HISTORICAL DEVELOPMENT OF The Sale of Food and Drugs Ordinance 1952 i

The food quality control activities were implemented since 1950's under the Sale of Food and Drugs Ordinance 1952 in Peninsular Malaysia. In 1974, the Food Quality Control Unit was formed under the Health Services Division to coordinate food quality control activities nationwide. It was upgraded to Food Quality Control Division (FQCD) at the Ministry level in 1993. In September 1994, FQCD was renamed Food Safety and Quality Division (FSQD). FSQD's activities include enforcement of law; monitoring and research; consumer education; promotion of food safety to the industries and participation in international standard setting bodies. The official site features Food Act 1983; Food Regulations 1985; nutrition and labelling guidelines; licensing of natural mineral water, packaged drinking water and non-nutritive sweetening; food import procedure; food handler forms (SLPM-Sekolah Latihan Pengendali Makanan and AKM-Asas Kebersihan Makanan); and info on CODEX. 

In recognition of the potentially hazardous nature of certain medicines, the Food and Drug Administration (FDA) was authorized by Congress in 1938 to monitor the manufacture, promotion, and sale of drugs.' FDA regulation, following the pattern which has recently prevailed in the control of product and environmental hazards, has shifted from reliance primarily on sanctions imposed after the fact of injury attributable to drug use, toward the establishment of specific preventive regulations. The Kefauver-Harris Drug Amendments of 1962,2 for example, the first major change in the Federal Food, Drug and Cosmetic Act of 1938,8 conferred on the FDA broad discretionary powers for the issuance of such regulations.' These 'regulations aroused more drugindustry opposition than the statutory provisions authorizing them, 6 and have led to the first law suits challenging FDA rules since the passage of the Act.'

This article examines FDA jurisdiction over the advertising and labeling of prescription drugs. Both prescription and over-the-counter medicines fall within the Act's definition of "drugs" 7 as any article intended8 to prevent or treat disease, or intended to affect the structure or function of the body. The Durham-Humphrey Amendment of 1951,°

however, established separate legal categories for prescription and nonprescription drugs. Drugs which are too hazardous for self-medication and which, therefore, can be obtained only with a doctor's prescription, are prescription or ethical drugs." These drugs are promoted excluively to the medical profession," while over-the-counter, or proprietary

drugs are advertised and sold directly to the public. FDA regulation of the labeling of over-the-counter drugs," and Federal Trade Commission (FTC) regulation of advertising for such drugs" are beyond the scope of this article.

Since each piece of written material published by or on behalf of the manufacturer of a drug concerning his product is either advertising or labeling as those terms are used in the Act, this article traces separately the regulations governing prescription drug advertising and those governing prescription drug labeling. Whenever identical or similar

regulations govern a particular aspect of both advertising and labeling, the significance of the issue involved is examined fully under advertising, and the regulations merely summarized under labeling. In each area where the federal government has acted, the article explores the need for regulation, the statutory scheme as proposd to deal with the problem and as finally enacted into law," the regulations proposed and issued to implement the statutory purposes, industry reaction, and the extent of compliance. The article concludes with an examination of the standard of care owed to the public in the promotion of prescription drugs, and an evaluation of the potential liability of physicians, drug

manufacturers and the federal government in drug reaction cases.

FOOD SAFETY LEGISLATION
SCIENCE AND RISK-BASED APPROACHES TO HARMONIZATION

FOOD SAFETY LEGISLATION IN MALAYSIA

Abstract

Food safety legislation should be developed and updated taking into consideration specific needs of consumers and food producers, development in technology, emerging hazards, changing consumer demands and new requirements for trade, harmonization with international and regional standards, obligations under the World Trade Organization (WTO) agreements, as well as social, religious and cultural habits. The implementation of food safety legislation throughout the food chain is essential in establishing an effective food safety system.

The Food Act 1983 and the Food Regulations 1985 are the Malaysian food legislations that form the backbone of the food safety programme. Other legislations that have an impact on food safety are the Pesticide Act 1974, the Fisheries Act 1983, the Veterinary Surgeon Act 1974 and the Animal Ordinance 1953, all under the Ministry of Agriculture and Agro-based Industry, the Trade Description Act under the Ministry of Domestic Trade and Consumer Affairs, etc.

