FDA Gets Tough on Juul, Other E-Cigarette Makers

Postado Setembro 13, 2018

Of the 3.6 million middle- and high-school students who said they are tobacco-product users, 2.1 million used e-cigarettes, according to the Centers for Disease Control and Prevention.

"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.

But the FDA said it is also investigating whether e-cigarette manufacturers have introduced new products after August 8, 2016, without premarket authorization.

The organisation warned the country's five largest e-cigarette makers that their products - Juul, Blu, MarkTen, Vuse and Logic - could be banned unless the companies could prove within 60 days that they had effective plans to stop sales to children.

"What we have learned from our experience with cigarettes and other products, is it is important to restrict sales to kids, but if you make products appealing to kids, market them in ways to attract kids, you can be certain kids will get them", Myers told AFP.

E-cigarettes are battery-powered devices that heat a nicotine liquid into a vapor that can be inhaled. "It's aimed at retail and online sales of e-cigarettes to minors".

The crackdown marked the "largest coordinated enforcement effort in the FDA's history", the agency said in a statement, warning of even harsher action to come. But when it comes to minors, he said, even e-cigarettes should be off limits.

"We need to go further", said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce tobacco use.

In a release, the FDA said it's taking "historic action" against companies that it believes promotes use and addiction of their products to young vapers. "Juuling", along with "vaping", has become a common term for e-cigarette use by teenagers on social media and at USA high schools.

The FDA found top-selling brands were popular among minors. As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of cigarettes. "Hindsight, and the data that's now available to us, fully reveal these trends".

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.

"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".

In addition, the FDA on Wednesday issued 12 warning letters to online retailers for selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies.

The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties.

"Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications", Gottlieb announced.