A U.S. appeals court has ruled that the U.S. Government may not block the sale or import of electronic cigarettes, which the Food and Drug Administration (FDA) calls dangerous, unregulated products.
The U.S. Court of Appeals for the District of Columbia ruled the FDA doesn't have the authority to outlaw the product if it is not being sold for therapeutic purposes.
So-called e-cigarettes are battery-powered nicotine-delivery devices that give off water vapor instead of smoke. They are marketed as a cigarette substitute.
The ruling came in the case of a particular brand of e-cigarette, NJOY, which challenged the government's attempt to ban the product. The company said the court rejected the FDA's contention that the product is a drug-delivery device.
"Agreeing with the company's argument, the Court ruled the company's devices are tobacco products, which are subject to regulation, like traditional cigarettes, under the Family Smoking Prevention and Tobacco Control Act," NJOY said in a statement.
Lifts restrictions
The company said the ultimate impact of the court decision will be to lift the current import restrictions on NJOY electronic cigarettes and provide a regulatory framework for NJOY to market its product.
"Today is a historic milestone in the development of our Company," said Matt Salmon, CEO for NJOY. "We believe that the Court's ruling paves the way to work constructively and cooperatively with the FDA to meet the rapidly growing demand for NJOY electronic cigarettes."
While NJOY was happy with the appeals court ruling, the anti-smoking group Campaign for Tobacco-Free Kids was not. Campaign president Matthew L. Myers said the decision was "wrong on the facts."
"This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time," Myers said. "We urge the government to appeal this ruling."
While the court found that the FDA could regulate electronic cigarettes as tobacco products, Myers said it will take the FDA time to assert jurisdiction over these products and issue regulations governing them, leaving these products unregulated in the meantime.
"This ruling invites the creation of a wild west of products containing highly addictive nicotine, an alarming prospect for public health," Myers said.