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Editorial: A Model to follow?

By Len Monheit

Many of the industry suppliers I’ve spoken with have told me that anything they can do get their brand and identity presented to a consumer audience is critical to program success. I’ve spoken in the past of companies with strategies for doing this and the support they are getting from industry manufacturers and recognition from retailers. In a successful integrated program all elements combine, a consistent message must be delivered, and no possible opportunities are lost to present the brand message. When the brand itself is supported by strong research and a defensible patent position, although a successful marketing program can be developed, it is frustrating to be forced to use bland or generic claims and to be unable to strongly cite literature, studies and evidence.

I have also spoken about the need for a model in the industry to support those companies making the investment in research and proprietary products. First amendment issues notwithstanding, we know that much credible scientific evidence cannot be used, hindering manufacturer, retailer and ultimately consumer education. Ironically, regulatory agencies claim that education is a critical part of their programs, but the knife cuts both ways. Companies performing research and studies are usually not rewarded and this is a disincentive.

Canada has published its proposed new regulations governing Natural Health Products, and although supporting guidance documents will contain the policies and principles under which the regulations will be enforced, many feel that the Natural Health Products Directorate may have struck an effective balance between Food and Drug regulations. This occurs just as Trans-Tasman harmonization or regulations is an issue in Australia and New Zealand and the US still waits for GMP’s from the FDA.

A Possible Model?

The model for protecting and rewarding proprietary research and IP could possibly be developed from the Canadian regulations. Perhaps other international agencies should take notice.

From the suggested regulations one learns that a range of Standards of Evidence will be used. On a product by product basis, research, traditional use and other data will be analyzed to determine safety and efficacy profiles. Is it possible that a two tiered claim system could be developed, one a general or family type claim, and the other a more targeted and specific claim based on the research and studies conducted by the manufacturer, supported by evidence of the study and allowing no blindly borrowed science?

This would mean that clinical trials and all participants would have to identify and track ingredients carefully, but presumably this is already being done, just sometimes not reported. Could we then educate the North American media in how to report the results and claim? A logical last step would be for the entire industry to work towards educating manufacturers, retailers and consumers about the program.

Obviously, in the US, FDA support for this process would be critical. Right now, I’m curious about the industry opinion and feedback. Could this work?

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