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Importance of plants in modern pharmacy and medicine

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Section 1

Phytotherapy
and pharmacognosy

SECTION CONTENTS
1. Importance of plants in modern pharmacy and medicine 3
2. Pharmacognosy and its history: people, plants and natural products 10

Heinrich, 978-0-7020-3388-9
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Chapter 1
c0005
Importance of plants in modern
pharmacy and medicine

AIMS AND DEFINITIONS
s0010
p0095 This introductory textbook aims to provide a scientific
basis for the use of plants in pharmacy (pharmacog-
nosy) and also to describe the main characteristics
of herbal medicines (herbal medicinal products,
herbal remedies, phytomedicines) and their clinical
uses [herbal medicine (UK), phytotherapy (Continen-
tal Europe)]. There is also an overview of some of the
historical aspects of medicinal plant use in different
societies (ethnobotany, ethnopharmacology) and of
the role of plants in a variety of popular ‘non-scientific’
medical systems (traditional medicine).
p0100 Pharmacognosy (derived from pharmakon,
‘remedy’, and gignosco, ‘knowledge’) is the science
of biogenic or nature-derived pharmaceuticals and
poisons. It deals with all medicinal plants, including
those yielding complex mixtures, which are used
in the form of crude herbs (comminuted herbal sub-
stance) or extracts (phytotherapy), pure compounds
such as morphine, and foods having additional
health benefits only in the context of having preven-
tive effects (nutraceuticals).
TYPES OF DRUGS DERIVED FROM PLANTS
s0015
s0020 HERBAL DRUGS DERIVED FROM SPECIFIC
PARTS OF A MEDICINAL PLANT
p0105 Botanical drugs which form the basis for herbal
remedies or phytomedicines include, for example:
u0095 l the herb of St John’s wort (Hypericum perforatum),
used in the treatment of mild to moderate
depression
© 2012 Elsevier Ltd. All rights reserved.
DOI: 10.1016/B978-0-7020-3388-9.00001-X
Heinrich, 978-0-7020-3388-9
l the leaves of Ginkgo biloba, used for cognitive u0100
deficiencies (often in the elderly), including
impairment of memory and affective symptoms
such as anxiety
l the flower heads of chamomile (Chamomilla u0105
recutita), used for mild gastrointestinal
complaints and as an anti-inflammatory agent
l the leaves and pods of senna (Cassia spp.), used u0110
for constipation.
From the perspective of pharmacognosy and rational p0130
phytotherapy, such products lie alongside, and in
some cases are, conventional pharmaceutical medi-
cines. Herbal medicines are often considered to be
part of complementary and alternative medicine
(CAM), and the use of herbal medicine products
(HMPs) and of CAM has increased across the devel- Au1
oped world.
NATURAL PRODUCTS OR COMPOUNDS s0025
ISOLATED FROM NATURE
These are pure chemical entities, often used in p0135
the form of licensed medicines. They are some-
times produced synthetically and referred to as
‘nature identical’ (if that is the case), but were
originally discovered from plant drugs. Examples
include:
l morphine, from opium poppy (Papaver u0115
somniferum), used as an analgesic
l digoxin and other digitalis glycosides, from u0120
foxglove (Digitalis spp.), used to treat heart
failure
l taxol, from the Pacific yew (Taxus brevifolia), u0125
used as an anticancer treatment
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4 Fundamentals of Pharmacognosy and Phytotherapy
u0130 l quinine, from Cinchona bark (Cinchona spp.),
used in the treatment of malaria
u0135 l galanthamine from Galanthus and Leucojum
species, used in the management of cognitive
disorders.
NUTRACEUTICALS OR ‘FUNCTIONAL FOODS’
s0030
p0165 Many foods are known to have beneficial effects on
health. Examples include:
u0140 l garlic, ginger, turmeric and many other herbs
and spices
u0145 l anthocyanin- or flavonoid-containing plants such
as bilberries, cocoa and red wine
u0150 l carotenoid-containing plants such as tomatoes,
carrots and many other vegetables.
