HerbalEGram: Volume 7, Number 12, December 2010
Taking a Closer Look at the US Black Cohosh Rhizome Trade
The
following article has been adopted from the International Trade Centre
Market News Service (ITC MNS) for Medicinal Plants & Extracts
Newsletter 36, September 2010, p. 45-52, with minor revisions. Reprinted
and revised with permission from ITC MNS Newsletter, Josef Brinckmann,
editor. (Mr. Brinckmann is a member of the ABC Advisory Board.)
The United States is the world‘s leading producer, consumer,
and exporter of the wild-harvested herbal drug black cohosh rhizome, which is native to eastern North America
from Ontario in the north, south to Georgia, and west to Missouri. Black cohosh
rhizome is traditionally used to help relieve muscle and joint pain associated
with rheumatic conditions (such as rheumatoid arthritis, osteoarthritis, and/or
fibrositis), among other therapeutic uses.
Botanical name:
Actaea racemosa L. (Family: Ranunculaceae) Synonym: Cimicifuga
racemosa L. Nutt. Common names: English
name: Black cohosh French name: Actée
noire German name:
Traubensilberkerze Spanish name:
Cimicifuga Pharmacopeial names: Cimicifugae rhizoma; Cimicifugae racemosae rhizoma
Definitions
Black Cohosh PhEur (European Pharmacopoeia) consists of the whole or
fragmented root and rhizome of A. racemosa harvested at the end of the
vegetation period. It contains a minimum of 1.0% triterpene glycosides
expressed as monoammonium glycyrrhizate (dried drug).1
Black Cohosh USP (United
States Pharmacopeia) consists of the dried rhizome and roots of A. racemosa
and is harvested in the summer. It contains not less than 0.4% of triterpene
glycosides, calculated as 23-epi-26-deoxyactein on the dried basis.2
Black Cohosh Fluidextract USP is prepared from Black
Cohosh USP by extraction with hydroalcoholic mixtures or isopropanol–water
mixtures. Each mL contains the extracted constituents of 1 g of plant material.
It contains not less than 90.0% and not more than 110.0% of the labeled amount
of triterpene glycosides, calculated as 23-epi-26-deoxyactein.
Powdered Black Cohosh Extract USP is prepared from Black
Cohosh USP by extraction with hydroalcoholic mixtures or other suitable
solvents. It contains not less than 90.0% and not more than 110.0% of the
labeled amount of triterpene glycosides, calculated as 23-epi-26-deoxyactein on
the dried basis.
Harmonized System
Tariff Codes (HS Codes)
Black cohosh rhizome HS 1211.90 Black cohosh extract HS 1302.19 (Source: World Customs Organization)
Native Habitat
Black cohosh is found growing in rich soils on wooded
hillsides of the Appalachian Mountains of North America. It ranges from
Southern Ontario and Wisconsin in the north, and south to South Carolina,
Georgia, Tennessee, Arkansas, and Missouri. It is considered to be relatively
more abundant in the southern portion of its range.3
Main Producing
Areas
In the United States, black cohosh is produced mainly in
Kentucky and Tennessee, but also in Georgia, Ohio, North Carolina, Michigan,
South Carolina, Virginia, West Virginia, Wisconsin,4 Arkansas, and
Missouri.5
Medicinal Uses
In the European Community black cohosh rhizome is regulated as
an active ingredient of licensed Well-Established-Use Herbal Medicinal Products
(WEU-HMPs) for oral use, requiring pre-marketing authorization from an EU
Member State National Authority. Therapeutic
indications are Herbal medicinal product for the relief of minor
neurovegetative menopausal complaints (such as hot flushes and sweating).6
In North America
(Canada), black cohosh rhizome is regulated as an active ingredient of
licensed Natural Health Products (NHPs) intended for oral use, which requires
premarketing authorization from Canada’s NHP Directorate. Therapeutic indications are as
follows:
(a) used in Herbal Medicine to help relieve muscle and joint
pain associated with rheumatic conditions (such as rheumatoid arthritis,
osteoarthritis, and/or fibrositis), and of pain associated with neuralgia (such
as sciatica);
(b) used in Herbal Medicine to help relieve the pain
associated with menstruation;
(c) used in Herbal Medicine to help relieve premenstrual
symptoms; and
(d) to help relieve symptoms associated with menopause.
The medicinal ingredient in Canadian products may comply with
the specifications outlined in the Black Cohosh, Black Cohosh Fluidextract,
Powdered Black Cohosh, Powdered Black Cohosh Extract, or the Black Cohosh
Tablets Monographs published in the USP.7
Quality Standards
The official pharmacopeial monographs for black cohosh rhizome
from PhEur and USP can be utilized for test and release specifications. Table 1, below, compares the
quality standards from the European Union and United States.
