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Botanical Adulterants Program Bulletin on Adulteration of Hydrastis canadensis root and rhizome
By Michael Tims, PhDMaryland University of Integrative Health, 7750 Montpelier Road,
Laurel, MD 20723
Correspondence: email
Keywords:
Hydrastis
canadensis, goldenseal
root, adulterant, adulteration
Goal: The goal of this bulletin is to
provide information and/or updates on issues regarding adulteration of goldenseal
(Hydrastis canadensis) root to the international
herbal industry and extended natural products community in general. It is
intended to present the available data on occurrence of adulteration, the
market situation, and consequences for the consumer and the industry.
1
General Information
1.1
Common name: Goldenseal1,2
1.2
Other common names:
English: Yellow root, yellow puccoon, ground
raspberry, wild curcuma*, Indian dye, eye root, eye balm, Indian paint,
jaundice root, Warnera3,4
French: Hydraste du Canada,
hydraste, fard inolien, framboise de terre, sceau d’or5
German: Goldsiegelwurzel, Kanadische Gelbwurz, Kanadische
Orangenwurzel5
Italian: Idraste, radice gialla6
Spanish: Hidrastis, hidrastis de Canadá, raíz
de oro, scello de oro5
1.3
Accepted Latin binomial: Hydrastis canadensis7,8
1.4 Botanical family:
Ranunculaceae
1.5
Plant part and form: Whole
fresh or dry roots and rhizomes, powdered dry roots and rhizomes, hydroalcoholic
and glycerin-water extracts and powdered dry extracts.9,10 Dried
whole or powdered roots and rhizomes complying with the United States Pharmacopeia (USP) are required to contain not less
than 2.0% of hydrastine and not less than 2.5% berberine.10
1.6
General use(s): Native American tribes used goldenseal root and rhizome preparations
as eye washes, treatments for skin disorders, bitter tonics, and for
respiratory ailments and the infectious diseases brought by European settlers.11
The plant was included in The American Eclectic Materia Medica and Therapeutics12 and King’s
American Dispensatory,13 which increased its use substantially
among Eclectic physicians for infections, mouth ulcers and thrush, inflamed
mucous membranes, chronic gonorrhea, jaundice, gastrointestinal complaints, as
a bitter tonic and as a uterine tonic. Goldenseal preparations are now used as
antimicrobial agents to treat infections of the mucosal membrane, including
mouth, upper respiratory tract, gastrointestinal tract, eyes, vagina, as well
as for wounds.9
2
Market
2.1
Importance in the trade: Echinacea-goldenseal
combination dietary supplements were ranked #15 in sales in the natural food
channel in the United States in 2013 and in 2014 (Table 1), with estimated
sales exceeding $5 million in 2014. Sales in the Mainstream
Multi-Outlet retail channel (excluding sales
data from Walmart and Club stores in 2013 and 2014, which were not available) were lower,
with echinacea-goldenseal products ranking between #41 and #53. (T. Smith [American
Botanical Council] e-mail to S. Gafner, September 2, 2015 and September
3, 2015)14,15
Goldenseal root/rhizome-only
supplements did not rank in the top 50 best-selling herbal supplements in the natural
food channel or the Mainstream Multi-Outlet retail channel from 2012-2014
(Table 2).
Table 1: Sales data for echinacea-goldenseal
dietary supplements from 2012-2014.
Channel
|
2012
|
2013
|
2014
|
|
Rank
|
Sales [US$]
|
Rank
|
Sales [US$]
|
Rank
|
Sales [US$]
|
Naturala
|
18
|
4,400,290
|
15
|
4,824,801
|
15
|
5,116,708
|
Mainstream
Multi-Outletb
|
41
|
2,665,724
|
53
|
1,697,591
|
53
|
1,566,916
|
Table 2: Sales data for goldenseal-only
dietary supplements from 2012-2014.
