As of late DNA Barcode testing has been a subject of heated debate, which can be a valuable tool when used appropriately. However, the appropriateness of its use is up to the manufacturer to determine.
What is DNA Barcode Testing?
DNA barcode testing is an analytical method used to identify genetic markers in the DNA of organic matter. This approach may be used to identify the species of a herbal ingredient when the ingredient is present in its unaltered, fresh form. However, it is important to note that this technique currently has limited usability within the dietary supplement industry since it often cannot be used as an accurate method to identify all plant materials due to the genetic similarities between some plant species and the processing methods used, including extraction, which often render the DNA to be of low quality or present in small amounts and thus cannot be detected.
DNA Barcode Testing & Industry Implications
Recently, DNA barcoding has received attention as the Attorney General of New York State relied on this method to allege that four large US retailers (i.e. GNC, Target, Walmart, and Walgreens) were selling poor quality dietary ingredients. While DNA barcoding may be a valid method to identify certain species plant matter, it is not considered acceptable as a sole test method for all dietary supplements which often contain processed herbal ingredients such as dried or extracted botanicals. Dietary supplements can be still considered high quality when the finished product contains undetectable amounts of DNA as the active components of the botanical tends to be phytochemicals, and not the DNA itself. At the present time, commonly used analytical methods for the identification of herbal ingredients present in a dietary supplement include those such as chromatography or microscopy. Industry experts have acknowledged the potential power of DNA barcoding, but have stated that the method must be fully tested and validated before it becomes available as a standard test method for identifying ingredients in dietary supplements.
DNA barcoding can be a useful tool for identifying herbal compounds in a dietary supplement, however, it must be conducted on the appropriate type of material and further validated with an established identification test method at the present time. While DNA bar coding has its uses it is not intended to be a standalone tool that is a replacement for other analytical testing, but if appropriate can be used in conjunction with other testing conducted on your product and ingredients.
At the present time there is no FDA mandate for industry to conduct DNA bar coding, moreover, as per the cGMPs it is up to the company to determine the most appropriate testing for your product. However, this current issue should serve as a reminder to industry of the importance of quality control and use this as an opportunity to reassess the current procedures that your company has put into place to confirm that your system is robust and effectively ensures the identity and quality of all your products. It is also advisable to ensure that appropriate allergen testing is conducted and your labelling is in compliance. At dicentra we can assist companies in determining the correct test methods for your product or ingredients, assist with GMP training and conduct on-site auditing to aid you with compliance. As this issue continues to unfold dicentra will be sure to provide you with pertinent updates. We can be reached at 1-866-647-3279 or email@example.com
dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces.