By Len Monheit
The past week has been busy, on and off headlines. Beginning with headlines first, the Baxter heparin issue continues to percolate, with product recalls in both Canada and the United States (thanks to those emphasizing this point), and a scramble to confirm the presence of over-sulfated chondroitin sulphate. On the industry front, work behind the scenes from our analytical gurus involves assessing the ability of the recently approved AOAC analytical method for chondroitin sulfate to be part of a toolkit moving forward, or at least for the method’s potential to be adapted for this purpose. Whether or not this does occur, it’s important to note that our (industry’s) analytical community is at work to ensure that, where suitable and validated methods are used in industry, that this particular contamination issue does not become a potential stumble for supplements.
As the heparin story evolves, the fragility of the supply chain becomes quite evident, as does the fragility of parallel chains. This is one aspect of the issue that makes it, while not specifically supplement-related, potentially supplement affecting. Melamine was not a supplement issue, but if you ask manufacturers and retailers what the most burning ingredient issue they face is, somewhere in the top two or three, they’ll identify ingredient source, specifically Chinese materials. The encompassing solution in both instances is supply chain integrity, certainly a key supplement (and food) concern.
Similarly, FDA recalls at the end of the week involving Total Body Formula (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=20901&zoneid=18) , Hero and Blue Steel (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=20909&zoneid=18) , one might argue, are not specifically supplement issues as they involve ‘unapproved new drugs’ or are issues of industry outliers practicing poor, if any, quality control. In the case of Hero and Blue Steel as unapproved drugs, the products are marketed and identified as a supplement, consumers perceive them as such and fundamentally, the news filters which send them to my (and other) system(s) are for ‘supplements’ and not ‘drugs’. In the case of Total Body Formula, we’ve got a concern with levels of selenium indicating a high likelihood of either fundamental quality control or basic record keeping integrity – a GMP issue you think?
All of the issues described above point to the rising importance of an increasingly communicative (and proactive) analytical community, and the need for much enhanced education of industry executives on analytical issues, definitions, problems and pitfalls. The other side of this issue is another long-standing vulnerability – supply chain integrity. If heparin doesn’t hammer it home, manufacturer and ingredient company responsibility for all supply chain practices and processes is on its way to becoming the single most defining practice for our sector.
Now for a whopping switch of gears, hopefully with a bit of a tie-up at the end.
This past week, I co-chaired the 5th annual Natural Health Products Research Society annual conference, Science Across Borders, in Toronto, Canada. Perhaps obviously, a good portion of the conference dealt with the subject of ethnobotany, as this field certainly envelops both borders and healing paradigms. The profile of the researchers and the quality of the presentations opened doors for me in beginning to understand his environment, and more importantly, the researchers who pursue ethnobotany with such passion and commitment. Over the course of three days, we heard about Peru, Micronesia, Cuba, India and more from aboriginal healing practices to cultural and socio-economic considerations and constraints which actually provide a new twist on sustainability in our industry. For just as the product must be produced in a long-term sustainable manner, so too cultural integrity and sustainability is absolutely critical. Would kava still be available and would health concerns be mitigated had its adoption been better managed to preserve cultural integrity? I saw researchers and collaborators involved in far-reaching projects intending to preserve integrity at many interface points, including the discussion of intellectual property rights as they apply to aboriginal traditions.
Of course, product quality and characterization becomes a challenge as scientific capability strikes traditional medicine. ‘Just because we can’, makes for an interesting transition as we try to characterize plants that have been in use for thousands of years, compounding the numerous other analytical challenges arising from GMP compliance and market forces. On this quality front, one of the NHPRS conference presentations was made by Canada’s Natural Health Products Directorate, specifically by Dr. Robin Marles, dealing with a regulatory response to an adverse event alleged to involve black cohosh, involving collaboration amongst several departments, ultimately determining that this adverse reaction involved a product that was not black cohosh, and therefore at least this specific incident could not be ascribed in any way to the consumption of black cohosh. Perhaps further work would indicate that other recent adverse events around the world, also represent adulterated product...
We are a global industry, and whether we’re talking sourcing, ethnobotany, adverse events, sustainability, product quality or other issues and parameters, it is only through the establishment and maintenance of international networks that industry and product integrity can reach fullest potential.
In my opinion, this past week points that out clearly.