The continuous revision and updating of the Food Regulations 1985 is conducted by the Technical Advisory Committee on the Food Regulations 1985 chaired by the Director of the Food Quality Control Division, Ministry of Health. It is an inter-agency committee consisting of relevant government agencies involved in food safety from farm-to-table, the food industry, professional bodies and the consumers. Proposals for new legislations as well as revision and updating of legislations are elaborated in a 14-step procedure, which closely follow the Codex step procedure in the elaboration of Codex standards. Proposed new legislations, revised and updated legislations are posted on the Food Quality Control Division Website for comments. Notification to the WTO is undertaken to fulfill obligations under the WTO. Efforts in harmonization of legislation with international standards are actively undertaken using Codex standards as a benchmark. As such, a risk-based approach has been taken into consideration by the risk assessment conducted by Joint Expert Committee on Food Additives (JECFA) (for chemical additives) and Joint Expert Meeting on Microbiological Risk Assessment (JEMRA) (for microbiological parameters).

Harmonization of the national legislation with Codex standards which is an enormous task as well as the generation of scientific data are challenges in standard setting work.

Introduction

Food safety should be addressed throughout the food chain from farm to table. The establishment and updating of food safety legislation throughout the food chain is essential in establishing an effective food safety system. Food safety legislation should be developed and updated taking into consideration specific needs of consumers and food producers, development in technology, emerging hazards, changing consumer demands and new requirements for trade, harmonization with international and regional standards, obligations under the World Trade Organization (WTO) agreements, as well as social, religious and cultural habits.

Background

Malaysia has realized that food safety can no longer be considered solely as a domestic entity nor can it be the responsibility of a single agency. Even though the mandate for food safety rests with the Ministry of Health, other government agencies are also responsible for food safety in the country. The Vision of the Food Quality Control Division (FQCD) of the Ministry of Health to uphold the nation's integrity by ensuring safe food through shared responsibility and accountability on the basis of tripartite management is testimony that food safety is not only the responsibility of the government but also the industries and consumers.

The Food Act 1983 and the Food Regulations 1985 are the Malaysian food legislations that form the backbone of the food safety programme. These legislations replace the Sale of Food and Drug Ordinance and Regulations 1952. The objective of the Food Act 1983 and the Food Regulations 1985 is to ensure that the public is protected from health hazards and fraud in the preparation, sale and use of foods and for matters connected therewith. It is enforced by the Ministry of Health and the Local Authorities. The legislation, applicable to all foods sold in the country either locally produced or imported, covers a broad spectrum from compositional standards to food additives, nutrient supplements, contaminants, packages and containers, food labeling, procedure for taking samples, food irradiation, provision for food not specified in the regulations and penalty.

Since food safety is addressed throughout the food chain, legislations pertaining to food safety under the jurisdiction of other agencies are also enforced by the relevant agencies. At the primary production level, the Pesticide Act 1974, the Fisheries Act 1983, the Veterinary Surgeon Act 1974 and the Animal Ordinance 1953, all under the Ministry of Agriculture and Agro Based Industry are implemented. At the processing and retail levels, apart from the Food Act 1983 and the Food Regulations 1985, other legislations that were mentioned earlier are also applicable to a certain extent. The Trade Description Act under the Ministry of Domestic Trade and Consumer Affairs also play an important role in terms of protecting consumers from misleading and false labelling of food product.

Present activities

Updating and harmonization of food safety legislation

In order to ensure that the food safety legislations are in tandem with the development in food technology as well as to keep abreast with the changing consumer demands, it has to be continuously revised and updated.

The continuous revision and updating of the Food Regulations 1985 is conducted by the Technical Advisory Committee on the Food Regulations 1985 chaired by the Director of the FQCD, Ministry of Health. It is an inter-agency committee consisting of relevant government agencies involved in food safety from farm-to-table, the food industry, professional bodies and the consumers. Request for updating the food safety legislations is mainly made by the food industries (especially on the use of new ingredients and additives) and consumers (who demanded to be informed of new technology and new processes so as to be able to make an informed choice of the food they buy).

To assist the Committee in ensuring that specific areas of concern in food safety is addressed, various working groups comprising experts in the specialized areas are established to undertake work, namely in the following areas:

• Food Additives and Contaminants
• Food Labelling
• Food Commodity Standards
• Nutrition and Claims
• Microbiology
• Pesticide Residue
• Drug residue
• Fats and Oils

Currently new Acts and Regulations being drafted to enhance the implementation of the food safety programme include:

• Food Hygiene Regulations
• Food Irradiation Regulations
• Food Import Regulations
• Food Analyst Act
• Animal Feed Act

Proposals for new legislations as well as revision and updating of legislations are elaborated in a 14-step procedure, which closely follow the Codex step procedure in the elaboration of Codex standards. Proposed new legislations, revised and updated legislations are posted on the FQCD Website for comments. Notification to the WTO is undertaken so as to ensure transparency and fulfillment of obligations under the WTO.

