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Location: Blogs Jim Lassiter -- Good News/Bad News
Posted by: jim	1/16/2008 11:52 PM
This is the first of a new series that talks about words and how their use affects this industry and what we should be aware of as an industry going forward. That is -- before the words we can use are chosen for us. Happy New Year Everybody! Now that the pleasantries are out of the way let me get to a relatively random thought that struck me earlier today. There is an opportunity here, for the dietary supplement industry. It’s one that is potentially fraught with risk but one that might assist in the ever-narrowing claims battle. Should a company determine that they have the wherewithal to address the matter directly – the information that follows is some ammunition to add. I would suggest that this is something that the Trade Associations of our industry would welcome as a challenge – but I rather think that individual company or law firm effort would be the most effective approach. Alright here goes. One of the unrecognized truths about the so-called “structure/function” claims arena is that without defense it will get smaller and smaller. This was made known to industry at the outset – That the consequences of educating the consumer too well could render a currently perfectly valid claim un-usable simply by raising the consumer’s awareness. While that topic is one that has been noted and will be discussed more in the future – today’s issue involves one word. That word is Maintain. Now let’s do as FDA would do and look in a dictionary to find the definition of the word. FDA tends to like Merriam Webster – so let’s look there first: “main·tain Function: transitive verb 1: to keep in an existing state (as of repair, efficiency, or validity) : preserve from failure or decline <maintain machinery> 2: to sustain against opposition or danger : uphold and defend <maintain a position> 3: to continue or persevere in : carry on keep up <couldn't maintain his composure> 4 a: to support or provide for <has a family to maintain> b: sustain <enough food to maintain life>5: to affirm in or as if in argument : assert <maintained that the earth is flat>” The first three definitions listed are most applicable for what follows. You see, in the preamble to the final rule on Structure/Function Claims (21CFR Section 101.93) FDA discussed how cholesterol claims could be made under this new regulation. They allowed as how perhaps you could make a claim by saying that a dietary supplement may help maintain healthy cholesterol levels. However, this would only be allowed if the following text were associated with it: “. . . that are already in the normal range.” Interesting turn of phrase that. But, here’s the scoop. That positioning of language is redundant in the extreme. Since (by virtue of rulings issued in Courtesy Letters dating back to at least 2003) the same additional wording is necessary when discussing how to maintain healthy blood sugar or healthy blood pressure – the applicability is more than against a single structure or function. Look at the first two definitions shown. Keeping in an existing state means just that. There is no equivocation in the language – it means that (in the examples of note) the state before consuming the dietary supplement is HEALTHY and thus the product is useful for KEEPING the parameter HEALTHY. Additional language is just butchering the English language for no purpose other than to perhaps mislead the general public about their own language capabilities. The second definition also makes the same case – the purpose is to keep the parameter (blood pressure, glucose level, cholesterol) from danger (elevated levels of these entities). Simple English. Yet, no one has gone against the position FDA has taken and Courtesy Letters continue to emanate regarding these claims. The Courtesy FDA could show is to allow for use of plain English, without redundancy in communicating truthful, substantiated information. If you are a company out there marketing a product that can help maintain healthy levels of these critical factors – you should be able to state this simply. More importantly you should be disallowed from using the words “blood pressure” or “blood glucose” or “cholesterol” simply because you choose not be redundant. Someone, please have the fortitude to confront this simple issue and see where the cracks in the narrowing walls of claims are before it is far too late and time and passed and all the days are gone. Sorry about that last sentence – it was just a redundancy or two that crept in again, and again.
Copyright ©2008 Jim Lassiter
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Re: Words, words words.

By lber on 1/22/2008 9:14 AM

No doubt, the blog makes sense. However, in order to challenge the current FDA thinking using just the logic is not enough. As you know, dietary supplements cannot carry "implied drug claims" which shifts the problem from the sphere of logic to the area of consumer perception. Therefore, in order to challenge current guidelines one will have to demonstrate that the consumer clearly distinguishes between different types of wording (which btw FDA should've done prior to making the recommendations and butchering the English language. Yet it was done simply on the hunch). A well designed consumer study is what one would need to do in order to resolve the situation.

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