Electronic Cigarette Ruling Reversal Sought

<"http://www.yourlawyer.com/topics/overview/Electronic-Cigarettes">E-cigarettes, a product that enables inhalation of nicotine without tar, tobacco, and carbon monoxide, are making headlines again. According to the Wall Street Journal, the U.S. Food and Drug Administration (FDA) is seeking to appeal “a federal judge’s ruling that the agency doesn’t have the authority to regulate electronic cigarettes.”

Earlier this week, the FDA asked a Washington, DC, federal appeals court to stay an order preventing the FDA from blocking electronic cigarettes from entering the country. According to the agency, it has authority to regulate some nicotine-containing products as drugs and devices, for instance, nicotine patches and lollipops, said the Journal. But, the agency said that the judge was wrong in the ruling saying, quoted the Journal, that he was “quite wrong to believe that no injury would result from the use of these harmful and addictive products.”

We previously wrote that Judge Leon criticized the FDA for attempting to oversee device jurisdiction, saying “This case appears to be yet another example of FDA’s aggressive efforts to regulate recreational tobacco products as drugs or devices,” quoted Reuters earlier. Of note, a law passed in 2009 provided power to the agency over regulation of cigarettes and tobacco products, said Reuters; however, e-cigarettes, although containing nicotine, are not considered to be subject to the 2009 regulation, said Reuters. The FDA disagrees, saying that the product is both a drug and a device, which places it under agency regulation, wrote Reuters.

E-cigarettes are viewed by many as a healthy alternative to traditional cigarettes; however, others are concerned about the safety data on electronic cigarettes, said the BBC recently, citing warnings from two Greek researchers. According to the British Medical Journal, said the BBC, the dearth of information leaves questions as to whether or not the alternative cigarette products actually offer a safe option or if they cause harm. Some studies have pointed to harm, but industry argues e-cigarettes offer smokers a better choice, said the BBC. According to the Department of Health, consumers are warned to “exercise caution,” quoted the BBC.

Last month, U.S. District Judge Richard J. Leon, taking the side of industry via electronic-cigarette makers Smoking Everywhere Inc. and NJoy, found the FDA to have no authority to regulate e-cigarettes and is not allowed to stop the devices entry into the United States, said the Journal. Judge Leon’s opinion was paired with a preliminary injunction permitting the two e-cigarette makers to continue their import of the controversial devices into the US, said the Journal.

Meanwhile, the FDA raised issues regarding the differences in nicotine delivered by the various brands of e-cigarettes, which are battery operated or rechargeable, and noted the presence of “powerful cancer-causing chemicals,” said the BBC. In the US, regulators have delayed and stopped a number of e-cigarette shipments, noted the BBC, which added that it is against the law in the UK to sell the products as an aid to quit smoking. E-cigarettes are readily available for purchase on the Internet as a “cigarette alternative” and can be found in a number of bars and clubs, said the BBC.

When the FDA recently seized shipments of the products it said e-cigarettes are drugs or devices being imported into the US without agency approval, explained the Journal. If subject to FDA approval, the manufacturers would have to “conduct extensive clinical safety testing and apply for formal FDA approval,” noted the FDA. Smoking Everywhere and NJoy, which are hoping to skirt FDA regulations, argue that their products are recreational and not smoking cessation aids.

In its appeal, the FDA said the an earlier Supreme Court decision does not prevent it from regulating tobacco products as drugs or devices and that Judge Leon “mistakenly” concluded that e-cigarettes could be regulated under 2009’s new tobacco law, reported the Journal, which prevent the FDA from regulating drugs or devices as tobacco products.

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