Have you ever considered what a single dietary supplement represents? Sure, it represents a customized combination of ingredients designed to affect one’s biochemistry and physiology. And, yes, it also represents the advance of nutritional science in terms of delivery format, extraction processes, and even alterations in the nutrients’ particle size. What you may not realize is that the globe is often well represented inside that capsule as well.
The globalization of the food and ingredient supply chain is quite significant. It is not unheard of to have ingredients sourced from Asia, the Middle East, Europe, and North America all within one product. Even relatively simple products with one active ingredient can have inactive ingredients sourced from all over the planet.
This globalized supply chain has significant quality implications. A recent situation illustrates this well. The American Herbal Products Association sent out an alert to its members in mid-July of this year that European authorities had traced the origin of the deadly E. coli outbreak in Europe to fenugreek originating in Egypt. As a result, EU authorities recalled certain lots of fenugreek seed imported from Egypt. Germany additionally recalled dietary supplements containing fenugreek. There appeared to be one culprit lot (lot #48088—15,000 kg of organic fenugreek seeds) that were imported into several European countries from Egypt and which were postulated to have been contaminated by human fecal material. It was not known whether seeds from this lot had been further exported to other countries or whether these seeds might be present in products in the United States.
Some products contained fenugreek from 3 different countries--all in one product. And that is just one ingredient.
Given the theoretical possibility that fenugreek from this lot might be present in U.S. products containing fenugreek, Emerson Ecologics* recently conducted a Corrective Action and Preventive Action (CAPA) to all of its suppliers with products containing fenugreek. There were 91 products containing fenugreek from 29 different brands. While, thankfully, no supplier has identified fenugreek from lot #48088, collectively, 6 different countries were identified as the source countries for fenugreek in these products. These countries included the United States, India, China, Morocco, Australia, and Egypt. Some products contained fenugreek from 3 different countries – all in one product. And that is just one ingredient.
This example illustrates the complex web of the ingredient supply chain and why the quality practices around sourcing and inventory identification are so critical. Typically, a manufacturer receives a certificate of analysis with each ingredient. The certificate of analysis should include the country of origin and the lot number. The manufacturer must keep this certificate of analysis in their records as a critical component of traceability, product recall investigation, and serious adverse event investigations. Additionally, the manufacturer bears responsibility for the authenticity of the certificate of analysis. In other words, if a certificate of analysis is fabricated (and that, unfortunately, does happen) then the manufacturer is liable for any ill effects from using that ingredient. This why one of the maxims of quality is to know your supplier. This also creates a challenge for manufacturers in that they cannot realistically visit every raw material supplier around the globe—particularly given that most manufacturers have dozens, if not hundreds, of ingredients sourced from a multitude of countries. What manufactures can do is validate other components found on the certificate of analysis by testing the raw material for those components. This helps to verify the quality of the raw material and the validity of the certificate of analysis. In addition, manufacturers that have established long-term relationships with reliable suppliers are less likely to encounter fraudulent material.
Next time you take a natural product, you may experience a whole new meaning to “The world is at my fingertips.”