By Sam Baker - 04/25/11 08:01 PM EDT
The Food and Drug Administration said Monday it plans to regulate electronic cigarettes as tobacco products rather than continue trying to classify them as a combined drug and medical device. The agency said it will soon be issuing a proposed rule on e-cigarettes.
Electronic cigarettes vaporize tobacco, along with a chemical compound that includes nicotine, without producing smoke. The government has said the chemicals in e-cigarettes are untested and potentially harmful.
The FDA tried to crack down on e-cigarettes over the past two years by stating that the products are a drug-device combination, which would require the agency's approval and make their sale illegal pending that approval. But a federal court in Washington, D.C., ruled last December that e-cigarettes are "tobacco products," meaning the agency could not ban them outright.
The agency said in a letter to stakeholders Monday that it "has decided not to seek further review of this decision" and "will comply with the jurisdictional lines established" by the ruling. The FDA gained the power to regulate tobacco in 2009.
Tobacco products are subject to controls such as registration and ingredient listing, and the FDA can set more specific pre-approval criteria for products that are marketed as being less risky than traditional cigarettes. The agency can still apply the drug-device classification to products marketed as having "therapeutic" value, such as smoking cessation products.