Hong Kong Health (Functional) Food Regulatory Report

Basic Overview:

Management and regulation of health foods in Hong Kong is primarily controlled with reference to a number of ingredient inventories. Ingredients are divided into different inventories based on their functional properties and the marketing claims made on final products. The regulatory obligations and market access requirements for associated products are outlined in this report in addition to detailing the various inventories used to regulate functional foods in Hong Kong.

1. Health (functional) food legislation in Hong Kong

1.1 Definition

There are no specific regulations to govern health (functional) food in Hong Kong. Different terms such as dietary supplements, nutraceuticals, designed foods, functional foods and natural health products are used on different occasions to refer to similar products. In most cases, the regulation of health (functional) food is based on their ingredient content and falls under the classification of either foods or drugs. Sports nutrition foods should also be classified based on their ingredients according to the following ordinances.

1.2 Classification

In Hong Kong, health (functional) food generally sold on the market, depending on their ingredients, are regulated by the following ordinances:

1.2.1 Pharmacy and Poisons Ordinance

Health (functional) foods which contain medicines or claim to have medicinal effect are regulated under the Pharmacy and Poisons Ordinance (Cap 138). The Ordinance provides a reference to guide the registration of products containing medicines to safeguard the safety, quality and efficacy of products, and includes requirements that any product claims made in the product descriptions must be truthful. The Ordinance also requires the licensing of manufacturers, importers, wholesalers and retailers of these products. Sale of unregistered pharmaceutical products is an offence under the Pharmacy and Poisons Ordinance. The maximum penalty is a fine of $100,000 and two years' imprisonment.

Who should apply for registration?

For the pharmaceutical products manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesaler who imported the pharmaceutical products, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer.

Documents required for registration

For the purpose of registration, the manufacturer is required to provide documents of the product to support its safety, efficacy and quality. The documents usually required are the manufacture and quality control procedure, the clinical study reports and overseas post-marketing study results of the product. For the specific documents required, please refer to the “Guidance Notes on Registration of Pharmaceutical Products/Substances” which is available at: http://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/guid.pdf

Labeling of registered medicines

Once a medicine is approved for registration, a registration number is issued. The registration number is required to be labeled on the sales packs of the medicine. Other particulars required to be labeled on a registered medicine are: the name of the product, the manufacturer, and the composition of the active ingredients. Additional information may also be required to be labeled on certain medicines, e.g. cautionary statements, dosage, route and frequency of administration.

1.2.2 Chinese Medicine Ordinance

All products which fall within the definition of proprietary Chinese medicines (pCms) under the Chinese Medicine Ordinance (Cap 549), i.e. products which are composed solely of Chinese medicines as active ingredients and for treatment and health promotion purposes, are regulated under the Chinese Medicine Ordinance. The Ordinance provides for a registration system of pCms. In approving applications for registration, the safety, quality and efficacy of the medicines, including the truthfulness of the claims in the product descriptions, will be examined. Under the Ordinance, manufacturers, importers, wholesalers, and retailers must obtain a license before manufacturing or selling products that contain such medicines in Hong Kong. The Chinese Medicine Ordinance requires the labeling of registered pCms to include main ingredients, method of usage, dosage, packing specifications, place of production, etc.

For pCms manufactured outside Hong Kong, the application for registration should be submitted by the importers or the local representatives/ agents. For the registration procedure and documents required, please refer to “Registration of Proprietary Chinese Medicines Application Handbook”, which is available at: http://www.cmchk.org.hk/pcm/pdf/reg_handbook_e.pdf

1.2.3 Public Health and Municipal Services Ordinance

Health (functional) foods which cannot be classified as Chinese medicine or western medicine are regulated under the Public Health and Municipal Services Ordinance (Cap 132) as general food products. The Public Health and Municipal Services Ordinance requires the manufacturers and sellers of food to ensure that their products are fit for human consumption and comply with the requirements in respect of food safety, food standards and labeling. According to the Food and Drugs (Composition and Labeling) Regulations (Cap 132W) under the Ordinance, all prepackaged food should bear labels which correctly list out: (a) name of the food; (b) list of ingredients; (c) indication of “use by” or “best before” date; (d) statement of special conditions for storage or instructions for use; (e) name and address of manufacturer or packer; and (f) count, weight or volume of the food.

