FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’

FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’

Gottlieb said the FDA recognized the impact this might have on adults trying to stop smoking, but said that emerging research on how flavored products encourage excessive use by young people shows action must be taken.

Many use fruit- or candy-flavored liquids that critics say appeal to kids, and risk addicting them to nicotine. Gottlieb is talking about reneging on the FDA's four-year extension of the deadline for seeking regulatory approval to continue selling e-cigarettes, which would wreak havoc with a market that he concedes has great potential for reducing smoking-related disease and death. The FDA is alarmed that, according to the National Youth Tobacco Survey (NYTS), "more than 2 million middle and high school students were current users of e-cigarettes in 2017". The agency may also ban sales of some flavored e-cigarette products, which Gottlieb says are particularly appealing to underage users, and consider shortening a grace period that now gives e-cigarette companies until 2022 to apply for FDA approval.

The federal government is threatening to eliminate that alternative even while tolerating conventional cigarettes, which are far more hazardous and also end up in the mouths of people who are not old enough to buy them legally.

Investors in Juul's competitors appeared to welcome the FDA announcement.

The agency said it plans to unveil a new e-cigarette public education campaign targeted to youth next week, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.

Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent. The FDA's delay on that requirement has allowed the industry to flourish with little oversight. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping. Shares of traditional cigarette maker Altria Group, which also owns the MarkTen brand, rose more than 6 percent, while Philip Morris International shares were up 3 percent. The agency issued 12 warning letters to companies that it says have deceptive marketing labels on e-liquids.

British American's R.J. Reynolds Vapor Company said it will comply with the FDA request, adding that "youth tobacco prevention is a priority for our companies".

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"JUUL Labs will work proactively with FDA in response to its request", said Kevin Burns, JUUL's CEO.

"By working together, we believe we can help adult smokers while preventing access to minors", the company said in a statement. Regulators said it was the largest coordinated crackdown in the agency's history.

"This could result in a bullet through the head of Juul, the driver of youth initiation", said Nico von Stackelberg, an analyst with Liberum in London, told the news agency.

The FDA is in the process of rolling out a sweeping anti-smoking initiative created to make it easier for smokers to quit by cutting the nicotine levels in regular cigarettes.

"The legal standard for FDA premarket review of a new tobacco product includes consideration of whether the product would be appropriate for the protection of the public health".

"Well, I'm here to tell them that this prior approach is over".

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