Review of the Regulation of Products at the Interface Between Cosmetics and Therapeutic Goods
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PO Box 100, Woden ACT 2606, Australia Review of the regulation of products at the interface between cosmetics and therapeutic goods 18 March 2005 Review of the regulation of products at the interface between cosmetics and therapeutic goods March 2005 Prepared for the TGA by David B Newgreen Review of the regulation of products at the interface between cosmetics and therapeutic goods CONTENTS ABBREVIATIONS ..........................................................................................................ii ACKNOWLEDGMENTS .............................................................................................. iii TERMS OF REFERENCE ..............................................................................................iv SUMMARY.....................................................................................................................vi RECOMMENDATIONS..................................................................................................x 1. INTRODUCTION ......................................................................................................13 2. OVERVIEW OF THE REGULATION OF MEDICINES AND COSMETICS IN AUSTRALIA AND NEW ZEALAND ....................................................................23 2.1 AUSTRALIA......................................................................................................23 2.2 NEW ZEALAND ...............................................................................................33 3. OVERVIEW OF THE REGULATION OF MEDICINES AND COSMETICS IN OTHER COUNTRIES..............................................................................................37 3.1 CANADA ...........................................................................................................37 3.2 UNITED KINGDOM & THE EUROPEAN UNION ........................................40 3.3 UNITED STATES OF AMERICA ....................................................................43 4. REGULATION OF PRODUCT CATEGORIES UNDER THE JOINT REGULATORY SCHEME FOR THERAPEUTIC PRODUCTS ...........................47 4.1. ANTIPERSPIRANTS........................................................................................47 4.2. ANTIDANDRUFF TREATMENTS.................................................................52 4.3. SUNSCREEN-CONTAINING PRODUCTS....................................................55 4.4 ANTIBACTERIAL HAND WASHES ..............................................................70 4.5 ACNE WASHES ................................................................................................77 4.6 TOOTHPASTES AND MOUTHWASHES.......................................................79 4.7. OTHER BORDERLINE PRODUCTS..............................................................84 APPENDIX 1 – DEFINITIONS.....................................................................................89 APPENDIX 2 – NICNAS LOW REGULATORY CONCERN CHEMICALS (LRCC) REFORM ..................................................................................................................95 16 January 2005 i Review of the regulation of products at the interface between cosmetics and therapeutic goods ABBREVIATIONS ACCC Australian Competition and Consumer Commission ACH Aluminium chlorohydrate ACSPA Australian Consumer & Specialty Products Association Agency Trans Tasman Agency to Regulate Therapeutic Products AGRD Vol.2 Australian Guidelines for the Registration of Drugs, Volume 2 AICS Australian Inventory of Chemical Substances ARTG Australian Register of Therapeutic Goods ASMI Australian Self Medication Industry AS/NZS Australia and New Zealand Standard (for sunscreens) COLIPA Comité de Liaison des Associations Européennes de L’Industrie de la Parfumerie, des Produits Cosmetiques et de Toilette. (The European Cosmetic, Toiletry and Perfumery Association) CTFAA The Cosmetic, Toiletry and Fragrance Association of Australia Inc CTFANZ The Cosmetic, Toiletry and Fragrance Association of New Zealand Inc ERMA Environmental Risk Management Authority (of New Zealand) FDA Food and Drug Administration (of the United States of America) GMP Good Manufacturing Practice, (Code of) HSNO Hazardous Substances and New Organisms Act 1996 (New Zealand) LRCC Low Regulatory Concern Chemicals MHRA Medicines and Healthcare products Regulatory Agency (of the United Kingdom) NCCTG National Coordinating Committee on Therapeutic Goods NDPSC National Drugs and Poisons Schedule Committee NICNAS National Industrial Chemicals Notification and Assessment Scheme NZSMI New Zealand Self Medication Industry OTC “Over the counter” i.e. non-prescription PBS Pharmaceutical Benefits Scheme RPBS Repatriation Pharmaceutical Benefits Scheme