Table 1: Comparison
of Black Cohosh Rhizome Pharmacopeial Quality Standards
Standard
|
PhEur
|
USP-NF
|
Identification tests
|
Macroscopic ID Test A
|
Macroscopic ID Test
|
Microscopic ID Test B
|
Microscopic ID Test
|
Thin-layer chromatography
(TLC) ID Test C
|
Thin-layer chromatography
(TLC) ID Test A
|
TLC tests for detection of
adulterations with Cimicifuga americana,
C. foetida, C. dahurica and C.
heracleifolia
|
TLC Tests B and C for
detection of adulterations with Cimicifuga
foetida
|
Loss on drying
|
NMT 12% (PhEur 2.2.32)
|
NMT 12.0% (USP <731>)
|
Foreign matter
|
NMT 5% (PhEur 2.8.2)
|
NMT 2.0% of foreign organic
matter and NMT 5.0% of stem bases (USP <561>)
|
Total ash
|
NMT 10.0% (PhEur 2.4.16)
|
NMT 10.0% (USP <561>)
|
Acid insoluble ash
|
NMT 5.0% (PhEur 2.8.1)
|
NMT 4.0% (USP <561>)
|
Content
|
NLT 1.0% of triterpene
glycosides, expressed as monoammonium glycyrrhizate (C42H65NO16;
Mr 840) (dried drug) as determined by HPLC.
|
NLT 0.4% of triterpene
glycosides, calculated as 23-epi-26-deoxyactein*
(C37H56O10) on the dried basis
|
Alcohol soluble extractives
|
No standard
|
NLT 8.0% (USP <561>
Method II)
|
Microbial contamination
(Note: PhEur
limits are for herbal drugs that will be further prepared or processed with
boiling water)
|
Total Aerobic
Microbial Count: Acceptance criterion: 107 /g; Maximum acceptable
count: 50,000,000 /g
Total Yeast and
Mould Count: Acceptance criterion: 105 /g; Maximum acceptable
count: 500,000 /g
Escherichia
coli: Acceptance
criterion: 103 /g
Salmonella: Absence (25 g)
|
Total aerobic microbial
count NMT 105 /g
Combined molds & yeasts
NMT 103 / g
Bile-tolerant Gram-negative
bacteria NMT 103 / g
Salmonella
species – absent
Escherichia coli – absent
|
Pesticide residues
|
Meets the requirements PhEur General Chapter 2.8.13
|
Meets the requirements of
USP General Chapter <561>
|
Heavy metals
|
NMT 1.0 ppm cadmium; NMT 5.0
ppm lead; NMT 0.1 ppm mercury
|
NMT 10 µg per g (USP
<231>)
|
Production Scenario
A useful book describing black cohosh harvesting practices,
A Digger’s Guide to Medicinal Plants, 2nd edition, is available from
American Botanicals in Eolia, Missouri.5 The following information
on black cohosh production is based, in part, on information from A Digger’s Guide, written by A. Lockard
and A.Q. Swanson in 2004, as well as on supplementary information found in the
general chapters of the United States Pharmacopeia,8 which
itself is partly based on the 2002 American Herbal Pharmacopoeia (AHP) black
cohosh monograph.4
Black cohosh is harvested after the plant becomes
reproductive, a stage that occurs anywhere from 2 to 8 years of age in
cultivated plants, depending on growing techniques. A portion of the rhizome
with a visible bud should be left in the ground to resprout the following year.
Refraining from harvesting plants until after they have set seed and leaving a
portion of the rhizome in the ground to resprout are key components to
sustainable wild harvesting.
Rhizomes and roots should be harvested in autumn, when the
plant is dormant and the subterranean parts of the plant have lower moisture
content than in other seasons. Fall harvesting also allows plants to produce
mature seeds before being uprooted.8 The older more mature roots
should be harvested from the patch, leaving the younger ones for future
harvests. At least 20% of any patch should be left to reseed. Rotate patches
from year to year.5
After harvesting, rhizomes with roots may be processed
fresh or dried. They should be thoroughly washed directly after harvest and
then laid out to dry. Freshly harvested roots should be solid but not woody.
Rhizomes with roots are then cut and air-dried at 35º to 45º C. Fully dried
rhizomes and roots are brittle and snap easily, with no evident moisture in the
cross section, either visibly or to the touch.
Make certain that the roots are thoroughly dry before
storing in paper or burlap bags. Never use plastic bags for storing black
cohosh rhizomes. Follow general guidelines for storage by packing in airtight
containers protected from light, heat, moisture, and insect infestation.
