This CASAA page could use an update. Frequently Asked Questions

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"The FDA currently considers e-cigarettes to be unapproved drug delivery devices".

The FDA is going to regulate them as a tobacco product. It has reserved the right to regulate as drug delivery device if smoking cessation claims are made.

Casaa.org - Harm Reduction

Are e-cigarettes approved by the FDA?


The FDA currently considers e-cigarettes to be unapproved drug delivery devices. It claims that e-cigarettes are being used as smoking cessation devices and therefore they need to be regulated the same as pharmaceutical nicotine replacement therapy drugs (NRTs). In 2009, the FDA ordered customs officials to start seizing e-cigarette shipments coming into the country.

The FDA was sued in federal court by two e-cigarette companies who argued that they do not market e-cigarettes as a treatment for nicotine addiction, only as an alternative for traditional cigarettes. The e-cigarette companies argued that they should be treated as tobacco products and not subject to stricter regulation than other tobacco products. Federal Judge Richard Leon ruled in favor of the e-cigarette companies. The FDA subsequently lost on appeal in the D.C. Appellate Court.