Transcript SAPRAA Sept 2012

CAMS UPDATE
FROM
HPA PERSPECTIVE
Celecia Pleass
Executive member of HPA
Terminology of TM/CAM
 “Traditional medicine” (TM) is used to refer to systems such as traditional
Chinese medicine, Indian Ayurveda and Arabic Unani Tibb medicine, and to
various forms of indigenous medicine in Africa, Latin America, South-East
Asia and the Western Pacific.
 In countries where the dominant health care system is based on allopathic
medicine, or where TM has not been incorporated into the national system,
it is termed “Complementary and Alternative” (CAM). For example in
Europe, North America and Australia.
 When referring in a general sense to all of the regions, the comprehensive
TM/CAM is used.
 Allopathic medicine refers to the broad category of medical practice that is
sometimes called Western medicine, biomedicine, scientific medicine, or
modern medicine.
CAMS categories
1. Aromatherapeutic Essential Oils
2. Auyrvedic Medicine
3. Biochemical Medicines & Salts
4. Chinese Medicine
5. Energy Substances
6. Herbal Medicine
7. Homoeopathic Medicine
8. Nutraceuticals (incl. vitamins and minerals)
9. Sowa Rigpa Medicine
10. Unani-Tibb Medicine
Who is the HPA?
 The HPA is the trade association representing the Complementary and
Alternative and Traditional Medicines (CAMS) industry.
 Established in 1978
 Over 100 health product manufacturers, distributors and raw material
suppliers
 Affiliated to IADSA (International Alliance of Dietary Food Supplements
Association)
 Founded in 1998 – represents 57 dietary supplement associations worldwide
 IADSA Objectives
• Establish, maintain, protect and promote international standards
• Harmonisation of regulatory standards
HPA ‘new’ Structure
Quality
Committee
Regulatory
SMAC
Marketing / PR
HPA
Research
Chairman/
secretariat &
Finance
Health Shops
Association
ASA
Infant Feeding
Association
Enteral
Nutrition
Association
Finance
International
HPA Objectives
 Ensure high profile visibility of the health
products industry as a dynamic, organized and
responsible force
 Reassure the public of the safety of health
products
 Maintain high ethical standards of production,
quality control, marketing and advertising
within the industry
Paradigms of Medicine
 Different “disciplines” of medicine including Orthodox
Medicine are based on belief systems that can be called
paradigms.
 Differs with respect to how it:
 Views wellness and well-being
 The human being
 Orthodox paradigm is dominant in the Western world,
other paradigms are equally relevant, growing rapidly and
operate within different contexts.
 We believe that no dominant paradigm should subsume
another.
What do we support?
 We support appropriate and equitable
changes to the regulations and guidelines
pertaining to the Quality, Safety and Efficacy
of the paradigm of Complementary,
Alternative and Traditional Medicines
(CAMS).
 We also support responsible advertising and
trading.
World Health Organization Policy
Framework for action for WHO and its partners, to enable TM/CAM
to play a far greater role.
Four objectives:
1. Policy: integrate TM/CAM with national health care systems.
2. Safety, efficacy and quality: expand knowledgebase on
TM/CAM; provide guidance on regulatory and quality
assurance standards.
3. Access: increase availability and affordability of TM/CAM,
with an emphasis on access for poor populations.
4. Rational use: promote therapeutically sound use of
appropriate TM/CAM by providers and consumers.
Source: WHO Traditional Medicine Strategy 2002–2005
ANC Health Plan of 1994
“People have the right of access to traditional
practitioners as part of their cultural heritage
and belief system.”
Source: ANC Health Plan 1994; South African Health Review 2007,
Chapter 12.
Market size
 Global vitamin and supplement market is
worth $68 billion
 Depending on the segment, growth is
steady, ranging between 3% and 12%
 SA Market size estimated at approx. R7
billion
% Category share
Energy Substances
0.1
Aromatherapeutic Essential Oils
0.3
Homoeopathy
1.0
Sports Nutrition
1.8
Health Foods & Beverages
2.2
Therapeutic Cosmetics
4.0
Weight Management
4.4
Ethical OTC Products
14.9
Herbals
16.2
Nutritional Food Substances and /or
Nutraceuticals
56.0
0.0
10.0
20.0
30.0
40.0
% Share of Products Surveyed
50.0
60.0
CAM usage in the USA
Source: National Center
for Complementary and
Alternative Medicine
(NCCAM)
Diseases for which CAM is used in adults
Source: National Center for Complementary and
Alternative Medicine (NCCAM)
Most common natural products used by
adults
Source: National Center for Complementary and Alternative
Medicine (NCCAM)
Reasons for use of CAMS
1. Increased responsibility for personal health
2. Perceived high cost of health services and
medicines
3. Ease of access in front shop of pharmacy
4. Increased education, knowledge and
awareness of the benefits of nutrition and
lifestyle
5. Safety and low incidence of side effects
Use of Dietary supplements with
prescription drugs
 As a result of consumer perceiving products to be
safe they also do not tell their GP or healthcare
provider about their use of a dietary supplement
 Cross-sectional study using data from 2002
National Health Interview Study (NHIS)
 31044 respondents
 21% used prescribed medicines and non-vitamin Dietary
supplements in past 12 months
 Of these, 69% did not tell their Family Practitioner
Extrinsic safety risks associated with
CAMS
Not related to the product itself but to Good
Manufacturing Procedures (GMP)






Misidentification – mostly organoleptic tests done
Standardisation – min. level of actives
Contamination – particularly of herbals
Substitution
Adulteration – with a medicinal active e.g. sildenafil
Labelling – misleading, untruthful claims
Legislative Issues considered
FUNDAMENTAL ISSUES THAT NEED TO BE ADDRESSED
INCLUDE:
 Safety
 Quality
 Efficacy (to a lessor degree as traditional aspects need to be
considered)
 Supporting marketing code (advertising)
 An electronic screening system
 A phased approach needs to be implemented with regards
to all aspects
Safety
SAFETY NEEDS TO BE ADDRESSED FOR BOTH:
Substances
Indications
It is recognized that the responsibility of safety
ultimately lies with the Applicant
HPA Scheduling task
 The substances that were changed recently are listed in attached
document (Schedules – March 2012). The new schedules have
included the following new substances into them –
Melatonin, L-Tryptophan and new levels for Vitamin D.
 Various other substances whose scheduling status has changed
over many years, which you may have not noticed before, these
substances include
Lactobacillus, certain Phospholipids (with claims), Glucosamine,
Vitamin D (restricted levels), Sylimarin (Milk Thistle), Horse
Chestnut (aescin in African pygeum), Wormwood (artemisia
species), enzymes (proteolytic enzymes such as Papaverine &
Bromelain), Methionine, Canthaxanthin, Ephedra alkaloids,
Ephedrine and Lithium Salts. (as attached and detailed in
schedules combined document)
Safety
THE FOLLOWING QUESTIONS AND PRINCIPLES WERE CONSIDERED AND
ADOPTED:
 Was the condition or the indication self–diagnosable?
 Was the condition or indication self-limiting in the acute case? (e.g.
Coughs and Colds vs. Bronchitis)
 All other dangers need to be addressed through warnings:





Direction warnings
Time warnings
Special precautions
Side effects
Contra-indications to risk group/s or ailment/s
 Such indications can all placed on a “Indications list”, together with the
relevant “pre-diagnosed & adjuvant status” along with relevant “time
warnings” and “wording recommendations for labels”
GUIDELINES –
LIST OF COMPULSORY WORDINGS AND PHRASES TO BE USED WHEN APPLICATIONS ARE MADE VIA THE e-SCREENING
PROCESS
(FOR EASE OF REFERENCE THE USE OF THE LETTER SC = SCHEDULE FOR COMPLEMENTARY AND TRADITIONAL MEDICINE.)
