Let’s be clear about DNA testing and herb identity. As we have stated in these pages in extensive articles in 2010 and 2013, DNA barcoding and related genetic testing methods are excellent means to determine the identity of plant raw materials, and DNA testing should be considered by the herb industry as another viable analytical tool to add to the existing “toolbox” of scientifically valid analytical methods. However, we have never suggested that DNA barcoding alone is appropriate for such testing (e.g., it cannot distinguish plant parts of the same plant, a Good Manufacturing Practices requirement in the US). In addition, as the recent case with the New York Attorney General’s misuse of DNA barcode testing has made abundantly clear, DNA testing is not appropriate for most herbal extracts, again, especially without corroboration and confirmation with other valid testing methods.
As reported in Tyler Smith’s extensively detailed overview of the NY AG’s actions thus far, the NY AG and retailer GNC have agreed that GNC will begin to employ DNA barcoding in its quality control regimens within 18 months. Per the deal, the NY AG has allowed GNC to resume sales in New York state of the six herbal extract supplements that, only a few weeks before, the NY AG had claimed were mislabeled, fraudulent, possibly “contaminated,” and posing a public health problem — all based on the NY AG’s sole reliance on DNA testing by a university lab with no apparent prior experience in this type of analysis.
The NY AG’s staff members have told industry representatives that they no longer care about the DNA issue — i.e., whether the method was appropriate or adequate — and thus presumably about the accuracy of the results. The NY AG has moved on to the bigger political issue of pushing the herb regulation agenda to the front pages and to Congress. In other words, the ends justify the means. However, as we went to press, the NY AG issued a statement with a trade organization suggesting his partial acknowledgement of the limitations of DNA testing, albeit three months after starting his campaign.
While we welcome a robust discussion of quality control related to herbal supplements, particularly with respect to their identity and authenticity — after all, ABC is the founding and managing partner in the four-year-old ABC-AHP-NCNPR Botanical Adulterants Program wherein we are attempting to educate industry and other interested stakeholders on issues related to accidental and intentional adulteration of botanical raw materials and extracts — we prefer to have such a discussion based on appropriate use of scientifically valid and validated analytical methodology. Accordingly, ABC will continue to press the issue regarding the NY AG’s entire case being built on probably faulty evidence — an analytical “house of cards” (or perhaps an even less-stable construction). As we stated previously in HerbalGram, we are attempting to defend appropriate scientific methodology and accuracy as a basis for legal action and public discourse.
This issue contains several articles related to botanical quality control. In addition to Tyler’s article on the NY AG DNA affair — probably one of the most extensively detailed on this subject — we also provide our Chief Science Officer Stefan Gafner’s review of two white papers released in March by experts on the capabilities and limitations of DNA analysis for herbal supplements — one by experts in analysis of botanical dietary supplements and the other by two former officials of the Food and Drug Administration. Although some critics might tend to dismiss the papers since they were commissioned and released by supplement industry trade associations, the content and results are scientifically and technologically sound and would most likely be generally accepted by most medicinal plant analytical experts.
Another article on “Botanical Integrity” is submitted by our good friends at the College of Pharmacy at the University of Illinois at Chicago, an internationally recognized center for medicinal plant research. New ABC Advisory Board member Professor Guido Pauli and UIC colleagues have written the first part of a proposed series on botanical integrity, i.e., the use of scientific techniques to assess botany (including DNA testing), chemistry, and biological activity (including safety), all of which are required to adequately determine the “integrity” of the botanical material.
In this issue we also warmly welcome 13 new members to our Advisory Board, including medicinal plant experts from Australia, Canada, Germany, the United Kingdom, and United States. The growing and increasingly international ABC Advisory Board provides a broad range of volunteer expert services to ABC, including peer review of ABC publications, advice on ABC policy, and more.
Finally, this issue contains six obituaries of persons who have contributed significantly to the botanical and medicinal plant community, some of whom have passed at relatively young ages — a reminder to all of us to make every day, and every breath, count.