LCQ12: Regulation of health food products

Unlocking the secrets: the regulation of health food products

Following is a question by the Hon Chan Hok-fung and a written reply by the Secretary for Health, Professor Lo Chung-mau, in the Legislative Council today (April 24):

Question:

It has been reported that as at the 29th of last month, five people in Japan had died after consuming health food products containing red fermented rice. Regarding the regulation of health food products, will the Government inform this Council:

(1) of the legislation currently in place to regulate health food products and nutrition supplements containing Chinese medicines, western medicines, and ingredients other than such two types of medicines, and which government departments are responsible for the related investigations and enforcement actions;

(2) whether it has compiled comprehensive statistics on the types and numbers of health food products which members of the public currently can purchase in the market and import through the Internet; if so, of the details;

(3) whether it received cases of health hazards caused by the consumption of health food products in the past five years; if so, of the number of such cases and their details, including the hazards caused and the organs affected; and

(4) given that the Government will establish the Hong Kong Centre for Medical Products Regulation to help restructure and strengthen the regimes for regulating, vetting and approving medicines (including Chinese medicines and western medicines), whether health food products will be subject to the Centre's vetting and approval in future; if so, of the details and timetable?

Reply:

President,

The Government has been keeping in view the recent incidents involving deaths after consumption of products containing red fermented rice in Japan. Red fermented rice is produced by fermenting steamed rice with a strain of red yeast fungus, and has been used in Asia as a food colourant, flavor enhancer, for meat preservation and wine brewing. During fermentation, red fermented rice could produce lovastatin, a chemical similar to cholesterol-lowering pharmaceutical substance. However, the level of lovastatin in ordinary conventional foods containing red fermented rice is very low under normal application, and normal consumption of these foods does not pose any health risk. Although the Japanese authorities are still investigating the recent incidents, according to the latest information released by the Ministry of Health, Labour and Welfare of Japan, the red fermented rice ingredient involved was found to contain an unintended ingredient, namely puberulic acid, which is not derived from the normal process of red fermented rice production, and the relevant authorities of Japan are investigating whether there is any causal relationship between the unintended ingredient and the occurrence of kidney disorders and deaths after consumption of these products.

The relevant products are not registered drugs nor regulated as pharmaceutical products in Japan. The products have not been marketed by the relevant company in Hong Kong. Considering that red fermented rice is widely used in food, in 2019, the Pharmacy and Poisons Board of Hong Kong (the Board), after making reference to the practices of other drug regulatory authorities, decided that products containing lovastatin with a daily dose of about 10 milligrams or more would be regarded as pharmaceutical product, which shall be registered by the Board before they can be sold or distributed in Hong Kong. According to the record, there is no registered pharmaceutical product in Hong Kong containing red fermented rice as active ingredient.

In consultation with the Environmental and Ecology Bureau, the Commerce and Economic Development Bureau, the Department of Health (DH) and the Hospital Authority, the reply to the question raised by the Hon Chan Hok-fung is as follows:

(1) The international community has no consistent definition and regulation of "health food products". Broadly speaking, such products may contain different names, e.g. dietary supplements, nutraceuticals, natural health products. The Government has been adopting a multi-pronged strategy in regulating these products. In Hong Kong, depending on their individual nature, composition, content of the claims made, usage, dosage, packaging specifications, etc, such products are regulated under different legislations and respective government departments, including the Pharmacy and Poisons Ordinance (PPO) (Cap. 138), the Chinese Medicine Ordinance (CMO) (Cap. 549), the Undesirable Medical Advertisements Ordinance (Cap. 231), the Trade Descriptions Ordinance (TDO) (Cap. 362) and the Public Health and Municipal Services Ordinance (Cap. 132).