The following information is
excerpted from a medicinal plant fact sheet on black cohosh rhizome that was
prepared by ethnobotanist and forest ecologist Jolie Lonner Egert.3
Black cohosh is a
slow-growing perennial with global demand. Because this species is primarily
wild harvested and the harvest results in mortality of the plant, wild black
cohosh populations may be susceptible to over-harvest. There are ongoing
efforts to research harvest impacts on black cohosh and provide information to
help collectors and resource manages make conservation decisions. Wild
populations must be monitored and greater emphasis must be given to
cultivation. The following good stewardship practices can help to maintain or
enhance wild black cohosh populations.
Wild-harvesters: Find out the legal
requirements for wild-harvesting black cohosh in your state; rotate harvest
areas; thin patches rather than collecting all available plants; leave a
portion of mature and juvenile individuals untouched; replant parts of
harvested roots.
Growers: Find out the legal
requirements for cultivating in your state; ensure planting stock is obtained
in a way that does not threaten wild populations; consult local experts and
resources for cultivation requirements in your area.
Practitioners and Consumers: Choose
sustainable-wildcrafted or verifiably cultivated sources of black cohosh bulk
herbs or supplements; use black cohosh only when it is best indicated; when
choosing substitutes, exercise caution not to choose a species that is equally
vulnerable to over-harvest.
Conservation status
In 2002, there was a proposal to include black cohosh in
Appendix II of the Convention on
International Trade of Endangered Species (CITES), but this was not
carried out.9 According to US Fish and Wildlife Service (USFWS
2002):
Black cohosh has a very broad range in eastern
North America and is frequently encountered in a wide variety of wooded
habitats across its range. It has not previously been proposed for CITES
listing. The primary threats to black cohosh are habitat loss and
over-collection. It is in great demand for its medicinal properties. Already
popular in Europe and Australia, where most of the harvest is shipped, black
cohosh has recently experienced a dramatic increase in consumption, especially
in the United States. Some raw material is exported from the United States to
Europe, where it is processed for re-export back to the United States.
Indicators show long-term growth in demand for black cohosh despite recent
wholesale price fluctuations. Most black cohosh is harvested from the wild in
the eastern United States. It is cultivated only on a very limited scale.
Average annual harvest from the wild is estimated to impact tens of millions of
individuals per year. Black cohosh is rare in Illinois, Massachusetts, Mississippi,
and Ontario, and extirpated in Iowa, but reportedly abundant in other portions
of its range.
However, many experts state with certainty that unsustainable
harvest is occurring and that populations are declining, especially on public
lands. Unauthorized collection on national forests is reported to be extensive,
and incidents of poaching from national parks have been documented in recent
years. Though it is unlikely that they are targeted for collection from the
wild, mountain bugbane (C. americana [=Actaea podocarpa]) and
Appalachian bugbane (C. [=Actaea] rubifolia) are suspected to be
incidentally collected along with black cohosh where they co-occur. There are
also 3 other species of Cimicifuga found in the western United States and
Canada that are likely to be indistinguishable in trade from C. racemosa. In
order to control illegal trade in these species and generate additional trade
data, we intend to review and consider listing US native species of the genus
Cimicifuga in CITES Appendix III. Consequently, the United States does not
intend to seek Appendix-II listing for this taxon at this time.
Market Prices
Information on spot market prices is available from some
wholesale distribution companies in the western United States. Larger quantity
pricing, such as pricing per metric ton, full-container-load (FCL) pricing, or
annual contract pricing would be significantly lower than these lower quantity
prices, which should be viewed cautiously as indicative only. Table 2, below, provides spot
market prices from 4 US companies: Good Hope Botanicals, Mountain Rose Herbs,
Pacific Botanicals, and San Francisco Herb & Natural Food Co.
Table
2: Black Cohosh Rhizome Spot Market Prices (USD per lb) / Selected U.S.
Distributors
Note: In the
U.S., many distributors sell in pound (lb) quantities rather than metric
kilogram (kg) quantities. 1 kg = 2.2046 lb.
