You must be thinking, Really? Who would think that let alone say it out loud. Well here’s the answer:

“There are no long-term studies on the health effects of just nicotine, minus the tobacco component. We know what smoking tobacco does to the body over the long term,” DeLancey said. “What we want to see are well-designed clinical studies. Personal reports are not enough,” DeLancy said. [Siobhan DeLancey who is a FDA Spokesperson]

This quote is from the Users love ‘e-cigarettes,’ but FDA wants to take closer look article published on September 30th, 2009.

First, let’s discuss the title of the article. Users, for the most part, do love their e-cigarette. However the FDA doesn’t want to “take a closer look”, what they are fighting for in their current legal battle is to classify the e-cigarette as a new drug / medical device thus named a combination product. This means it would be pulled off the market and made illegal until someone spends the money on the FDA application and does clinical trials to prove that it helps people quit smoking. And after the millions have been spent and the years pass, they would bring it back to be sold in pharmacies either OTC or by prescription. It is hard to compete with tobacco when you can’t sell in gas stations, tobacco shops, or online.

Now let’s look at what DeLancey from the FDA said, “There are no long-term studies on the health effects of just nicotine, minus the tobacco component.” – For the most part this is true.

Next, “We know what smoking tobacco does to the body over the long term,” – Yes, we do. It kills a rather large percent of the users

Then, “What we want to see are well-designed clinical studies. Personal reports are not enough,” – I am unclear about how you do a clinical study to provide data about usage over the long term. A 25 year clinical study?

The article then quotes some e-smokers who are very happy with their e-cigarettes. DeLancey ends with, “I feel their pain,” she said. “We don’t know if this is any better for them.”

Two immediate thoughts come to mind:

1) Based on this argument, if e-cigarettes are put through clinical trials and they are shown to kill a large percent of the users, will the FDA approve them for sale just as cigarettes are allowed? If not, why do combustible cigarettes get a free pass. Monopoly?

2) If DeLancey is a 25 year smoker who has tried to quit 14 times without success, then maybe she does feel their pain. However if that was the case, she would probably want to make the decision of what is better for herself. Smokers can do research on the competing products [e-cigarettes vs tobacco cigarettes]. There is data available, even if incomplete, to make a decision for themselves. It is not the FDA’s job to make decisions for adult Americans. It is their job to make sure that consumers have the proper information to make that decision. We applaud efforts by the FDA to ensure companies are not improperly marketing their products. We also hope they will see the potential of this product as we do and begin working with the industry, not try to re-locate it to pharmaceutical land.

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