Channel
|
2012
|
2013
|
2014
|
|
Rank
|
Sales [US$]
|
Rank
|
Sales [US$]
|
Rank
|
Sales [US$]
|
Naturala
|
68
|
1,046,775
|
70
|
1,111,038
|
69
|
1,110,546
|
Mainstream
Multi-Outletb
|
60
|
1,287, 453
|
106
|
217,617
|
102
|
207,312
|
aAccording to SPINS (SPINS does not track Whole Foods Market sales, which is a major natural products
retailer in the US)
bAccording to SPINS/IRI
(the Mainstream Multi-Outlet channel was formerly known as food, drug and mass
market channel [FDM]; possible sales at Walmart and Club stores are excluded in
2013 and 2014) n/a: not available Source: T. Smith
(American Botanical Council) e-mail September 2, 2015 and September 3, 2015
2.2
Supply sources: Historically, the majority of the goldenseal root and rhizome on the market has come from wild-harvested
material, with Kentucky and Tennessee as the major producers. Other states
along the Appalachian Mountains and in the northeastern United States provide
additional supplies.9 There is no credible evidence that H. canadensis is cultivated commercially
outside of the United States and Canada.
2.3 Conservation status: In 1997 goldenseal was listed on
Appendix II of the Convention on International Trade in Endangered Species of
Wild Fauna and Flora,17 which also controls global trade and markets
for H. canadensis.18 Several
states consider H. canadensis in need
of conservation: Pennsylvania lists the plant as vulnerable, at high risk of endangerment in the wild; Maryland,
Michigan and New York list the plant as threatened, at risk of extinction in
the wild sometime in the near future; Connecticut, Georgia, Massachusetts,
Minnesota, New Jersey and Vermont list the plant as endangered, at high risk of extinction in the wild; North Carolina
and Tennessee list the plant as endangered
with special concern, at critically high risk of extinction in the wild.19
2.4 Raw material forms: Bulk goldenseal root and rhizome raw
material is sold as whole roots and rhizomes (fresh or dry), cut and sifted, or
as powder.
2.5 Market dynamics: Despite a general trend of price
increases since 1986, the costs vary considerably from year to year. Prices per
kg paid to collectors of dried wild goldenseal root and rhizome ranged from US $44–$77
between 1996 and 2005, and $77 wild to $110 for organic woods-cultivated material
for the same time frame.20 The price per kg of dried wild root and
rhizome peaked at $77 in 2001, dropping to $44 per kg in 2005, and fluctuating
between $44–55 per kg through 2010.21 In its tonnage report, the American
Herbal Products Association (AHPA) reported an average yearly harvest of 10
metric tons (MT) of cultivated compared to 30 MT of wild-harvested dry
goldenseal root and rhizome between 2004 and 2010. The amounts of fresh
goldenseal root and rhizome have remained below one MT in the same timeframe. Generally,
the quantities of goldenseal root and rhizome harvested between 2004 and 2010
have been relatively steady.22
3 Adulteration
3.1
Historical adulterants: At
the height of the Eclectic medical movement in the United States during the
early 1900s, the price of goldenseal had risen to the point that several plant
species were being used as economic adulterants on a regular basis; these included
goldthread or coptis (Coptis spp., Ranunculaceae), yellow root (Xanthorrhiza simplicissima, Ranunculaceae), European peony (Paeonia
officinalis, Paeoniaceae),and twin leaf (Jeffersonia
diphylla, Berberidaceae).23,24
The adulteration of
goldenseal with Virginia snakeroot (Aristolochia
serpentaria, Aristolochiaceae), which is of concern due to its content of
nephrotoxic and carcinogenic aristolochic acids, was initially documented in
1892, and described again in 1900.25 However, there are no reported
cases of adulteration with Virginia snakeroot in recent times. Additional historical
adulterants and contaminants of goldenseal that have been documented include
Athyrium filix-femina (Athyriaceae), Stylophorum diphyllum (Papaveraceae), Cypripedium calceolus (Orchidaceae), Collinsonia canadensis
(Lamiaceae), Trillium spp. (Melanthiaceae), Caulophyllum thalictroides
(Berberidaceae), and Polygala senega
(Polygalaceae) as admixtures or contaminants.26 It is unlikely that adulteration is occurring
with these species in commerce today.