USE OF HERBAL MEDICINES
s0035
p0185 The use of these remedies is extensive, increasing
and complex. In several surveys 20–33% of the UK
population claimed to regularly use CAM alone or
in addition to orthodox or conventional medicine
and treatments. In the UK, usage is particularly fre-
quent amongst those who are over-the-counter
medicines-users. There is not, on the whole, a wide
understanding of what herbal medicines are (or are
not) (IPSOS-MORI 2008). Healthcare professionals
and students also commonly use such products.
Forty-three percent of students at a University School
of Pharmacy reported using at least one type of CAM
during the last 12 months (Freymann et al 2006).
p0190 In the United States, approximately 38% of adults
and approximately 12% of children are using some
form of CAM (NIH/NCCAM). Kennedy et al (2008)
showed that in the preceding 12 months about
38 million adults in the US (18.9% of the population)
used herbal medicines or supplements, but that only
one-third revealed this use to their physician.
Data for other regions are even more limited, but
the usage of herbal medicines is widespread in
countries like, India, Indonesia, Australia and
China, to name just a few.
p0195 In addition, market research data reveal high
levels of expenditure on herbal medicines, although
it is difficult to obtain precise figures for sales of
such products since some are classed as food sup-
plements and are sold through numerous outlets.
For similar reasons, it is usually not possible to
compare properly the estimates for expenditure
Heinrich, 978-0-7020-3388-9
on herbal medicines using different studies and in
different countries. For 2009, it is estimated that
the total value of the global market in herbal medi-
cines was around $83 billion. In 2009 in the USA
alone consumers spent an estimated total of $5 bil-
lionon herbal dietary supplements. In the UK in
2007, the market for herbal medicines was estimated
to be almost £700 million, which, compared with
many other European countries, is rather low.
The European market for herbal supplements and
herbal medicines is currently worth about $7.4 billion.
Germany is the largest European market, with a
27% share, followed by France (24%), Italy (12%)
and the UK (9%). The Indian healthcare market is
valued at $7.3 billion, 60% of which is controlled by
pharmaceutical drug manufacturers, while 30% is
controlled by Ayurvedic medicine manufacturers;
the Chinese market comes in at around $8 billion
(Gruenwald 2008). Au2
In most continental European countries, such p0200
phytomedicines are licensed medicinal products
and are used under medical supervision. However,
the widespread use of herbal medicines by the
general public raises several important issues.
Some of these relate to how individuals, whether
consumers or healthcare professionals, perceive
and use these preparations; other concerns relate
to the quality, safety and efficacy of the herbal
medicines themselves.
As part of the primary healthcare team, pharma- p0205
cists, as well as nurses and general practitioners,
need to be competent in advising consumers
on the safe, effective and appropriate use of all
medicines, including herbal medicines. Healthcare
professionals also need to be aware of the products
and healthcare choices that patients are making,
often without their knowledge.
There are many reasons for the increased use of p0210
herbal medicines. These may range from the appeal
of products from ‘nature’ and the perception that
such products are ‘safe’ (or at least ‘safer’ than con-
ventional medicines, which are often derogatorily
referred to as ‘drugs’), to more complex reasons
related to the philosophical views and religious
beliefs of individuals.
In developed countries, most purchases of HMPs p0215
are made on a self-selection basis from pharmacies
and health-food stores, as well as from super-
markets, by mail order and via the Internet. Nor-
mally, with the exception of pharmacists, there is
no requirement for a trained healthcare profes-
sional to be available on the premises to provide
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Chapter 1 Importance of plants in modern pharmacy and medicine
information and advice. In any case, most HMPs can
be sold or supplied without the involvement of a
healthcare professional and several studies have con-
firmed that many individuals do not seek profes-
sional advice before purchasing or using such
products, even when purchased from a pharmacy
(Barnes et al 1998, Gulian et al 2002). Rather, consu-
mers of HMPs tend to rely on their own (usually lim-
ited) knowledge, or are guided by advice from
friends and relatives or the popular media. Consu-
mers who do seek professional advice (e.g. from their
pharmacist or general practitioner) may find that he
or she is not able to answer their question(s) fully. In
some cases this may be because the information sim-
ply is not available, but it is also recognized that, at
present, many healthcare professionals are not ade-
quately informed about herbal medicines, particu-
larly with regard to their quality, safety and
efficacy. This book attempts to redress that omission.
