The Food and Drug Administration is appealing a federal judge’s ruling that the agency doesn’t have the authority to regulate electronic cigarettes.
The FDA on Monday night asked a federal appeals court in Washington to immediately stay an order that prevented the agency from blocking electronic cigarettes from entering the country.
The FDA said it does have the authority to regulate some products containing nicotine as though they are drugs and devices, such as nicotine patches and nicotine lollipops. The agency said the judge was “quite wrong to believe that no injury would result from the use of these harmful and addictive products.”
The case is testing the reach of FDA’s regulatory powers, and the agency and public health advocates have said it could have severe public health implications.
In January, U.S. District Judge Richard J. Leon sided with electronic-cigarette makers Smoking Everywhere Inc. and NJoy in finding that the FDA has no authority to regulate the products and can’t stop them from entering the country. His opinion came with a preliminary injunction that allowed Smoking Everywhere and NJoy to continue importing their products into the country.
The FDA has seized shipments of electronic cigarettes, which contain nicotine and look and taste like cigarettes but don’t contain tar, amid concerns the products were being marketed as safer alternatives to cigarettes kent. The FDA asserted its power by saying the electronic cigarettes were essentially drugs or devices that were being imported without FDA approval. Regulating the products as drugs or devices means the companies would have to conduct extensive clinical safety testing and apply for formal FDA approval.
Smoking Everywhere and NJoy are trying to avoid that. The companies say their products are used for recreation and, unlike nicotine patches, aren’t used as smoking cessation aids.
Judge Leon’s decision was based on a Supreme Court case decided in 2000 called FDA v. Brown & Williamson Tobacco Corp. In that case, the court decided that allowing cigarettes and smokeless tobacco products to be marketed as drugs or devices would result in their being banned from the market.
The FDA said in its appeal that the Supreme Court decision doesn’t preclude the agency from regulating tobacco products as though they are drugs or devices. The FDA said Judge Leon also “mistakenly” concluded that electronic cigarettes could be regulated under new tobacco powers signed into law in 2009.
The FDA said those laws preclude the FDA from regulating drugs or devices as tobacco products.
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