FDA states its position on e-cigarettes

I’ve discussed e-cigarettes on a number of previous occasions, but yesterday there was a new statement on e-cigarettes and mention of some new data from the U.S. Food and Drug Administration (FDA).

The FDA has continued to state that e-cigarettes are being marketed as a combination drug and drug delivery device and so clearly full under its jurisdiction in that capacity. Not only have the manufacturers not submitted a New Drug Application, they have not provided FDA with any appropriate data to show that e-cigarettes are safe and effective. Furthermore, recent small-scale studies by FDA scientists show that e-cigarettes contain toxins including known carcinogens (albeit at much lower levels than traditional cigarettes). The studies also found that the e-cigarettes appeared to be rather inconsistent in the amount of nicotine they contain (within the same claimed dose), which raised questions about product quality and consistency).

So the bottom line with e-cigarettes is that we know very little about them, but there is enough information to suggest that they may be neither harmless nor reliable. I have previously commented that in addition to these concerns about what is contained in the product and the vapor it produces, there are also doubts that the product is effective in delivering nicotine to the consumer.

The message from FDA and others to consumers is that these devices have not been properly evaluated with regards to safety and efficacy and people who want to use a nicotine product to help them quit smoking are recommended to use one that has been approved as safe and effective by FDA (i.e. nicotine patch, gum, lozenge, nasal spray or inhaler).

Full details of FDA’s analysis of e-cigarettes can be found at:

Previous posts on e-cigarettes:
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About the Author

MA, MAppSci, PhD

Dr. Jonathan Foulds is an expert in the field of tobacco addiction.