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FDA Close to Issuing Some E-Cigarette Regulation

Apr 23, 2014

United States regulators are expected to issue the first regulations concerning electronic cigarettes—e-cigarettes—by month-end. At issue with the emerging devices is if the devices help people to quit smoking or if the devices attract new people to the highly addictive nicotine, and what health hazards the devices present.

Health experts seek broad limits on the rapidly growing products, according to NBC News; however, there is also an understanding that the U.S. Food and Drug Administration (FDA) is faced with some uncertainty regarding the nature of the cigarettes and how they are being used. The FDA received tobacco regulation power by Congress in 2009; however, the legislation does not provide authority to ban tobacco products. The legislation does allow the agency to mandate that ingredients be listed and that warning notices on packets be regulated.

“The failure of FDA to act before this has allowed the e-cigarette market to explode in uncontrolled ways,” Matthey Myers, president of the Campaign for Tobacco-Free Kids, told NBC News. “People are not using e-cigarettes to quit smoking but are using them to maintain their smoking habits,” he noted, expressing a concern many have feared.

e-Cigarettes sales have been steadily growing over the past 10 years with some 250-300 brands on the market. Users of the products call the habit “vaping,” which is a nod to the vapor produced by the device, which heats a mix of nicotine, water, propylene glycol, other chemicals, and flavors. Today, according to NBC News, manufacturers are not required to list ingredients.

Experts who spoke with NBC News say they seek a mandate that e-cigarette manufacturers list ingredients on packaging; ban sales to people under the age of 18; and limit or ban advertisements, especially ads geared to children and teens. Any more than that is not likely to occur, Gregg Haifley, federal relations director for the American Cancer Society’s lobbying arm, the ACS Cancer Action Network, told NBC News, “We are faced with this initial hurdle of FDA asserting its authority over these products. It is going to be a long and cumbersome process,” Haifley added. The FDA had previously tried to ban the devices, calling them medical devices; however, the tobacco industry fought and won in appeals court. The devices should be regulated as tobacco products, according to the appeal.

“Every day that tobacco products go without regulation, more people become addicted and suffer the consequences associated with those products,” Haifley said. “We are grateful that it is finally happening,” he told NBC News. “The jury is out on that,” says Dr. Thomas Glynn, director for cancer science at the American Cancer Society. “Some studies suggest they are about as effective as a nicotine patch. Other studies suggest they are not helpful at all.” Dr. Neil Schluger, Chief Scientific Officer at World Lung Foundation, points out that if e-cigarette makers believed the devices were successful quit smoking aids, they’d market them that way. “They could have gone to FDA and said ‘we have a terrific tobacco cessation device,’” Schluger said. Instead, they sued the FDA. “I don’t think tobacco companies deserve the benefit of the doubt,” he added. “All they are really selling is nicotine addiction,” he added.

The science on the nicotine used in the device is unclear, says Glynn. “For youths and pregnant women, nicotine is an unhealthy chemical," and the ingredients in the products are not known and some appear to contain carcinogens, he told NBC News.

The devices have also been associated with increasing reports of injuries and complaints filed with the FDA and cite breathing troubles; headache; cough; dizziness; sore throat; nose bleeds; chest pain and other cardiovascular problems; and allergic reactions, including itchiness and lip swelling, Fox News reported. The public, wrote Forbes, is unaware of the toxicity of ingesting nicotine, and the toxicity of nicotine skin absorption and related symptoms such as rapid heart beat, elevated blood pressure, nausea, vomiting, diarrhea, dizziness, confusion, and seizures that lead to coma and death. Severe exposure may lead to low blood pressure and a low heart rate. e-Liquids are considered significantly more toxic than tobacco as the liquid is more readily absorbed, even when diluted.

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