Wholesale distributors
|
Processed
form
|
1-4 lb
|
5-9 lbs
|
10-24 lbs
|
25-49 lbs
|
50-99 lbs
|
>100 lbs
|
Good Hope
Botanicals
|
|
|
|
|
|
|
|
-
Wild collected
|
Cut and sifted
|
$13.90
|
$12.51
|
$11.82
|
$10.43
|
Inquire
|
Inquire
|
Mountain
Rose Herbs
|
|
|
|
|
|
|
|
-
Certified
organic
|
Cut and sifted
|
$19.50
|
$17.55
|
$16.58
|
$15.60
|
$13.65
|
$11.70
|
-
Certified
organic
|
Powdered
|
$22.00
|
$19.80
|
$18.70
|
$17.60
|
$15.40
|
$13.20
|
Pacific
Botanicals
|
|
|
|
|
|
|
|
-
Wild collected
|
Cut and sifted
|
$11.90
|
$10.60
|
$10.60
|
$10.00
|
$10.00
|
$9.20
|
-
Wild collected
|
Powdered
|
$13.50
|
$12.50
|
$12.50
|
$10.50
|
$10.50
|
$9.70
|
San
Francisco Herb & Natural Food Co.
|
|
|
|
|
|
|
|
-
Wild collected
|
Cut and sifted
|
$12.50
|
$11.88
|
$11.25
|
$10.63
|
Inquire
|
Inquire
|
-
Wild collected
|
Powdered
|
$12.75
|
$12.11
|
$11.48
|
$10.87
|
Inquire
|
inquire
|
-
Certified
organic
|
Powdered
|
$14.00
|
$13.30
|
$12.60
|
$11.90
|
Inquire
|
Inquire
|
SOURCES: Good Hope Botanicals http://www.goodhopebotanicals.com/herbs_spices.htm Mountain Rose Herbs Wholesale: http://www.mountainroseherbs.com/wholesale.html Pacific Botanicals Online Store: http://www.pacificbotanicals.com/store San Francisco Herb
& Natural Food Co. Wholesale Catalog 2010: http://www.herbspicetea.com/SFPromo.
Editor’s
Note: The American Botanical Council, publisher of HerbalEGram, has republished
for educational purposes only this pricing information as it was published in
the original version of the ITC/MNS newsletter. The listing of suppliers’ names
should not be misinterpreted as an ABC recommendation or endorsement of these
suppliers or the black cohosh raw materials.
Volume of North American Black
Cohosh Trade
Although this native American species is widely used in
Canada and the United States, much of the supply is exported to Europe, where
black cohosh extracts have become very popular remedies, particularly in
Germany which is the largest EU market. However, because black cohosh does not
have a unique 10-digit tariff code assigned in the Harmonized Tariff Schedule
of the United States (HTSUS), it would be difficult to determine how much of
the harvest is exported.
Estimates of annual trade quantities are available in trade
association surveys of member companies. In February 2007, the American Herbal Products Association (AHPA)
published its fifth survey quantifying annual harvests of selected native North
American medicinal and aromatic plants (MAPs) harvested from wild populations.
This report, the 2004–2005 Tonnage Survey of Select North American
Wild-Harvested Plants,10 covers harvests from 2004 to 2005 for
26 botanicals derived from 22 plant species. It features data on quantities of
wild-harvested and cultivated materials. Recognized as a vital index of native
US botanicals consumption, it also includes data from the 4 earlier surveys
dating back to 1997. AHPA is presently carrying out the sixth survey covering
the harvests from 2006 and 2007, a report on which should be published in 2010.
Table 3,
below, shows the estimated quantities
of black cohosh rhizome wild harvested and cultivated as reported in the AHPA
tonnage surveys. Over the 9-year period of surveys, the average annual trade
volume appears to be about 120,566 kg.
Table 3: Black Cohosh Estimated Annual Trade Quantities / 1997-2005 / dry
weight in kg
YEAR
|
Estimated
quantity (kg)
from
cultivation
|
Estimated
quantity (kg)
from
wild-collection
|
1997
|
0
|
102,967
|
1998
|
16,071
|
329,304
|
1999
|
1,179
|
65,938
|
2000
|
68
|
53,453
|
2001
|
2,958
|
80,596
|
2002
|
128
|
76,856
|
2003
|
186
|
144,309
|
2004
|
1,502
|
144,575
|
2005
|
3,143
|
61,857
|
9-year total
|
25,235
|
1,059,855
|
SOURCE: American Herbal Products Association. Tonnage
Survey of Select North American Wild-Harvested Plants, 2004-2005. Silver
Spring, MD: American Herbal Products Association. February 2007.
Each edition of the MNS
for Medicinal Plants & Extracts bulletin provides selected
specifications that are either industry specifications or specified quality
grades (e.g. PhEur-grade or USP-grade) commonly used by exporters and
importers. Table 4 provides a trade specification for powdered black cohosh
extract that corresponds to the USP quality standards monograph.
