So given the content for this week, let’s think about this. Some of you are saying, and pointing out, that e-cigs are drug delivery devices rightfully regulated by the FDA. If this is a Class III device, it would mean that clinical trials are necessary for EVERY e-cig on the market. So, if I want to copy a competitor’s e-cig model, I still need to run a clinical trial on my own e-cig.

You will see in our Clinical Trials module that running studies like that is not cheap. Keep in mind that companies who want to get involved in selling e-cigs have none of the apparatus that J&J or even a small med device company has, i.e. a regulatory department, QA/QC, implementation of ISO 13485, etc. This would instantly put them out of business.

I am playing devil’s advocate here, but think for a moment about how many companies are suddenly marketing illegal products.

Also look at this: https://www.nytimes.com/2017/07/28/health/electronic-cigarette-tobacco-nicotine-fda.html