The Story of the Disclaimer

If you regularly buy natural supplements for health, you may have noticed this disclaimer somewhere on the label:

“This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Before I understood who the FDA is, and the reason for the disclaimer, I remember frowning at such a label. I thought it was like the fine print under sweepstakes ads. “Sign up and win $1000! (By the way, you only have 1 in a billion chance of winning 😉 )”

However, as experience trumps suspicion (the supplements worked), the disclaimer became little more than a curiosity to me. When I eventually learned the story behind the disclaimer, I was appalled. An administration created to work for our interests, and meant to protect us, working for their own interests instead? Of course this was years ago, and these sorts of things no longer surprise me. There is too much information to include it here, but if you wish to look into it further, I will leave you this quote as a starting point:

“The thing that bugs me is that the people think the FDA is protecting them. It isn’t. What the FDA is doing and what the public thinks it’s doing are as different as night and day.”
—Dr Herbert L. Ley, former Commissioner of the FDA.

And now, the story behind the disclaimer.

The FDA’s definition of a drug is “a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” They further state that “only a drug can treat, cure, or prevent disease.” This means that any product, natural or otherwise, cannot legally make such a claim unless it has been officially approved for such use by the FDA. Pretty reasonable, right? Hang on a second.

A conservative estimate for the cost of bringing a new drug to market is between 50-185 million dollars. [1] A report by the CSDD and published in the Scientific American states that the cost of bringing a new drug to market has more than doubled in the last ten years, and that it now exceeds 2.5 billion dollars! [2]

Did you know that investors have a legal obligation to their shareholders to turn a profit? Because natural substances cannot be patented, [3] to license such a product could never produce a return of investment, even if it were legal.

Since “only a drug can treat, cure, or prevent disease”, nothing except a drug can legally make that claim. It follows, then, that since a natural substance can be neither patented nor approved by the FDA and licensed as a drug, that a manufacturer of such a product must include the above disclaimer to avoid legal persecution.

Part Two: The Case for Natural Medicine

cited sources:
1. Doctors Without Borders 2. Scientific American 3. Patent Laws

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