Electronic Cigarette Litigation Update

Electronic Cigarette This week, the U.S. Circuit Court of Appeals for the District of Columbia ruled that the full court will not review a three-judge panel’s decision, issued in early December. That panel’s decision was that electronic cigarettes cannot be regulated by the FDA as a drug or medical device, but can be regulated as a tobacco product by the FDA–provided the manufacturer refrains from marketing the product as having therapeutic purposes.

The lawsuit issue considered last year by the three-judge panel was whether the FDA could regulate electronic cigarettes under the drug and device provisions of the Federal Food, Drug and Comestic Act (FDCA) or as tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) passed in 2009.

In this litigation, the FDA had argued that electronic cigarettes are drug or medical devices under the FDCA, which require approval from the agency–similar to approvals given to nicotine gum and nicotine patch products. However, the three judge panel determined that electronic-cigarette manufacturers had not made therapeutic claims and, for that reason, the products could not be regulated under the drug and device provisions of the FDCA.

With the full U.S. Circuit Court of Appeals deciding not to review the three-judge panel’s decision, the FDA has the option of requesting the U.S. Supreme Court to hear the case. Media reports indicate that the FDA is considering its legal and regulatory options.

source: CSP Category News

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