1.
Wording to be used within the e-screening process relating to the Complementary, Alternative and Traditional
Medicine Schedules
The following wording must be used with respect to all Indications and Health Claims when Registration
Applications are submitted through the e-screening process.
There are four “SC0” and three “SC1” Wording Requirements that appear attached to each of the
Indications and Health Claims in the Schedules with respect to Indications, Health Claims and Time
Warnings for Complementary, Alternative and Traditional Medicines for which compulsory wording is
required:
SC0
a. SCO
b. SC0 adjuvant
c. SC0 pre-diagnosed
d. SC0 pre-diagnosed adjuvant
SC1
a. SC1
b. SC1 pre-diagnosed
c. SC1 pre-diagnosed adjuvant
SCO:
o For SC0, the required wording is:
A (Insert the Class) medicine for the [“treatment of, protection from, relief of”], applicant to choose one of
these three as well as the [“Indication”],
The following warning statement must also be included as part of the wording:
Should the condition not improve within [“Time Warning”] please consult your practitioner.
o
For SC0 adjuvant, the required wording is:
A (Insert the Class) medicine [“which assists in the treatment of, assists in protection from, assists in relief
of”], applicant to choose one of these three as well as the [“Indication”].
The following warning statement must also be included as part of the wording:
Should the condition not improve within [“Time Warning”] please consult your practitioner.
o
For SC0 pre-diagnosed the required wording is:
A (Insert the Class) medicine for the [“treatment of, protection from, relief of”], applicant to choose one of
these three as well as the [“Indication”].
The following warning statement must also be included as part of the wording:
Before taking this medicine please ensure that the condition has been diagnosed by a practitioner.
Should the condition not improve within [“Time Warning”] please consult your practitioner.
o
For SC0 pre-diagnosed adjuvant the required wording is:
A (Insert the Class) medicine [“which assists in the treatment of, assists in protection from, assists in relief
of”], applicant to choose one of these three as well as the [“Indication”].
The following warning statement must also be included as part of the wording:
Before taking this medicine please ensure that the condition has been diagnosed by a practitioner.
Should the condition not improve within [“Time Warning’] please consult your practitioner.
WORDING
STANDARDISATION
It is proposed that he following
wording is recommended for all
CAMS
Quality
FOUR ISSUES ARE IMPERATIVE
A PHASED APPROACH WILL NEED TO BE ADOPTED IN ORDER FOR THIS TO BE
ACHIEVED
 Identification of substance
 Contamination by unwanted impurities (e.g. heavy metals, pesticides,
micro etc.)
 Strength (where this was applicable e.g. label claims or with regard to
safety)
 Stability (appropriate to each category of substance) (e.g. homoeopathic
preparations will be different to standardized herbals) based on a risk
management process in the longer term
It is recognized that the responsibility of quality lies with the Applicant
How to control Quality
GMP
 The manufacturing or distribution license
 Via the quality and testing of the INITIAL substances themselves
(the idea is to build quality into the CAM from the beginning
through ID and contamination testing)
•
All substances to be purchased from an compliant /
accredited / certified supplier
•
The importation quality criteria needs to be focused on
•
Importers of CAMS substances having to gain a license
or be approved to import where they agree on certain
quality testing criteria of the substances that they are
importing in
EFFICACY
EFFICACY REQUIREMENT FOR CAMS:
Levels of evidence that are internationally acceptable include:
 Higher level claims
 Lower level claims
Proof of efficacy lies with the Applicant
LEVELS OF CLAIMS
LOW LEVEL CLAIMS
 These claims generally will be self-diagnosable, self-treatable and self-limiting in
the acute case. The criteria for these types of claims or diseases follow the
following format:






