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Health food regulations in foreign countries: implications in Hong Kong

Yip, Pui-yu, Janice; 葉沛渝 Yip, P. J. [葉沛渝]. (2009). Health food regulations in foreign countries : implications in Hong Kong. (Thesis). University of Hong Kong, Pokfulam, Hong Kong SAR. Retrieved from http://dx.doi.org/10.5353/th_b4517533 2009

http://hdl.handle.net/10722/132338

The author retains all proprietary rights, (such as patent rights) and the right to use in future works.

Health Food Regulations in Foreign Countries: Implications in Hong Kong

by Yip Pui Yu Janice

MPH Project The University of Hong Kong 2009

Abstract of project entitled Health Food Regulations in Foreign Countries: Implications in Hong Kong

Submitted by Yip Pui Yu Janice

MPH Project The University of Hong Kong 2009

Abstract

Health food has become increasingly popular in Hong Kong as the public regard consuming health food products as a way to enhance health and promote longevity. The number of health food available on the market has increased exponentially as demands grow. Health food is not legally defined in Hong Kong and there are also no specific laws for the regulation of these products which post serious threats to public health. This article reviews health food regulations in Hong Kong, Australia and Canada and suggests appropriate regulations for Hong Kong. The review has shown that Hong Kong is lagging behind of other foreign countries in terms of health food regulation. With reference to experiences in foreign countries, changes can be made to

the current health food regulations in Hong Kong in order to safeguard public health, as well as easing the burden of overall healthcare costs in Hong Kong. A two-tiered registration approach supported by frequent post-market assessments is suggested with reference to regulations in Australia and Canada.

Declaration

I declare that this project represents my own work, except where due acknowledgement is made, and that it has not been previously included in a thesis, dissertation, or report submitted to this University or to any other institutions for a degree, a diploma, or other qualifications.

Signed,

________________________ Yip Pui Yu Janice

i

Acknowledgements

I would like to thank my supervisor, Dr Daniel Ho for his guidance and support of my project. I would also like to thank my family and friends for their advice and unlimited support during the preparation of my project.

ii

Table of Contents

Declaration Acknowledgements Table of contents

i ii iii

Introduction Methods Health food regulations in Hong Kong Pharmacy and Poisons Ordinance Chinese Medicine Ordinance Public Health and Municipal Services Ordinance Undesirable Medical Advertisements Ordinance

1 4 5 5 6 7 7

Regulations of Complementary Medicines in Australia The Therapeutic Goods Act 1989 Therapeutic Goods Regulations Code of Good Manufacturing Practice (GMP) The Therapeutic Goods Advertising Code Pre-market and post-market assessment

8

Implications in Hong Kong Conclusion

9 9 11 11 12 13 15 16 17 17 18 20 25

List of References

26

Natural Health Product Regulations in Canada Product licensing Site Licensing Good Manufacturing Practice Clinical Trials Labeling, Packaging and Health Claims

iii

Introduction

Due to cultural and historical differences, there have been various terms and definitions for describing health food worldwide. In United States, health food is named as dietary supplement; in Canada they are called natural health products and in Australia they are referred to as complementary supplements. Health food in Hong Kong is generally understood as natural food that is believed to promote or maintain good health. Although it has not been defined in law in Hong Kong, the Hong Kong Health Food Association describes health food as "non-conventional food that is intended to maintain or promote health. Its ingredient(s) could be one or any combination of the following: A vitamin, a mineral, a herb or other botanical, an amino acid, a dietary substance, a concentrate, or a metabolite constituent or extract that is suitable for human consumption and maintaining or improving health".1

In recent years, people have become more aware of their health and have been looking for ways to promote longevity due to ageing of the population. The 2005 Thematic Household Survey Report estimated that 23% of the Hong Kong population has taken health food in that year.2 At the same time, health food products are being intensively promoted through various media channels, often emphasizing their 1

unsubstantiated claims of benefit to health. Most health food nowadays is readily available in grocery stores, pharmacies and even on the Internet. All of these factors have lead to enormous increase in health food usage, both worldwide and locally in Hong Kong, despite the lack of regulatory control.

Health food incidents are becoming more common as the popularity of these products grows. The event that has drawn the most attention would be Ephedra in United States in the year of 2003. The meta-analysis of Ephedra by Shekelle and colleagues has casted doubt on its effectiveness on weight loss and athletic performance enhancement. They also expressed concerns about the safety of the product as it is associated with increased risk of psychiatric, gastrointestinal, or autonomic symptoms, and heart palpitations.3 As a result, a White Paper was established by the US Food and Drug Administration requesting the manufacturers to remove unproven claims for the products. Labels were also required on the packages of products containing Ephedra, displaying warnings that there had been reports of adverse events and deaths after use of such substance.4

In Hong Kong, there have also been a number of health food issues that hit the headlines of the newspapers. For example, in 2005, the consumer council has 2

discovered western drug ingredient – sibutramine, in two slimming herbal health foods.5 The drug ingredient was uncovered during a sampling test of 30 slimming products conducted by the consumer council. Products that contain sibutramine are regulated as Third Schedule poisons under the Pharmacy and Poisons Ordinance and are required to be registered before being sold. However, the herbal health foods were only regulated as ordinary food products and did not declare the presence of such substance in the contents; hence the products were not registered. Luckily, the drug only induced mild side effects such as headache and insomnia and no hospitalization was reported after consumption of the products. In 2008, the Consumer Council has uncovered inconsistency between the claimed and the actual contents of eicosapentanoic acid (EPA) and Omega-3 fats docosahexanoic acid (DHA) in a test which involved a total of 28 fish oil products. In the most remarkable case, a fish liver oil supplement was revealed to contain only 12% of the claimed amount of EPA.6 These incidents have revealed the loophole and deficiencies in the current health food regulations which post serious health hazard to Hong Kong consumers.

In addition, Hong Kong's health care funding is under vast pressure and it is predicted to worsen as the population ages. The Harvard Report projected that healthcare expenditure my take up to 23% of the total budget by 2016.7 Primary care has been 3

promoted in Hong Kong recently as a way to reduce the long-term health care costs. Health food, with its main function as health improvement, can play an important part in relieving the health care burden that Hong Kong is facing, if it is properly regulated and promoted. With reference to the experience in foreign countries, changes can be made to the current health food regulations in Hong Kong in order to safeguard public health, as well as easing the burden of overall healthcare costs in Hong Kong.

The objectives of this article are: (1) to review and examine health food regulations in Hong Kong, Australia and Canada. (2) to suggest appropriate regulations for health food in Hong Kong.

Methods

In order to identify relevant articles in the literature, an initial search was conducted using the database PUBMED and MEDLINE with the following keywords: health food, natural health product, complementary medicine, regulations, Hong Kong, Australia and Canada. The inclusion criterion was the relevance of the article to the aforementioned objectives. Only two papers matched this criterion, therefore another literature search was conducted using GOOGLE SCHOLAR using the above 4

keywords.

Eleven articles were retrieved from this database. Regulations of health

food were found in the Government websites of the relevant countries.

Health food regulations in Hong Kong

"Health food" is not legally defined in Hong Kong. It has been indicated by the Government that there is no universally accepted definition of health food. There is also no specific legislation for health food products regulation. Therefore, health food products are governed under various ordinances depending on their ingredients.

Pharmacy and Poisons Ordinance

Health food products which contain western medicines are subject to regulation of the Pharmacy and Poisons Ordinance (PPO). Products being registered under the PPO must be safe, efficacious and of high quality. It is required that the claims in the product descriptions must be truthful. The manufacturers, importers, wholesalers and retailers of these products should obtain a license before products containing such medicines can be manufactured or sold in Hong Kong. The Pharmacy and Poisons Regulations made under the PPO also require details of the products' dosage, 5

frequency and route of administration to be displayed in detail on the labels. All products that contain western medicines must comply with the PPO and the Pharmacy and Poisons Regulations no matter where they are manufactured or imported from.8

Chinese Medicine Ordinance

Health food products which are composed solely of Chinese medicines as active ingredients for treatments and health promotion purposes are defined as proprietary Chinese medicines and therefore are regulated under the Chinese Medicine Ordinance (CMD).9 The ordinance aims to ensure the safety and quality of proprietary Chinese medicines. Under the CMD, the Chinese Medicine Council is empowered in the regulation of proprietary Chinese medicine. There is a registration system for proprietary Chinese medicines. In order to be approved for registration, the safety, quality, efficacy and the truthfulness of the claims of the products will be examined. Manufacturers, importers, wholesalers and retailers of these products are also required to be licensed before products could be manufactured or sold.

