FWD 2 Taking A Closer Look at the US Black Cohosh Rhizome Trade

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