U.S. FDA - judges ruling regarding e-cigarettes must be appealed - ASAP..

January 31, 2010 - On Thursday, January 14th advances in public health suffered a defeat when Judge Richard J. Leon of Federal District Court in Washington ordered the Food and Drug Administration (FDA) to stop blocking the importation of electronic cigarettes from China and indicated that the devices should be regulated as tobacco products rather than drug or medical devices.

Obviously this judge was not primed properly - surely it's the FDA's responsibility to protect citizens from products that are inherently unsafe or that make claims of effectiveness that cannot be substantiated. Like other consumer products, electronic cigarettes should be regulated to protect public health before they are permitted to be sold to consumers.

Judge Leon's decision came in response to a lawsuit filed by two e-cigarette manufacturers that challenged the FDA's jurisdiction over these products and the agency's attempt to prohibit their importation under the Federal Food, Drug and Cosmetic Act.

Nicotine alone is an extremely toxic poison that is also sold commercially in the form of a pesticide. E-cigarettes usually come in various nicotine strengths and in various flavors such as mint, almond, chocolate, cherry, regular, menthol, apple and strawberry.

As stated by President Diana Zuckerman of the National Research Center for Women & Families: This is a misguided and mind-boggling decision by the court. Nicotine is an addictive drug, and therefore e-cigarettes are a drug delivery system." This preliminary injunction must be overturned as quickly as possible. (UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA: SMOKING EVERYWHERE, INC., Plaintiff and SOTTERA, INC., d/b/a NJOY, Intervenor-Plaintiff v. U.S. FOOD AND DRUG ADMINISTRATION, et al.

As pointed out by Matthew L. Myers, President, Campaign for Tobacco-Free Kids.. If upheld, Judge Leon's decision opens a gaping loophole in the protection FDA has provided against the sale and distribution of non-tobacco products that a manufacturer laces with unregulated quantities of nicotine. For years, the FDA has stringently regulated all products containing nicotine when sold to consumers in any form other than a traditional tobacco product because of nicotine's dangerous and addictive impact. (Federal Court Deals Blow to Public Health in Ruling FDA Cannot Regulate E-Cigarettes As Drugs or Medical Devices, Statement of Matthew L. Myers, President, Campaign for Tobacco-Free Kids, 1/14/2010)

At issue in the case was whether e-cigarettes were "drug devices" as claimed by the FDA or whether they were "tobacco products" as claimed by the plaintiffs. This really is a non-issue since the FDA is responsible for regulating "drug devices" and with the passage of the bill to regulate tobacco is now responsible for all tobacco products.

Electronic cigarettes, which are manufactured primarily in China, pose several serious potential risks to public health. There is no credible scientific evidence that these products are safe for human consumption or that they are effective at helping smokers or other tobacco users quit, as some manufacturers have claimed. In contrast to tobacco cessation products that have been approved by the FDA, there are no controls on the amount or potency of the nicotine or other substances in electronic cigarettes. (E-cigarettes - scientists want more safety studies before use..) Last year, the FDA announced that a laboratory analysis of electronic cigarette samples found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.

These products could serve as a pathway to nicotine addiction for children, leading them to smoke cigarettes and use other tobacco products. Electronic cigarettes have been marketed in youth-friendly candy and fruit flavors including bubblegum, cookies and cream, and cola. These products are also readily accessible to youth because they are widely sold in shopping malls and over the Internet and because they are not traditional tobacco products, they are not subject to age verification laws.

Why hasn't the FDA taken action to overturn Judge Leon's ruling??