E-cigarette use is an 'epidemic', FDA chief says

Maricruz Casares
Setiembre 14, 2018

Gottlieb echoed those concerns, saying he's anxious about the effects of nicotine in e-cigarettes on the developing brain, and that a proportion of teenagers who use the devices will end up on regular cigarettes.

"The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end". "It be simply no longer tolerable".

In addition to JUUL, 4 other vape companies face the FDA's ultimatum: Vuse, Blue, Markten XL, and Logic (who collectively make up 97% of the U.S. e-cig market). That could lead to the removal of some major flavoured e-cigarette brands, including the popular products made by Juul Labs Inc., if they do not address the issue to the agency's satisfaction. The agency had for decades had no power to regulate cigarettes or other tobacco products, but Congress passed a law in 2009 giving FDA limited power to do so. "But in closing the on-ramp for kids, we're going to have to narrow the on-ramp for adults".

"The FDA should immediately move to regulate flavored e-cigarettes, instead of waiting until 2022, as it is now planning to do", Bloomberg said in a statement.

Eaton, a professor of environmental and occupational health sciences at the University of Washington School of Public Health, said that "in some circumstances, such as their use by nonsmoking adolescents and young adults, their adverse effects clearly warrant concern".

"We're committed to the comprehensive approach to address addiction to nicotine that we announced past year".

The FDA says it has issued "more than 1,300 warning letters and fines to retailers" as a result of "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors". If they can't, the flavored products could be pulled from store shelves.

Beyond that, vaping research and development is actually costing tobacco companies as they attempt to gain market share in the burgeoning industry, Lavery said. "We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people. In the coming weeks, we'll take additional action under our Youth Tobacco Prevention Plan to immediately address the youth access to, and the appeal of, these products", said FDA Commissioner Gottlieb.

To gain clearance to return to the market, the companies would have to prove that the benefits to adults who use e-cigarettes to stop smoking outweigh the risks associated with youth vaping.

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In the US, about 12 percent of high school students use e-cigarettes at least once a month, the US Centers for Disease Control and Protection estimated in 2017.

The FDA said it was cracking down hard on sales of vaping products to teenagers and said it was reconsidering a grace period to allow makers to apply for FDA approval of their products.

Gottlieb called the action the largest coordinated enforcement effort in the agency's history.

"The action FDA threatened to "consider" using against the manufacturers of five e-cigarette brands - removing certain products that are clearly aimed at youth from the market - is the very authority the American Lung Association has urged the FDA to actively use, broadly".

A Food and Drug Administration crackdown on e-cigarettes could be a boost for big tobacco, Piper Jaffray's Michael Lavery told CNBC on Thursday.

"Our mission is to improve the lives of adult smokers by providing them with a true alternative to combustible cigarettes", Juul said in a statement.

"I certainly am in possession of evidence that warrants that", Gottlieb said, without disclosing the evidence.

On Wednesday, Gottlieb put manufacturers on notice that the agency's balancing act will lean more heavily on preventing youth addiction.

Bottles of flavor packets for e-cigarettes stand displayed in a tobacco shop in New York on June 23, 2015.

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