FDA barred from regulating e-cigarettes as medical devices

An appeals court rules that the agency can't request clinical trials before makers can sell the battery-powered products.

By Alicia Gallegos — Posted Dec. 29, 2010

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An appellate ruling has blocked the Food and Drug Administration from regulating electronic cigarettes as "medical devices," a designation that would have required clinical trials before manufacturers could market the products.

The Dec. 7 decision by the U.S. Court of Appeals for the District of Columbia Circuit Court found that the FDA has jurisdiction over e-cigarettes as "tobacco products" but not under the more rigid Federal Food Drug and Cosmetic Act, which calls for mandatory testing for FDA approval. The court said the devices fall under the FD&C Act only when marketed for therapeutic use.

The plaintiff, e-cigarette maker NJOY, had argued that its products are promoted for "smoking pleasure," rather than smoking cessation (link).

The FDA is reviewing its next steps, said spokesman Jeff Ventura. The agency has several options, including taking the case to the U.S. Supreme Court, allowing the appellate decision to stand or trying to regulate e-cigarettes under the Tobacco Control Act.

E-cigarettes are battery-powered products designed to look like traditional cigarettes that allow users to inhale nicotine vapor without fire, smoke or ash. The plastic mouthpiece on the product, however, contains liquid nicotine, an ingredient derived from tobacco plants that has prompted safety concerns from the FDA and public health organizations.

Because e-cigarettes are not submitted for evaluation, the agency said it has no way of knowing the types of chemicals that are being administered to consumers.

Support for FDA regulation

At its Annual Meeting in June, the American Medical Association House of Delegates adopted policy recommending that e-cigarettes be classified as drug delivery devices subject to FDA regulation.

The Court of Appeals opinion said the FDA still could regulate e-cigarettes under the Tobacco Control Act, which would let the agency control nicotine levels and enforce age restrictions. But the regulation would take time, because the FDA would have to draft regulatory language and conduct a public proposal process.

"It will take the FDA time to assert jurisdiction over these products and issue regulations governing them, leaving these products unregulated in the meantime," said Matthew L. Myers, president of Campaign for Tobacco-Free Kids, a national nonprofit group.

E-cigarette company owners such as Vitali Servutas argue that more testing of the products by the FDA would have translated to unnecessary and costly measures for manufacturers. Servutas, co-owner of Virginia Beach, Va.-based Premium E-Cigarettes, said he was not concerned with tobacco regulation, because most e-cigarette companies already follow related guidelines such as posting nicotine health warnings on packages.

Richard Samp, chief counsel for the Washington Legal Foundation, a conservative public interest and policy center that advocates limited government, said he would have liked to see a broader court opinion that applies to regulating a wider spectrum of products. The foundation, which filed a brief opposing FDA regulation, argues that the FDA too often tries to exceed its authority over alternative uses of drugs and devices such as e-cigarettes.

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