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Federal judge instructs the FDA to start looking at e-cigarettes



A customer smokes an e-cigarette at Digita Ciggz January 28, 2015 in San Rafael, California.

Justin Sullivan | Getty Images

A federal judge pages along with public health groups sue the Food and Drug Administration to begin reviewing thousands of e-cigarettes in the US market.

On Wednesday, the hearing decided in the district court that the agency was performing its legal duty when it exposed to reviewing all US arms products for several years.

The American Academy of Pediatrics, Campaign for Tobacco Free Kids and other groups filed the federal lawsuit in Maryland last year. The groups say the lack of FDA supervision has led to an explosion in teenage weapons by teenagers, threatening to link a generation of Americans to nicotine.

"It is now the FDA's responsibility to take immediate action to protect our children and require manufacturers to apply for the FDA if they want to keep their products on the market," the groups said in a statement.

E-cigarettes are nicotine-emitting devices that have grown into a multibillion dollar industry in the United States despite little research into their long-term health effects, including whether they are useful in helping smokers quit cigarettes.

The FDA was given authority to regulate the products in 201

6, but it has allowed thousands of products to remain on the market without formal rules or product standards. The agency says both FDA employees and manufacturers need more time to prepare for regulation.

Health care groups have warned that lack of supervision may reject decades of tobacco work that youths migrate to newer weapons products. [19659002] US Judge Paul Grimm agreed to call the FDA's delay "as extreme as charging an abdication of its statutory liability."

The FDA spokesman Michael Felberbaum said in an e-mail statement that the agency is considering the court decision and "will continue to tackle the worrying epidemic of e-cigarette use among children." The Agency will have the opportunity to appeal the decision.

Gregory Conley of the US Coalition said the government "must appeal this decision" to "protect adult access to less harmful alternatives to cigarettes."

Under President Donald Trump's FDA Commissioner, Scott Gottlieb – who left last month – the FDA said it would not require the e-cigarette manufacturers to submit their products for consideration by 2022. Shortly before the trot, Gottlieb came to the deadline until 2021.

But Grimm's decision suggests the FDA must move much faster. He urges the health groups and the FDA to submit plans to move on with product reviews within 30 days.

Wednesday's decision follows a similar decision in September, when a federal judge said the FDA should go ahead with adding graphic warning labels to cigarette packs. The FDA was required to take this step after a law in 2009, but the process has been hampered by legal challenges from tobacco companies.

"The courts clearly press the FDA – at the request of medical and consumer groups – to increase its regulatory pressure on the industry," said Marc Scheineson, a former FDA official, who now advises companies with the law firm Alston & Bird.

Scheineson said he expects the FDA to argue that it does not have the resources to deal with the flood of applications that the industry would submit if enforcement is enforced.

The FDA and most health experts agree that e-cigarettes are probably less harmful than traditional cigarettes because they do not produce carcinogenic by-products. But there is little research on their long-term health effects, especially for young people.

Nicotine is what makes both cigarettes and e-cigarettes addictive, and health experts say the chemical is harmful to developing brains.

Separately on Wednesday, North Carolina's lawyer general announced the first lawsuit against e-cigarette giant Juul, which dominates the US arms market.


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