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E-Cigarettes Not Subject to FDA Regulation, Federal Judge Rules
January 15, 2010

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News Summary

The U.S. Food and Drug Administration (FDA) cannot block the importation of electronic cigarettes into the U.S. because they are not tobacco products -- and thus not under the FDA's jurisdiction -- a federal judge has ruled.

The Washington Post reported Jan. 15 that U.S. District Judge Richard J. Leon sided with two e-cigarette makers, Smoking Everywhere and Sottera, in the case. Leon was harsh in his assessment of FDA's confiscation of e-cigarettes imported by the companies, calling the action "yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices" and part of a "tenacious drive to maximize its regulatory power."

Agency officials said they are reviewing the ruling, saying in a statement, "The public health issues surrounding electronic cigarettes are of serious concern to the FDA."

The FDA does have regulatory authority over some non-tobacco products, such as nicotine gum, based on the fact that they are considered devices used to help smokers quit. However, Leon agreed with lawyers for the e-cigarette companies who contended that the product is another type of cigarette, not a drug device regulated by FDA.

COMMENTS ON THIS ARTICLE:

Posted by maxwood on 15 Jan 10 05:09 PM EST
I am sorry this judge thinks the extent of FDA regulatory authority is a more important issue than whether the e-cigarette can eliminate the hot burning overdose genocide (i.e. anti-drug device). But thanks for removing a roadblock to the potential benefits.

Posted by Bill Godshall on 19 Jan 10 12:00 PM EST
Judge Leon's life-saving 32 page opinion is at: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 Judge Leon's court order is at: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-55 I cannot think of a more inhumane (but effective) strategy to protect cigarette markets and to harm/kill millions of suffering smokers than for the FDA to try denying them legal access to smokefree tobacco/nicotine alternatives that are i.e. 99%(+/-1%) less hazardous than cigarettes, while simultaneously allowing lethal cigarettes to be marketed at 500,000 retail stores nationwide. Ironically and tragically, it wasn't the cigarette companies that deployed this outrageous strategy to protect cigarette markets, but rather the FDA, CTFK, ACS, AHA, ALA, ASH, and a trade association of abstinence-only smoking cessation service providers. I consider the FDA's e-cigarette prohibition policy to be the most egregious public health malpractice ever by the US government, dwarfing the notorious Tuskeegee Study.

Posted by Diane on 19 Jan 10 12:43 PM EST
I am really surprised by the decision. Does the FDA not currently control the administration route of insulin (syringes) and pain medication (patches), etc, irrespective of the substance being administered? In this case, then, the FDA should be targeting whatever goes INTO the devices,which is tobacco in some form, which they CAN regulate.

Posted by SisterCrystal on 21 Jan 10 11:23 AM EST
The difference between 'drugs' and 'drug devices' cannot be glossed over. A drug is a chemical compound having measurable physiological effects. A 'drug device' can be anything used in the preparation or ingestion of drugs. Should the FDA regulate spoons, pop bottles, paper clips, lighters etc.? Should a hammer be considered a weapon because it can be used to hit someone on the head? Does anyone really believe that attempting to regulate such things will prevent users from using?

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