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The following article was published in our article directory on September 1, 2011.
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Article Category: Society
Author Name: Bob Thomas
The relationship between businesses supplying e cigarettes and the FDA has only recently been clarified. Since 2008 and there have been attempts to regulate the industry and block imports but the confusion over jurisdiction and classification has not helped the circumstance much.
Electronic cigarettes work by vaporizing a liquid that can then be inhaled like smoke and the general belief is that they're an entirely harmless alternative to tobacco products and that they can even be a replacement for people who want to stop smoking. These claims are not supported and they are not supported by the food and drug administration as smoking cessation aids.
A public warning was issued in 2009 after 19 different e cigarette cartridges from two different manufactures where tested. It was found that they contained tobacco specific carcinogens and irritants and one of them even contained ethylene glycol that is a sort of anti-freeze. There were also concerns that the fruit flavors and misleading marketing could make the product irresistible to young people and non smokers.
It was discovered that just one of the cartridges which was meant to be free of nicotine actually was. Cartridges were also marked as having low medium levels of nicotine but when tested they were discovered that different cartridges in the same category would release completely different levels of nicotine. This led them to feel that manufacturing standards needed to be regulated.
The accompanying year the food and drug administration sent out letters to five different manufacturers warning them that they would be dependent on regulation due to claims made about their products. A few of them had advertized their products as aids to stop smoking which is a medical claim and one of them had even made claims that they might treat erectile dysfunction and help with weight loss.
Originally imports where banned as e cigarettes where considered unregulated drug shipping devices but this didn't stop the sale of these products. One or more of the manufacturers who had their imports blocked appealed this decision in court saying that their products did not need to be regulated as a drug shipping device if they didn't make therapeutic claims.
Eventually the court ruled in their favor but for the time being the Tobacco Control Act had been enacted which gave the food and drug administration jurisdiction over tobacco products. Under the new act there are provisions for merchandise marketing, as an example tobacco products cannot be advertised together with any other product that is subject to regulation. Products and ingredients likewise need to be listed and good manufacturing practices have to be adhered to.
New products in the marketplace would also now be dependent on pre market review. Any products which where in the marketplace before February 2007 would not require pre market review nonetheless. If items are advertized for therapeutic benefits they will still be dependent on regulation as medical products and it is still being decided whether guidance ought to be issued therapeutic claims. Overall it sounds as if the relationship between the makers of e cigarettes and the FDA will only be of help to the consumer now.
Keywords: e cigarette, electronic cigarette, electric cigarette, vapor cigarettes, smokeless cigarettes
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