by: Lise Alschuler, ND, FABNO
Dietary supplement products leave their own trails; however, I think my dog would meet her match in trying to follow these paths. For one thing, the trails leading to dietary supplements start in all parts of the globe. For another, the trails branch and intersect their way to the final product. There are very few linear, entirely transparent paths from starting material to finished product. As ingredients work their way from their original source to the final product, they can be mixed with the same ingredient from other parts of the world. The ingredients, while the same by name, may have different histories of cultivation, processing, extraction, and testing. The globalization of the dietary supplement industry along with the increasing demand on ingredients has turned the traceability into a veritable maze.
In the midst of this layered and complex supply chain, manufacturers are left with the formidable challenge of identifying safe and pure ingredients that they can reliably utilize in their products. Thus, manufacturers source every ingredient with a myriad of considerations in mind. These considerations include things like ingredient price, availability, quality, processing, and traceability. A good manufacturer will set specifications for each of these areas and will use these specifications to determine from whom to purchase their ingredients. While this may seem challenging enough, to make matters even more complicated, for many ingredients there are multiple layers of supply. An ingredient may actually be sourced from multiple suppliers around the globe, and then mixed and sold to the manufacturer by a broker of that ingredient. This layering of suppliers can make it very challenging to identify the traceability of raw materials. Ultimately, manufacturers have three choices. They can decide to test every receipt of raw material for all known quality attributes (ie, identity, potency, known possible contaminants); they can vertically integrate, taking responsibility for all of their products’ ingredients from seed to bottle; or they can qualify their raw material suppliers to be reliable purveyors of acceptable-quality materials and do skip-lot testing verification. The majority of dietary supplement manufacturers fall into this last category.
The process of evaluating the source of ingredients is referred to as supplier qualification. Supplier qualification is a complex and involved process that really goes beyond the scope of this article. However, a few of its key components are worth mentioning, as this is such a critical part of the supply chain and traceability. Supplier qualification is typically risk-based. Through a variety of analyses, manufacturers can determine which of their suppliers represent the highest and the lowest risks. A supplier of raw materials that is a pharmaceutical company making commodity ingredients such as ascorbic acid or glycerin, for instance, may be determined to be low risk. On the other hand, a small or new supplier of botanical or complex nutraceutical ingredients like curcumin standardized extract or chondroitin sulfate may be considered high risk. High-risk suppliers require extensive qualification that involves an analysis of the company’s quality practices, on-site audits, repeated validation of the company’s certificate of analysis through independent testing, and a thorough understanding of the traceability of the ingredients provided by the supplier. Given the increasing globalization of the supply chain, the importance of frequent and thorough checkpoints as an integral part of supplier qualification cannot be overstated.
It is the responsibility of dietary supplement manufacturers to ensure that their products contain the intended ingredients and are absent of contaminants. This is achieved through a combination of extensive testing, thorough supplier qualification, and ingredient traceability. As practitioners and consumers of dietary supplements, traceability should be very important to us. While this trail can be very difficult to sniff out, it is not impossible. Fortunately, there are some excellent, well-maintained trails to follow—trails that reputable manufacturers would be happy to guide you along.
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Dr. Sara Knuth, ND
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