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 has
published a new Laboratory Guidance Document on black cohosh (Actaea racemosa) root and
rhizome. The new LGD is part of the Program’s series of
comprehensive, authoritative, extensively peer-reviewed, and up-to-date
summaries and assessments of analytical methods for the authentication of
botanical ingredients and the detection of potential adulterants.
The
approximately 8,000-word document on black cohosh is the third publication in the
ongoing series of Laboratory Guidance Documents (LGDs). The Program released
lab guidance for bilberry (Vaccinium myrtillus) fruit extract in August and for skullcap (Scutellaria lateriflora) herb in January. Published and
unpublished analytical reports have shown that each of these herbs is subject
to adulteration in both US and international markets.
“Adulteration
of black cohosh, mainly with herbal ingredients from Chinese Actaea species, remains a
problem in the dietary supplement industry,” noted Stefan Gafner, PhD, chief
science officer of ABC and technical director of the Botanical Adulterants
Program. “In the absence of easily recognizable morphological features, e.g.,
when cut or powdered roots and rhizomes, or root and rhizome extracts are
purchased, authentication of black cohosh material is difficult.”
The
Program’s LGDs are intended for quality control personnel and lab technicians
in the herbal medicine, botanical ingredient, dietary supplement, and food
sectors of industry to help them choose the most appropriate techniques and
methods for their specific analytical needs. The LGDs provide reliable, expert
guidance on suitable methods to comply with the mandate to establish identity
as part of the testing requirements (identity, purity, strength, and
composition) outlined in the US Food and Drug Administration’s current Good Manufacturing Practices (cGMPs)
for dietary supplements and/or conventional foods, as well as
government-mandated cGMPs in other countries.
According to
the black cohosh LGD, “Authentication of cut or powdered black cohosh rhizome
is challenging due to the existence of closely related and sometimes
co-habiting Actaea
species with similar morphological features and chemical composition.… The need
for sound analytical methods is further emphasized by the abundance of
materials from China sold as ‘black cohosh’ but composed of root and sub-aerial
material from entirely different species.”
Dr. Gafner
explained that the new BAP publication is designed to help address this
confusion. “This Laboratory Guidance Document discusses the advantages and
shortcomings of various analytical approaches to authenticate black cohosh and
to detect adulteration, and it will help in making an educated choice when
selecting the appropriate method in a quality control setting,” he said.
The black
cohosh LGD’s conclusions are based on a thorough review of available analytical
methods (e.g., from official and unofficial compendia [e.g., pharmacopeias], as
well as the peer-reviewed scientific literature) and input from peer reviewers
from academia, government, and industry in multiple countries. The black cohosh
LGD was peer-reviewed by 20 such experts. The primary assessment of each method
is based on its performance characteristics (i.e., suitability in detecting
known adulterants, if they
are present in a tested material); labor and analysis time comprise the
secondary evaluation criteria.
“We have
received overwhelmingly positive feedback on our previous two Lab Guidance
Documents from dozens of quality control and analytical laboratory directors in
the herb and dietary supplements industry as well as directors at third-party
laboratories,” said Mark Blumenthal, founder and executive director of the nonprofit
American Botanical Council and director of the Botanical Adulterants Program.
“Experts in academia, government, and industry recognize the high level of
value of these documents. They are a strong tool in helping to choose an
appropriate analytical method to authenticate botanical materials and extracts
and to detect possible adulteration.”
Like the
previous two LGDs in this series of technical publications, the black cohosh
LGD begins with a statement of purpose and scope, followed by a short overview of
the botanical nomenclature of the species and its known adulterants. Also
included are sections on analytical techniques (generally including
macroscopic, microscopic, chemical, and genetic assays) and a phytochemical
composition overview of the species and known adulterants. The LGDs conclude
with a concise table of strengths and limitations of the various assays.
Complete references are provided with links to original source documents.
The black
cohosh guidance document reviews 36 analytical methods, including macroscopic and
microscopic analyses, DNA-based tests, high-performance thin-layer
chromatography (HPTLC), high-performance liquid chromatography (HPLC) and
nuclear magnetic resonance (NMR), among others. The LGD includes three tables,
five figures, and an appendix with expert comments on published HPLC methods
for A. racemosa.
LGDs are
available to industry members, researchers, health professionals, and the
general public at no cost as part of the Botanical Adulterants Program’s policy
of producing freely available educational documents on adulteration, made
possible through funding by the Program’s underwriters and supporters. So far,
more than 170 American and international parties have financially supported or
otherwise endorsed the Program.
To date, the
ABC-AHP-NCNPR Botanical Adulterants Program has published five extensively
peer-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 cohosh
adulteration. These open-access articles are available on the
Program’s webpage. The Program also publishes a
quarterly e-newsletter, the "Botanical Adulterants Monitor," that
highlights new scientific publications related to botanical authenticity and
analysis to detect possible adulteration, recent regulatory actions, and
Program news. BAP plans to publish its fourth Lab Guidance document on the
detection of adulterants in so-called “grapefruit seed extract” in the coming
months.
About
Black Cohosh
Black cohosh
(Actaea racemosa,
syn. Cimicifuga racemosa)
belongs to the buttercup family (Ranunculaceae) and is native to eastern
portions of North America. It is a perennial herb that can grow up to eight
feet 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 milk
production, and to treat rheumatism, snake bites, and nervous system disorders.
Modern research has focused on the root’s ability to relieve menopausal
symptoms, with numerous human clinical trials supporting these effects.
Black
cohosh root is typically sold in whole, powdered, and liquid or dry extract
forms. In 2014, the botanical was the fourth highest-grossing herbal dietary supplement
in US mainstream retail outlets with total documented sales of more than $42.4
million, plus additional sales in other market channels. More information on
potential adulteration concerns (e.g., from nomenclatural confusion of North
American and Asian species of Actaea)
can be found in a detailed 2013 article in HerbalGram issue 98.
About
the ABC-AHP-NCNPR Botanical Adulterants Program
The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium
of independent nonprofit organizations whose mission relates to education,
scientific research, and quality of botanical dietary ingredients and related
plant-derived materials. The consortium is headed by three nonprofit groups
dealing with education and research on medicinal herbs and other beneficial
plants: the American Botanical Council, the American Herbal Pharmacopoeia (AHP), and the National Center for Natural
Products Research at the University of Mississippi (NCNPR). The program has been
underwritten and/or endorsed by more than 170 natural products industry
companies, independent analytical laboratories, nonprofit and professional
organizations, industry trade associations, accredited institutions of
education in natural medicine, and other parties that are involved in the
production, supply, manufacture, distribution, marketing, analysis, research,
and/or education of herbal ingredients and products, in the United States and
internationally. All publications of the Program are available free-access on
the Program’s homepage including the "Botanical Adulterants Monitor," an
e-newsletter that conveys Program news, regulatory updates, and recent
scientific publications related to adulteration, contamination, identity, and
authenticity of botanical raw materials, extracts, and essential oils.
Companies, organizations, foundations, and/or individuals interested in
supporting this program are invited to contact Ms. Denise Meikel, ABC
Development Director, at (512) 926-4900, ext. 120, or by email.