Economically motivated adulterants in the natural products supply chain.
A global network of natural products supply chains produces the ingredients that are formulated into dietary supplements and functional foods that we Americans rely on for basic daily wellness maintenance. Perhaps in no other major US industry does the term “globalization” apply better. From traditional botanical ingredients, to marine sources of DHA/EPA, to minerals, vitamins, oils, carotenoids, enzymes, probiotics, and prebiotics, almost every nation and region on Earth supplies the functional ingredients from which our finished dietary supplements are made. Yet in the past decade, global climate change has induced greater turbulence in our weather systems. Political instability, natural disasters, human-made pollution and other catastrophes have caused greater supply chain disruptions. Stressed and cost-conscious consumers are demanding lower prices and greater value in their supplements. The logical outcome. The economic incentive for supply chain players to cut corners on purity, strength, and/or identity in their ingredients has never been higher. Hence the term: “economically motivated adulterant” or “EMA”. Although some ingredient adulteration is surely accidental, too much of it is intentional. Too much of it is designed to evade the quality control tests that are in place.
For example, knowledgeable botanical industry sources have claimed that globally rising demand and higher supply chain prices for Black Cohosh root (Actaea racemosa), a native forest understory medicinal herb of eastern North America, have caused as much as 60-70% of raw material in circulation to be EMA-tainted material, derived from various Asian species including Actaea cimicifuga and from other native North American forest understory “cousins” to true Black Cohosh–whose roots appear similar to dried Actaea racemosa but in fact contain different phyto-complex constituents. FDA has mandated in dietary supplement Good Manufacturing Practices (21 CFR 111) that manufacturers conduct 100% identity confirmation tests. Yet the tests deployed must be capable of detecting the known EMA’s. Too often this is not happening. If a high degree of material purported to be true Black Cohosh is in fact EMA-tainted, then all responsible supply chain stakeholders must push back with EMI: economically motivated integrity.
EMI means taking a coordinated approach among foreign and domestic raw material suppliers, consolidators and brokers, US distributors, manufacturers, analytical laboratories, retailers, and trade associations to align in oppostion to EMA. It means taking a moral, ethical, and scientifically-valid stance against EMA on a case-by-case basis. This would be something like a “neighborhood watch” program along every link of the ingredient supply chain from raw producer to branded finished product seller. All supply chain parties have a clear economic incentive to root out EMA. FDA GMP’s provide a strong motive not to be linked to an EMA, because a buyer’s quickest corrective and preventive action (CAPA) to a discovered adulterant is not to do business with that supplier… ever again. Recently, an industry consortium led by Mark Blumenthal of the American Botanical Council (www.herbalgram.org), has formed to systematically identify botanical EMA’s and their detection methods through a series of white papers that will educate industry stakeholders, practitioners, and consumers about them. Bent Creek Institute, USBSL’s executive manager, has committed to supporting this industry adulterant consortium’s efforts. We can do this by providing authenticated botanical reference materials from the Bent Creek Germplasm Repository to participating analytical laboratories, by providing phyto-chemical and genomic data on adulterants, and by USBSL assisting supply chain stakeholders in their efforts to positively confirm the identity, purity, and composition of their herbal ingredients.
In the battle of EMI vs EMA, EMI will ultimately prevail in the US when enough of the supply chain players who provide our ingredients choose rigorous science, transparency, and traceability over short-term gain, denial, and deceipt.