Efforts in harmonization of legislation with international standards are actively undertaken. Codex Alimentarius is the benchmark for food safety legislation, whilst standards under the International Plant Protection Convention (IPPC) and the International Organization on Epizootics (OIE) are benchmarks for plant and animal health, respectively. Efforts to harmonize the classification of food categorization and food additives and food undertaken with the assistance of a local university. This is a follow-up of the recommendation of the ASEAN Food Safety Standards Harmonization Project undertaken with the International Life Sciences Institute (ILSI) South-East Asia.

At the ASEAN level, harmonization of maximum residue levels (MRLs) with Codex for pesticide residue is actively undertaken, wherever appropriate. However, where Codex standards are absent especially for products that are peculiar to the region, efforts to harmonize using regional standards are carried out.

Science and risk-based approach

In general, the continuous process of revision and updating of legislations incorporates a science and risk-based approach to determine acceptable level of control involving the entire food supply chain from primary production (use of pesticides and veterinary drugs, contamination from the environment) to food processing (use of additives and ingredients). Using the Codex Alimentarius as a reference in the promulgation of legislation, a risk-based approach has been taken into consideration by the risk assessment conducted by Joint Expert Committee on Food Additives (JECFA) (for chemical additives) and Joint Expert Meeting on Microbiological Risk Assessment (JEMRA) (for microbiological parameters).

The Ministry of Health has proposed a regulation for genetically modified food (GMF). The regulation utilizes a risk-based approach in the approval of GMF. In the proposed regulation, risk assessment will be conducted by GMAC under the Ministry of Natural Resources and Environment before it is allowed to be marketed in the country. The Biosafety Bill, which is being formulated, is the overall legislation pertaining to biosafety in Malaysia. Streamlining the approval process for risk assessment under the Biosafety Bill and the proposed regulations on GMF is a challenge to both ministries.

Currently, the risk-based approach is also used in the updating of ingredients to be added to food. Application for the addition of new ingredients must be justified so as not to cause any risk to consumers especially the vulnerable groups.

Consumer's rights

The food safety legislation has always given due recognition to consumer rights e.g. the new regulations for nutrition labelling and claims ensure that consumers are getting the right information and able to make a wise choice when buying food. The new regulations not only benefit the industries in making nutrition labels and claims but also ensure that the consumers are not misled by the attractive claims on the food labels. The consumers too, should play their role by reading the labels before making the right choice in buying food especially in ensuring that they are eating correctly based on the Food Pyramid.

Besides this regulation, the proposed regulation for GMF also incorporates provision on the labelling of GMF to provide consumer choice. The Consumer Protection Act enforced the Ministry of Domestic Trade and Consumer Affairs, although not specific to food safety do offer consumer protection.

Economic impact of food safety measures

The implementation of food safety legislation throughout the food chain is essential in establishing an effective food safety system. Such legislation should be updated to cater for the rapid development in food technology, the internationalization of food tastes and also emerging and re-emerging food borne diseases. Failure to adhere to such needs could lead to contaminated food and occurrence of food borne disease as a consequence, loss of trade and productivity.

The implementation of the Food Quality Control Programme has decreased health care costs, improved worker productivity due to decrease disease burden. It has also increased the availability of palatable and wholesome food through the reduction of substandard food into the country. The implementation of the programme has also increased consumer confidence in the food supply with the enforcement of food standards and food labelling regulations. Provisions of standards in the regulations have increased trade opportunities and export premiums.

Recommendations/Lessons learnt

Harmonization of the national legislation with Codex standards is an enormous task especially as it involves human and financial resources, and expertise. It is essential that personnel undertaking such work have a good understanding of the current national legislations as well as Codex Standards. In Malaysia, the establishment of committees and sub-committees that specifically undertake this work has benefited the country in ensuring that food safety legislations are harmonized to the extent possible.

In the promulgation of food safety legislation, availability of scientific data is very important, as the scientific and risk-based approach is the basic requirement for standard setting work. In Malaysia, scientific data is gathered through surveys and research conducted in collaboration and cooperation with research institutes and institutes of higher learning. This smart partnership has benefited Malaysia in terms of the optimization of limited resources, expertise and funds. However, this effort could still be enhanced.

The implementation and enforcement of food safety legislation remains the sovereign right of a country. However, the SPS Agreement under the WTO requires that food safety legislations enforced in a country do not discriminate between domestically produced foods and imported foods. Food safety legislations enforced in Malaysia are applicable to domestic as well as imported foods.