p0220 HMPs are used for general health maintenance,
as well as for treating diseases, including serious
conditions such as cancer, HIV/AIDS, multiple
sclerosis, asthma, rheumatoid arthritis and osteoar-
thritis. Older patients, pregnant and breastfeeding
women, and children also take HMPs, and this
raises concerns because, as with conventional med-
icines, precautions need to be taken. For example,
few medicines (whether conventional or herbal)
have been established as safe for use during preg-
nancy and it is generally accepted that no medicine
should be taken during pregnancy unless the benefit
to the mother or fetus outweighs any possible risk to
the fetus. Similarly, HMPs should be used with cau-
tion in children and the elderly, who, as with con-
ventional medicines, differ from adults in their
response to, and metabolism and clearance of drugs.
The use of herbal medicines by patients who are
already taking prescribed medicines is of particular
concern as there is the potential for drug–herb inter-
actions to occur. For example, important pharmaco-
kinetic and pharmacodynamic interactions between
St John’s wort (Hypericum perforatum) and certain
conventional medicines have been documented
(Williamson et al 2009) and mechanisms for such
interactions have been identified. Generally, infor-
mation on interactions between HMPs and conven-
tional medicines is limited, although potential
drug–herb interactions can sometimes be identified
based on the known phytochemistry and pharmaco-
logical properties of the herbs involved.
p0225 These issues illustrate once more the need for
healthcare professionals, and especially pharmacists,
Heinrich, 978-0-7020-3388-9
5
to be knowledgeable about HMPs, and professional
bodies are increasingly mindful of their responsibil-
ities regarding herbal medicines and have taken
steps to address the issue. It is now recognized
by the UK Committee on Safety of Medicines and
the Medicines and Healthcare Products Regulatory
Agency that pharmacists have an important role to
play in pharmacovigilance with regard to HMPs; this
involves reporting suspected adverse reactions and
disseminating information to patients and the public
about safety concerns. Calls for healthcare profes-
sionals to be competent with regard to herbal medi-
cines and other ‘complementary’ therapies are now
coming from outside the professions.
In summary, the use of herbal products continues p0230
to be a popular healthcare choice among patients
and the general public. Most pharmacies sell herbal
medicines and it is likely that pharmacists will be
asked for advice on such products or that they will
have to consider other implications of herbal pro-
duct use, such as interactions with conventional
medicines. This book provides the scientific back-
ground to the use of plants as medicines.
SOME FUNDAMENTAL ASPECTS OF THE s0040
REGULATION OF HERBAL MEDICINES
The regulation of herbal medicines is complex, var- p0235
ies greatly and is constantly changing. These diverse
regulatory framework form an essential basis for the
activities of all healthcare professionals and for
research on such products. For example, in the
UK, until recently Ginkgo biloba was considered a
food and now is, as in other European countries,
regulated as a traditional herbal medical product;
it is a herbal medical product in Germany and a food
supplement in the USA. In the UK Echinacea may be
a traditional herbal medical product or a food sup-
plement or a registered medicine. It is classed as a
dietary supplement in the USA and a medicine in
Germany. Therefore here a brief and selective over-
view of the regulation of herbal medicines in key
English-speaking countries is given, excluding the
regulation of the professions involved in their pro-
duction, prescription and dispensing.
