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Circuit Rejects Stricter|Rules for ‘E-Cigarettes’

(CN) - The D.C. Circuit upheld an order barring the Food and Drug Administration from blocking the importation of electronic cigarettes, saying the agency can't impose stricter regulations on "e-cigarettes" than on traditional cigarettes.

Smoking Everywhere and NJOY filed suit after the FDA banned them from importing e-cigarettes, which allow users to inhale vaporized nicotine without the fire, smoke, ash, carbon monoxide or smell of traditional cigarettes. The battery-powered tubes look like cigarettes and are touted as an "alternative to traditional cigarettes that delivers the same sensation as smoking," but "without combustion or the use of cancerous byproducts."

The FDA said e-cigarettes qualified as a "drug-device combination" under the Food, Drug, and Cosmetic Act (FDCA), giving the agency the power to halt imports.

Under Supreme Court precedent, the FDA can invoke the Act to regulate only tobacco products sold for "therapeutic" uses, such as for diagnosing, treating, curing or preventing a disease.

NJOY and Smoking Everywhere insisted they marketed their e-cigarettes for "smoking pleasure," and not as a therapeutic product or a tool to help users quit smoking.

In January, a federal judge ruled that the FDA lacked the power to ban e-cigarette imports under the FDCA.

The federal appeals panel in Washington, D.C., upheld the injunction, agreeing that the Act excludes from regulation "customarily marketed tobacco products," including e-cigarettes.

The Supreme Court's decision in FDA v. Brown & Williamson reinforces the agency's limited authority under the drug-device provision of the FDCA, according to the ruling.

"As customarily marketed, tobacco products were to remain the province of Congress," Senior Circuit Judge Stephen Williams wrote.

To fill the regulatory gap, Congress passed the Tobacco Act in 2009, which allowed the FDA to regulate all tobacco products except those that qualified as drugs, devices or drug-device combinations under the FDCA.

The D.C. Circuit said the FDA's power to regulate e-cigarettes is governed by the Tobacco Act, unless the products are marketed for therapeutic purposes.

"Given the likelihood of NJOY's success on the merits, the irreparable harm to NJOY's business, and the FDA's unquestioned Tobacco Act authority to mitigate any public harm, the district court did not abuse its discretion in granting the preliminary injunction," Williams wrote.

"Of course, in the event that Congress prefers that the FDA regulate e-cigarettes under the FDCA's drug-device provisions, it can always so decree," he added.

Judge Merrick Garland agreed with the panel's ruling, but wrote separately to express his view that the Supreme Court's ruling did not necessarily bar the FDA from regulating e-cigarettes under the FDCA. Instead, he said, the Tobacco Act merely required the FDA to regulate tobacco-derived products under that law, rather than the FDCA.

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