Will EC Directives stop people

buying herb rubbish?

Vic Perfitt MBE

“Perceptions of Herb Quality”

Monday July 24 2006
Ryton Organic Gardens.
 Perceptions of herb quality.
 “A Canadian study showed that none of
the Feverfew products made in the US
contained enough of the active
ingredient needed to be effective”
 “75% of US herbal products are of poor
quality”. Dr Gail Mahady WHO
collaborating centre.University of Illinois
Chicago USA.
 Do we have a problem in the
UK?
 Valeriana officinalis L.
 Valerian wallichii used as an adulterant and
substitute. “BPC 1963 Adulterants &
substitutes” A problem recognised over 40
years ago.
 Does it still happen today? When the cost of
Valeriana wallichii is approx. 33% of the cost
of Valeriana officinalis L conforming to BP
monograph. What do you think?
 DOES IT MATTER?
 A resounding yes yes yes.
 If you do not know by precise binomial
nomenclature the plant, and its identification,
every aspect of the quality of the product
becomes suspect.
 Safety becomes compromised immediately.
 Efficacy becomes suspect and ineffective due
to application of incorrect specie.
 QUALITY EXAMPLES.
 Valerian officinalis, Valeriana wallichii,
Valeriana edulis (mexicana).
 Zanthoxylum clava herculis L. testing of
Powdered dry extract Prickly Ash Bark
for manufacturing a licensed herbal
medicinal product, to ensure correct
specie is being used in the product.
Then there was Black Cohosh!
 Newspaper headlines 19.07.2006.
 “Herbal remedy harms the liver”
 “Herb pill warning”
 “Millions of women alerted to danger of
HRT herb”
 Source: The Sun.Daily Mail.The Times.
 MHRA action on safety concerns over
Black Cohosh and liver injury.
 Is Black Cohosh Cimicifuga
racemosa L Nutt hepatotoxic?
 The link to Cimicifuga racemosa L Nutt
is tenuous.See EMEA statement &
evaluation London 18.07.2006.
 What about the quality of the products?
 Are all the Black Cohosh products
produced containing the correct specie?
 This is the current challenge to the
Herbal industry.
 BLACK COHOSH cont.
 “With the increasing demands for black
cohosh plant material for the production of
menopausal dietary supplements in the
United States, the adulteration of black
cohosh,especially with Asian Actaea
species,may increase further.Products-
contain Asian Actaea species indicates that
black cohosh products commercially available
in the United States may not be as claimed”
 Journal of Agriculture & Food Chemistry
Volume 54 No 9 2006.
 Black Cohosh cont.
 “To date,in large part,(if not exclusively)
“Black Cohosh” extracts are produced in
China from specie(s) other than Cimicifuga
racemosa. It is also interesting to note that
the plant itself, Black Cohosh (Cimicifuga
racemosa) is not present in China.The
incentive behind this adulteration is
economic.Several plants from China have
been identified as an economic adulterant”
 ChromaDex Inc.Santa Ana.CA.USA
 Black Cohosh cont.
 “A newer problem of adulteration with
extracts from less expensive Asian species
seem to be emerging. Effective enforcement
and improvement of regulatory requirements
for the quality control of these products is
necessary.We have little safety profiles of
Asian Actaea species”
 Journal of Agriculture & Food Chemistry
Volume 54 No 9 2006.
Will EC Directives stop people
buying herb rubbish?
 Directive 2004/24/EC amending as regards
traditional herbal medicinal products,
Directive 2001/83/EC on the Community code
relating to medicinal products for human use.
 Article 1 Definition:- “Herbal Medicinal
product is any medicinal product,exclusively
containing as active ingredients one or more
herbal substances or one or more herbal
preparations, or one or more such herbal
substances in combination with one or more
such herbal preparation”
 Herbal Substance.
 “Herbal substances are precisely
defined by the plant part used and the
botanical name according to binomial
system (genus, specie,variety and
author)”
 Quality standard as per current
European Pharmacopoeia Ph Eur.
monographs or BP.
 Ph.Eur. BP.Monograph
standard examples.
 Identification test – Combination of
Macroscopical, Microscopical,
Chromatographic procedures,Chemical
reactions.
 Tests.- Foreign Matter, Total Ash, Ash
insoluble in hydrochloric acid, Water soluble
extractive, Extractable matter.
 Loss on drying. Microbial limits,Pesticide
residues, Mycotoxins.
 Assay
Browse: British Pharmacopoeia 2004 Addendum (electronic) British Pharmacopoeia Volume I & II
Monographs: Medicinal and Pharmaceutical substances ___________Valerian____________________ _________
Valerian
General Notices
(Valerian Root, Ph Eur monograph 0453)
Action and use
Sedative.
When Powdered Valerian is prescribed or demanded, material complying with the appropriate requirements below shall be dispensed or
supplied.
Ph Eur
DEFINITION
Valerian root consists of the dried, whole or fragmented underground parts of Valeriana officinalis L. s.l., including the rhizome surrounded by
the roots and stolons. It contains not less than 5 ml/kg of essential oil for the whole drug and not less than 3 ml/kg of essential oil for the cut
drug, both calculated with reference to the dried drug and not less than 0.17 per cent of sesquiterpenic acids expressed as valerenic acid
(C15H22O2; Mr 234), calculated with reference to the dried drug.
CHARACTERS
Valerian root has a characteristic odour.
It has the macroscopic and microscopic characters described under identification tests A and B.
IDENTIFICATION
A. The rhizome is yellowish-grey to pale brownish-grey, obconical to cylindrical, up to about 50 mm long and 30 mm in diameter; the base is
elongated or compressed, usually entirely covered by numerous roots. The apex usually exhibits a cup-shaped scar from the aerial parts; stem
bases are rarely present. When cut longitudinally, the pith exhibits a central cavity transversed by septa. The roots are numerous, almost
cylindrical, of the same colour as the rhizome, 1 mm to 3 mm in diameter and sometimes more than 100 mm long. A few filiform fragile
secondary roots are present. The fracture is short. The stolons show prominent nodes separated by longitudinally striated internodes, each 20
mm to 50 mm long, with a fibrous fracture.
B. Reduce to a powder (355). The powder is pale yellowish-grey to pale greyish-brown. Examine under a microscope using chloral hydrate
solution R. The powder shows cells containing a pale brown resin or droplets of essential oil; isolated rectangular sclereids with pitted walls 5 urn
to 15 urn thick; reticulately-thickened xylem vessels; occasional fragments of cork cells and epidermal cells, some with root hairs. Examine
under a microscope using a 50 per cent V/V solution of glycerol R. The powder shows numerous fragments of parenchyma with cells, containing
single or compound starch granules; the single granules are rounded or elongated, 5 urn to 15 Mm in diameter and have sometimes a cleft or
radiate hilum; the compound granules have two to six components with an overall diameter of up to 20 urn.
©Crown Copyright 2005
 Pharmaceutical GMP.
 “Good manufacturing practice means the part
of quality assurance which ensures that
medicinal products are consistently produced
and controlled to the quality standards
appropriate to their intended use,the
principles and guidelines of which are
specified in chapter 2 of Commission Directive
91/356/EEC”
 Rules & Guidance for Pharmaceutical
Manufacturers & Distributors 2002.TSO.
 CONCLUSIONS.
 Herbal remedies are medicinal products and
should be regulated as such.
 Quality, Safety, and Efficacy are imperatives
for medicinal products.
 Poor quality,(garbage in garbage out) source
of most safety issues with herbal products.
 Will EC Directives Stop…..they will stop
manufacturers producing rubbish and thereby
safe effective herbal medicinal products will
be available to the consumer.