6

Public Health and Municipal Services Ordinance

Health food products that do not belong to the western medicine or Chinese medicine are regulated as general food products under the Public Health and Municipal Services Ordinance (PHMSO).10 This ordinance provides that manufacturers, importers and retailers of food are responsible for ensuring their products are suitable for human consumption. Under this ordinance, it is an offence to display a food label which misleadingly describes the nature substance or quality of the food product. In addition, according to the Food and Drugs (Composition and Labelling Amendment: Requirements for Nutrition Labelling and Nutrition Claim) Regulation, all pre-packaged food must comply with the latest statutory requirements on nutrition labeling and nutrition claims.

Undesirable Medical Advertisements Ordinance

Under the Undesirable Medical Advertisements Ordinance, in health food products, claims about preventive or curative effects on any of the 14 diseases specified in the Schedule of the Ordinance are prohibited.11

7

Regulations of Complementary Medicines in Australia

In Australia, "health food" is not defined in law. Products for oral consumption are regulated either as foods or therapeutic goods. However, some products lie between the definitions of foods and therapeutic goods and they are known as "complementary medicines". These are low risk products including traditional medicines, herbal medicines, nutritional supplements, special purpose foods, homoeopathic and naturopathic products.12 In an Australian context, complementary medicines includes "herbal medicines, vitamin and mineral supplements, other nutritional supplements, traditional medicines such as Ayurvedic medicines and traditional Chinese medicines (TCM), homoeopathic medicines, and aromatherapy oils (where they make therapeutic claims)".

The responsibility for the regulation of complementary medicines is delegated by the Commonwealth Department of Health and Aged Care to the Therapeutic Goods Administration (TGA). The TGA has an office called the Office of Complementary Medicine, which is dedicated to this role. It is responsible for product safety, registration, quality, claims, post-marketing monitoring as well as for setting the standards for product manufacturing.12 The 1989 Therapeutic Goods Act, the 8

Therapeutic Goods Regulations, the Code of Good Manufacturing Practice (GMP) and the Therapeutic Goods Advertising Code together provide a statutory regulatory framework for the manufacture, import, export, supply and advertising of complementary medicines in Australia.

The Therapeutic Goods Act 1989

The Therapeutic Goods Act 1989 requires that all the complementary medicines, both manufactured locally or imported from elsewhere, must be included in the Australian Register of Therapeutic Goods (ARTG) prior to their supply.13

Therapeutic Goods Regulations

The Commonwealth of Australia has announced a list of ingredients that are allowed to be included in complementary medicines and are shown in Table 1. Depending on their ingredients and purpose of use, they may be "Listed" or "Registered" in the ARTG.14 It is considered that listed products are low risk and not every products are required to be evaluated. They are assessed individually by the TGA for compliance with the legislation; however their safety, quality and efficacy are not evaluated before 9

they are being sold in the market.

Listed complementary medicines may only carry

claims for health maintenance, symptoms relieving, risk reduction and health enhancement. The TGA will not evaluate the claims before the product being released to the market, but it is required by the Act that there must be appropriate evidence supporting the claims made at the time the product is included as a Listed complementary medicine in the ARTG. If the public health or safety concern about the claims for a product is raised, the sponsors may be called upon by the TGA to provide the evidence that support the claims. The evidence can be scientific of evidence of traditional use. On the other hand, registered products are required to be evaluated for safety, quality and efficacy, on a case-by-case basis. Therefore, the difference between listed and registered goods is that registered goods have been evaluated for efficacy. Most complementary medicines are considered to be of low risk and thus are Listed products. The products are also required to comply with the Code of GMP standards.

