E-cigarettes need FDA regulation

Sales of the devices without FDA approval should be prohibited, AMA delegates voted at their June Annual Meeting.

Posted July 19, 2010.

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When it analyzed electronic cigarettes, the Food and Drug Administration found diethylene glycol, a toxic chemical used in antifreeze. Other samples of cartridges from the battery-operated devices contained carcinogens, including nitrosamines.

Following the findings, in July 2009, the FDA addressed the potential health risks of e-cigarettes and voiced concerns that the devices can increase nicotine addiction among young people and lead to trying other tobacco products. E-cigarettes may contain ingredients toxic to humans, the agency said in a consumer health warning, and their safety is unknown, because clinical studies were not submitted to the FDA. The agency noted that e-cigarettes are sold without age restrictions and come in different flavors, such as chocolate and strawberry, which may appeal to youths.

The FDA is not alone in raising questions about e-cigarettes and their safety. The American Medical Association, among others, has echoed the agency's concerns.

In June, the AMA House of Delegates recommended that e-cigarettes be classified as drug-delivery devices, making them subject to FDA regulation. The policy also calls on state legislatures to prohibit sales of e-cigarettes and all other nicotine devices that are not FDA-approved. In addition, e-cigarettes should be included in substances banned under smoke-free laws. An FDA spokeswoman said the agency welcomed the AMA's call for regulation.

The new policy came from a report the AMA Council on Science and Public Health examining the characteristics of e-cigarettes, current regulations and potential health impacts. The report describes what is known about electronic cigarettes: that they are nonflammable devices that deliver synthetic or tobacco-derived nicotine; that they were invented in China; and that they are sold via the Internet and in shopping malls.

But the report had much more to say about what is not known about e-cigarettes.

Little independent research has been done on the ingredients and health impact of these devices. The dosage, production and ingredients are not consistent, and the products are not clearly labeled.

E-cigarettes are marketed as a safer alternative to cigarettes -- a point on which some public health advocates agree -- and as smoking-cessation aids for those trying to cut down or quit smoking. But e-cigarette makers did not submit applications required for FDA approval as a smoking cessation aid. In 2008, the World Health Organization said it knew of no peer-reviewed studies showing that e-cigarettes were a safe and effective nicotine replacement therapy.

Last year, the FDA blocked the importation of e-cigarettes on the basis that they were unapproved drug-device combinations. But two distributors took the matter to court, where oral arguments are expected this fall. In the meantime, importation continues.

The action taken by the House of Delegates came about a year after the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate the manufacture and marketing of tobacco. It is essential that the FDA now oversee this electronic cousin of the cigarette. And with good reason: What's touted as a replacement for cigarettes may be just that -- a new health risk. We won't know until oversight is in place and the appropriate studies are done.

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