UNITED KINGDOM
s0045
In essence, today’s regulatory framework in the UK, p0240
is very similar to the ones in other countries of the
European Union. Historically, in the UK, many of
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6 Fundamentals of Pharmacognosy and Phytotherapy
the concerns regarding herbal medicinal products
have arisen from the lack of regulation of such pro-
ducts. Consequently, such products lacked evi-
dence for acceptable standards for quality, safety
and efficacy. A range of safety problems occurred
as a result of the use of unlicensed herbal prepara-
tions of inadequate pharmaceutical quality.
p0245 The basis for the current regulatory regime for the
licensing of medicines in the UK is set out by the 1968
Medicines Act and other regulations which have
arisen from the implementation of relevant European
Commission legislation, namely Directive 65/65/
EEC, now revised as Directive 2001/83/EC. Under
this legislation, manufacturers of products, including
herbal remedies, which are classed as medicinal pro-
ducts must hold a marketing authorization (MA, or
product licence, PL) for that product unless it satisfies
the criteria for exemption from the requirement for a
MA. In essence, medicinal products are defined as
those that are medicinal by presentation or (not
and) by function. Manufacturers of products com-
prising new chemical entities, including isolated con-
stituents from plant or other natural sources, are
required to submit applications for MAs for those
products, based on the full dossier of chemical, phar-
maceutical, pharmacological, toxicological and clini-
cal data.
p0250 Herbal products are available on the UK market as:
u0155 l licensed herbal medicines
u0160 l traditional herbal medical products registered
under the European ‘Traditional Herbal
Medicinal Product Directive’ (THMPD)
u0165 l herbal medicines exempt from licensing
u0170 l unlicensed herbal products, sold as food or
dietary supplements
u0175 l prescription-only medicines (POM); these
potentially hazardous plants may only be
dispensed by order of a prescription by a
registered doctor
u0180 l pharmacy-only medicines (P); certain others
may only be supplied by a registered pharmacist,
or may be subject to dose (but not duration of
treatment) and route of administration
restrictions.
s0050
Licensed herbal medicines
p0285 Most licensed herbal products in the UK were initially
granted a product licence of right (PLR) because they
were already on the market when the licensing
system was introduced in the 1970s. When PLRs
were reviewed, manufacturers of herbal products
Heinrich, 978-0-7020-3388-9
intended for use in minor self-limiting conditions were
permitted to rely on bibliographic evidence to support
efficacy and safety, rather than being required to
carry out new controlled clinical trials. So, many
licensed herbal medicinal products have not necessa-
rily undergone stringent testing. The ‘well-established
use’ directive (99/83/EC) was intended to allow
greater flexibility on the use of bibliographic data
to demonstrate safety and efficacy, and it was hoped
that this legislation would provide a regulatory
framework for the many unlicensed herbal products
on the market. Unfortunately, interpretations of
the provisions of the directive vary between EU mem-
ber states and this directive is not widely accepted
in the UK.
Traditional herbal medical products s0055
The THMPD 2004/24/EC (see http://www.mhra. p0290
gov.uk) is a regulatory process established to
provide a mechanism whereby manufacturers of
good-quality herbal medicines can register their pro-
ducts as medicinal products and make (restricted)
medicinal claims on the packaging and the patient
information leaflet (PIL). Examples of the informa-
tion that may be displayed are given here: Au3
l Evidence that a corresponding herbal product u0185
(i.e. one derived from the same botanical drug
and prepared in a similar way) has been used
traditionally for at least 30 years (15 years’ non-
EU and 15 years in the EU, or more than 30 years
in the EU).
l Bibliographic data on safety with an expert u0190
report.
l A quality dossier specifying how the company u0195
complies with the quality guidance requirements
of the regulators.
l Details on the patient information leaflet (PIL), u0200
packaging, naming and labeling.
Products registered under this Directive can only be p0315
used for minor, self-limiting conditions. Overall, it
provides an assurance that the patient is receiving
not only a good-quality product, but also more
reliable advice on its use.