The Office of Complementary Medicines (OCM) within

the TGA is responsible for the evaluation of the quality and safety of new Listed complementary medicines and the quality, safety and efficacy of Registered complementary medicines. The OCM staff will prepare a comprehensive report of the product based on the data supplied by the sponsor and the Complementary Medicine Evaluation Committee, which is an independent statutory committee, will examine the 10

report.

Code of Good Manufacturing Practice (GMP)

The Code of GMP is a set of principles and practice that have to be followed so that products can be assured to be safe and reliable.15By ensuring that medical products have met defined standards of quality and safety, the GMP aims to protect the health of the public. It consists of requirements relating to premises, personnel, documentation, equipment and quality control. Mandatory licensing and audits of factories which manufacture complementary medicines are the key mechanisms used for enforcing the GMP requirements.

Manufacturers must be licensed and must

meet certain standards of safety, quality and conditions of manufacture.

The Therapeutic Goods Advertising Code

Finally, the Therapeutic Goods Advertising Code ensures that the advertising and marketing of therapeutic goods to consumers is socially responsible, does not mislead or defraud consumers and is conducted in a manner that promotes the quality use of therapeutic.16 All complementary medicines advertisements must comply with the 11

Code. Prior formal approval must be obtained for all advertisements which will be broadcasted or published in the mainstream media.

Table 1 Kind of ingredients permitted in complementary medicines An amino acid Charcoal A choline salt An essential oil Plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll A homoeopathic preparation A microorganism, whole or extracted, except a vaccine A mineral including a mineral salt and a naturally occurring mineral A mucopolysaccharide Non-human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates A lipid, including an essential fatty acid or phospholipid A substance produced by or obtained from bees, including royal jelly, bee pollen and propolis A sugar, polysaccharide or carbohydrate A vitamin or provitamin Therapeutic Goods Regulations 199013

Pre-market and post-market assessment

All complementary medicines must undergo a pre-market assessment before they can be released to the market. Listed products are allowed to have the assessment conducted by the sponsors themselves so that the processing time of the application for listing in the ARTG can be shortened. The assessment has to be conducted by the TGA for Registered products. Apart from the pre-market assessments, there are also 12

post-marketing assessments such as laboratory testing of products on the market, problems investigations and monitoring of market activities to ensure compliance with legislation.

However, the Office does not usually collect and test samples

proactively, rather, they are more often problem-driven. Australia has a well-established adverse reaction reporting system which allows timely identification and appropriate regulatory responses to the problem. Suspected adverse reactions to drugs are reported to the Adverse Drug Reactions Advisory Committee. However it is not compulsory to report to the Committee. 12

Natural Health Product Regulations in Canada

On January 1, 2004, the Canadian Government promulgated the Natural Health Products Regulations (NHP Regulations), and added a new term to the global list of synonyms for health supplements – Natural Health Products (NHP). Prior to the introduction of the regulation, these products were regulated either as food or drugs under the Food and Drugs Act and Regulations. The aim of the NHP Regulations is to provide consumers in Canada with access to NHP that are safe, efficacious and of high quality.

13

According to the NHP Regulations, there are a substance component and a function component in the definition of NHP. Substance component include substances, either presence alone or in combination with other substances, stated in Schedule 1 of the NPH Regulations, which is shown in Table 2.17 The function component includes products consist of the substances mentioned in Table 2, that is manufactured, sold or represented for use in: "(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; (b) restoring or correcting organic functions in humans; or (c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health."17 Table 2. Components of Natural Health Product Substances 1. A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material 2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation 3. Any of the following vitamins: biotin folate niacin pantothenic acid riboflavin thiamine vitamin A vitamin B6 vitamin B12 vitamin C vitamin D vitamin E 4. An amino acid 5. An essential fatty acid 6. A synthetic duplicate of a substance described in any of items 2 to 5 7. A mineral 8. A probiotic

Natural Health Product Regulations17 14

The regulations include five elements: product licensing, site licensing, good manufacturing practices (GMP), clinical trials, and labeling and packaging, and are administered by the Natural Health Products Directorate (NHPD).

