FDA cracking down on e-cigarettes

A Juul vaping system with accessory pods in varying flavors on May 02 2018 in Washington DC

Such a step would be a major blow to the e-cigarette companies - Juul, Vuse, Blu, Logic and MarkTen - which often feature cream and fruit flavorings in their products.

The agency remains committed to the tobacco framework, Gottlieb told staffers Wednesday, but he acknowledged that it "didn't predict what I now believe is an epidemic of e-cigarette use among teenagers".

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. It reserved its strongest action for the manufacturers themselves.

The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties. The FDA received congressional approval to regulate e-cigarettes in August 2016, although it's trying to ease regulation to help stop cigarette smoking among adults.

When electronic cigarettes hit the market in 2004, they were seen as a positive alternative to tobacco smoking.

"This may create some obstacles for adults who want to enjoy e-cigarettes", Gottlieb said.

It will also "re-visit" the policy it announced past year, which gave e-cigarette companies more time to apply for regulatory approval. And it warned more than 1,100 retailers about selling e-cigarettes to underage buyers.

Chris Hansen, president of the American Cancer Society Cancer Action Network, lamented the delay, as well as the years it took for the FDA to implement regulations following the 2009 law that provided it with new powers.

Juul Labs, which controls about 70% of the market, said in its order that "acceptable flavors" play a job in adults changing their smoking habits, but added that they "are committed to combating underage employ of our product, and we want to be allotment of the resolution in preserving e-cigarettes out of the hands of children". "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", he said. That's why combating youth use of nicotine-containing products is a core priority and the guiding principle behind the FDA's Youth Tobacco Prevention Plan.

The burgeoning popularity of e-cigarettes among young smokers has caused traditional cigarette industry players a great deal of trouble by eating into their market share.

E-cigarettes were the most commonly used nicotine/tobacco product among young people past year, with 2 million middle and high school students reporting use. "And if they are under 18 or they don't have their ID, they have to immediately leave the store", says Allison Vandeveld, Director of Operations at Vapin USA. "We're seriously considering a policy change that would lead to the immediate removal of these flavored products from the market", Gottlieb said in a speech at FDA headquarters.

JUUL, which is already facing FDA investigation for its marketing practices, said it would "work proactively with FDA in response to its request". But the FDA nonetheless intends to stand in the way of JUUL and other products that could help millions of Americans, disproportionately poor, take an important step toward improving their health. Why?

"I'll be clear. The won't tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products", Dr. Gottlieb said.

Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent. They're generally considered a less risky alternative to regular cigarettes. But "the youth risk is paramount", he said.

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.



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