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Location: Blogs Jim Lassiter -- Good News/Bad News |
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| Posted by: jim |
2/29/2008 12:33 PM |
This last is a series of three spews about words and the impact they have on our industry points to some other definitional issues we, as an industry, would have if we were paying attention.
A couple of last words on words. There are various interpretations of meanings of words to be sure. Nowhere is this more evident than in the claims structure for foods and dietary supplements in the United States. Consider that the information you present on your product’s package must be truthful and not misleading. This is the first standard that has to be crossed. It is not, however, the only standard.
You may not use words like flu or migraine in your labeling. No matter how much evidence you may have concerning the efficaciousness of your product. You also can’t use cure, treat, diagnose or prevent in relation to your product except in the statutory disclaimer for your claims. Moreover, apparently, you cannot use the word mitigate anywhere. Not that it is a commonly used term anyway.
An interesting pronouncement from FDA is as follows”
Margaret Glavin, associate commissioner for regulatory affairs, said: "The FDA will not tolerate unsubstantiated health claims that may mislead consumers.
"The FDA will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe, truthfully labeled products to consumers."
The context is the key here. The measure of truth is apparently in relation to Health Claims. Recall that these are claims that FDA allows to be used because they have been reviewed and found to be truthful (i.e. proven to be substantiated to the level of “significant scientific agreement”). What’s wrong with that? Not much until you start looking closer at the definitions FDA is imposing on some of these terms.
Start with truthful FDA is beginning to define this as applicable only when they have reviewed and passed the claims being made. They presently do not have full authority to do so for structure/function claims but if they broaden the definition of “Health Claims” just a bit more – presto they have achieved the goal. Skeptical? Try and use the terms “maintain” and “cholesterol” in the same sentence claim and have it pass muster with FDA.
Thus Truthful is a term that instead of residing definitionally in a dictionary – resides in the evaluative eyes of the Food and Drug Administration. “It’s not true unless I say it is” would be the distillation of thought.
Then let’s apply the old saw “significant scientific agreement.” This phrase has long been defined by FDA to mean far more than the standard definitions applied. In practice this phrase has come to mean “unanimity of findings” relative to the claims being made. Science just doesn’t work that way. Skeptical? Look at ANY display of clinical data for any drug product. Still the degree of control over dietary supplement claims is closing in on this standard.
Lastly look closely at the pronouncement from FDA. The most distressing phrase is “necessary legal action.” FDA has plans to apply legal force (i.e. spending its relatively limitless resources in litigation against a deep but not infinitely pocketed industry) to make its point. Or more correctly – to change the definitions of the words we use today.
Skeptical? Tune in one year from now and see what definitions have shifted and then re-read this post. Or – take action now, directly, forcefully yet respectfully toward the definition changers. At least that’s what I think the truth is.
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| Copyright ©2008 Jim Lassiter |
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