Appeals Court Decision is praised by users and makers of e-cigs

Sellers and users of so-called electronic cigarettes celebrated a major victory over federal regulators last week after a court of appeals ruled that the U.S. Food and Drug Administration (FDA) can control the sales and advertising of the products, but has no right to restrict them.

According to the ruling of the U.S. Court of Appeals the FDA can oversee electronic cigarettes only as tobacco products.

electronic cigarettes

Electronic cigarettes or simply e-cigs are devices that resemble conventional cigarettes and deliver vaporized nicotine solution to the users, who call the process of using electronic cigarettes as “vaping”. The overwhelming majority of electronic cigarettes’ ingredients are manufactured in China.

Appeals Court ruling resulted from a legal action initiated last year by Smoking Everywhere Inc., against the FDA checking and stopping shipments of electronic cigarettes at the U.S. customs. The FDA considers electronic cigarettes as untested and unregulated drug delivery devices and was eager to require e-cig makers and sellers to receive the agency’s approval for drug marketing.

A district court gave a preliminary injunction preventing the federal regulators from requiring U.S. customs to ban importations of electronic cigarettes.

In 2000, the Supreme Court decided that Congress didn’t entitle the FDA with authority to oversee tobacco-containing products as drug delivery devices in accordance with the Food, Drug and Cosmetic Act.

The makers of electronic cigarettes, like Sebastian Cangemi, owner of Liberty Six in Willoughby, praised the decision.

Mr. Cangemi admitted that in case the court had ruled in favor of the FDA, he would have to carry out thorough clinical tests and get FDA approval, what could cost him nearly $20 million.

“That is great news,” Cangemi declared. “I am delighted. It’s a victory of common sense.”

Like most electronic cigarette makers, Cangemi received the ingredients for his products from China.

Cangemi admitted he had to pay thousands of dollars on lawyers in order to get confiscated products returned from the U.S. Customs Service. The confiscations prevented him from delivering his products to retailers, which comprise more than a thousand across the United States and several other countries.

The Food and Drug Administration is examining and deciding over next steps, said the agency’s senior spokesman Jeffrey Ventura.

Many public health organizations like Campaign for Tobacco-Free Kids, American Cancer Association and American Lung Foundation criticized the ruling.

The FDA has been deeply concerned about the safety of electronic cigarettes since they initially reached U.S. market three years ago.

Last year, the agency published results of a research of 18 samples of e-cigarettes and their ingredients manufactured by two leading e-cig companies. Half the samples had cancer causing substances, and diethylene glycol, a hazardous chemical contained in antifreeze.

Cangemi noted his products do not include diethylene glycol or other carcinogens. He said that Liberty Stix’s “juice” – the liquid that made of nicotine, distilled water, propylene glycol and various flavorings – is manufactured in the United States.

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