3.2 Recent adulterants: Over the past 20–30 years, economic
adulterants have reappeared in goldenseal products,27-29 based in
part on erroneous use of goldenseal to negate illicit drug testing in the 1980s.30
The adulterating species include Japanese goldthread (Coptis japonica), yellow root (Xanthorrhiza simplicissima), Oregon grape (Mahonia
aquifolium, Berberidaceae),
celandine (Chelidonium majus,
Papaveraceae), barberry (Berberis spp., Berberidaceae), and yellow
dock (Rumex spp., Polygonaceae) root.2,9,27
There is a single case of the sale of other root materials labeled as
goldenseal, e.g., plantain (Plantago spp.,
Plantaginaceae) root, nettle (Urtica dioica,
Urticaceae) root, or passionflower (Passiflora
incarnata, Passifloraceae) root colored with a yellow dye, as reported on
the website of an analytical laboratory.31
Historically, market pricing
for H. canadensis has displayed
instability.20 As noted above, over the more recent 15 years the
price has ranged between $44-110/kg for dry root and rhizome material. Assuming
that the relatively higher goldenseal price level drives intentional economic
adulteration, the addition and/or substitution with several of the adulterating
plant species would represent substantial cost savings to an unscrupulous
supplier. Over the past 20 years, dried roots of the species Mahonia have sold at $6.1-$8.8 per kg and Berberis at $7.3-14.30 per kg. Over the
past 10 years the price/kg of adulterating species ranged as follows: celandine
$3.7-6.9, barberry $5.6-19.3, yellow dock imported $9.5-10.1 and domestically
grown $12.9-14.8. (S. Yeager [Mountain Rose Herbs] e-mail, August 25,
2015) The price/kg for Coptis spp. was approximately $14.1 per kg
in 2011 and $11.0/kg in 2015.32
3.3 Sources of information supporting
confirmation of adulteration: Goldenseal
adulteration can be detected through the presence or absence of several
alkaloids, namely the presence of berberine, canadine, hydrastine, and hydrastinine,
and the absence of palmatine.9 Although most species used as
adulterants contain berberine, the alkaloids hydrastine and canadine are unique
to goldenseal.9 The presence of palmatine is indicative of
adulteration by Coptis spp., the most
common adulterant of goldenseal.27 An analysis of several dietary
supplement products marketed as goldenseal root extract using the AOAC official
method 2008.04-2008, a high-performance liquid chromatography (HPLC) method for
the analysis of goldenseal material, revealed that several products contained
palmatine.33
A
validated HPLC-mass spectrometry (MS) method was used to analyze H. canadensis root from three suppliers
along with the common adulterants – Coptis
spp. root, M. aquifolium root, Berberis
spp. bark, and C. majus herb.29 Of the three commercial lots that were
purchased, all contained the expected goldenseal
alkaloids: hydrastinine berberastine, tetrahydroberberastine, canadaline,
berberine, hydrastine, and canadine. However, one product contained additional alkaloids
not associated with goldenseal – palmatine, coptisine, and jatrorrhizine – thus
suggesting admixture of an adulterating species. Avula et al. used an ultra-high
performance liquid chromatography (UHPLC) method to detect the non-goldenseal
constituents palmatine, coptisine and jatrorrhizine in a commercial goldenseal
product.34 An emerging adulterant problem stems from the use of
goldenseal leaf material, which contains both berberine and hydrastine, but in a
different ratio from goldenseal root.27
A
recent report by a company specializing in DNA-based species identification
analyzed several off-the-shelf goldenseal products, including those from a company
described as “a major manufacturer.” The company used their proprietary
ConfirmIDNATM method, a DNA barcoding method using universal primers,
to identify plantain root, nettle root, or passionflower root rather than
goldenseal. In addition, the product was colored with a yellow dye.31
No additional tests were carried out to confirm these findings.
Although this publication is focused on H. canadensis root, commercial trade in H. canadensis
leaf
does occur. Dried leaf harvest for the years 2004-2010 was estimated to range
from 3.5-8.5 MT.22 During that time the price was approximately $2.2-11.0/kg
(E. Burkhart [Pennsylvania State University] e-mail, September 21, 2012). Goldenseal leaf is an article of commerce, and there
are allegations of its use as a low-cost adulterant.27 Actual evidence of non-declared goldenseal leaf
as an adulterant to goldenseal root/rhizome is rare. One analysis of hydrastine and berberine in goldenseal leaf found levels of these alkaloids ranging at
0.27-0.29% and 0.36-0.39%, respectively, while levels in the root were 2.25-3.32%
and 2.61-3.75%, respectively. As
part of this 2002 study, three commercial echinacea/goldenseal products
were tested with one containing only berberine in the expected range of goldenseal-derived
isoquinoline alkaloids, which may indicate an adulterant species was used.
Another contained very low alkaloid content suggesting possible leaf
adulteration.29
3.4 Accidental or intentional
adulteration: Historically
as well as recently, the use of adulterating species appears to be motivated
primarily by economic gain,24-29 particularly when bulk goldenseal
root is selling for up to $110 per kg.
3.5
Frequency of occurrence:
There is no comprehensive study on the frequency of goldenseal adulteration. One
analysis in 2003 of three lots of purchased commercial goldenseal root powder
found goldenseal alkaloids hydrastinine, berberastine, tetrahydroberberastine,
canadaline, berberine, hydrastine, and canadine in all samples, while only one
sample from a single supplier also contained palmatine, coptisine, and
jatrorrhizine, presumably indicating that adulteration with coptis occurred in that one sample.29
3.6
Possible therapeutic/safety issues:
Although no systematic investigation into human toxic effects associated with the
use of Berberis spp., Coptis spp., or M. aquifolium could be found,
no other spontaneous or anecdotal reports of adverse effects could be found.
The second edition of the American
Herbal Products Association’s Botanical Safety Handbook (BSH2) lists B. vulgaris and C. chinensis as class 2b safety ingredients, meaning that these
botanicals should not be used during pregnancy. The safety concerns in the BSH2
are based on studies using pure berberine, and may not directly apply to
extracts made from barberry or coptis. Mahonia
aquifolium, which also contains berberine, is presented as a safety class 1
ingredient, which is a botanical that is considered to be safe when used
appropriately. Nevertheless, use of Oregon grape during pregnancy is not
recommended. In addition, all berberine-containing plants are not recommended
for use during lactation.35
Case studies of Chelidonium majus herb in Germany have
associated consumption of the herb with liver toxicity. Ad hoc
causality assessments in 22 spontaneous cases employing a liver-specific,
standardized, quantitative assessment method (Council for International
Organizations of Medical Sciences) found causality to be highly probable (n = 2),
probable (n = 6), possible (n = 10), unlikely (n = 1), and excluded (n = 3). The
pattern of liver injury was observed predominantly among female consumers. The
average treatment was 36.4 days, and the latency period until first symptoms
and jaundice was 29.8 and 35.6 days, respectively. The study did not identify
which of the constituents were responsible for the liver injury.36 No
product analysis was conducted and manufacturer observance of cGMP (current
Good Manufacturing Practices) was assumed. As such, it is unknown if
adulterated products impacted the reported adverse effects.