Typical food / structure function claims
Health maintenance, including nutritional support & nutrition content claims
Health enhancement (of normal health) – general level of health claims
Vitamin and mineral supplementation supplying at least 25% of RDA
Relief of symptoms (not related to a disease, disorder or condition)
Specifically relief of symptoms of a joint, bone and rheumatic disease are seen as low
risk claims
 Examples
 Calcium for the prevention of osteoporosis
 Indigestion with defined time limit
 Nappy rash
LEVELS OF CLAIMS
 LOWER LEVEL CLAIMS cont. - typically these claims relate to diseases / conditions
that require CAMS screening and/or registration and could typically be accepted
through the screening process
 These claims are generally self-diagnosable and self-treatable, but it is noted that in
most cases a time limit will be needed along with certain contra-indications and
interaction criteria. It is important to implement the exact CAM claims wording
recommendation in this case. The criteria for these types of claims or diseases
follow the following format:
 Health enhancement (of normal health not enhancement from a compromised state)
 Reduction of risk of a disease / disorder / condition
 Assists in the management of a named symptom / disease / disorder / condition – with defined time
limit for self-treatment
 Reduction in frequency of a discrete event
 Relief of symptoms of a named disease, disorder or condition by enhancing innate healing properties of
the body
 Examples
 Acne, Allergic Rhinitis, Athlete's Foot, Dandruff, Dermatitis etc.
LEVELS OF CLAIMS
HIGH LEVEL CLAIMS - Diseases / Conditions that require full registration and typically
would be “rejected” via the screening process and would require a full registration
 Generally these claims are not self-diagnosable or self-treatable, these products
would need to be registered (based on claim) and in most cases a time limit will be
needed (and still needs to be defined) along with certain contra-indications and
interaction criteria.
 It is important to implement the exact CAM claims wording recommendation in this
case. It is also noted that in these case that the following recommendation will be
needed on pack – “It is recommended that sufferers should seek medical advice”. The
criteria for these types of claims or diseases follow the following format:




Diseases / Conditions that REQUIRE HIGH LEVEL registration include;
Wording – “Treats / Cures / Manages any disease / condition or disorder”
“Prevent any disease / disorder or condition”
Treatment of specific named vitamin and mineral deficiency diseases
CONTRA-INDICATIONS, SIDE-EFFECTS AND WARNINGS
Note: codes to be entered in label sequence
RESTRICTION
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
This warning applies
only to oral dosage
forms
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
WARNINGS linked to
DIRECTIONS
This warning applies
only to oral dosage
forms
WARNINGS linked to
DIRECTIONS
Use only one U
warning
Use only one U
warning
Use only one U
warning
Use only one U
warning
Use only one U
warning
Use only one U
warning
WARNINGS linked to TIME
RESTRICTIONS
WARNINGS linked to TIME
RESTRICTIONS
WARNINGS linked to TIME
RESTRICTIONS
WARNINGS linked to TIME
RESTRICTIONS
WARNINGS linked to TIME
RESTRICTIONS
WARNINGS linked to TIME
RESTRICTIONS
CODE
Contra-indication, Side-effect and/or Warning to
be stated on label
A
WARNINGS linked to DIRECTIONS
Unless otherwise prescribed; Do not exceed the
stated dose.
C
Dilute with water.
G
Do not take before meals as may cause nausea
and vomiting.
Do not take simultaneously with other
homoeopathic remedies.
Q
For external use only.
Q1
Not to be taken.
Q2
Do not apply to open wounds.
Q3
Shake before use.
Q4
Refrigerate after opening.
Q5
Do not use for more than 30 days after opening.
D
Y
Take on sugar as not soluble in water.
WARNINGS linked to TIME RESTRICTIONS
SIDE-EFFECTS AND SPECIAL
PRECAUTIONS linked to
INGREDIENTS
SIDE-EFFECTS AND SPECIAL
PRECAUTIONS linked to
INGREDIENTS
U1
Do not take for longer than 1 week at a time.
U3
Do not take for longer than 8 days at a time.
