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E-cigarettes Contain Diethylene Glycol, Toxic To Humans - US FDA

by Gopalan on July 27, 2009 at 1:36 PM
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 E-cigarettes Contain Diethylene Glycol, Toxic To Humans - US FDA

The U.S. Food and Drug Administration has said that e-cigarettes contain toxic chemicals such as diethylene glycol.

Electronic cigarettes, also called "e-cigarettes," are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.

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"The FDA is concerned about the safety of these products and how they are marketed to the public," said Margaret A. Hamburg, commissioner of food and drugs.

The e-cigarettes, already freely available online and in shopping malls, are packaged in different flavors, such as chocolate and mint, increasing their destructive appeal to young people.
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And they do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes whereas public health experts think that electronic cigarettes could increase nicotine addiction and tobacco use in young people.

Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user, the agency's website says.

The FDA's Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA's analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.

In addition, there were problems in quality, with some products testing positive for nicotine even though the label said no nicotine was present. There was also variability in how much nicotine was delivered — even from the same type of product.

All known e-cigarettes are imported to the U.S. and are illegal because they considered unapproved drugs or medical devices. So far, 50 shipments have been blocked at the border. The agency is considering other enforcement actions against importers of these products and the domestic distributors.

The FDA said that it has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court.

Source: Medindia
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