3.7 Analytical methods to detect
adulteration: Brown
and Roman conducted a multi-laboratory collaborative study utilizing a HPLC-ultraviolet
(UV) detection method, previously validated using AOAC International
single-laboratory validation guidelines, to measure hydrastine and berberine in
goldenseal root raw materials, extracts, and dietary supplements at
concentrations of 0.4 to 6% (w/w). In addition to the quantification of
berberine and hydrastine, the method also detected the presence of palmatine,
an indicator of adulteration with Coptis spp.33
Based on the results of the study the method was subsequently adopted as AOAC
official method 2008.04-2008.37 Weber et al., generated different
alkaloid profiles for H. canadensis root and two berberine-containing Coptis species using a
validated HPLC-MS method.38 Kamath and colleagues investigated alkaloid
compositions of H. canadensis,
American goldthread (C. trifolia) and
coptis (C. chinensis). They determined that the spectrum of alkaloids in C. chinensis was different from those in H. canadensis and C. trifolia,
showing that the alkaloid fingerprint was suitable to distinguish the species.39
Another HPLC-MS method was shown to separate 10 analytes (berbamine, berberine,
canadine, chelerythrine, coptisine, hydrastinine, hydrastine, jatrorrhizine,
palmatine and sanguinarine) from six different plant species (H. canadensis,
Coptis japonica, B. vulgaris, Chelidonium majus, M. aquifolium and S.
canadensis), allowing analysts to quantify the presence of adulterants at
concentrations as low as 5%.40 More
recently, a UPLC method with UV detection was used to identify the non-goldenseal
constituents palmatine, coptisine, and jatrorrhizine in a commercial goldenseal
product.34
Govindan and Govindan developed a thin-layer
chromatography (TLC) method to detect hydrastine, hydrastinine, and berberine
of several goldenseal preparations.41 Their analysis identified three
samples containing only berberine, and one sample that contained none of the alkaloids, potentially indicating economic adulteration. The results of the TLC analysis
were confirmed by subsequent HPLC tests.41 The American Herbal Pharmacopoeia
adopted a validated high performance TLC (HPTLC) method that simultaneously
detects palmatine, which is found in adulterants, plus berberine, hydrastine,
and hydrastinine. Upton noted the usefulness of hydrastinine as a reliable
marker for old or poor quality H. canadensis, since it is formed as a
degradation product of hydrastine.42 Finally, a TLC/desorption
electrospray ionization (DESI)-MS method was shown to detect non-goldenseal
alkaloids from adulterants in goldenseal products.43
Several official compendial methods exist that may also
be applied to adulterant detection, including the European Pharmacopoeia44 and the United States Pharmacopeia–National Formulary.45 Criteria
to perform identification using macroscopic and microscopic examinations of goldenseal
rhizome and root are presented in several references.42,44,45 In addition to the macroscopic and microscopic characteristics of goldenseal, the
AHP monograph also lists such characteristics for Oregon grape, Coptis spp., yellow dock, and yellow
root.42
Other, unique analytical systems have been developed that
detect both major and minor H. canadensis alkaloids. These methods, including
capillary electrophoresis-mass spectrometry (CE-MS),46 pH-zone
refining counter current chromatography (CCC),47 shift subtracted
Raman spectroscopy (SSRS),48 and an enzyme-linked immunosorbent
assay (ELISA) linked to a HPLC,49 may be adapted for the detection
of adulterants.
4 Conclusions: Habitat
destruction in some areas of the eastern United States, goldenseal’s native
range, has decreased the availability of this important medicinal plant. Pricing
pressure has historically increased the incentive for economically motivated
adulteration of goldenseal root. Although the actual extent of adulteration of
goldenseal root and rhizome in the current market is not clear, a number of authenticated
methods exist to detect such adulteration, including some that have been
validated.
*Although
it has sometimes been called wild curcuma, goldenseal should not be confused with
turmeric root (Curcuma longa,
Zingiberaceae).
5
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REVISION SUMMARY
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