Medicine

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

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

Tobacco stocks are surging after the Food and Drug Administration threatened Wednesday to pull flavored electronic cigarettes like Juul off the market if the industry fails to combat the epidemic of youth e-cigarette use.

But Gottlieb said in an address at FDA headquarters that he failed to predict the current "epidemic of addiction" among youth, mainly driven by flavored products.

The FDA is also targeting retailers who have sold e-cigarettes to minors. But at the same time, 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. More than 2 million middle-school and high-school students used e-cigarettes in 2017.

The FDA told five major e-cigarette manufacturers on Wednesday to come up with ways to address youth use in 60 days or the agency could require them to stop selling flavored products that appeal to children. Those five brands account for about 97% of the US e-cigarette market, the agency reported.

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

Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent.

Though Juul is by far the most popular e-cigarette device, two other companies, Vuse and Blu, have also received warnings.

As of September 1, the FDA said it has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law, and initiated 18,560 civil money penalty cases in its checks of retail establishments selling tobacco products. "Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes". But health officials have warned nicotine in e-cigarettes is harmful to developing brains.

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MarkTen's flavors, for example, include "menthol", "classic", and "summer blend", while Juul's flavors have included "fruit medley" and "creme brulee", recently shortened to "fruit" and "creme". That initiative emerged from the agency's broader plan to regulate nicotine and tobacco, unveiled in July 2017, under the Family Smoking Prevention and Tobacco Control Act.

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. "We can not allow a whole new generation to become addicted to nicotine".

"JUUL Labs will work proactively with FDA in response to its request", a JUUL spokesperson told Business Insider in a statement. "Appropriate flavors play an important role in helping adult smokers switch", Burns said in a statement. 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 agency said it continues to check retail stores that sell tobacco, to ensure they are in compliance with federal laws.

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

Watch Altria and British American Tobacco trade in real time here.

Logic Technology Development, owned by Japan Tobacco Inc, said it will demonstrate to the FDA "that Logic markets its products only to adults".


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