Product licensing

The NHP Regulations require all NHP to undergo premarket review in order to obtain a product license and a Natural Product Number (NPN), or a DIN-HM for homeopathic medicines. A product license will be granted after the successful review of a Product License Application (PLA) submitted by the importer, labeler, packager, distributor or manufacturer. The Directorate will evaluate the safety, quality, efficacy and proposed label texts of the products with the information provided on the PLA. The PLA must include sufficient information for the evaluation to be processed smoothly. However, the details in the information required depend on the type of submission. If the ingredients of a product have been included in the Compendium of Monographs of the NHPD, they are referred to as compendia product and no additional data is needed to support safety or efficacy if the intended conditions of use for the ingredient are in line with those outlined in its monograph. For Non-compendial products, a full examination of all data is required. After a NPN or 15

DIN-HM is issued to a product, it is required by the Regulations that the licensee must keep records of all the ingredients and information for at least one year after the expiry date of the product in case a lot of batch recall is required. A system for reporting adverse reaction for the NHP must be implemented and maintained by the licensee.17

Site Licensing

All Canadian sites that are involved in manufacturing, packaging, labeling, distribution and importation must hold a site license. The applicant should submit a site license application to the NHPD. If the NHP is manufactured, packaged or labeled, the importer is required to list all the foreign sites on their site license. By requiring a site to be licensed, the NHPD aims to safeguard the safety and quality of the finished product, by ensuring that the manufacturing, packaging, labeling, distribution and importation comply with the NHP GMP requirements. Site licenses are subject and have to be renewed regularly.17

16

Good Manufacturing Practice

Good Manufacturing Practice (GMP) for natural health products is a series of requirements that must be met in order to ensure product safety and quality. While ensuring safe and high quality products, the GMP also allows manufacturers, labelers, importers and distributors of NHPs to implement quality systems that are suitable for their businesses in a flexible manner. The GMP for NHPs covers four aspects which include people, places, processes and products. It ensures that: the people that are involved in the NHP production have appropriate qualifications and training; there are proper sites and equipments for NHP production; there are appropriate sanitation and hygiene programs in place; and that the products meet their established specification.17

Clinical Trials

A clinical trial may be required to provide evidences of safety and efficacy of a product if there is no human data available for product license application. A clinical trial application should be submitted and an approval from the NHPD must be obtained before conducting a trial. The requirements for the conduction of a clinical 17

trial are outlined in the NHP Regulations. The regulations are put in place to ensure that the clinical trial subjects are safe, and that the trial complies with good clinical practice. It also ensures that the clinical trial protocol, investigational product and placebo are safe, efficacious and of high quality. The Clinical Trials for Natural Health Products Guidance Document provides recommendations about how to meet the legal requirements stated in the NHP Regulations.18

Labeling, Packaging and Health Claims

The labeling and packaging of NHP being sold in Canada are required to comply with the requirements outlined in the NHP Regulations. While submitting the product license application, the applicant must also provide a printed version of the proposed label texts that will appear on the product. Information related to the proper use of the product, risk information, recommended use of the product, name and address of the product license holder and importer, a list of all ingredients, quantity of all medical ingredients, as well as the assigned NPN, must be clearly labeled on the NHP. The products are required to be packaged securely, so as to assure consumer that the product has not been opened before. The security feature of the product must be identified on the label of the product if it is not evident in the packaging of the 18

product.17

Previously when NHPs were regulated under the Food and Drugs Regulations as ordinary food products, they are not allowed to carry health claims. The opportunity for health claims is now better accommodated after the NPH Regulations has been introduced. Based on the strength, credibility and quality of the evidence supporting the claim, various categories and types of claims can be made. There are three types of permitted claims: treatment claims, risk reduction claims and structure-function claims. These three types of claims are categorized into traditional use claims and non-traditional use claims. Traditional use claims refers to practices based on "the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness for at least 50 years."19 Non-traditional use claims must be supported by scientific evidence. In order to successfully obtain a license for a NHP, appropriate evidences supporting the claim must be provided in the product license application.