U2
Do not take for longer than 4 weeks at a time.
U4
Do not take for longer than 6 weeks at a time.
U
Do not take for longer than 8 weeks at a time.
U5
N5
Seek professional advice before using long term.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS linked
to INGREDIENTS
A slight rise in body temperature or swelling of the
lymph nodes is a favourable sign and should not
be suppressed by drugs.
X1
Caution: Chaparral may cause liver damage, use
only under medical supervision.
WARNINGS
STANDARDISATION
It is proposed that he following
warnings are recommended for
all CAMS.
These are linked to both the
indications and the substances.
INDICATIONS
All indications broken down into:
CAMS indications (SC0 = CAMS Schedule 0)
SC0
SC0 adjuvant
SC0 pre-diagnosed
SC0 pre-diagnosed adjuvant
All indications to be supported by the approved
references (e.g. 4, 27, 28 & 22 for Panax ginseng)
and at the appropriate strengths
AN EXAMPLE
Single herb CAM
Active ingredient Ginseng
An indication is being made
Extract from herbal schedules list
Panax ginseng
Panax japonicus var. major
Panax notoginseng
Panax quinquefolium
Panicum milliaceum
Papaver somniferum
Parameria laevigata
Parietaria diffusa
Paris polyphylla
Paris quadrifolia
Parthenocissus tricuspidata
Paspalum notatum
Passiflora caerulea
Passiflora incarnata
Patrinia scabiosaefolia
Patrinia villosa
Paullina cupana
Paullinia pinnata
Pausintalia yohimbe
Pelargonium graveolens
Pelargonium species
Peltigera canina
Penicillium chrysogenum
Penicillium digitatum
Penicillium expansum
Penicillium glaucum
Penicillium notatum
Perilla frutescens
Persea gratissima
Petroselinium sativum
Panax pseudoginseng,
Panax schunseng, Ren
Shen
San Qi
Korean ginseng, Panax
≤ 1g
ginseng, Asian ginseng,
Chinese ginseng, True
ginseng, Japanese ginseng,
Oriental ginseng, Ginseng
Ginseng
≤ 1g
Tienchi ginseng, American
≤ 1g
ginseng, Western ginseng,
Five-fingers, Sang,
Notoginseng, Pseudoginseng
SC0
> 1g
SC1
Root
E5, R5, U5
SC0
SCO
> 1g
>1g
SC1
SC1
Root
Root
E5, R5, U5
E5, R5, U5
≤ 1g
SCO
>1g
SC1
Root
E5, R5, U5
SC0
SC0
SC0
Seed
n/a
Food
Food
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
SC0
SC0
SC0
SC0
SC0
SC0
SC0
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
SC0
SC0
SC1
SC0
SC4
SC0
n/a
n/a
n/a
n/a
n/a
n/a
n/a
SC0
SC0
SC0
SC0
SC0
SC0
SC0
SC0
Herb, tubers, root
n/a
n/a
n/a
n/a
n/a
n/a
n/a
Food
SC0
Fruit, Fruit Oil
Food
SC0
Leaves, seeds, root
Panacis Quinquefolii, Xi Ginseng, American ginseng,
Yang Shen
Sanchi ginseng, Tienchi
ginseng
Millet
Poppy seed
Parameria bulbata,
Akar gerip pootih
Ecdysanthera barbata
Parietiaria officinalis
Pellitory-of-the-wall
Himalayan Paris
One berry, Herb berry
Ampelopsis veitchii
Boston ivy, Japanese ivy
Bahia grass
Blue passion flower
Passiflorae herba
Maypop passion flower,
Passiflora, passion vine
Paullinia sorbilis
Corynanthe yohombe
Perilla arguta , Perilla
ocymoides
Persea americana,
Laurus persea
Petroselinium crispum,
Apium petroselinum,
Woolly patrinia
Guarana
Barbasco, Nistamul
Yohimbe
Rose geranium, Sweet
scented geranium
English liverwort
Stilton cheese fungus
Citrus fungus
Apple fungus
Glucose oxidase fungus
Penicillin fungus
Bushy perilla
Avocado tree, Avocado,
Avocado Oil
Parsley
Dried aerial parts
None
seeds
U2
bark
L, L1, A
A, E5, L
PANAX GINSENG
Information gained from the substance list
 Approved Name:
 Synonym:
 Common name :





Low criteria :
Upper criteria :
Plant part used :
Caution codes :
References :
Panax Ginseng
Panax pseudoginseng, Panax schunseng, Ren Shen
Korean ginseng, Panax ginseng, Asian
ginseng, Chinese ginseng, True ginseng,
Japanese ginseng, Oriental Ginseng
<1g = SC0
>1g = SC1
Root
E5, R5 & U5
4, 27, 28 & 22
PROPOSED INDICATION WORDING
•
SC0:, the required wording is:
– A (Insert the Class) medicine for the [“treatment of, protection from, relief of”],
applicant to choose one of these three as well as the [“Indication”],
– Should the condition not improve within [“Time Warning”] please consult your
practitioner.
