The U.S. Food and Drug Administration (FDA) was able to receive a go-ahead from a federal appeals court to regulate e-cigarettes as tobacco products, but not as drug-delivery devices in the same vein as nicotine patches and gum, according to a report on Bloomberg BusinessWeek.
The ruling was made by a three-judge panel of the U.S. Court of Appeals in Washington on Tuesday. The panel decided to uphold a ruling made by a lower court, which called for the FDA to consider the products under its authority over tobacco.
The FDA, however, along with a number of health organizations that include the American Heart Association (AHA), sought to have the products regulated as drug-delivery devices, which would entail that they be proven as safe and effective as a tool for smoking-cessation. Such a requirement will require the conduct of expensive clinical trials.
Bill Godshall, founder of Smokefree Pennsylvania, a non-profit group that supports e-cigarettes, wrote the following statement in an e-mail, as shared in a post on The New York Times: “This is a huge victory for public health and civil justice… It’s time for F.D.A. officials to come to their senses by reclassifying (and promulgating reasonable regulations for) e-cigarettes as tobacco products.”
Nancy Brown, AHA chief executive, also issued a statement regarding the ruling, which read in part: “The appeals court has cleared the way for the industry to peddle these products to consumers without any scrutiny as to their safety or efficacy. There is no scientific evidence that e-cigarettes are effective smoking cessation devices and, until they undergo rigorous evaluation by the Food and Drug Administration, they should be pulled from the marketplace. With this ruling, e-cigarette manufacturers will continue to make misleading claims that their products can help smokers quit.”
Tags: e-cigarette, e-cigarette regulation, ecigarette, ecigarette regulation
