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—Non-Validated DNA Barcode Testing on Finished Products Ignores Well-Established Quality Control Procedures for Herbal Products—
Washington, D.C., February 3, 2015—In response to actions taken today by the New York State Attorney General toward four retailers requesting they stop the sale of specific herbal supplement products, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
“These actions today by the New York State Attorney General’s (AG) office smack of a self-serving publicity stunt under the guise of protecting public health. Supposed concerns about the products in question are based on a novel testing method that has been roundly criticized by botanical scientists who question whether DNA barcoding technology is an appropriate or validated test for determining the presence of herbal ingredients in finished botanical products. Processing during manufacturing of botanical supplements can remove or damage DNA; therefore while a DNA testing method can be useful in some cases, this method well may be the wrong test for these kinds of products.
Nor does the DNA testing method provide information on the amounts of food contaminants found in the products. This is important because there are well-established legal thresholds that allow for trace amounts of some ingredients like gluten, and trace amounts of DNA from rice, beans, pine, citrus, etc. are not considered harmful or required on labels. Announcing the detection of minute amounts of these substances unnecessarily alarms consumers without informing them whether the detection of DNA from these substances poses any allergic risk.
Instead of giving companies a reasonable opportunity to respond to these concerns, the AG unfortunately chose to label them guilty without a fair trial. Not only is the testing method itself suspect for these kinds of products, but the scientist who developed the assay and conducted the testing is not a botanical or a food expert. He is an evolutionary biologist who specializes in testing DNA in dinosaurs and lizards.
Dietary supplement companies are required by law to adhere to Good Manufacturing Practices (GMPs) which include identity testing for all botanical materials used. Different identification test methods, from simple titration to chromatography and mass spectrometry, are appropriate for different stages of the processing—from the whole plant to the extract, to the finished product. Companies identify all incoming materials and keep records of these test results, and those test results could have been shared if companies had been approached in a reasonable manner with a reasonable timeframe. The FDA, which enforces these identity requirements through routine inspections, does not require DNA barcode testing; nor should it, given that this novel approach has not been validated for finished products.
Responsible manufacturers and retailers take careful measures to ensure their consumers can purchase high-quality botanical supplements that contain what is on the label. We stand by the safety and regulation of these products. We urge the New York State Attorney General to subject its own questionable testing methods to the same public scrutiny and peer review that he has called upon for our products.”