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ABC-AHP-NCNPR Botanical Adulterants Program Publishes Black Cohosh Laboratory Guidance Document

International quality consortium’s third Lab Guidance Document reviews 36 laboratory methods for the analysis of black cohosh root and rhizome to ensure proper identity and to detect potential adulterants

AUSTIN,Texas(December 2, 2015) — The ABC-AHP-NCNPR Botanical Adulterants Program haspublished a new Laboratory Guidance Document on black cohosh (Actaea racemosa) root andrhizome. The new LGD is part of the Program’s series ofcomprehensive, authoritative, extensively peer-reviewed, and up-to-datesummaries and assessments of analytical methods for the authentication ofbotanical ingredients and the detection of potential adulterants.

Theapproximately 8,000-word document on black cohosh is the third publication in theongoing series of Laboratory Guidance Documents (LGDs). The Program releasedlab guidance for bilberry (Vaccinium myrtillus) fruit extract in August and for skullcap (Scutellaria lateriflora) herb in January. Published andunpublished analytical reports have shown that each of these herbs is subjectto adulteration in both US and international markets.

“Adulterationof black cohosh, mainly with herbal ingredients from Chinese Actaea species, remains aproblem in the dietary supplement industry,” noted Stefan Gafner, PhD, chiefscience officer of ABC and technical director of the Botanical AdulterantsProgram. “In the absence of easily recognizable morphological features, e.g.,when cut or powdered roots and rhizomes, or root and rhizome extracts arepurchased, authentication of black cohosh material is difficult.”

TheProgram’s LGDs are intended for quality control personnel and lab techniciansin the herbal medicine, botanical ingredient, dietary supplement, and foodsectors of industry to help them choose the most appropriate techniques andmethods for their specific analytical needs. The LGDs provide reliable, expertguidance on suitable methods to comply with the mandate to establish identityas part of the testing requirements (identity, purity, strength, andcomposition) outlined in the US Food and Drug Administration’s current Good Manufacturing Practices (cGMPs)for dietary supplements and/or conventional foods, as well asgovernment-mandated cGMPs in other countries.

According tothe black cohosh LGD, “Authentication of cut or powdered black cohosh rhizomeis challenging due to the existence of closely related and sometimesco-habiting Actaeaspecies with similar morphological features and chemical composition.… The needfor sound analytical methods is further emphasized by the abundance ofmaterials from China sold as ‘black cohosh’ but composed of root and sub-aerialmaterial from entirely different species.”

Dr. Gafnerexplained that the new BAP publication is designed to help address thisconfusion. “This Laboratory Guidance Document discusses the advantages andshortcomings of various analytical approaches to authenticate black cohosh andto detect adulteration, and it will help in making an educated choice whenselecting the appropriate method in a quality control setting,” he said.

The blackcohosh LGD’s conclusions are based on a thorough review of available analyticalmethods (e.g., from official and unofficial compendia [e.g., pharmacopeias], aswell as the peer-reviewed scientific literature) and input from peer reviewersfrom academia, government, and industry in multiple countries. The black cohoshLGD was peer-reviewed by 20 such experts. The primary assessment of each methodis based on its performance characteristics (i.e., suitability in detectingknown adulterants, if theyare present in a tested material); labor and analysis time comprise thesecondary evaluation criteria.

“We havereceived overwhelmingly positive feedback on our previous two Lab GuidanceDocuments from dozens of quality control and analytical laboratory directors inthe herb and dietary supplements industry as well as directors at third-partylaboratories,” said Mark Blumenthal, founder and executive director of the nonprofitAmerican Botanical Council and director of the Botanical Adulterants Program.“Experts in academia, government, and industry recognize the high level ofvalue of these documents. They are a strong tool in helping to choose anappropriate analytical method to authenticate botanical materials and extractsand to detect possible adulteration.”

