HerbalEGram: Volume 9, Number 5, May 2012

by Greg Cumberford, President, Bent Creek Institute, Inc.

An intricate, global network of supply chains produces the botanical and other functional ingredients that are formulated into dietary supplements and functional foods on which we Americans rely for daily wellness maintenance. Perhaps in no other major industry in the United States does the term "globalization" better apply. However, an article in the March 2012 issue of Functional Ingredients magazine exposed a gap between the American consumer’s perception of supplement ingredient origins and the reality.¹ Citing a recent May 2011 survey by United Natural Products Alliance (UNPA), a trade association of dietary supplement producers, Functional Ingredients reports that Americans perceive the origins of their supplement ingredients as follows: 77% from the United States, 10% from China, 7% from Europe, and 6% from Japan.

We Americans believe that a large majority of our ingredients comes from domestic US sources and, presumably for botanicals, also from within a USDA Certified Organic inspection and audit framework for cultivated herbs. However, the reality is far different. According to Functional Ingredients and UNPA, 60% of the ingredients used in dietary supplements in the United States actually come from China, with 13% from Europe, just 12% from the United States, 10% from Japan, and 5% from other areas. This means that the majority of what we Americans believe comes from domestic sources in fact comes from Asia.

To knowledgeable stakeholders in the natural products industry supply chain, the dominance of foreign sourcing for supplement ingredients is an accepted fact. To the consumers and many alternative and integrative healthcare practitioners who accept or even recommend the use of dietary supplements as part of their clinical practice, however, the true origins of their supplement ingredients may be a bit of a revelation.

From traditional botanical ingredients, to marine sources of the popular omega-three fatty acids DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid), to minerals, vitamins, oils, carotenoids, enzymes, probiotics, and prebiotics, almost every nation and region on Earth supplies the functional ingredients from which finished dietary supplements in America are made. Yet in the past decade, global climate change has induced greater turbulence in global weather systems. Political instability, natural disasters, anthropogenic pollution, and other catastrophes have caused greater supply chain disruptions. All the while, cost-conscious consumers are demanding lower prices and greater value in their supplements—thus raising the economic incentive for supply chain players to cut corners on purity, strength, and/or identity in their ingredients, an occurrence known as "economically motivated adulteration" or EMA. Although some ingredient adulteration is surely accidental, based on inadequate quality-control procedures or legitimate confusion stemming from differing cultural interpretations of an ingredient’s nomenclature, too much of it is intended. Too much of it is designed to evade a responsible distributor’s or manufacturer’s quality control test methods. Too much is flying under the radar.

Illustrating the complexity and seriousness of EMA, Edward Fletcher of Strategic Sourcing, Inc., and other knowledgeable botanical industry sources claim that globally rising demand and higher supply chain prices for black cohosh root (Actaea racemosa, syn. Cimicifuga racemosa)—a native forest understory medicinal herb of eastern North America—have revealed significant amounts of circulating raw material to be EMA-tainted material. Much of the adulterated material is derived from various Asian species of Actaea including A. cimicifuga (formerly Cimicifuga foetida, so-called “Chinese” black cohosh—a name that is not accepted by the American Herbal Products Association’s Herbs of Commerce, 2d, ed.,² an FDA-recognized listing of common names for herbs and their corresponding Latin binomials), A. dahurica, and A. heracleifolia. Other closely related North American species have been identified as adulterants including A. podocarpa, A. pachypoda, and A. rubra, in addition to other native North American forest understory "cousins" to true black cohosh, like herbs in the genera Caulophyllum, Astilbe and Aruncus—whose above-ground foliage or dried roots can appear visually similar to A. racemosa but in fact contain different phyto-complex constituents. Fletcher noted that industry-wide attention to the issue of black cohosh adulteration in recent years has improved overall quality in this herb's supply chain. (e-mail, E. Fletcher to G. Cumberford, April 3, 2012.)

The US Food and Drug Administration (FDA) has mandated in dietary supplement Good Manufacturing Practices (GMPs, 21 CFR 111) that manufacturers conduct 100% identity confirmation tests. Yet the tests deployed must be capable of detecting the known EMAs. 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, ethical supply chain stakeholders must push back with EMI— economically motivated integrity.

EMI means aligning in opposition to EMA through a coordinated approach among foreign and domestic raw material suppliers, consolidators and brokers, US distributors, manufacturers, analytical laboratories, retailers, and trade associations. It means taking a moral, ethical, and scientifically valid stance against EMA on a case-by-case basis. This would be something like a self-policing "neighborhood watch" program along every link of the ingredient supply chain, from raw producer to branded finished product retailer. All supply chain parties have a clear economic incentive to root out EMA. FDA GMPs provide manufacturers with a strong motive not to be linked to an EMA, as 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-funded consortium led by Mark Blumenthal of the American Botanical Council (ABC), Roy Upton of the American Herbal Pharmacopoiea (AHP), and Ikhlas Khan, PhD, of the University of Mississippi’s National Center for Natural Products Research (NCNPR)—the ABC-AHP-NCNPR Botanical Adulterants Program—has formed to systematically identify botanical EMAs and their detection methods through a series of white papers that will educate industry stakeholders, practitioners, and consumers. Bent Creek Institute, the executive and administrative manager of the new non-profit US Botanical Safety Laboratory, has committed to supporting this consortium's efforts, as well as the efforts of the American Herbal Products Association’s (AHPA) planned Botanical Authentication Wiki Project—a Wikipedia-like resource of herb-specific analytical methods for assuring correct botanical identity. Bent Creek will provide participating analytical laboratories with authenticated botanical reference materials from the Bent Creek Germplasm Repository (under direction of Joe-Ann McCoy, PhD); input on botanical identity confirmation methods backed by authenticated, reproducible, and traceable vouchers; phytochemical and genomic data on adulterants; and will assist supply chain stakeholders in their efforts to produce positive confirmation of the identity, purity, and composition of their herbal ingredients.

In the battle of EMI vs. EMA, EMI will ultimately prevail in the United States when enough of the supply chain players who provide our ingredients align with values-conscious consumers, choosing to reward rigorous science, transparency, and traceability over short-term gain, denial, and deceit. As more branded natural products and supplement companies adopt ingredient and lot traceability platforms, consumers will feel ever more inspired and empowered to choose natural products backed by EMI.

Greg Cumberford is the President of Bent Creek Institute, Inc., a nonprofit botanical research, conservation, and strategic services organization based at The North Carolina Arboretum focused on medicinal plant and endophyte research, analysis, and economic development in Asheville, North Carolina. A veteran of the herbal industry, he was formerly the Vice President – Strategic Initiatives at Gaia Herbs.

References

1. Schultz H. Ingredient insomnia: what keeps supply chain managers up at night? Functional Ingredients. March 2012:32.

2. McGuffin M, Kartesz JT, Leung AY, Tucker AO. American Herbal Products Association’s Herbs of Commerce, 2d. ed., Silver Spring, MD: American Herbal Products Assn., 2000.