Product that falls within the definition of pharmaceutical product under the PPO and proprietary Chinese medicine (pCm) under the CMO must comply with the respective regulatory requirements for safety, quality and efficacy and be registered before they can be sold and supplied in Hong Kong. The PPO and the CMO also stipulate the licensing and practicing requirements for drug dealers. The DH has a market surveillance mechanism in place to monitor the safety, efficacy and quality of drugs. To protect the public from being induced by medical or health claims and thereby seeking improper self-medication that may result in delay in seeking medical treatment, the Government also regulates the labelling and promotion of products with medical or health claims (including products that are not pharmaceutical product or pCm) through the Undesirable Medical Advertisements Ordinance. The Customs and Excise Department (C&ED), as the principal enforcement agency of the TDO, will take enforcement actions against unfair trade practices (including false trade descriptions) prohibited under the TDO.

As for food in general, it is regulated under relevant provisions of the Public Health and Municipal Services Ordinance. The Centre for Food Safety under the Food and Environmental Hygiene Department, as the enforcement agency, carries out relevant work to ensure that relevant food is fit for human consumption, and is in compliance with relevant food safety standards and food labelling requirements. The relevant requirements also apply to those "health food products" which fall within the definition of "food".

In addition, the claims of "health food products" in licensed broadcasting services are also subject to regulation by the relevant provisions or codes under the Broadcasting Ordinance (Cap. 562) and the Broadcasting (Miscellaneous Provisions) Ordinance (Cap. 391). The Communications Authority will continue to take enforcement and regulatory actions in accordance with the relevant provisions and codes.

Different regions have adopted various practices as to whether to adopt more specific regulatory regimes for "health food products". Indeed, the nature and risks associated with different types of "health food products" also differ. The Government will continue to closely monitor the latest international regulatory developments and the market situation for "health food products", conduct risk assessment and review the relevant legislation and regulatory arrangements in a timely manner. At this stage, the Health Bureau is of the view that, from risk perspective, the safety of the products concerned has already been appropriately regulated under the prevailing framework, and that it would be more appropriate to strengthen relevant public education and publicity as well as the provision of information than to directly regulate the health claims of "health food products".

(2) and (3) The DH has been monitoring the safety, efficacy and quality of drugs through an established market surveillance mechanism. The DH collects samples of products in the market from various channels (including the Internet) for drug-related testing. If a product is found to have failed to comply with relevant statutory requirements (such as not registered, or found to have quality defects or adulterated with harmful substances), the DH will issue a press release as soon as possible to safeguard public health. Upon receipt of reports of suspected contravention of drug-related offences, including suspected illegal sale or possession of unregistered pharmaceutical products or pCm, the DH will follow up the cases immediately. If there is any contravention of drug-related offences found, the DH will take enforcement action and will conduct joint enforcement operations with the C&ED or the Hong Kong Police Force, or refer the cases to other law enforcement departments for follow-up actions.

In the past five years (from 2019 to 2023), the DH conducted about 41 370 inspections against Authorised Sellers of Poisons (commonly known as pharmacies) and Listed Sellers of Poisons (commonly known as medicine stores), and about 23 570 test purchase operations. In addition, the DH also conducted a total of about 28 590 inspections against licensed Chinese herbal medicines retailers. During the same period, the DH handled 137 conviction cases involving unregistered pharmaceutical products, with the highest penalty of imprisonment of 10 months or a fine of up to HK$75,000. There were also seven cases involving unregistered pCm, and the maximum fine was HK$10,000. The above 137 convictions included four cases in which the products claimed to be "health food products" were actually found to contain controlled drug ingredients.

In addition, the DH has also established a surveillance mechanism against online sales platforms and social media platforms. In the past five years, the DH has detected about 16 680 Internet links that might involve suspected illegal sale of controlled drugs, and about 330 Internet links involved in suspected illegal sale of unregistered pCm in the Internet. The relevant platforms have removed the problematic links as requested by the DH.

Other relevant bureaux and departments do not keep the information mentioned in the question.

(4) It is announced in "The Chief Executive's 2023 Policy Address" that the Government will enhance the current evaluation and registration mechanism for drugs, and establish an internationally renowned regulatory authority of drugs and medical devices, to progress towards the primary evaluation of applications of new drugs and medical devices.

