Saturday, June 4, 2011

An Explanation of the FDA Process....

I had a call from a client last evening. He is from the raw food/vegan world and a believer in holistic cures whenever possible. He inquired about a product utilized to promote reduction in mercury levels in humans. He indicated the he could no longer get the product because the FDA will not allow its sale. The predictable rant about the FDA and how they are ruining can imagine.

Many do not seem to understand that the FDA does not "approve" products for medical uses. They "clear" them for marketing after the manufacturer has proven that the claims that will be made can be substantiated and medically/scientifically proven.

I did some research into this product and it was not the product itself that proved to be a problem for the FDA, it was the claims that the manufacturer was making. The claims may well have been legitimate but there was no independent validation.

The FDA is not a governmental agency hell bent on destroying holistic medicine. It is here to protect us from unsubstantiated claims. Do we want the days of snake oil salesman to return?? Ohhh, wait, there are a ton of snake oil salesman today!! LOL

I am not defending or promoting the FDA. There are plenty of times that I disagree with them either as a scientist or an attorney. Recently in fact, I strongly disagreed with a position of an examiner and we talked about it and he saw that my points were valid.

If you are going to make claims about efficacy of a product that is utilized to cure, prevent or maintain and illness, you better seek FDA clearance...

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