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Implications in Hong Kong

There is no one single office or department that is in charge of the regulation of health food in Hong Kong. Different departments are responsible for enforcing different ordinances. The Food and Environmental Hygiene Department is responsible overseeing the implementation of the Public Health and Municipal Services Ordinance as well as testing samples of health food. The Pharmacy and Poisons Board is responsible for the enforcement of the Pharmacy and Poisons Ordinance. Both the Chinese Medicine Ordinance and the Undesirable Medical Advertisement Ordinance are enforced by the Department of Health. In addition, the consumer council will occasionally conduct tests on a wide range of products including health food to provide consumer information or to verify product claims. There may be delays or misunderstandings due to complicated interdepartmental communications.

Both the PHSMO and the PPO were established back in the middle of the last century, when the consumption of health food has not yet been so popular. As the Hong Kong society has been modernizing at an exponential rate in the past centuries, these ordinances are not up-to-date to serve the needs of the modernized society.

20

The regulation framework of health food is fragmented and more importantly, the ordinances were not designed to regulate health food in the first place. It may not be appropriate to regulate health food with the ordinances because the ingredients of health food are difference from those of food and drugs. As health food contains different ingredients from food and drugs, these ordinances should not be used to regulate health food. For example, in Hong Kong, health products which contain vitamins are required to be registered as pharmaceutical product as Hong Kong does not have a specific group for health food. These substances have long been used worldwide and there has not been long-term safety issue. Furthermore, there have already been numerous studies confirming that vitamins and minerals are safe for human consumption back in the 1980s.20,

21

Their purpose is mainly for health

enhancement and benefits rather for treatment of diseases, therefore it should not be necessary for them to be registered as drugs. In Australia and Canada, vitamins are regulated as complementary medicines and NHP respectively. On the other hand, some herbal supplements are regulated as ordinary food under the current regulations. However, it has been shown that some herbal supplements are potential hepatotoxins and will cause damage to the liver if too much is consumed.22 There is really a need to suggest a new category and regulations for health food just like how Australia and Canada regulated these products, so that their safety and quality can be properly 21

controlled and regulated.

Although requiring health food to be registered and to undergo pre-market assessments before sale is an effective way in ensuring safe and high quality products, it could also advocate monopoly which would restrain the public's health food choices. According to Biggs, in 2008, four years after the new regulations came into effect, it was estimated that there were more than 20,000 fewer NHP available in the Canadian market. One of the reasons is that the NHP suppliers cannot afford the money or time for license application and therefore they reduced the number of products they sold in Canada.23 As a result, the public had fewer choices when purchasing NHPs. Moreover, it was estimated that, in 2008, about 60% of all product license were unsuccessful and had to be removed from the market. If this trend persists, there will be 60% less NHP in the market.24

Hong Kong, as a democratic city, should protect the public's freedom of choice. Therefore, it is better for Hong Kong to adopt a system like Australia, in which health food can be classified into two classes according to their risks. By using a risk-based management system, the Australian Government has allowed timely market access for the industry and preserved the rights of the public to self-treat, using complementary 22

medicines. On the other hand, sufficient level of control is also being maintained to ensure the quality and safety of the products, safeguarding public health and safety. The shortened pre-market processes provide manufacturers early market access, while the safety and quality aspects are supported by various post-market actions. However, this two tiered approach also has its disadvantages. The fact that pre-marketing safety evaluation is not required for Listed products means that some products which have not met the safety and quality standards might have been released to the market without being noticed by the Government. As audits and safety tests are not usually conducted proactively, these unsafe or low quality products might remain on the market being unchecked for a long time, which post a great danger to the public's health. For example, in 2003, it was found that the Pan Pharmaceuticals Ltd., which is the largest manufacturer of herbal medicines, minerals and vitamins in Australia, had committed quality assurance breaches. The Pan were guilty of fabricating the assays of some vitamin preparations and substituting beef cartilage for shark cartilage.25 This was only found out when the TGA received reports about adverse reactions after consuming two of their pharmaceutical products, Travacalm tablets and Travacalm HO hyoscine hydrobromide.26 According to the TGA, ''the frequency of audit of manufacturers is based on the degree or risk to consumers in relation to the extent to which a manufacturer complies with GMP and the type of products manufactured." 27 23

