Sunday, August 28, 2011

Regulation Is Settled Between Makers Of E ... - Health & Fitness

The relationship between companies 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 situation much.

Electronic cigarettes work by vaporizing a liquid which can then be inhaled like smoke and the general belief is that they are a completely harmless alternative to traditional tobacco products and that they can even be a replacement for those who want to stop smoking. These claims are not supported and they are not endorsed by the FDA as smoking cessation aids.

In 2009 a public warning was issued after testing 19 different e cigarette cartridges from two different brands and considering the viewpoints of interest groups. The tests revealed that smoke from e cigarettes contained a carcinogen and irritants found in tobacco completely harmless and one of the cartridges even contained the anti-freeze ethylene glycol. The viewpoint from certain groups was that the benign marketing and fruit flavor would appeal to children.

It was discovered that only one of the cartridges which was supposed to be free of nicotine actually was. Cartridges were also marked as having low medium levels of nicotine but when tested they were found that different cartridges in the same category would release completely different levels of nicotine. This led them to believe that manufacturing standards needed to be regulated.

In 2010 warnings where also issued to five different suppliers that they would become subject to regulation. They could be regulated by the FDA at the time because they advertised their products as aids for stopping smoking which is a medical claim. One company was also warned about advertising their products as versions Cialis which is used for erectile dysfunction and the weight loss aid Rimonabant.

Originally imports where banned as e cigarettes where considered unregulated drug delivery devices but this did not stop the sale of these products. One of the manufacturers who had their imports blocked appealed this decision in court stating that their products did not have to be regulated as a drug delivery device if they did not make therapeutic claims.

The courts agreed with them and the restrictions where lifted but by that time the new Tobacco Control Act had been enacted which amended the Federal Food, Drug and Cosmetic Act (FDCA). The FDA now had jurisdiction over tobacco products and all products derived from tobacco and allowed them to control certain aspects that they had expressed concerns about such as the listing of products and ingredients and the standard of manufacturing. Marketing would also be subject to control, for example electronic cigarettes could not be able to be advertised alongside any other products which where subject to regulation such as cosmetics or drugs.

Before products could be released onto the market they would also be subject to pre market review unless they had already been sold prior to February 2007 and where considered ?grandfathered.? Product that where advertised as having therapeutic benefit would still be subject to regulation as drug delivery devices and it is still being considered as to what regulation therapeutic claims should be subject to. Now that issues concerning e cigarettes and the FDA are finally on a firm footing it can only be good for the consumer.

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Source: http://health.blogmeout.net/2011/08/regulation-is-settled-between-makers-of-e-cigarettes-and-the-fda/

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