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Location: Blogs Jim Lassiter -- Good News/Bad News |
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| Posted by: jim |
9/5/2007 9:49 PM |
Amazing what this last summer brought. Here's a little reminder that out here in the Wild Wild West -- sometimes you have to be careful what you wish for -- you just might get it -- plus a little bonus.
It was a long, hot summer. Make no mistake. With the issuance of a Final Rule for Good Manufacturing Practices at the very beginning of the season, time has flown by with sweltering speed. Couple the digestion and interpretation of this Final Rule with the other things that come up during the day-day business of working in the dietary supplement industry and, well quite honestly, I have fallen significantly behind in my reading.
Thus it was only just a few days ago that I finally opened my June 2007 issue of Nutraceuticals World (a trade magazine I enjoy thoroughly). While thumbing through it I stumbled across a full page advertisement that gave me significant pause.
Let me digress a bit. Since it is now a matter of record, I spent a day in New York, New York at the end of July. Not the finest time of year to visit the Big Apple but it could have been worse – it could have been Washington. Regardless, the purpose of the visit was to meet face-to-face with the National Advertising Division of the Better Business Bureau (NAD) concerning the “advertising” associated with a specific company’s product. At the end of the day, the positions they chose to take should give us all pause (more on this later). With many corrective actions already having taken prior to the issuance of the original notification from NAD, some of the matters had been pre-emotively addressed. However, there is a precedent "leave behind" that should give everyone in the industry pause.
Precedents? I know, such a legal term but you should know that among the findings of NAD was that an allowable, substantiated structure/function claim does not necessarily pass muster with them. Moreover, even though they acknowledged supportive evidence regarding some claims for a key ingredient in the dietary supplement being advertised, they believed that lack of evidence on the supplement itself negated this substantiation. The reasoning being that the other components of the product might “interfere” with the activity of the active agent. During our face-to-face I offered clarification of the company’s position. My argument in response was manifold but looks like this (in ascending order of weight):
- Long-standing industry practice has been to use the existing scientific evidence performed on a specific entity (say Glucosamine) and apply that evidence as substantiation for a dietary supplement product containing the material. This requires the material used to be the same as that studied and that the supplement contains the studied quantities.
- I further allowed as how there is a practice well-known in the industry as “borrowed science” wherein a company will use material that carries roughly the same name as a studied ingredient and apply that information as substantiation when in fact it is not the same ingredient (the most obvious example being claims of mental function enhancement through the use of a “generic” Ginkgo extract versus the European material used to generate the substantiating data). I further expressed my dismay over this practice as well as my strong stance in opposition to it.
- The Food and Drug Administration (the dietary supplement industry’s primary regulatory governing body) published a Draft Guidance document on substantiation requirements for structure/function claims. This guidance makes very clear that substantiation may be evidence of an ingredient or a product showing benefit.
- The Food And Drug Administration (as above) holds as the standard for approving Health Claims (literally disease claims available for foods including dietary supplements) the same standards. The studies of an ingredient or substance demonstrating “significant scientific agreement” as to the benefits derived from its consumption regardless of presentation, serves as the standard for reviewing evidence. As long as the requirements of each specific CFR Health Claim citation are met for food quality, the claim is applicable whether the product is fortified bread, the margarine spread upon it or a dietary supplement.
- Finally allowing as how no specific studies had been performed on whether consumption of Orange Juice that contains Calcium helps prevent osteoporosis, I offered to challenge the presence of this Health Claim on each such product offered up in the marketplace today.
Yes, the original NAD position was off the mark and they mildly acceded to the presentation. However, their findings included an acknowledgement that a claim might very well be an acceptable structure/function claim but not be allowed as part of advertising (or even the name of the product itself). NAD’s view is that the front panel of the product under review constitutes advertising specifically because of its prominence. NAD’s perception is that the take away by a consumer viewing the front panel of the label itself comes under NAD purview. The obvious rebuttal to that was not in argument over their jurisdiction but rather that the name of the product (in this instance not a specific claim but a descriptor derived from the claim) was in fact substantiated since the claim itself passes the substantiation test. In fact, if the name of the product were to change slightly in wording to be phrased exactly as a claim, notified to FDA in accordance with 21CFR Section 101.93 and appropriately footnoted to the statutory disclaimer – NAD would have us officially pass through the looking glass in hot pursuit of Alice and a white rabbit.
This thinking places the FDA acceptance of the “name/claim” and (owing in large measure to the substantiation) as an interesting bit of irrelevant fact. NAD disallows the same wording from being shown to the consumer. In other words, third-party retailers of the product particularly are prevented from even naming the product in their advertising. (“PSSSSTT . . . I got something really good here. I can’t tell you the name of the product but, trust me . . . it’s really really good.”) Once again a bureaucracy has seen fit to morph the standards governing legitimate practices of an industry by making determinations bordering on the absurd.
What does all of that have to do with an advertisement in Nutraceuticals World? Simple. The advertisement was a full-page ad presented by one of the primary trade associations “representing” this industry. The main title of the ad is “There’s a New Sheriff in Town . . . YOU”. The purpose of the ad is to strongly suggest that industry members take action against the rampant, egregious practices demonstrated in the advertising for dietary supplements and blow the whistle on these miscreants by turning them over to (you guessed it) the NAD. Without debating the merits of having NAD involved and without denying that there are plenty of bad bits of advertising out there, I still have a couple of burning questions lingering in my mind as I recover from the near heat stroke of walking around NY, NY on that muggy Monday:
- Is it the role of a trade association to undermine an industry with open calls for potential regulatory action against its own?
- Is it the role of a trade association to address these matters more directly rather than characterizing the whole of the industry as “the Wild West” and openly inferring that there is so much wrong with the industry that they want informers turning in other industry members?
- Is it now the role of a trade association to offer guidance down the rabbit hole, past the Mad Hatter and on to the Tea Party for their membership based on the results of the efforts they initiated?
Without offering my opinion on the first two questions, I can answer the third – the trade association should be held accountable for its role in developing a precedent so onerous as to undermine the industry it purports to represent.
Now that I think about it, I think I’ll just take a little time in this end-of-summer to review the advertising of some industry members I know – applying my newly acquired, first-hand knowledge and armed with the precedent set forth by NAD. More efficiently, rather than randomly reviewing advertising of my fellow Wild-West citizens I should select companies by working from a list. Let’s see, I put that list of the trade association board members somewhere. That should make for an ideal start.
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| Copyright ©2007 Jim Lassiter |
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