Thursday, February 2, 2012

First they came for the Walnuts....

... but I didn't speak up, because I was not fond of walnuts...

It was mildly amusing when the FDA told Diamond Walnuts that they could not sell walnuts because they are making statements about the health benefits of walnuts on their packaging. Surely this would be cleared up in a few weeks. Surely the FDA wasn't really going be this foolish and nit picky. Walnuts are a natural food-of course they are going to have health benefits. How wacko is this nation's zeal for imposing more regulations?

Then they came for the cherries and products containing cherry juice, but, again I didn't speak out because I didn't use a lot of cherry containing products and only ate cherries once in a while...

There came the article about the FDA making the same demands on the producers of cherries. Because cherries have been said to have an anti-inflammatory effect on arthritis and gout, if the growers of cherries should attempt to say so on the packaging of any cherries or cherry products, that makes cherries a drug and they must have FDA approval before they can be sold.

By this point, rational people are saying "riiight" and having a decent chuckle at the expense of the bean counters and nit-pickers at the FDA. Hold onto your hats, folks because this next one is going to floor you.

Then they came for me, and I couldn't speak out because all of the conventional foods had been declared to be illegal drugs by the FDA and I was too weak from lack of good, nutritious, natural food to speak out...

The FDA, in it's infinite maze of regulatory burdens waiting to be imposed, is now saying that your own stem cells are drugs—and stem cell therapy is interstate commerce, possibly because it affects the bottom line of FDA-approved drugs in other states.

So, if you are going to travel across state lines to have your own stem cells removed from your own blood to treat yourself, the FDA thinks they have the authority to regulate you.

"(This is the FDA's) latest claim in its battle with a Colorado clinic over its Regenexx-SD™ procedure, a non-surgical treatment for people suffering from moderate to severe joint or bone pain using adult stem cells.

The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons:

Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)

The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”"

Where is all this nonsense originating? In the court documents for the stem cell case, the FDA says straight out that they want to protect the market for FDA approved drugs. That would seem to indicate that crony capitalism is alive and well in the FDA. However, things are seldom so simple. It seems that the FDA lost a case in 1999, Pearson vs Shalala, because the court ruled that the FDA had no evidence demonstrating that disclaimers could not correct for deceptiveness and overturned existing regulations as not giving sufficient deference to first amendment considerations.

In order to address that defeat, in 2000, the FDA sent out notices that they would be exercising "enforcement discretion" with regard to certain categories of dietary supplement health claims. Then, not satisfied with that degree of "helpfulness", (or one could say, not content with any infringement of it's overarching power) the FDA, in 2002, expanded that "enforcement discretion" action to include conventional foods as well as dietary supplements. No one paid much much attention and, Viola!, here we are today.

Hmmm..... Seems to me that we have a self evident right to choose our own food, supplements and health care procedures whether the FDA approves or not. It is not the job of the FDA, (at least not as I understood it) to provide a market monopoly for themselves or for particular businesses. It is the job of the FDA to say whether or not something meets their safety guidelines for an intended use. They are supposed to be a safeguard, giving us information regarding the safety and efficacy of those drugs and treatments which they have looked at and found to be reasonably safe and effective. Not to block the use of drugs and treatments that people may turn to because they don't like the ones so approved.

In other words, they are to act as an information provider, not a dictator. We have the self evident freedom to make our own choices. Do people get upset when they find that they are occasionally duped by snake oil salesmen when they are desperate for a cure? Yes. That's one of the inherent risks of the choice to avoid the FDA approved products and procedures. But really-cherries, walnuts, all conventional foods and our own stem cells?

I don't need the FDA to approve walnuts, cherries or my own cells. There is a legitimate place for an agency that tests food and drugs to see if they are safe, but this is not it. Simply because something is not included in the Constitution, does not mean it is not a self evident right. I have the self evident right to feed myself and make my own medical decisions. I may choose to consult with a doctor or other health care professional, but, if I do, it is always MY decision what to do with regard to their advice.

My stem cells are none of the FDA's business. Neither is what I eat. And I encourage my fellow Americans to let congress know that the FDA is exceeding their authority.

"And God said, Behold, I have given you every herb bearing seed, which is upon the face of all the earth, and every tree, in the which is the fruit of a tree yielding seed; to you it shall be for meat." ~ Genesis 1:29

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