•
For SC0 adjuvant, the required wording is:
– A (Insert the Class) medicine [“which assists in the treatment of, assists in protection
from, assists in relief of”], applicant to choose one of these three as well as the
[“Indication”].
– Should the condition not improve within [“Time Warning”] please consult your
practitioner.
•
For SC0 pre-diagnosed the required wording is:
– A (Insert the Class) medicine for the [“treatment of, protection from, relief of”],
applicant to choose one of these three as well as the [“Indication”].
– Before taking this medicine please ensure that the condition has been diagnosed by a
practitioner. Should the condition not improve within [“Time Warning”] please consult
your practitioner.
•
For SC0 pre-diagnosed adjuvant the required wording is:
– A (Insert the Class) medicine [“which assists in the treatment of, assists in protection
from, assists in relief of”], applicant to choose one of these three as well as the
[“Indication”].
– Before taking this medicine please ensure that the condition has been diagnosed by a
practitioner. Should the condition not improve within [“Time Warning’] please consult
your practitioner.
INDICATIONS – PANAX GINSENG
 Indications –




Physical or mental exhaustion
Stress
Men or Women’s Tonic
Inadequate resistance to infections
 Dosage – Justify efficacy (dose per day needs to justify the indication)


Panax Ginseng : 0.5g – 2g dried root daily
Take one capsule daily
 Check list:





Is this claim on the claims list?
Are these claims on the ASA prohibited list?
Is there a caution code?
Is there a time warning?
Does dose support claim – levels of active ingredients vs. efficacy of product?
EXTRACT FROM DRAFT INDICATIONS
LIST
Indications
Prediagnosed
Adjuvant
Schedule
Time Warning
Exhaustion (see Fatigue)
SC0
4 weeks
Fatigue: mental
SC0
4 weeks
Fatigue: physical
SC0
4 weeks
Stress
SC0
3 weeks
Male or Female Tonic
YES
Check list:
Is this claim on the claims list?
Are these claims on the ASA prohibited list?
Is there a caution code?
Is there a time warning?
Does dose support claim – levels of active ingredients?
