Federal Judge Orders FDA to Start Examining Electronic Cigarettes

A federal judge is siding with public health groups suing the Food and Drug Administration to begin examining thousands of electronic cigarettes in the US market.

Wednesday's decision in a district court indicates the agency failed to meet its legal obligation by postponing for several years the review of all products sold in the United States.

The American Academy of Pediatrics, Campaign for Tobacco-Free Children, and other groups filed federal lawsuits in Maryland last year. The groups say the lack of FDA oversight has led to an explosion of vaping among miners, threatening to hook a generation of Americans to nicotine.

"It's now up to the FDA to take immediate action to protect our children and to force manufacturers to contact the FDA if they want to keep their products on the market," said groups in a statement.

E-cigarettes are nicotine-emitting devices that have become a multi-billion dollar industry in the United States despite little research on their long-term health effects, including their usefulness in helping smokers quit. To smoke.

The FDA obtained the power to regulate products in 2016, but it has allowed thousands of products to remain on the market without formal rules or product standards. The agency says FDA staff and manufacturers need more time to prepare for the regulations.

Public health groups have warned that the lack of surveillance could cancel decades of tobacco control efforts as young people migrate to new vaping products.

US Judge Paul Grimm agreed, calling the FDA's delay "so extreme that it would be an abdication of its statutory responsibilities".

The FDA spokesman, Michael Felberbaum, said in an email that the agency was reviewing the court's decision and "will continue to fight the eerie epidemic of using the electronic cigarette in children ". The agency will have the opportunity to appeal the decision.

Gregory Conley, of the American Vaping Association, said the government "must appeal this ruling" to "protect adult access to less harmful alternatives to cigarettes".

Scott Gottlieb, president of the FDA President Donald Trump, left last month. The FDA has stated that it would not require that electronic cigarette manufacturers submit their products for review until 2022. Shortly before resigning, Mr. Gottlieb had postponed the deadline at 2021.

But Grimm's decision suggests that the FDA must act much more quickly. He is calling on health groups and the FDA to submit plans to advance product reviews within 30 days.

Wednesday 's decision follows a similar decision made last September, when a federal judge said the FDA should go ahead with the addition of labels. graphic warning on cigarette packs. The FDA was required to take this step under a 2009 law, but the process is bogged down under the legal challenges of the tobacco companies.

"The courts are clearly urging the FDA – at the request of consumer advocacy groups and doctors – to step up their regulatory pressures on the industry," said Marc Scheineson, a former FDA official who now advises drug companies. Alston & Bird Law Firm.

Scheineson said that he expects the FDA to state that it does not have the resources to deal with the flood of requests that the industry would submit if the decision was applied.

The FDA and most health experts agree that electronic cigarettes are probably less harmful than traditional cigarettes because they do not produce carcinogenic byproducts of burned tobacco. However, little research has been done on their long-term effects on health, especially among young people.

Nicotine is what makes cigarettes and electronic cigarettes addictive, and health experts say this chemical is harmful to brain development.

Meanwhile, the North Carolina Attorney General announced on Wednesday the first lawsuit against the giant electronic cigarette Juul, which dominates the vaping market in the United States.