CAMS UPDATE FROM HPA PERSPECTIVE Celecia Pleass Executive

CAMS UPDATE FROM HPA PERSPECTIVE Celecia Pleass Executive member of HPA

Terminology of TM/CAM v “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. v 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 lternative” (CAM). in Europe, North America and Australia. v When referring in a general sense to all of the regions, the comprehensive TM/CAM is used. TM/CAM v Allopathic medicine refers to the broad category of medical practice that is Allopathic medicine 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? v The HPA is the trade association representing the Complementary and Alternative and Traditional Medicines (CAMS) industry. v Established in 1978 v Over 100 health product manufacturers, distributors and raw material suppliers v Affiliated to IADSA (International Alliance of Dietary Food Supplements Association) v Founded in 1998 – represents 57 dietary supplement associations worldwide v 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 v Ensure high profile visibility of the health products industry as a dynamic, organized and responsible force v Reassure the public of the safety of health products v Maintain high ethical standards of production, quality control, marketing and advertising within the industry

Paradigms of Medicine v Different “disciplines” of medicine including Orthodox Medicine are based on belief systems that can be called paradigms. v Differs with respect to how it: v Views wellness and well-being v The human being v Orthodox paradigm is dominant in the Western world, other paradigms are equally relevant, growing rapidly and operate within different contexts. v We believe that no dominant paradigm should subsume another.

What do we support? v 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). v 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 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 v Global vitamin and supplement market is worth $68 billion v Depending on the segment, growth is steady, ranging between 3% and 12% v SA Market size estimated at approx. R 7 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 v 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 v Cross-sectional study using data from 2002 National Health Interview Study (NHIS) v 31044 respondents v 21% used prescribed medicines and non-vitamin Dietary supplements in past 12 months v 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) v v v 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: v Safety v Quality v Efficacy (to a lessor degree as traditional aspects need to be considered) v Supporting marketing code (advertising) v An electronic screening system v A phased approach needs to be implemented with regards to all aspects

Safety SAFETY NEEDS TO BE ADDRESSED FOR BOTH: v Substances v Indications It is recognized that the responsibility of safety ultimately lies with the Applicant

HPA Scheduling task v 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. v Various other substances whose scheduling status has changed over many years, which you may have 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: v Was the condition or the indication self–diagnosable? v Was the condition or indication self-limiting in the acute case? (e. g. Coughs and Colds vs. Bronchitis) v All other dangers need to be addressed through warnings: v Direction warnings v Time warnings v Special precautions v Side effects v Contra-indications to risk group/s or ailment/s v 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”

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 v Identification of substance v Contamination by unwanted impurities (e. g. heavy metals, pesticides, micro etc. ) v Strength (where this was applicable e. g. label claims or with regard to safety) v 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 v GMP v The manufacturing or distribution license v 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 REQUIREMENT FOR CAMS: Levels of evidence that are internationally acceptable include: v Higher level claims v Lower level claims Proof of efficacy lies with the Applicant

LEVELS OF CLAIMS LOW LEVEL CLAIMS v 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: v v v 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 v Examples v Calcium for the prevention of osteoporosis v Indigestion with defined time limit v Nappy rash

LEVELS OF CLAIMS v 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 v 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 time limit contra-indications interaction criteria. It is important to implement the exact CAM claims wording interaction recommendation in this case. The criteria for these types of claims or diseases follow the following format: v Health enhancement (of normal health not enhancement from a compromised state) v Reduction of risk of a disease / disorder / condition v Assists in the management of a named symptom / disease / disorder / condition – with defined time limit for self-treatment v Reduction in frequency of a discrete event v Relief of symptoms of a named disease, disorder or condition by enhancing innate healing properties of the body v Examples v Acne, Allergic Rhinitis, Athlete's Foot, Dandruff, Dermatitis etc.

LEVELS OF CLAIMS HIGH LEVEL CLAIMS - Diseases / Conditions that require full registration and typically full would be “rejected” via the screening process and would require a full registration v 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. v 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: v v 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

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 v All indications broken down into: v. CAMS indications (SC 0 = CAMS Schedule 0) v. SC 0 adjuvant v. SC 0 pre-diagnosed adjuvant v 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 v. Single herb CAM v. Active ingredient Ginseng v. An indication is being made

Extract from herbal schedules list

PANAX GINSENG Information gained from the substance list v Approved Name: v Synonym: v Common name : v v v 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 <1 g = SC 0 >1 g = SC 1 Root E 5, R 5 & U 5 4, 27, 28 & 22

PROPOSED INDICATION WORDING • SC 0: , 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 SC 0 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 SC 0 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 SC 0 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 v Indications – v v Physical or mental exhaustion Stress Men or Women’s Tonic Inadequate resistance to infections v Dosage – Justify efficacy (dose per day needs to justify the indication) v v Panax Ginseng : 0. 5 g – 2 g dried root daily Take one capsule daily v Check list: v v v 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) SC 0 4 weeks Fatigue: mental SC 0 4 weeks Fatigue: physical SC 0 4 weeks Stress SC 0 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? SC 0

CAUTION CODES v Approved Name : Panax Ginseng v Caution codes : E 5, R 5 & U 5 v. E 5 - do not use when pregnant except under practitioner supervision (except for Men’s product) v. R 5 - do not use with pre-diagnosed high blood pressure except under practitioner supervision v. U 5 - seek professional advise before using long term (for SC 1) v 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 (1 st & 2 nd edition) 7 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 Ph. D 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 Mc. Donald 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 (1 st edition, 2000) 22 Medicinal Plants of South Africa, Ben-Erik van Wyk & Bosch van Oudtshoorn & Nigel Gericke : ISBN 1 875093 09 5 (1 st 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, 15 th edition : ISBN 0 7020 26174 (2002) 25 Principles and Paractice of Phytotherapy, Simon Mills & Kerry Bone, 1 st edition : ISBN 0 443 060169 (2000) 26 Herbal Medicines, Joanne Barnes, Linda Anderson and J David Phillipson, 2 nd 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, 1 st 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 v British Herbal Compendium v Medicinal Plants of South Africa, Ben-Erik van Wyk & Bosch van Oudtshoorn & Nigel Gericke : ISBN 1 875093 09 5 (1 st edition, 1997) v Herbal Medicines, A guide for health care professionals, Carol A Newall, Linda A Anderson and J David Phillipson, 1 st edition : ISBN 0 85369 289 0 (1996) v Herbal Medicine, Expanded Commission E Monographs : ISBN 0 -9670772 -1 -4 (2000)

DRAFT SAMPLE LABEL v PANAX GINSENG – providing there is at least 0. 5 g of ginseng in the product. v v v 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 1 g = SC 1)

Legislative Issues considered FUNDAMENTAL ISSUES THAT NEED TO BE ADDRESSED INCLUDE: v Safety v Quality v Efficacy (to a lessor degree as traditional aspects need to be considered) v Supporting marketing code (advertising) v An electronic screening system v A phased approach needs to be implemented with regards to all aspects

CAMS Marketing Code 1. It is noted that Section 18 C 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 v Ensure high profile visibility of the health products industry as a dynamic, organized and responsible force v Reassure the public of the safety of health products v 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