Electronic cigarettes not a drug device, judge says

Electronic cigarettes will remain on the market for now, after a federal judge’s ruling this week that could have wider implications for federal regulation of tobacco products.

Some tobacco-control advocates warned that if upheld, the ruling could give rise to a host of new, nicotine-laced products that historically have been restricted by the U.S. Food and Drug Administration.

The preliminary ruling said electronic cigarettes are not drug-delivery devices but should be treated as tobacco products.

“This opens the door for manufacturers of non-tobacco products to insert nicotine, a highly addictive substance and, in certain uses, dangerous, into a wide variety of non-tobacco products that would previously have been forbidden,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

Made mostly in China, the tube-shaped e-cigarettes are battery-powered and include a heating element that vaporizes a mix of nicotine and a type of alcohol for the smoker to inhale. Imported e-cigarettes have been advertised in the United States as alternatives to conventional cigarettes, sometimes with claims that e-cigarettes are less harmful to smokers’ health.

The FDA considers e-cigarettes to be unapproved drug-delivery devices and has halted some shipments into the country, prompting a lawsuit by two importers based in Florida and Arizona. The companies say they have sold hundreds of thousands of e-cigarettes in the U.S. in the past two years, but the FDA action has depleted inventories and threatened their businesses.

Judge Richard J. Leon of U.S. District Court in Washington sided with the importers, issuing a preliminary injunction on Thursday ordering the FDA to stop blocking importation of e-cigarettes. Leon wrote that the importers are likely to prevail in their argument that e-cigarettes are not subject to regulation by the FDA’s drug division.

Instead, e-cigarettes fall under the agency’s new authority to regulate tobacco products, Leon wrote.

Congress passed legislation last year that for the first time gives the FDA oversight of the tobacco industry. Among other powers, the agency has authority to review for approval any new products that claim to be less harmful than conventional tobacco products.

“This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” Leon wrote.

The FDA “has not cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public,” Leon wrote.

The ruling, if upheld, raises questions about how the FDA will approach “hybrid products” that contain nicotine but are not clearly either traditional tobacco products or nicotine-cessation products, said John F. Banzhaf III, a professor of public-interest law at George Washington University.

Banzhaf said the FDA could argue on appeal that the judge overstepped by failing to give deference to the agency’s scientific expertise.

“The question of how best to regulate [novel products] . . . should lie first with the agency and not the judge, who does not have any particular skill or expertise in this field,” he said.

Myers with the Campaign for Tobacco-Free Kids said he believes the decision will be overturned on appeal. “I think it is a misunderstanding of long-standing law,” he said.

The FDA said it is reviewing the ruling and considering options.

“Nicotine in products currently regulated as drugs and devices is derived from tobacco products, but that doesn’t make them tobacco products,” Myers said.


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