Unlicensed herbal medicines s0060
HMPs still exempt from licensing are those ‘com- p0320
pounded and supplied by herbalists on their own
recommendation’ [specified under Section 12(1)
of the Medicines Act 1968] and those consisting solely
of dried, crushed or comminuted (fragmented)
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Chapter 1 Importance of plants in modern pharmacy and medicine
plants. They must not contain any non-herbal ‘active’
ingredients and are sold under their botanical name
and with no written recommendations for use [speci-
fied under Section 12(2) of the Medicines Act]. The
exemptions were initially intended to give herbalists
the flexibility to prepare remedies for their patients,
although, at present, there is no statutory regulation
of herbalists in the UK (this is under review).
p0325 Traditional medicines used by ethnic groups
include traditional chinese medicines (TCM) and
Ayurvedic medicines. These products are subject
to the same legislation as are ‘Western’ herbal med-
icines. Some toxic species, like Aristolochia sp., are
banned. There still remain problems associated with
some imported medicines: in addition to containing
non-herbal ingredients such as animal parts and/or
minerals, some manufactured (‘patent’) ‘herbal’
products have been found to contain conventional
drugs which may have POM status in the UK
(e.g. dexamethasone and glibenclamide) or which
are banned. Non-herbal active ingredients of any
type (chemically synthesized, animal products)
cannot legally be included in herbal remedies, and
inclusion of drugs with POM status represents an
additional infringement of European and US legis-
lation. Some ingredients, such as certain species of
plants, are also restricted under the Convention
on International Trade in Endangered Species of
Wild Fauna and Flora (CITES).
AUSTRALIA
s0065
p0330 In Australia, Western herbal medicine is one of
the most popular forms of CAM and a range of eth-
nic medicines, especially TCM, are increasingly
becoming popular. All medicines, including herbal
and other complementary medicines, are covered
by the Therapeutic Goods Act (1989) and regulated
by a federal agency, the Therapeutic Goods Adminis-
tration (TGA, http://www.tga.gov.au/). A statutory
expert committee, the Advisory Committee on Com-
plementary Medicines (formerly the Complementary
Medicines Evaluation Committee) provides the TGA
with advice on the regulation of complementary
medicines. The Australian regulatory guidelines for
complementary medicines ( http://www.tga.gov.
au/docs/html/argcm.htm) provide information to
help producers and distributors of complementary
medicines to meet their obligations under therapeutic
goods legislation.
p0335 Australia adopts a two-tiered, risk-based ap-
proach to the regulation of all medicines. Low-risk
medicines, including most herbal and complementary
Heinrich, 978-0-7020-3388-9
7
medicines, are included in the Australian Register
of Therapeutic Goods (ARTG) as listed medicines
and identified by a unique AUST L number of the
label. Medicines deemed to be of higher risk are
entered on the register as registered medicines and
identified by an AUST R number. While registered
medicines undergo full pre-market safety and efficacy
evaluation, listed medicines are not evaluated for
efficacy, but product sponsors must hold evidence to
support the claims they make about the product.
Random and targeted post-market audits of this
evidence are carried out by the regulator. Indications
and claims for listed medicines are limited to health
maintenance, health enhancement or non-serious,
self-limiting conditions and may be supported by
evidence from traditional use or scientific evidence.
Both listed and registered medicines must be made
to pharmaceutical GMP standards, and herbal ingre-
dients must conform to the relevant BP (AH thu
EurPhar) monograph, if one exists.
Medicines extemporaneously compounded for a p0340
specific patient following consultation are exempt
from inclusion on the ARTG; this allows herbalists
and other practitioners to compound individualized
formulae for their patients.
CANADA
s0070
In Canada herbal medicines are classified as ‘natural p0345
health products’ which require a product licence
before they can be marketed. The relevant agency
is ‘Health Canada’. Since 2004 this is regulated in
the The Natural Health Products Regulations. The
system is intended to find an equilibrium between
openness towards various health paradigms (e.g.
Traditional Chinese Medicine, Ayurveda, Western
traditional herbalism, etc.) and scientific rigor.
Hence, specific health claims are allowed on the
basis of a variable evidence base that becomes more
stringent with the severity of the condition treated
with a product. A manufacturer has to submit
detailed information on the product to Health
Canada, including: medicinal ingredients, source,
potency, non-medicinal ingredients and recom-
mended use(s). Once a product has been assessed
and granted market authorization by Health
Canada, the product label will bear an eight digit
product licence number preceded by the distinct let-
ters NPN (Natural Product Number), or, in the case
of a homeopathic medicine, by the letters DIN-HM
(Homeopathic Medicine Number).