SC0
CAUTION CODES
Approved Name : Panax Ginseng
Caution codes :
E5, R5 & U5
E5 - do not use when pregnant except under
practitioner supervision (except for Men’s
product)
R5 - do not use with pre-diagnosed high blood
pressure except under practitioner supervision
U5 - seek professional advise before using long term (for
SC1)
References :
4, 27, 28 & 22
Extract from reference list
CRITERIA WITH RESPECT TO EFFICACY for HERBAL REFERENCE LIST
Acceptable reference list to use when establishing the safety & efficacy of herbal preparations
3
British Herbal Pharmacopoeia
4
British Herbal Compendium
5
Handbook of Medicinal Herbs, James A. Duke – CRC Press, Florida ISBN 0-8493-3630-9
6
Herbal Medicine, Rudolf Fritz Weiss (translated from the German) – Beaconsfield Publishers, England ISBN 0-906584-19-1 (1st & 2nd edition)
7
The New Honest Herbal The New Honest Herbal, Varro E. Tyler – George F. Stricley Company, Philedelphia ISBN 0-89313-078-8
8
Herbal Remedies Harmful and Beneficial Effects, Professor S Talalaj & Dr AS Czechowicz – Hill of Content Publishing Pty Ltd, Melbourne, Australia ISBN 0-85572-189-8
9
The Wild Rose Scientific Herbal, Terry Willard – Wild Rose College of Natural Healing Ltd, Calgary, Canada ISBN 0-9691727-0-3
10
Potter’s New Encyclopedia of Botanical Drugs and Preparations, R.C. Wren – C.W. Daniel Company Ltd, Saffron Walden, England ISBN 0-85207-197-3
11
A Modern Herbal, Mrs M Grieve – Penguin Handbooks
12
The New Honest Herbal – A sensible Guide to Herbs and Related Remedies, Varro E Tyler PhD ISBN 0-89313-078-8 Pub George F Stickly & Co. USA
13
A Dictionary of useful and everyday plants and their common names – FN Nowes
14
The Herb Book by Johan Last ISBN 0-553-26770-1 (A Bantam book)
15
The McDonald Encyclopaedic of Medicinal Plants ISBN 0-356-0541-Jhb; ISBN 0-356-10542-3 pb
16
Advanced Textbook on Traditional Chinese Medicine and Pharmacology Volume 1: ISBN 7-80005-195-1
17
Advanced Textbook on Traditional Chinese Medicine and Pharmacology Volume 2: ISBN 7-80005-262-1
18
Advanced Textbook on Traditional Chinese Medicine and Pharmacology Volume 3: ISBN 7-80005-296-6
19
Medicinal Plants in China ISBN 93-9061-102-2 (Series 2)
20
Medicinal Plants (Eastern / Central) Steven Festi / James le Dire ISBN 0-395-46722-5
21
People's Plants, Ben-Erik van Wyk & Nigel Gericke : ISBN 1 875093 19 2 (1st edition, 2000)
22
Medicinal Plants of South Africa, Ben-Erik van Wyk & Bosch van Oudtshoorn & Nigel Gericke : ISBN 1 875093 09 5 (1st edition, 1997)
23
WHO monographs on selected medicinal plants volume 1, WHO : ISBN 92 4 154517 8 (1999)
24
Trease and Evans Pharmacognosy, WC Evans, 15th edition : ISBN 0 7020 26174 (2002)
25
Principles and Paractice of Phytotherapy, Simon Mills & Kerry Bone, 1st edition : ISBN 0 443 060169 (2000)
26
Herbal Medicines, Joanne Barnes, Linda Anderson and J David Phillipson, 2nd edition : ISBN 0 85369 474 5 (2002)
27
Herbal Medicines, A guide for health care professionals, Carol A Newall, Linda A Anderson and J David Phillipson, 1st edition : ISBN 0 85369 289 0 (1996)
28
Herbal Medicine, Expanded Commission E Monographs : ISBN 0-9670772-1-4 (2000)
REFERENCES
Supports the dose and indication (efficacy & safety of
substance)
PANAX GINSENG
 British Herbal Compendium
 Medicinal Plants of South Africa, Ben-Erik van Wyk & Bosch van
Oudtshoorn & Nigel Gericke : ISBN 1 875093 09 5 (1st edition,
1997)
 Herbal Medicines, A guide for health care professionals, Carol A
Newall, Linda A Anderson and J David Phillipson, 1st edition :
ISBN 0 85369 289 0 (1996)
 Herbal Medicine, Expanded Commission E Monographs : ISBN
0-9670772-1-4 (2000)
DRAFT SAMPLE LABEL
 PANAX GINSENG – providing there is at least 0.5g of ginseng in
the product.