The Government will set up a preparatory office under the DH in the first half of 2024 to review the current regulatory function within the DH including Chinese medicines, western medicines and medical devices, study the restructuring and strengthening of the regulatory and approval regimes for drugs, medical devices and medical technology and put forward proposals and steps for the establishment of the Hong Kong Centre for Medical Products Regulation (CMPR). The CMPR will adopt the primary evaluation approach in approval of registration applications of new drugs and medical devices under relevant legislations regulating Chinese medicines, western medicines and medical devices, with a view to attracting more local, Mainland and overseas pharmaceutical and medical device enterprises to conduct research and development and clinical trials in Hong Kong.

"Health food products" that are not classified as drugs and medical devices will continue to be regulated in accordance with other legislations and arrangements currently applicable to them.

Source: AI-generated images

Empowering innovation: a recap of sj's inspiring speech at the 26th icca congress

Following is the speech by the Secretary for Justice, Mr Paul Lam, SC, at the 26th ICCA Congress Opening Ceremony today (May 5):

Dr Alexandrov (President of the International Council for Commercial Arbitration (ICCA), Dr Stanimir Alexandrov), Justin (Co-Chair of the ICCA 2024 Hong Kong Host Committee Mr Justin D'Agostino), Neil (Co-Chair of the ICCA 2024 Hong Kong Host Committee Mr Neil Kaplan), Rimsky (Co-Chairperson of Hong Kong International Arbitration Centre (HKIAC) Mr Rimsky Yuen, SC), David (Co-Chairperson of HKIAC Mr David Rivkin), Joanne (Secretary-General of HKIAC, Ms Joanne Lau), distinguished guests, ladies and gentlemen,

Let me begin by expressing my gratitude to ICCA for agreeing to host the Congress in Hong Kong, which is a very strong vote of confidence in Hong Kong as an international arbitration centre. I must also congratulate the HKIAC on its successful organisation of the Congress. The Department of Justice is indeed very pleased to be one of the supporting organisations by providing financial and other supports.

I can now understand why the ICCA Congress is hailed as the Olympics of the international arbitration community. The Olympics is renowned for the great diversity and high standard of the participants. This ICCA Congress has attracted over 1 300 leading experts in international arbitrations from more than 70 jurisdictions. This is a new record, which I believe will be extremely difficult to break.

With so many friends from other parts of the world and the Mainland, as the Secretary for Justice of Hong Kong, I feel duty bound to seize the opportunity to impress on you that Hong Kong is and will remain to be a leading international arbitration centre. I am going to recast the four letters "ICCA" as an acronym to illustrate the unique strengths and qualities possessed by Hong Kong that make it stand out as one of the best venues for international commercial arbitration.

"I" - Institutional support

"I" stands for "institutional support". Hong Kong is home to many world-class and internationally renowned arbitral institutions. As our home-grown dispute resolution institution, HKIAC has always been ranked as one of the most-preferred arbitral institutions in the world. It is very encouraging to see that HKIAC received a total of 281 arbitration filings in 2023. I think Joanne mentioned some other relevant figures. They continued to be predominantly international arbitration featuring parties from 45 jurisdictions. The total amount in dispute in all arbitration cases was HK$92.8 billion, which is equivalent to about US$12.5 billion, representing a record high for HKIAC.

Among sponsors of the ICCA Congress are other reputable arbitral institutions with offices based in Hong Kong, such as the China International Economic and Trade Arbitration Commission (CIETAC), and the South China International Arbitration Center (Hong Kong) (SCIA(HK)).

"C" - Comprehensive legal framework

The first "C" stands for our "comprehensive legal framework" in arbitration. The Arbitration Ordinance in Hong Kong forms the backbone of our arbitration framework. Coming into effect in 2011, the Ordinance is largely based on the Model Law on International Commercial Arbitration of the United Nations Commission on International Trade Law, which is familiar to practitioners from both civil law and common law jurisdictions, as well as the international business community.

Taking note of arbitration users' needs for flexible funding options, we have refined our arbitration law to specifically provide for third party funding of arbitration in February 2019. In addition, the Outcome Related Fee Structures for Arbitration (ORFSA) was fully implemented in Hong Kong in December 2022. As at March 2024, based on statistics provided by our arbitral institutions, 88 arbitration cases were disclosed to be conducted with third party funding and five cases were conducted with ORFSA.

