The FDA Is Considering Pulling Some Flavored E-Cigarettes From the Market to Fight 'Epidemic' of Youth Vaping
16 September, 2018, 15:32
Gottlieb said if the five e-cigarette manufacturers that received FDA letters do not come up with plans to address youth use of their products, the agency might "reconsider" its decision to delay the date at which e-cigarettes will need agency approval to remain on the market.
"We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger", said FDA Commissioner Scott Gottlieb in a statement.
WASH/LA-The Food and Drug Administration said on September 12-they are considering a ban on flavored e-cigarettes in response to an "epidemic" of young people using e-cigarettes, the agency's leader said. The academy said Gottlieb has the authority to intervene in the market to protect minors, and any further delay runs the risk that "a generation of young people will become addicted to these risky products".
The FDA also requested Juul and four other manufacturers provide plans to mitigate youth sales within 60 days or face potential criminal or civil action.
"In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products, and as they did, these risks have mounted", Gottlieb said. More than 2 million middle and high school students were users of e-cigarettes in 2017, according to the agency.
The latest data, not yet published, show a 75 percent increase in e-cigarette use among high school students this year compared to 2017.
The appeal of e-cigarettes to teens is widespread and has raised alarms in other countries, including the UK.
It marks a shift in the agency's tone on e-cigarettes.
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.
It has warned that most such products contain nicotine, which is addictive and can affect brain development. You know, the FDA's been going after e-cigarette use among young people for a while now, but it says it's taking that to a whole new level. Juul isn't one of them, but the company's websiteclaims they're working on it. Blu does offer nicotine-free juice and actually suggests it to people who just want flavors. Although these products were the subject of the agency's action in May, they are no longer being sold with the offending label no advertised by the companies that received the letters in May.
Over the past several years, e-cigarettes (vaping) were the most commonly used tobacco product by youth. 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.
Gottlieb called the action the largest coordinated enforcement effort in the agency's history. The agency may require the companies to revise their sales and marketing practices, to stop distributing products to retailers that sell to kids and to stop selling some or all of their flavored e-cigarette products until the companies clear the application process. However, e-cigarettes can deliver a higher nicotine content. "Juul is a product for adult smokers". The FDA took the largest enforcement action against more than 1,300 retailers and five manufacturers of selling e-cigarettes on Wednesday.
A Juul spokesperson, Victoria Davis, argued in a statement to Reuters that "appropriate flavors play an important role in helping adult smokers switch".
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