A herbal medicine for the treatment of mental and physical
exhaustion, should the condition not improve within 4 weeks
please consult your practitioner.
A herbal medicine for the treatment of stress, should the condition
not improve within 3 weeks please consult your practitioner.
Do not use when pregnant except under practitioner supervision
(unless the product is for Men)
Do not use with pre-diagnosed high blood pressure / hypertension
except under practitioner supervision
Seek professional advise before using long term (this would be
applicable for Ginseng greater than 1g = SC1)
Legislative Issues considered
FUNDAMENTAL ISSUES THAT NEED TO BE ADDRESSED
INCLUDE:
 Safety
 Quality
 Efficacy (to a lessor degree as traditional aspects need to be
considered)
 Supporting marketing code (advertising)
 An electronic screening system
 A phased approach needs to be implemented with regards
to all aspects
CAMS Marketing Code
1. It is noted that Section 18C of the Medicines Act 101 of 1965 (“the Act”)
empowers the Minister, after consultation with the Complementary,
Traditional and Alternative Medicine (CAMS) industry and other stake
holders, to develop appropriate regulations and guidelines relating to the
marketing of CAMS, including an enforceable CAMS Code of Practice;
2. The CAMS industry have developed a draft CAMS Code;
3. The companies in the CAMS industry have agreed to subscribe to a code of
practice for the marketing of CAMS in South Africa based on the principle
of self-regulation as set out in this CAMS Code;
4. The enforcement of the CAMS Code will be entrusted to either the
Advertising Standards Authority of SA (ASA) and / or the Marketing Code
Authority (“MCA”) and / or the Health Products Association (HPA).
CAMS Marketing Code
5. The CAMS Code is envisaged to be reviewed on an annual basis in line
with the approved enforcers annual reviews;
6. The CAMS Code is envisaged to cover all classes of CAMS, all combinations
of CAMS and all foodstuffs and cosmetics making “claims”;
7. The CAMS Code draft principles will and still need to be approved by all
relevant and respective stakeholders;
8. The CAMS Code draft definitions will and still need to be approved by all
relevant and respective stakeholders;
9. The CAMS Code will and still needs to be approved by the Minister and the
Department of Health along with the approved enforcer.
CAMS Marketing Code
TABLE OF CONTENTS – PART A
Registration and Legality of CAMS
Advertising and Promotion of CAMS
Information in Advertising
Information, Claims and Comparisons
Disparaging References
Suitability and Taste
Disguised Promotion
Provisions of Reprints and the Use of Quotations
Certification of Promotional Material
Joint Ventures and Co-Promotions
Product Training and Information
Compliance with Undertakings
Classes and Categories:
Advertising of Complementary Slimming Products
Advertising of Complementary Cosmetic Products
Advertising of Nutritional Food Substances
Advertising of CAMS via Mail Order
Advertising of Pets Products containing CAMS substances
Advertising of Potency / Libido enhancing products containing CAMS substances
Advertising of Sports products containing CAMS substances
CAMS Marketing Code
TABLE OF CONTENTS – PART B
Application
Registration status of CAMS
Advertising and / or Promotion
Prescribing of CAMS
Abbreviated Advertisements
Suitability and Taste
Provision of Reprints and Use of Quotations
Behaviour of Sales Representatives
Gifts, Inducements and Promotional Items
Donations and Charities
Hospitality and Payments
Raw Materials
Statutory Health Professions Council
HPA Objectives
 Ensure high profile visibility of the health
products industry as a dynamic, organized and
responsible force
 Reassure the public of the safety of health
products
 Maintain high ethical standards of production,
quality control, marketing and advertising
within the industry
Thank you
For further information
www.hpasa.co.za
Or contact Deirdre Allen
011 789 4464