RICHMOND, Va. — A federal appeals court says electronic cigarettes should be regulated as tobacco products by the Food and Drug Administration rather than as drug-delivery devices, which have more stringent requirements.

The ruling means their makers won’t have to conduct expensive clinical trials to prove to the FDA that the products are safe and effective as a stop-smoking aid.

The decision is a setback to the FDA and other public health organizations, which had argued e-cigarettes should be regulated like nicotine replacement gum or patches. They also have warned that e-cigarettes contain dangerous chemicals and are being marketed to children.

A three-judge panel of the U.S. Court of Appeals in Washington backed a lower court ruling that the devices should be considered under the agency’s authority over tobacco, which means they would follow the same restrictions as traditional cigarettes and tobacco products.

Some sellers of e-cigarettes sued the FDA last year after the agency told customs officials to refuse entry of shipments into the U.S. A federal judge ruled in January that the FDA can’t stop those shipments, saying the agency had overstepped its authority.

E-cigarettes are plastic and metal devices that heat a nicotine liquid in a disposable cartridge, creating vapor that the “smoker” inhales. A light on the tip even glows like a cigarette.

Users and distributors say e-cigarettes address both the nicotine addiction and the behavioral aspects of smoking without the more than 4,000 chemicals found in a traditional cigarette.

 


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