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Regulating the Regulators: NY AG Relies Only on DNA Testing for Commercial Herbal Supplements – Significant Problems with the Misuse of an Analytical Method

As many are now aware, on February 3, New York State Attorney General Eric T. Schneiderman announced that he had commissioned lab testing of a total of seven herbal dietary supplements sold by four major national retail chains. The test results indicated that most of the supplements were deficient in regards to identity and purity. Extensive mainstream media coverage followed the lamentable lead of the New York Times, which introduced the story with a front-page, above-the-fold article by reporter Anahad O’Connor. Mr. O’Connor contacted the American Botanical Council (ABC) for input, but our comment was not included. We issued a press release questioning if any of the tested products were extracts in pill form, which subsequent information has suggested that possibly about 75% were. Experts have noted that using DNA testing alone to identify an extract in a single-herb commercial product has limited application as most plant extracts do not contain the DNA of the source plant material; also, heat and other processing conditions can degrade any DNA that may migrate into an extract. Many medicinal plant and analytical experts believe that the NY AG relied too heavily on results determined solely by the DNA testing method, and that other appropriate analytical methods also should have been used. Validated methods published in official pharmacopeias include microscopy to identify plant cell structures and various chemical tests to detect the presence or absence of key chemical marker compounds that are characteristic of the herbs and their extracts. As we pointed out to the Associated Press and in other media interviews, Mr. Schneiderman, the highest law enforcement official in New York, should be committed to the highest levels of due diligence — procedurally and scientifically. Unfortunately, this appears questionable.

ABC is not attempting to defend the tested products or the companies; instead, we, and many others, question the appropriateness of the analytical method and scientific protocol used in this case, on which legal and regulatory enforcement actions have been based. One of many problems is that consumers have a misunderstanding of the relevance of DNA in herbal extracts due to some popular media such as television crime dramas, and will presume that the NY AG’s methods and data are accurate and sufficient.

The American Herbal Pharmacopoeia (AHP) sent a 58-page document to the NY AG that presented pharmacopeial standards and test methods for all of the seven contested herbs, and the United States Pharmacopeia has issued statements emphasizing the need for multiple analytical methods to confirm the identity of botanical supplements.

ABC is the managing partner, with AHP and the University of Mississippi’s National Center for Natural Products Research (NCNPR; a Food and Drug Administration-funded Center of Excellence for Botanical Dietary Supplement Research), in the ABC-AHP-NCNPR Botanical Adulterants Program, an international educational program designed to educate industry members and related stakeholders about the prevalence of adulteration of botanical dietary ingredients and supplements. We recognize that there is a quality problem in the global herbal industry. However, the actions of the NY AG — which we have called premature — do not meet the criteria for the basis of strong evidence for rational law enforcement and only further muddy the water regarding the perception of the quality of herbal products. Consumers deserve both reliable herbal products and responsible and accountable actions from their elected officials. The misuse of analytical methods and lack of scientific discipline do not benefit the public’s welfare.

In this issue, our friend and ABC Advisory Board member Giovanni Appendino and his colleagues in Italy have reviewed the Mediterranean plant Helichrysum italicum, a traditionally used herb and source of an essential oil with a wide range of applications.

As part of our ongoing series of herb profiles, veteran ABC staffer Gayle Engels and ABC Advisory Board member Josef Brinckmann of Traditional Medicinals provide a concise review of andrographis, one of my most trusted herbs during cold-and-flu season.

Finally, old friend and herbal tea expert Brian Keating and HerbalGram Editor Ash Lindstrom and colleagues have written this publication’s first-ever Tea Market Report. The 2014 Tea Market Report joins our long series of Herb Market Reports, which are often our most-cited articles.