Nutrasource Position Statement: Herbal Product DNA Testing Commissioned by the Attorney General of New York

February 19, 2015

Testing herbal products using DNA-based methods reveals gaps between labelling requirements and test methods

February 19, 2015

Nutrasource performs analytical testing programs on dietary supplements, including active ingredient analysis, species identification, genetic engineering biotechnology (GMO) detection, stability testing and quantification of allergens, pesticides, polychlorinated biphenyls (PCBs), heavy metals and many more.  Test equipment and methods include gas chromatography (GC), digital polymerized chain reaction (PCR), quantitative PCR (QPCR), ultra-high performance liquid chromatography (UPLC) and mass spectrometry (MS), Sanger sequencing, high resolution melting curve analysis (HRMCA), and Next Gen Sequencing.  Based on our experience, it is very difficult to negate the validity of a particular test result without a comprehensive background in analytical chemistry, and a full understanding of the study design, methods and procedures used.  Ideally, test methods are developed, validated and verified using the specific matrix or sample type of interest.  Individual test results are verified by replicate testing of identical samples at different testing facilities, using comparable methods.

We design our testing and related certification programs to be as cost-effective as possible in order that companies with many products and multiple active ingredients may efficiently verify their products’ contents by applying innovative testing within the supply chain.  Transparency in method design, verification and validation is part of our business model, as we develop new methods at our in-house laboratories, outsource routine testing, and transfer low-cost testing techniques to our customers.

Nevertheless, when valid unexpected testing results reveal the presence of undesired compounds, or the absence of desired compounds, one may conclude that their presence, or absence, is either intentional or accidental. 

Genetic identity testing that reveals incorrect label claims on foods or supplements is of great concern to those producers who strive to maintain the highest quality products and transparency with consumers.  It is the responsibility of regulators to respond, in order to ensure that incorrect labelling does not have any human health risks to consumers.  For example, if a product labelled as “Atlantic salmon” or “allergen free” is found to be inaccurate, several questions should arise.   What does the product actually contain?  Where did it originate?  Are other inherent claims of safety or purity correct?  With little in the way of mandatory requirements for testing to verify such label claims, incidents of incorrect label claims will continue to be uncovered during random testing by various other stakeholders.

Each year, we at Nutrasource test thousands of dietary supplement products, and the ingredients used to manufacturer them, for hundreds of different active ingredients and contaminants.  The vast majority of manufacturers and brands for whom we carry out this testing know exactly what is in each batch of product that is produced, because they perform the required testing at each point in the supply chain.  These companies have also achieved the highest level of process control verification by such global standards as Good Manufacturing Practices (GMP) and the International Organization for Standardization (ISO).  With complex supply chains, and complex ingredient production techniques, testing reveals that occasionally undesired compounds unintentionally end up in products.  Without comprehensive testing at each point in the supply chain, regulators and retailers should expect to find unintended compounds in products from time to time.

Nutrasource helps companies in the dietary supplement and food industries determine if there has been any inadvertent contamination in their supply chains, so that they can take corrective action to ensure that their products on the marketplace shelves are labelled correctly, and present the highest quality standards for consumers.  For species identification, Nutrasource combines the DNA analysis and species identification expertise of TRU-IDTM with mass spectrometry analysis of the molecules or active ingredients attributed to the species.

The dietary supplement industry, retailers and regulators should continue in their efforts to weed out those companies in the supply chain that are intentionally substituting ingredients that result in incorrect product label claims, and that may  cause harm to consumers.

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About Nutrasource:

Nutrasource is a full service contract research organization offering regulatory consulting, clinical trials and product testing services for the food, dietary supplement and pharmaceutical industries | www.nutrasource.ca

For more information, please contact:
William J. Rowe, President and CEO, Nutrasource Diagnostics Inc.

519-341-3360 | wrowe@nutrasource.ca


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