Sale or distribution of products which do not comply with Hong Kong labeling regulation, whether or not attached to or printed to wrapper or container, which (a) falsely describes the food; or (b) misleads as to its nature, substance or quality, is designated as illegal and subject to punitive measures. Upon conviction by the Court, the offender is liable to a maximum fine of $50,000 and 6 months imprisonment.

2. Labeling and advertisements

2.1 Undesirable Medical Advertisements Ordinance (Click here for details)

Under the Undesirable Medical Advertisements Ordinance (Cap. 231), for health (functional) foods, claims about preventive or curative effects on any of the 14 diseases specified as below are prohibited:

1. Any benign or malignant tumor

2. Any viral, bacterial, fungal or other infectious disease, including tuberculosis, dysentery, hepatitis and leprosy

3. Any parasitic disease

4. Any venereal disease, including syphilis, gonorrhoea, soft chancre, lymphogranuloma venerum, genital herpes, genital warts, urethritis, vaginitis, urethral or vaginal discharge, acquired immunodeficiency syndrome (AIDS), and any other sexually transmitted disease

5. Any respiratory disease, including asthma, bronchitis, and pneumonia

6. Any disease of the heart or cardiovascular system, including rheumatic heart disease, arteriosclerosis, coronary artery disease, arrythmias, hypertension, cerebrovascular disease, congenital heart disease, thrombosis, peripheral artery disease, oedema, retinal vascular change and peripheral venous disease

7. Any gastro-intestinal disease, including gallstone, cirrhosis, gastro-intestinal bleeding, diarrhoea, hernia, fistula-in-ano and haemorrhoids

8. Any disease of the nervous system, including epilepsy, mental disorder, mental retardation and paralysis

9. Any disease of the genitourinary system, including kidney stone, nephritis, cystitis, any prostatic disease and phimosis

10. Any disease of the blood or lymphatic system, including anemia, neck glands, bleeding disorders, leukemia and other lympho-proliferative diseases

11. Any disease of the musculo-skeletal system, including rheumatism, arthritis and sciatica

12. Any endocrine disease, including diabetes, thyrotoxicosis, goitre and any other organic or functional condition related to under or over activity of any part of the system

13. Any organic condition affecting sight, hearing or balance

14. Any disease of the skin, hair or scalp

2.2 Nutrition claims

Nutrient content claims, nutrient comparative claims and nutrient function claims are permitted in Hong Kong. However, disease risk reduction and therapeutic claims are prohibited. Nutrition function claims are allowed if there are local nutrient reference values (NRV) for that nutrient or the required level has been prescribed by the regulation. Nutrient comparative claims can only be made if there is at least a 25% difference in the nutrient levels between the two products being compared. Nutrient content claims are permitted when there is an objective standard on what is meant by high or low in the context of a balanced diet. This is to prevent consumers from being misled about the actual nutrient content in a product.

Examples of acceptable/not acceptable nutrition claims

2.3 Nutrition labeling

Nutrition label must include the information on energy and seven nutrients specified for labeling (1+7), namely, protein, carbohydrates, total fat, saturated fatty acids, trans-fatty acids, sodium and sugars. Furthermore, the nutrition label must list the amounts of any claimed nutrients. In case where there is a nutrition claim in relation to any type of fat, the amount of cholesterol will also be available.

The labeling unit of energy can either be in kilocalorie or kilojoules and the nutrition labels in either per 100 g/ml or per serving format. The product labeling can either be in English, Chinese or both.

2.4 Allergen labeling

Allergen labeling is required if a product consists of or contains any of the following substances:

• Cereals containing gluten (namely wheat, rye, barley, oats, spelt, their hybridized strains and their products)

• Crustaceans and crustacean products

• Eggs and egg products

• Fish and fish products

• Peanuts, soybeans and their products

• Milk and milk products (including lactose)

• Tree nuts and nut products

The name of the substance shall be specified in the list of ingredients.