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How Will the FDA Handle E-Cigarettes?

Jan 22, 2015

The U.S. Food and Drug Administration (FDA) is faced with questions about how it will deal with electronic cigarettes, as the devices have become more widely usd in the United States.

Using e-cigarettes, or "vaping", produces vapor instead of burning tobacco leaves. Some contain nicotine while other do not. Manufacturers market the products as being safer than combustible cigarettes and push it as a cessation tool, but some experts are concerned about the lack of research to support these claims. Recently, two leading cancer organizations released a joint statement calling for greater regulations and research for the devices. A growing body of research suggests that e-cigarettes are not without health risks.

According to a New York Times opinion article, there has been greater scrutiny over e-cigarettes amidst reports of inaccurate labeling, faulty counterfeits and poorly made e-cigarettes that still expose users to toxins and carcinogens. This situation is worsened by the fact that the U.S. Food and Drug Administration (FDA) has not established regulations, the NYT article says.

The FDA has made efforts, however; last April, the agency proposed a "deeming rule" in which it drafted rules for e-cigarettes and an overwhelming 135,000 public comments were submitted in response. Given the importance of the issue, it is unlikely that clear cut regulations will be established anytime soon, the NYT piece predicts.

The proposal contains some help provisions, such as rules banning sales to minors or requiring a list of ingredients. However, the NYT article also expresses concerns that the proposal would result in only large tobacco companies surviving the pre-market application process due to high costs. Interim safety rules, instead of a long burdensome regulatory process, may prove useful in the meantime. The NYT article recommends that guidelines should outline basic good-manufacturing practices for the devices and liquids; this includes limits on harmful chemicals such as formaldehyde and metals. Some contaminants should be banned altogether. Additionally, the NYT piece says, the FDA should immediately ensure that all chemicals can be traced and verify the source of all hardware. The packing of e-cigarettes should also be child-proof and carry a warning against use in minors.

NYT also notes that although e-cigarettes are popular, the initial enthusiasm is beginning to wane. Last year, the American Journal of Preventative Medicine showed that 65 percent of smokers believed e-cigarettes were safer than combustible cigarettes in 2013, down from 85 percent in 2010.

There are likely to be concerns over e-cigarettes in the future, the NYT article says. Manufacturers in China, where safety oversight is most common, are expected to ship over 300 million e-cigarettes to the US and Europe. As the article points out, however, no regulatory system is in place to determine which products are safe and which are not.

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