SPF Sun Protection Factor SUSDP Standard for the Uniform Scheduling of Drugs and Poisons TGA Therapeutic Goods Administration ZACH Zirconium aluminium chlorohydrate ZAG Zirconium aluminium glycine ii 16 January 2005 Review of the regulation of products at the interface between cosmetics and therapeutic goods ACKNOWLEDGMENTS The Report acknowledges the advice and assistance provided by: Mr Paul Archer Dr Susan Martindale Mrs Margaret Barry Mr Tony Miller Ms Melanie Cantwell Mr Phil Morrish Mrs Bronwyn Capanna Dr Trevor Nisbet Mr Pio Cesarin Mrs Gail O’Bryen Dr Ian Copeland Mr Khay Ooi Mrs Kathy Daly Mr Glenn Probyn Mrs Mary Emanuel Ms Janet Ramsay Associate Professor Joan Faoagali Professor Barry Reed Dr Graeme Haley Mrs Juliet Seifert Dr Donald Hannah Mr Roger Smart Dr Margaret Hartley Mrs Anthea Steans Dr Roshini Jayawardene Mr John Woods Mrs Keri Jones Mr Garth Wyllie Submissions Written submissions or comments were received from, or interviews conducted with: Australian Competition & Consumer Commission Australian Consumer & Specialty Products Association Australian Health Industry Inc Australian Self Medication Industry Cancer Council of Australia Consumers’ Health Forum of Australia Cosmetic, Toiletry and Fragrances Association of Australia Inc Cosmetic, Toiletry and Fragrances Association of New Zealand Inc Direct Selling Association of New Zealand Employers & Manufacturers Association (Northern) Inc Environmental Risk Management Authority (of New Zealand) Healthcare Manufacturing Group National Industrial Chemicals Notification & Assessment Scheme The Australian Society for Microbiology Inc The Australian Society of Cosmetic Chemists Inc Therapeutic Goods Administration 16 January 2005 iii Review of the regulation of products at the interface between cosmetics and therapeutic goods TERMS OF REFERENCE 1. Review the appropriateness of current legislation and guidelines in the regulation of products at the interface incorporating: a) A summary of the current Australian and New Zealand regulatory frameworks (including Commonwealth and State schemes); b) A summary, discussion and comparison of these regulatory frameworks with those in the USA, Canada and Europe; c) Identification of any ‘grey areas’ in the current regulatory frameworks; 2. A review of the current Australian and New Zealand systems for the regulation of the following product categories to determine whether they would be most appropriately regulated as medicines through the joint regulatory scheme for therapeutic products or separately as cosmetics in Australia and New Zealand: • antiperspirants; • mass market antidandruff shampoos; • sunscreens (including moisturisers containing a sunscreen); • antibacterial skin washes; • antibacterial skin cleansers (anti-acne products); • toothpastes and mouthwashes; and • any other product categories that may be candidates for reform. 3. Recommendations on changes that could improve regulation at the interface for product categories listed above, including changes that could enhance the transparency and useability of regulatory documents such as the ‘Cosmetic Claims Guidelines’. 4. Consultation with stakeholders including: a) The Therapeutic Goods Administration – Non-prescription Medicines Branch and NICNAS; b) The Australian Competition and Consumer Commission (ACCC); c) The Cosmetic, Toiletry and Fragrance Association of Australia (CTFA); d) The Cosmetic, Toiletry and Fragrance Association of New Zealand; e) The Australian Chemical Specialty Products Association (ACSPA); f) The Australian Self-Medication Industry (ASMI); g) Australian Society of Cosmetic Chemists (ASCC) h) The New Zealand Self Medication Industry i) Consumer’s Health Forum of Australia; j) Medsafe (New Zealand); k) Medicines Evaluation Committee; l) Complementary Medicines Evaluation Committee m) State and Territory governments; n) National Coordinating Committee on Therapeutic Goods (NCCTG). iv 16 January 2005 Review of the regulation of products at the interface between cosmetics and therapeutic goods Guiding principles for reform of the regulation of products at the cosmetic- therapeutic interface The Therapeutic Goods Administration, through its NICNAS and Non-prescription Medicines regulators, is undertaking a review of the regulation of products at the interface between cosmetics and medicines. The review was commenced in response to recommendation 5.4 of the Final report and recommendations for NICNAS low regulatory concern chemicals (LRCC) reform initiative (June 2003). The outcomes of this review may include recommendations for reform of the regulation of products at the cosmetic-therapeutic interface. Where this is the case, the following principles will apply. 1. The primary consideration will be to maintain and enhance the protection of public health, safety and environmental standards, consistent