As to enforcement, arbitral awards made in Hong Kong are enforceable in Hong Kong, and over 170 contracting parties to the New York Convention. But more importantly, Hong Kong enjoys a unique strength that is not shared by other jurisdictions. Under the principle of "one country, two systems", Hong Kong has entered into three mutual legal assistance arrangements with the Mainland on not only mutual enforcement of arbitral awards, but also mutual assistance in interim measures which allow parties to arbitral proceedings administered by the designated arbitral institutions to apply to the Mainland courts for interim measures for preservation of asset, evidence and conduct, before an arbitral award is made. As at March 2024, Hong Kong's arbitral institutions had processed 118 applications for interim measures made to the Mainland courts, and court orders in respect of over RMB16.3 billion worth of assets had been issued.

"C" - Court's pro-arbitration approach

The second "C" stands for "the Court's pro-arbitration approach". The Hong Kong judiciary has long been adopting a very pro-arbitration approach. And such an approach is confirmed by a number of recent court judgments.

Last year, a landmark judgment C v D was handed down by the Hong Kong Court of Final Appeal. The judgment recognised the distinction between admissibility and jurisdiction, and held that there is a presumption that the issue of non-compliance with a precondition to arbitration is a question of admissibility to be decided by the arbitral tribunal, thereby limiting the scope of court intervention in the arbitral process. In a more recent case of CNG v G, the Court of First Instance reaffirmed the fundamental principles that arbitration is a voluntary and consensual process of final dispute resolution; and it was stressed that the Court must not only respect the autonomy of the tribunal, but also leave the tribunal free to decide the dispute with the proper exercise of its case-management powers, when the tribunal is clearly in the best position to manage its own proceedings and procedure. Lastly, in two very recent judgments handed down around two weeks ago, Re Simplicity & Vogue Retailing (HK) Co Ltd, and Re Shandong Chenming Paper Holdings Ltd, the Hong Kong Court of Appeal noted and ruled that, save in wholly exceptional circumstances, the court should decline to entertain a petition for winding up or bankruptcy when there is an arbitration agreement concerning the debt in question.

"A" - Accessibility to the international legal community

Lastly, the letter "A". Letter "A" stands for the accessibility to the international legal community. I wish to emphasise that the international arbitrations in Hong Kong are accessible to the international legal community. There is no doubt that Hong Kong itself has a very strong tool of legal talents specialised in international arbitrations. This is demonstrated by the large number of sponsors and organisers of not just official events but side events, many of which are leading law firms and barristers' chambers in Hong Kong.

But the point that I really wish to make is that Hong Kong welcomes friends from the Mainland and other parts of the world to take part in international arbitrations conducted here. As an example, to enhance immigration convenience, last year, the Government has expanded the Pilot Scheme on Facilitation for Persons Participating in Arbitral Proceedings in Hong Kong for all visitors to participate in arbitral proceedings here as arbitrators, expert and factual witnesses, counsel in the arbitration, and parties to the arbitration, without the need to obtain any employment visa. From March 2023 to March 2024, 96 persons were allowed to participate in Hong Kong arbitral proceedings without the need to obtain any employment visa under the scheme.

I truly and firmly believe that Hong Kong's reputation as a leading international arbitration centre is well deserved. However, to enable Hong Kong to maintain and enhance such a status, we need your trust and support, in particular, those of you from overseas. Seeing is believing. I hope that, apart from taking part in the official and side events of this ICCA Congress, you will have the chance to experience the Hong Kong life including our delicious food, unique culture and beautiful scenery. I am sure you will be convinced that Hong Kong remains to be a very open, friendly and diversified international society with a solid foundation based on the rule of law.

On this note, I wish to say thank you again, and I wish you all a pleasant evening in celebrating the commencement of the ICCA Congress, and of course, a very fruitful, constructive and pleasant stay in Hong Kong. Thank you very much.

Speech by SJ at 26th ICCA Congress Opening Ceremony Source: HKSAR Government Press Releases