Like theprevious two LGDs in this series of technical publications, the black cohoshLGD begins with a statement of purpose and scope, followed by a short overview ofthe botanical nomenclature of the species and its known adulterants. Alsoincluded are sections on analytical techniques (generally includingmacroscopic, microscopic, chemical, and genetic assays) and a phytochemicalcomposition overview of the species and known adulterants. The LGDs concludewith a concise table of strengths and limitations of the various assays.Complete references are provided with links to original source documents.

The blackcohosh guidance document reviews 36 analytical methods, including macroscopic andmicroscopic analyses, DNA-based tests, high-performance thin-layerchromatography (HPTLC), high-performance liquid chromatography (HPLC) andnuclear magnetic resonance (NMR), among others. The LGD includes three tables,five figures, and an appendix with expert comments on published HPLC methodsfor A. racemosa.

LGDs areavailable to industry members, researchers, health professionals, and thegeneral public at no cost as part of the Botanical Adulterants Program’s policyof producing freely available educational documents on adulteration, madepossible through funding by the Program’s underwriters and supporters. So far,more than 170 American and international parties have financially supported orotherwise endorsed the Program.

To date, theABC-AHP-NCNPR Botanical Adulterants Program has published five extensivelypeer-reviewed and referenced articles on the history of adulteration,adulteration of skullcap herb, and adulteration of bilberry fruit extract,so-called “grapefruit seed extract,” and a comprehensive 12,500-word article on black cohoshadulteration. These open-access articles are available on theProgram’s webpage. The Program also publishes aquarterly e-newsletter, the "Botanical Adulterants Monitor," thathighlights new scientific publications related to botanical authenticity andanalysis to detect possible adulteration, recent regulatory actions, andProgram news. BAP plans to publish its fourth Lab Guidance document on thedetection of adulterants in so-called “grapefruit seed extract” in the comingmonths.

AboutBlack Cohosh

Black cohosh(Actaea racemosa,syn. Cimicifuga racemosa)belongs to the buttercup family (Ranunculaceae) and is native to easternportions of North America. It is a perennial herb that can grow up to eightfeet tall with small, white flowers and stalk-like racemes (flower clusters)that resemble fluffy spikes.

Traditionally,black cohosh has been used as an insect repellent, to stimulate breast milkproduction, and to treat rheumatism, snake bites, and nervous system disorders.Modern research has focused on the root’s ability to relieve menopausalsymptoms, with numerous human clinical trials supporting these effects.

Blackcohosh root is typically sold in whole, powdered, and liquid or dry extractforms. In 2014, the botanical was the fourth highest-grossing herbal dietary supplementin US mainstream retail outlets with total documented sales of more than $42.4million, plus additional sales in other market channels. More information onpotential adulteration concerns (e.g., from nomenclatural confusion of NorthAmerican and Asian species of Actaea)can be found in a detailed 2013 article in HerbalGram issue 98.

Aboutthe ABC-AHP-NCNPR Botanical Adulterants ProgramThe ABC-AHP-NCNPR Botanical Adulterants Program is a consortiumof independent nonprofit organizations whose mission relates to education,scientific research, and quality of botanical dietary ingredients and relatedplant-derived materials. The consortium is headed by three nonprofit groupsdealing with education and research on medicinal herbs and other beneficialplants: the American Botanical Council, the American Herbal Pharmacopoeia (AHP), and the National Center for NaturalProducts Research at the University of Mississippi (NCNPR). The program has beenunderwritten and/or endorsed by more than 170 natural products industrycompanies, independent analytical laboratories, nonprofit and professionalorganizations, industry trade associations, accredited institutions ofeducation in natural medicine, and other parties that are involved in theproduction, supply, manufacture, distribution, marketing, analysis, research,and/or education of herbal ingredients and products, in the United States andinternationally. All publications of the Program are available free-access onthe Program’s homepage including the "Botanical Adulterants Monitor," ane-newsletter that conveys Program news, regulatory updates, and recentscientific publications related to adulteration, contamination, identity, andauthenticity of botanical raw materials, extracts, and essential oils.Companies, organizations, foundations, and/or individuals interested insupporting this program are invited to contact Ms. Denise Meikel, ABCDevelopment Director, at (512) 926-4900, ext. 120, or by email.