Table 4: Botanical Product Specifications For US Powdered
Black Cohosh Extract
PRODUCT
|
Powdered Black Cohosh Extract USP11
|
Botanical name
|
Actaea racemosa L. (Fam. Ranunculaceae).
|
Pharmacopoeial
name
|
Cimicifugae rhizoma extractum siccum normatum
|
Part used
|
Dried rhizome and roots collected in the
autumn
|
Cultivated or
wild
|
Mainly wild
collected; some supply may be cultivated
|
Production
|
The extract is
produced from Black Cohosh USP by extraction with hydroalcoholic
mixtures or other suitable solvents
|
Storage
|
Preserve in tight, light-resistant
containers, and store in a cool place.
|
|
|
IDENTIFICATION
|
|
Thin layer
chromatography (TLC)
|
TLC ID Test A;
TLC ID Test B
for detection of adulterations with other species (Cimicifuga foetida)
|
|
|
TESTS
|
|
Content
|
The extract contains not less than 90.0 percent and
not more than 110.0 percent of the labeled amount of triterpene glycosides,
calculated as 23-epi-26-deoxyactein (C37H56O10)
on the dried basis.
|
Loss on drying
|
NMT 5.0%
|
|
|
CONTAMINATION
|
|
Total aerobic microbial count
|
NMT 104
CFU/g
|
Total combined
yeast/moulds count
|
NMT 103
CFU/g
|
Escherichia coli
|
Absent in 10 g
|
Salmonella spp.
|
Absent in 10 g
|
|
|
Heavy metals
|
Maximum 10 µg per g
(USP Method II <231>)
|
Pesticide
residues
|
Meets the
requirements of USP General Chapter <561>
|
Residual
solvents
|
Meets the
requirements of USP General Chapter <561>
|
—Josef Brinkmann
References
1. European Pharmacopoeial Committee. Draft Monograph: Black
Cohosh. PHARMEUROPA. July 2010;22(3):265-268.
2. United States Pharmacopeial Convention. Black Cohosh. In: United
States Pharmacopeia – National Formulary (USP 32 – NF 27). Rockville, MD:
United States Pharmacopeial Convention. 2010.
3. Egert JL. Medicinal Plant Fact Sheet: Cimicifuga
racemosa / Black Cohosh. A collaboration of the IUCN Medicinal Plant
Specialist Group, PCA-Medicinal Plant Working Group, and North American
Pollinator Protection Campaign. Arlington, Virginia: PCA-Medicinal Plant
Working Group. April 2007. Available at: http://www.plantconservationwiki.org/wiki/images/4/4b/Fact_sheet-Cimicifuga_racemosa.pdf.
4. Upton R et al. Black Cohosh Rhizome. Actaea racemosa L. syn. Cimicifuga racemosa (L.) Nutt.
American Herbal Pharmacopoeia™ and Therapeutic Compendium. Santa Cruz,
CA: American Herbal Pharmacopoeia. 2002.
5. Lockard A, Swanson AQ. A Digger’s Guide to Medicinal
Plants, 2nd Edition. Eolia, MO: American Botanicals. 2004;19-22.
6. European Medicines Agency (EMEA) Committee on Herbal
Medicinal Products (HMPC). Draft Community Herbal Monograph on Cimicifuga
racemosa (L.) Nutt., Rhizoma. London, UK: EMEA. 17 Sep 2009. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Herbal_-_Community_herbal_monograph/2009/12/WC500018213.pdf
7. Health Canada Natural Health Products Directorate (NHPD).
Monograph: Black Cohosh. Ottawa, ON: Health Canada. 19 Sept 2008 Available at: http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monoReq.do?id=44&lang=eng
8. United States Pharmacopeia Convention. Supplemental
Information and General Guidance Protocols Black Cohosh Actaea racemosa L.
[Cimicifuga racemosa (L.) Nutt.] (Fam. Ranunculaceae). Pharmacopeial Forum:
2009;35(6):1551.
9. United
States Fish and Wildlife Service (USFWS). Conference of the Parties to the
Convention on International Trade in Endangered Species of Wild Fauna and Flora
(CITES); Twelfth Regular Meeting; Proposed Resolutions, Decisions, and Agenda
Items Being Considered; Taxa Being Considered for Amendments to the CITES
Appendices; Public Meeting Reminder. Federal Register. April 18,
2002;67(75):19207-19235.
10. American Herbal Products Association. Tonnage Survey of
Select North American Wild-Harvested Plants, 2004-2005. Silver Spring, MD:
American Herbal Products Association. February 2007.
11. United States Pharmacopeia Convention. Powdered Black Cohosh
Extract. In: United States Pharmacopeia – National Formulary (USP 32 – NF
27). Rockville, MD: United States Pharmacopeia Convention
|