains on Thursday.
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The plan focuses on reducing access and appeal of e-cigarette products. The delay was denounced by public-health groups, which have sued to restore the tighter timeline.
Warning that e-cigarettes use by minors has reached "epidemic proportions", the FDA imposed fines Wednesday and sent warning letters to 1,300 retailers that sell vaping devices. But health officials have warned nicotine in e-cigarettes is harmful to developing brains.
In a speech at the agency's headquarters in Silver Spring, Md., Gottlieb acknowledged that e-cigarettes present a public health conundrum. "They must demonstrate they're truly committed to keeping their products out of the hands of kids". The devices resemble flash drives, bedeviling teachers and parents who are trying to catch children with e-cigarettes. Those five brands account for about 97% of the USA e-cigarette market, the agency reported.
"Juul was a game changer", Myers said in an interview.
The FDA has been widely criticized by anti-smoking groups for extending the product review application period for e-cigarettes introduced to the market before August of 2016 to the summer of 2022. The aerosol that e-cigarette users inhale contains volatile organic compounds, heavy metals and other chemicals that may cause cancer, according to the CDC. The study will take three years.
- Products created to help adults kick the habit may be encouraging addiction in kids.
Still, Myers said, there's "no way to put that genie back in the bottle" with youth use.
In a June interview with CBS News, Juul's chief administrative officer Ashley Gould insisted that the company never intentionally marketed to teens.
Another guess is Big Tobacco is looking to protect their own market share.