FDA takes 'ancient action' on formative years e-cigarette 'epidemic'
16 September, 2018, 13:15 | Author: Darnell Patrick
Teen use of electronic cigarettes is growing-especially the Juul device, which is considered so fetch in many underage circles that it has reached an "epidemic proportion", writes the FDA, according to the New York Times.
In April, JUUL sent thousands of pages of records to be reviewed by the FDA - but apparently, it didn't bode well for the nicotine king.
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.
It has warned that most such products contain nicotine, which is addictive and can affect brain development. The FDA should also be moving to remove all flavored tobacco products from the market - unless a manufacturer shows that they help adults switch completely from cigarettes and do not attract youth - which is clearly not the case for the most popular products now on the market. Now the FDA has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law and initiated approximately 18,560 civil money penalty cases, as of September 1, 2018.
FDA announces action against retailers selling e-cigarettes to minors.
In his remarks, Gottlieb criticized e-cigarette manufacturers for failing to address teen use of their products.
Actions being considered - but not yet undertaken - include the immediate removal of certain flavored e-cigarettes from the market and shortening the time to market review for most cigarettes now being sold.
Although Gottlieb conceded that e-cigarettes may help adults stop smoking, it seems as though he won't be swayed by Juul's work to prevent kids from accessing the product.
STEIN: Yeah, so the companies that make these products, they say, look; you know, we don't think kids should be using them either.
Today more middle-and- high school students (over two million) are vaping than smoking tobacco cigarettes.
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 enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers", he says, "we won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products". The agency states that there is a clear need for strong federal enforcement of youth access restrictions and the FDA will continue to hold retailers accountable by vigorously enforcing the law with the help of the agency's state partners.
"In addition, today the FDA also issued 12 warning letters to other online retailers that are selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies".
The other companies also said they would work with the FDA on youth prevention efforts.
Dr. Gottlieb said he believes that certain flavors make the products appealing to teens.
According to the company's website, the mission of JUUL products is to improve the lives of the world's 1 billion adult smokers.
"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".
Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent. "Appropriate flavors play an important role in helping adult smokers switch", the company said.
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