e-cigarettes - FDA approval needed prior to marketing..


April 17, 2009 - e-cigarette basic idea: it looks like a cigarette, delivers nicotine like a cigarette, and even puffs "smoke" like a cigarette (actually water vapor.) But an e-cigarette doesn't have any of the tobacco or additives of a cigarette. It's just a battery-charged cartridge.

In order for any drug or drug delivery device to be marketed in the U.S., it must first be approved by the FDA. To gain FDA approval, the company intending to market a specific drug must conduct clinical tests to demonstrate that the drug is both safe for use and that it works for the purpose for which it is intended. Once clinical testing is complete, the results are presented to an FDA panel of experts for evaluation. If the panel believes the clinical test results demonstrate both safety and efficacy, the drug is recommended for approval.

The U.S. Supreme Court ruled on March 21,2000 that the Food and Drug Administration has no authority to regulate tobacco products as addictive drugs.

E-cigarettes contain nicotine NOT tobacco so it is necessary to have the product approved by the FDA prior to making it available to the U.S. consumer. The FDA has opened an investigation and has refused to allow e-cigarettes, e-cigars and e-pipes to cross the border because they're considered new drugs that require FDA approval.

FDA spokeswoman Rita Chappelle: "We're concerned about the potential for addiction to and abuse of these products. Some people may mistakenly perceive these products to be safer alternatives to conventional tobacco use."

References: TobaccoWatch.org and in part FDA Lights Up "E-Cigarette" Ban Controversy by Matthew Bandyk, U.S. News & World Report, 4/16/2009.

Related news briefs: Canada - to launch an advertising campaign on the problem of tobacco smuggling..; E-cigarettes need to establish efficacy and safety - FIRST...

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