The Pan would probably continue to produce substandard products until the problems were exposed at their next scheduled audit if not for the adverse reactions to the Travacalm products. Therefore when adopting this two-tiered regulatory framework, frequent post-market tests for low risk products is necessary to ensure the safety and quality of the products.

The majority of health food products are imported from USA, Japan, Australia, Canada and China.28 In 2008, the Hong Kong and Canada health authorities has signed the "Plan of Action for Regulatory Cooperation on Natural Health Products" to cooperate in the regulation of NHP. The plan establishes a framework for the exchange of information on NHP and communication of adverse reaction reports and recalls between the two places.29 Hong Kong should also cooperate with more places to acquire more health food information in order to enhance the safety, efficacy and quality of imported health food. In addition, the Government should inform the public about the health food regulations and educate them to make use of the information on the label while purchasing health food.

24

Conclusion

Hong Kong, as an international city, is lagging behind of many countries in terms of health food regulation. Some of the current ordinances regulating health food dated back to the middle of the past decade, which results in the lack of standardization of health food products as well as clinically verified safety and efficacy. In other words, the Government has transferred to the manufacturers or importers the responsibility for ensuring that health claims are substantiated, and that the products are safe, as pre-market approval is not required for non-medical or non-pharmaceutical products before products are launched into the market. In order to amend these loopholes, new regulations that are specifically formulated for health food control should be introduced. The two-tiered approach with the support of post-market assessments should provide better protection to the public while defending their freedom of choices.

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List of References 1. Hong Kong Health Food Association. Available at http://www.hkhfa.org [Accessed May 10, 2010] 2. Thematic Household Survey Report - Report No.26. Available at http://www.censtatd.gov.hk/freedownload.jsp?file=publication/stat_report/social_ data/B11302262006XXXXB0100.pdf&title=Thematic+Household+Survey+Repo rt+-+Report+No.26&issue=-&lang=1 [Accessed May 10, 2010] 3. Shekelle, P. G., M. L. Hardy, et al. (2003). "Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis." JAMA 289(12): 1537-1545. 4. US Food and Drug Administration White Paper on Ephedra. Evidence on the safety and effectiveness of ephedra: implications for regulation. Available at http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html [Accessed May 10, 2010] 5. Western drug ingredient uncovered in two slimming herbal health foods. Consumer Council, 2005. Available at http://www.consumer.org.hk/website/ws_en/news/press_releases/2005080402.htm l [Accessed May 10, 2010] 6. Discrepancy in Omega-3 levels found in fish oil dietary supplements. Consumer Council, 2008. Available at http://www.consumer.org.hk/website/images/news/p384/full.pdf [Accessed May 10, 2010] 7. Hsiao w. and Yip W. Improving Hong Kong's Health Care System: Why and for Whom?. Food and Health Bureau. Available at http://www.fhb.gov.hk/en/press_and_publications/consultation/HCS.HTM [Accessed May 10, 2010] 8. Pharmacy and Poisons Ordinance. Department of Justice. Bilingual Laws Information System. Available at http://www.legislation.gov.hk/blis_pdf.nsf/6799165D2FEE3FA94825755E0033E 532/0F66D4839C78DBDA482575EE00438DD5/$FILE/CAP_138_e_b5.pdf [Accessed May 10, 2010] 9. Chinese Medicine Ordinance. Department of Justice. Bilingual Laws Information System. Available at http://www.legislation.gov.hk/blis_ind.nsf/WebView?OpenAgent&vwpg=CurEng Ord*546*100*546.1#546.1 [Accessed May 10, 2010] 10. Public Health and Municipal Services Ordinance. Department of Justice. Bilingual Laws Information System. Available at 26

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