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Herbal Quality Consortium Publishes Major Article on Black Cohosh Adulteration
(AUSTIN, Texas, May 28, 2013)
Interest in the North American herb black cohosh (Actaea racemosa;
synonym, Cimicifuga racemosa) has increased immensely during the past 60
years, and with it, incidences of accidental and economically motivated
adulteration with lower-cost Chinese species whose scientific names may appear
similar. “Exploring the
Peripatetic Maze of Black Cohosh Adulteration,” a new report by noted author and photographer
Steven Foster, has been published in the latest issue of HerbalGram, the
peer-reviewed journal of the nonprofit American Botanical Council.1
The article is the latest in a series from the ABC-AHP-NCNPR
Botanical Adulterants Program. The
report thoroughly examines the many facets of the real concern of black cohosh
adulteration, including confusing nomenclature, market economics, history of
alleged liver toxicity possibly associated with the adulterants, and analytical
tests available to ensure correct identity of black cohosh.
Black cohosh frequently is used to treat symptoms of menopause, in addition to
other conditions related to female reproductive health that have been supported
to various extents by published clinical trials. In the United States, it is
unlawful for any herb other than Actaea racemosa to be sold as black
cohosh. The article states, “Any designation of a botanical material or
finished product in the US by the common name of ‘black cohosh’ on product
labels (and presumably in the supply chain) is required to be Actaea
racemosa and no other species.” To apply the name “black cohosh” to any
other species violates federal law, resulting in misbranding of the finished
product offered to consumers. Such a product is considered adulterated under
the law.
“The sheer volume of offerings, prices ranges, varied specifications, and
differing species listed as ‘black cohosh extract’ from Chinese sources
requires that the daunted buyer [in the herb industry] attempting to source
black cohosh work closely with a qualified analytical lab to authenticate black
cohosh extracts before securing any supply source,” the report says.
In 2002, reports of alleged liver toxicity related to black cohosh began to
appear. According to the report, adulteration of black cohosh with other plant
species is likely to blame, at least in part, for those incidents, as later
analyses found the association of true black cohosh with liver disease to have
a weak or uncertain causal link or no causal link at all.
The report states that, “Mislabeling or confusion may be due to simple language
and translation variations, or, in some cases, the actual intent to sell a
lower-cost material that is not an acceptable substitute for authentic North
American black cohosh. However, these are possibly moot points as all of the
identification and authentication scientific tools necessary to distinguish
authentic black cohosh from any other plant materials of any origin are readily
available.”
A number of laboratory authentication methods are outlined by Foster, including
various types of chemical testing and the more recently developed DNA
fingerprinting. The report also cites the American Herbal Pharmacopoeia’s (AHP)
2002 black cohosh rhizome monograph, a comprehensive resource on known
adulterants that includes botanical, microscopic, and chemical analyses of
black cohosh.2
AHP executive director Roy Upton, editor of the AHP Black Cohosh
Rhizome monograph stated, "This issue
of black cohosh adulteration is not new. The black cohosh monographs of
AHP and the U.S. Pharmacopeia, as well as a number of analytical papers
published the past few years, provide the primary tools needed by industry to
develop appropriate specifications and implement the necessary quality control
processes to keep adulterated materials from entering into the
consumer product market. The key is to get this information disseminated to
management, quality control, analytical, and purchasing personnel in
the herb and dietary supplement industry. This is the goal of the Botanical
Adulterants Program."
“Solving the problem of economic adulteration of black cohosh products is
within reach,” according to the report. “Many in the herb industry are acutely
aware of the need for fulfillment of current Good Manufacturing Practices
(cGMPs) as FDA increases cGMP inspections, compliance, and the issuance of
letters [by the US Food and Drug Administration]. Clearly, the crux of the
problem of black cohosh adulteration lies squarely on the doorstep of
intentional economic adulteration of black cohosh with less expensive materials
from China.”
“From this point on, there is literally no excuse for any manufacturer or
reseller of herbal dietary supplements to purchase raw material or extracts
labeled as being ‘black cohosh’ without conducting appropriate analytical
procedures to verify and authenticate the herb’s proper identity,” said Mark
Blumenthal, founder and executive director of ABC, and editor-in-chief of HerbalGram.
“In our view, anyone offering for sale the Chinese species of Actaea (primarily
A. cimicifuga, A. dahurica, A. heracleifolia, and A. simplex)
as ‘black cohosh’ is most likely knowingly selling adulterated material. This
is likely fraud, and such sellers of these adulterants should be prosecuted to
the fullest extent of the law.”
“The first priority in quality control of botanicals is ensuring proper
identity,” Blumenthal continued. “There are many ethical and responsible
manufacturers of black cohosh dietary supplements that produce authentic
products. It is highly unfortunate that this traditional North American herb
has been adulterated by suppliers of inauthentic raw materials.”
Blumenthal added that, “The purpose and intention of the ABC-AHP-NCNPR
Botanical Adulterants Program is to educate the botanical dietary supplement industry
and its related stakeholders regarding the presence of confirmed botanical
adulterants within the global supply chain. This helps manufacturers ensure
that they detect adulterated material so that their products contain properly
identified, authenticated herbal raw materials and extracts. Ultimately, this
Program’s vision is that consumers will have access to more reliable dietary
supplements and related herbal products.”