This number on the label will inform consumers p0350
that the product license application has been
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8 Fundamentals of Pharmacognosy and Phytotherapy
reviewed and approved by Health Canada to meet
the standards in terms of safety, efficacy and qual-
ity. GMPs (Good Manufacturing Practices) must
be guaranteed in the products production in order
to ensure the product’s quality and thus its safety.
In addition the system requires that all Canadian
producers and importers of natural health products
are licensed.
p0355 Similar to the UK, an Adverse Reaction Reporting
System for natural health products is in place and is
usedtowarnthepublic(http://www.hc-sc.gc.ca/dhp-
mps/prodnatur/about-apropos/index-eng.php).
INDIA
s0075
p0360 India has an ancient heritage of traditional medicine
(see Chapter 12) with a well-recorded and widely
practiced knowledge of herbal medicine. The Depart-
ment of Ayurveda, Yoga & Naturopathy, Unani,
Siddha and Homoeopathy (AYUSH) within the Min-
istry of Health & Family Welfare focuses on its regu-
lation and on the improvement of standards in the
areas of quality control and standardization of drugs,
the availability of raw material, research and devel-
opment, education/training of professionals, and a
wider outreach with regard to these traditional
medical systems.
p0365 The Traditional Herbal Medicines Act, 2006 reg-
ulates the sale of the traditional herbal medicines
which are marketed without any licence and control
on the basis of being from ancient texts. According
to the act every retailer or seller of traditional herbal
medicines needs to have a licence to sell traditional
herbal medicines from the Authority. Every manu-
facturer of traditional herbal medicine needs to
work under the principles of GMP and has to list
the ingredients of each medicine on the packing of
the medicine along with their accurate quantity. Side
effects and warning of contraindications need to be
stated on the package. Pharmacopoeia Committees
have been established to develop quality standards
for the main groups of therapeutically relevant drugs
of Ayurveda, Unani, Siddha and homoeopathy
(Mukherjee et al 2007).
p0370 The Indian Government also established an inde-
pendent body – the ‘National Medicinal Plants Board’
under the Ministry of Health and Family Welfare. It is
responsible for co-ordinating all matters relating to the
development of medicinal plants, including policies
and strategies for conservation, proper harvesting,
cost-effective cultivation and marketing of raw mate-
rial in order to protect, sustain and develop this sector.
Heinrich, 978-0-7020-3388-9
Uniquely, the Indian government has established
programmes for the documentation of traditional
Indian knowledge, which is already available in public
domain. The political goal is to safeguard the sover-
eignty of this traditional knowledge and to protect
it from being misused in patenting on non-patentable
inventions. The Traditional Knowledge Digital
Library (TKDL) is an original proprietary database,
which is fully protected under national and interna-
tional laws of Intellectual Property Rights and is main-
tained and developed by the government. TKDL also
allows automatic conversion of information from San-
skrit into various languages. The information includes
names of plants, Ayurvedic description of diseases
under their modern names and therapeutic formula-
tions (Mukherjee et al 2007).
UNITED STATES OF AMERICA (USA)
s0080
In the USA, herbal medicines are generally regu- p0375
lated as ‘dietary supplements’. The US Food and
Drug Administration (FDA, www.fda.gov/Food/
DietarySupplements/) is in charge of these compara-
tively loose regulations (http://nccam.nih.gov/
health/supplements/wiseuse.htm). Some key charac-
teristics stand out:
l Prior to marketing, dietary supplements do not u0205
have to be assessed for safety and effectiveness.
Limited therapeutic claims may be made, e.g. that
a dietary supplement addresses a nutrient
deficiency, supports health, or is linked to a
particular body function (e.g. immunity).
However, this requires supportive prior research.
Such a claim must be followed by the words ‘This
statement has not been evaluated by the U.S.
