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FDA proposed crackdown on flavored e-cigs puts Juul on notice

13 September 2018

The US Food and Drug Administration (FDA) is considering a ban on flavored e-cigarettes in response to what it warned is an "epidemic" of young people using the devices and getting hooked on nicotine, it was announced on Wednesday. A government-commissioned report in January found "substantial evidence" that young people who use e-cigarettes are more likely to try cigarettes.

He said the FDA move could "represent a fundamental turning point" if the agency requires "all of these products undergo premarket review now, not four years from now". "It's now clear to me, that in closing the on-ramp to kids, we're going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs". They noted the survey did not ask specifically about Juul, a sleek, heavily-marketed e-cigarette brand that exploded onto the market and accounts for 70 percent of USA sales, according to analyst estimates.

Other studies have indicated that while e-cigarettes may have milder effects on the lungs, they are just as bad - if not worse - for the cardiovascular system, raising risks of heart disease and high blood pressure. But it also sent letters to five leading manufacturers of "electronic nicotine delivery systems" (ENDS), insisting that they do more to keep their products away from teenagers.

If the plans fall short, the FDA could block sales of the products by enforcing a requirement that companies provide detailed design and health data about their products before marketing them. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping.

The agency will also be increasing federal enforcement actions on e-cig sales to minors in convenience stores and other retail sites, Gottlieb said, and would look closely at a practice called "straw purchases", in which adults visit web-based stores and buy in bulk to resell to minors.

Shares of Big Tobacco companies surged in trading Wednesday.

Shares of British American Tobacco, which owns the Vuse brand, closed up almost 6 percent, while shares of cigarette-maker Imperial Brands PLC, which owns Blu, rose more than 3 percent.

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. "By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission".

And some of the retailers that received warning letters are still advertising and selling these products, he said. The company has more than two-thirds of the US e-cigarette market, according to Nielsen data. "Juul is a product for adult smokers".

In July 2017, the FDA said it was considering lowering nicotine levels in traditional cigarettes.

"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".

Many use fruit- or candy-flavored liquids that critics say appeal to kids, and risk addicting them to nicotine.

FDA proposed crackdown on flavored e-cigs puts Juul on notice