Continuing the e-cigarette drama, the FDA issued a news release reporting results of a chemical analysis the agency performed on two different e-cigarette brands. The FDA analysis revealed diethylene glycol (anti-freeze, a toxic compound) in one sample, and several carcinogens, including nitrosamines, in several other samples. The report also warns of concerns about the marketability of e-cigarettes to young people and their potential danger as a “gateway” product to actual smoking.
In the US, e-cigarettes have been classified as both a drug and a class III medical device. The FDA is peeved that e-cigarette companies have been marketing their products direct to consumers without submitting their devices for approval by the FDA.
From the FDA’s press release:
“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.
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 FDA 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. The agency is also planning additional activities to address its concerns about these products.
Read the press release and more here…
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