Food and Drug Administration (FDA). This
product is not intended to diagnose, treat, cure,
or prevent any disease.’
l Since 2008 ‘Good manufacturing practices’ u0210
(GMPs) is expected in order to ensure that
dietary supplements are processed consistently
and meet quality standards.
l Once a dietary supplement is on the market, u0215
the FDA monitors the claims made and the
product’s safety. If inappropriate claims are
made the manufacturer receives a warning
letter or is required to remove the product
from the marketplace. If a product is found
to be unsafe, the FDA takes similar action
against the manufacturer and/or
distributor.
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References
Barnes, J., Mills, S.Y., Abbot, N.C.,
et al., 1998. Different standards for
reporting ADRs to herbal
remedies and conventional OTC
medicines: face-to-face
interviews with 515 users of herbal
remedies. Br. J. Clin. Pharmacol.
45, 496–500.
Freymann, H., Rennie, T., Bates, I.,
Nebel, S., Heinrich, M., 2006.
Knowledge and use of herbal
medical products and other CAM
among British undergraduate
Au4
Further reading
Barnes, J., Phillipson, J.D.,
Anderson, L.A., 2009. Herbal
medicines. A guide for healthcare
professionals, third ed.
Pharmaceutical Press,
London.
Bruneton, J., 1995. Pharmacognosy,
phytochemistry, medicinal plants.
Springer-Verlag, Berlin.
Cavaliere, C., Rea, P., Lynch, M.E.,
Blumenthal, M., 2010. Herbal
supplement sales rise in
all channels in 2009. HerbalGram
86, 82–85.
Evans, W.C., 2009. Trease and Evans’s
pharmacognosy, sixteenth ed. WB
Saunders, London.
Hänsel, R., Sticher, O. (Eds.), 2010.
Pharmakognosie –
phytopharmazie. Springer, Berlin.
B978-0-7020-3388-9.00001-X, 00001
Chapter 1 Importance of plants in modern pharmacy and medicine
pharmacy students. Pharm. World
Sci. 27, 13–18.
Gulian, C., Barnes, J., Francis, S.A.,
et al., 2002. Types and preferred
sources of information concerning
herbal medicinal products: face-to-
face interviews with users of herbal
medicinal products. International
Journal of Pharmaceutical Practice
10 (Suppl.), R33.
IPSOS – Mori, 2008. Public
perceptions of herbal medicines
general public qualitative &
McEwen, J., 2004. What does TGA
approval of medicines mean?
Australian Prescriber 27, 156–158.
Mills, S., Bone, K., 2000. Phytotherapy.
Principles and practice. Churchill
Livingstone, London.
Mukherjee, P.K., Venkatesh, M.,
Kumar, V., 2007. An overview on the
development in regulation
and control of medicinal
and aromatic plants in the
Indian system of medicine.
Boletı́n Latinoamericano y del
Caribe de Plantas Medicinales y
Aromáticas (BLACPMA) 6, 129–136.
Robbers, J.E., Speedie, M.K.,
Tyler, V.E., 1996. Pharmacognosy
and pharmacobiotechnology.
Williams & Wilkins, Baltimore.
Heinrich, 978-0-7020-3388-9
9
quantitative research. IPSOS-Mori,
London, UK.
Kennedy, J., Wang, C.C., Wu, C.H.,
2008. Patient disclosure about herb
and supplement use among adults
in the US. Evid. Based
Complement. Alternat. Med. 5,
451–456.
Williamson, E.M., Driver, S.,
Baxter, K. (Eds.), 2009.
Stockley’s herbal medicines.
Interactions Pharmaceutical Press,
London.
Ross, I., 1999. Medicinal plants of the
world, vol. I. Humana Press,
Totawa, NJ.
Ross, I., 2000. Medicinal plants of the
world, vol. II. Humana Press,
Totawa, NJ.
Schulz, V., Haensel, R., Tyler, V., 1998.
Rational phytotherapy. Springer-
Verlag, Berlin.
Thomas, K.J., Nicholl, J.P.,
Coleman, P., 2001. Use and
expenditure on complementary
medicine in England: a population
based survey. Complement Ther.
Med. 9, 2–11.
Williamson, E., 2003. Potter’s herbal
cyclopedia. CW Daniels, Saffron
Walden.
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