“It is past time for all members of the herb and dietary supplement
industry in the United States, and the botanical products industry around the
world, to institute and adhere to appropriate quality control measures related
to properly identifying and authenticating black cohosh products, as well as
all herbal products,” wrote Blumenthal in his Dear Reader column in the same issue of HerbalGram.3
This comprehensive black cohosh
adulteration report contains
several tables and 91 references, is the fifth article in the ABC-AHP-NCNPR
Botanical Adulterants Program series, and is the fourth that has been written
by Foster. Foster’s previous articles in the series include the history of
adulteration of herbs, spices, and botanical drugs during the past 2,000 years; the
adulteration of skullcap (Scutellaria
lateriflora) with germander (Teucrium spp.); and the
adulteration of commercial bilberry (Vaccinium myrtillus) extracts. The series also includes a review article by John H. Cardellina II, PhD, of
analytical studies on so-called
“grapefruit seed extract,” which
has been shown to be adulterated with synthetic industrial disinfectants.
References
1. Foster S. Exploring the
peripatetic maze of black cohosh adulteration. HerbalGram. 2013;98:32-51.
Available at: http://cms.herbalgram.org/herbalgram/issue98/hg98feat-blackcohosh.html.
2. Upton R (ed). Black Cohosh
Rhizome, Actaea racemosa L., syn. Cimicifuga racemosa (L.) Nutt.:
Standards of Analysis, Quality Control, and Therapeutics. Santa Cruz, CA:
American Herbal Pharmacopoeia; 2002.
3. Blumenthal M. Adulteration of
black cohosh [Dear Reader column]. HerbalGram. 2013;98:6. Available at: http://cms.herbalgram.org/herbalgram/issue98/hg98dearreader.html.
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 research and education on medical herbs and other beneficial plants: the American Botanical Council, the American Herbal Pharmacopoeia, and the National Center for Natural Products Research at the University of Mississippi. The program is underwritten or endorsed
by more than 100 natural product industry companies, independent analytical
laboratories, contract research organizations, nonprofit and professional
organizations, trade associations, accredited institutions of education in
natural medicine, law firms, and media companies — which are involved in the
production, supply, manufacture, distribution, marketing, analysis, research,
and/or education of herbal dietary ingredients and supplements, in the United
States and internationally. 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.
Underwriters and Supporters of the ABC-AHP-NCNPR
Botanical Adulterants Program (as of May 23, 2013)*
Financial
Underwriters
21st Century Healthcare
AdvoCare International L.P.
Amen Clinics
Amway/Nutrilite Health Institute
Aveda Corporation
BI Nutraceuticals
Bioceuticals
Blackmores
Cepham, Inc.
Chemi Nutra
dicentra, Inc.
Doctor's Best
Dr. Bronner's Magic Soaps
Emerson Ecologics
Enzymatic Therapy, Inc.
Ethical Naturals, Inc.
EuroMed
EuroMedica
EuroPharma
Eu Yan Sang International
Flavex Naturextrakte GmbH
FoodState/MegaFood
Gaia Herbs
Gencor Nutrients, Inc.
GNC, Inc.
Helios Corp.
Herbalife International, Inc.
Herb Pharm
Horphag Research
Indena USA, Inc.
Markan Global Enterprises, Inc.
Martin Bauer, Inc.
Metabolic Maintenance Products
Metagenics, Inc.
Natural Factors Nutritional
Products, Inc./Bioclinic Naturals
Nature's Sunshine Products
Nature's Way
Naturex, Inc.
NBTY, Inc.
New Chapter, Inc.
The New Frontier Foundation Fund
of the Greater Cedar Rapids
Community Foundation
Ningbo Greenhealth
Pharmaceutical Co., Ltd.
Novel Ingredients
NOW Foods
Nu Skin Enterprises/Pharmanex
Nutritional Laboratories
International
Pacific Nutritional Inc.
Paragon Laboratories
Perrigo Company
Pharmavite, LLC
Pure Encapsulations
Rainbow Light Nutritional Systems
RFI Ingredients, LLC
Sabinsa Corporation
Schwabe North America
Standard Process, Inc.
Thorne Research, Inc.
Traditional Medicinals, Inc.
Triarco Industries, Inc.
Valensa International
V.D.F. FutureCeuticals
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Verdure
Sciences
Vitamin Shoppe
Weil Lifestyle, LLC
Whole Foods Market
ZMC-USA
Trade Associations
Consumer Healthcare Products
Association
Council for Responsible Nutrition
Natural Products Association
United Natural Products AllianceNonprofit/Professional
Associations
American
Association of
Naturopathic Physicians
Council of Colleges of Acupuncture
and Oriental Medicine Colleges/Universities
Bastyr
University
Boucher Institute of Naturopathic
Medicine
National College of Natural Medicine
Southwest College of Naturopathic
Medicine
University of Bridgeport College of
Naturopathic Medicine
Third-Party
Analytical Laboratories
Alkemists
Laboratories
Bent Creek Institute
British Columbia Institute of
Technology
ChromaDex
Covance Laboratories
Eurofins Scientific Inc.
Flora Research Labs
NSF International
Spectrix Labs
Tampa Bay Analytical Media
Delicious
Living
Engredea
Functional Ingredients
Integrator Blog
Natural Foods
Merchandiser
Natural Products INSIDER
New Hope 360.com
Nutraceuticals World
NutraingredientsUSA.com
Nutritional Outlook
Nutrition Business
Journal
Nutrition Industry
Executive
Virgo Publishing
Vitamin Retailer
Whole Foods Magazine Law
Firms
Amin
Talati, LLC
Greenberg
Traurig, LLP (James
Prochnow)
Law
Office of Holly Bayne, P.C.
Contract
Research Organizations
KGK
Synergize
Medicus
Research
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*By
acknowledging the generous support of these companies and organizations, ABC,
AHP, and NCNPR are not endorsing any ingredients or products that may be
produced or marketed by them.
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