February 6, 2015

The American Herbal Pharmacopoeia (AHP), a nonprofit research and education organization, on February 6 sent an extensive communication to New York Attorney General Eric Schneiderman to explain why DNA barcoding is not a scientifically valid technology for determining the identity of botanical extracts. The 58-page document also provides widely recognized standard testing methodologies citing monographs from AHP, the European Pharmacopoeia (EP), and the United States Pharmacopeia (USP). AHP provides national and international monographs for each of the seven herbal dietary supplements tested by the New York Attorney General, highlighting the appropriate characteristics of each plant and extract.

February 6, 2015

Attorney General Eric Schneiderman

Office of the Attorney General

The Capitol Albany, NY 12224-0341

Dear Attorney General Schneiderman,

I thought it would be helpful to provide some feedback regarding your recent testing of herbal supplements. It is clear that adulteration in the herbal products industry, as with all industries, occurs. Unfortunately, your testing methodology was not appropriate for determining this. Based on my review of the company websites and the products tested, it appears that a significant number of these were extracts. With rare exception, DNA barcoding is not an appropriate technology for testing the identity of ingredients in extracts. By definition, extracts are made by extracting the desired constituents from the plant material itself into a liquid medium, a process that either does not maintain the DNA or significantly denatures it. The extract is then processed and dried onto an appropriate carrier. In that process, an extract is sometimes subjected to heating or further mechanical filtering, which similarly either removes or further denatures DNA if present. With most extracts there is no actual plant tissue left or, if any material remains, it can be greatly degraded. Because of this, there is either no DNA in finished products, such as those tested, or there is too little intact DNA to get an accurate finding.

There is a possibility that some of these products may have been adulterated, but the percentages will likely change if the appropriate testing technology is applied. Once the source plant is extracted and DNA is no longer present, other technologies are needed to determine the IDENTITY of the ingredient. Additional tests may be needed to determine the POTENCY of the finished product. Still different tests are needed to determine the PURITY of products in order to determine if "contaminations" are in fact present.

As plant materials are products of nature they are subject to the presence of other organic materials, such as specks of grass, insect fragments, and miscellaneous filth that is both common and acceptable in all food and dietary supplement products within specific limits. Foreign organic matter limits are established in national and international standards (e.g., pharmacopoeial monographs such as those included with this communication) and by regulatory bodies (e.g., Defect Action Limits established by the Food and Drug Administration (FDA). All organic matter has DNA that can be readily picked up and interpreted as "contaminants". The high sensitivity of DNA barcoding can pickup even minute fragments of DNA if present but cannot determine if this is due to acceptable levels of foreign organic matter or truly a contaminant. Similarly, there are national and international guidelines for determining the identity, quality, and purity of these products and experienced labs that can conduct the tests. National and international standards are reflected predominantly in the American Herbal Pharmacopoeia (AHP), European Pharmacopoeia (EP), United States Pharmacopeia (USP), and the World Health Organization (WHO). Additional standards for Ayurvedic and Chinese herbs are available in the Ayurvedic Pharmacopoeia of India, Indian Pharmacopoeia, Pharmacopoeia of the People's Republic of China, and Hong Kong Standards. I have included appropriate monographs for each of the botanicals tested. Dietary supplement GMPs also allow manufacturers to develop their own specifications, due to the wide array of different products that are available, so actual values can vary and should be compared against the label claim. Additionally, adherence to the standards and requirements of pharmacopoeial standards is voluntary. Not all values cited in pharmacopoeia monographs are relevant for all products. Never the less, the testing methodologies for identity and potency are largely considered the industry standards and are relevant to the majority of products.

Appropriate independent laboratories to conduct this type of analysis and whose services are used in a forensic capacity by FDA, USDA, and others include: Covance Laboratories; Flora Research Laboratories; Eurofins; NSF International; Midwest Laboratories, National Center for Natural Products Research at the University of Mississippi, as well as numerous others.

Regarding testing methodology, I have attached a sampling of the primary nationally and internationally accepted methods for the testing of the various botanicals you tested and some guidance on what should be tested. While these tests can be applied to finished products, it is important to note they were specifically designed for raw materials and extract that go into finished products. Thus, finished product values may vary but should be close to the values provided. While it is likely such analytical methodologies are not familiar to you, they are familiar to any analytical chemist and can guide future analytical work that is scientifically valid, whereas the current DNA barcoding technology is likely not scientifically valid for determining the identity of botanical ingredient identity in extract products. Similarly, without an ability to do a quantitative assay, it is not appropriate for determining if a product is "contaminated" as acceptable limits of foreign organic matter will potentially show up as "contaminants", when in reality they may not be.

In conjunction with the American Botanical Council (ABC), Austin, TX and the University of Mississippi, Oxford, MS, AHP is engaged in an active review of herbal ingredients with the express purpose of identifying confirmed adulterations, raising awareness of such problems within industry, and to providing solutions, such as articulating the appropriate testing methodologies that should be conducted, as we have done above. This program has broad support from industry and academic institutes internationally showing that a significant segment of the herbal products market is committed to the quality and integrity of their products. More information about this program can be accessed at: http://cms.herbalgram.org/BAP/index.html?ts=1418665529&signature=003bdb220a482eabe942ba7e299089c4 &ts=1423272362&signature=49a186414e8b367db4d970c708a6deb3

We hope this information is helpful. If we can provide further guidance on botanical related issues, please let us know. We wish you well in your work.

Sincerely,

Roy Upton

Executive Director

American Herbal Pharmacopoeia

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