Sure thing!
WASHINGTON—A U.S. federal appeals court in a decision Tuesday found that as long as electronic cigarettes aren't marketed as a way to treat or cure a disease, the U.S. Food and Drug Administration has no authority to block the importation of the battery-powered products.
The U.S. Court of Appeals for the D.C. Circuit ruled that the FDA's powers are limited when it comes to regulating e-cigarettes.
The FDA had appealed a federal judge's ruling that the agency doesn't have the authority to regulate electronic cigarettes.
In a case that tests the reach of the federal government's regulatory powers, 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.
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 traditional tobacco. 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.
That case "leaves the FDA without jurisdiction over these products under the FDCA's [Food, Drug and Cosmetic Act] drug/device provisions," the appeals court said in Tuesday's decision.