Singapore

I. HEALTH SUPPLEMENTS

Health supplements are defined under the Guidelines for Health Supplements as “A product that is used to supplement a diet, with benefits beyond those of normal nutrients, and / or to support or maintain the healthy functions of the human body.”

Health Supplements contain one or more, or a combination of the following ingredients:

(i) Vitamins, minerals, amino acids (natural and synthetic);

(ii) Substances derived from natural sources, including non-human animal and botanical materials in the forms of extracts, isolates, concentrates

Under the description health supplements are presented in any of the following dosage forms and are to be administered in small unit doses: eg. capsules, softgels, tablets, liquids, syrups, or any other dosage forms deemed suitable by the HSA.

A health supplements should not include (i) any product as a sole item of a meal or diet, (ii) any product that is defined otherwise in the legislation; (iii) any injectable and sterile preparation.

In case of doubt on the classification of a health supplements, an inquiry with the Health Science Authority may be submitted.

II. REGISTRATION OF HEALTH SUPPLEMENTS IN SINGAPORE

Health supplements are under the control of the Singapore Health Sciences Authority. Registration is not required for health supplements. The dealers of health supplements should however assure compliance with the applicable requirements under the Guidelines for Health Supplements and other existing laws and regulations.

The Guidelines refer to the following acts regarding the regulation of Health Supplements:

(i) Medicines Act (Chapter 176) & its Subsidiary Legislation especially:

• Medicines (Prohibition of Sale & Supply) Order;
• Medicines (Traditional Medicines, Homoeopathic Medicines and Other Substances) (Exemption) Order;
• Medicines (Non-Medicinal Products)(Consolidation) Order;
• Medicines (Labelling) Regulations;
• Medicines (Medical Advertisements) Regulations;
• Medicines (Licensing, Standard Provisions & Fees) Regulations

(ii) Medicines (Advertisement & Sale) Act (Chapter 177)

(iii) Sale of Drugs Act (Chapter 282) & its Regulations especially:

• Sale of Drugs (Prohibited Substances) Regulations;
• Sale of Drugs (Prohibited Drugs) (Consolidation) Regulations;
• Sale of Drugs (Rhodamine B) Regulations 1993

(iv) The Poisons Act (Chapter 234) & The Poisons Rules.

III. CONTENT AND COMPOSITION OF HEALTH SUPPLEMENTS IN SINGAPORE

By way of the Guidelines for Health Supplements, Health Supplements shall:

(i) not contain any other active substances except those stated on the label;

(ii) not contain any human part or substance derived from any part of the human body;

(iii) not contain substances controlled under the Poisons Act (Chapter 234);

(iv) not exceed the limits for microbial contamination and toxic heavy metals as specified in Tables 1 and 2 [of the Guidelines];

(v) not contain any substance above the limit specified in the List of Restricted Substances, such as for Vitamins and Minerals[1] shown in Table 3 [of the Guidelines];

(vi) not contain any substance specified in the List of Prohibited Substances shown in Annex 1 [of the Guidelines];

(vii) not contain any active substance which is a chemically-defined isolated constituent of plants, animals or minerals, or a combination of any one or more of these, that has documented inherent pharmacological properties that could lead to the use of the substance for a medicinal purpose of treatment or prevention of any disease or disorder, including its related conditions;

(viii) not contain any substance that may adversely affect the health of the person taking the product;

(ix) not contain agents that can lead to animal-transmissible diseases such as Transmissible Spongiform Encephalopathy (TSE), if they contain ingredients derived from animal sources.

(x) be of acceptable standards of quality in terms of product stability, have adequate shelf-life period, proper packaging and labeling; and are manufactured and/or assembled under proper conditions; and

(xi) require the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) import permit if they contain substances (e.g. Hoodia, etc) listed under the Endangered Species (Import & Export) Act. Dealers should contact the Agri-Food & Veterinary Authority (AVA) for further information.

[1] [Includes applicable maximum levels and sources of Iron, Iodine, Potassium and Copper; Vitamin A, Nicotinic Acid, Vitamin D, Vitamin E, Vitamin B1, Vitamin B6, Vitamin B12, Vitamin K]

IV. MANDATORY LABELLING REQUIREMENTS OF HEALHT SUPPLEMENTS IN SINGAPORE

The labelling of health supplements is established under the Guidelines for Health Supplements (points 11-12).

Where the size of the label does not permit the display of all mandatory particulars, the information may be included on an insert, leaflet, hang tags, in appropriate format. However the product name, the recommended dosage, the batch reference and relevant precautionary statements should be displayed on the final product or package.

Labelling information should be provided in English. The mandatory particulars are as follows:

(i) Name of the health supplement

(ii) Names and quantities of the active ingredients

(iii) Product indications/intended purpose

(iv) Instructions on proper usage

(v) Pack size

(vi) Batch Number

(vii) Expiry date (or “Use by”, “Use before” or words with similar meaning)

(viii) Names of the inactive ingredients including sweeteners, preservatives, colorants and other additives if present

(ix) Name and address of the manufacturer of packer (or local assembler)

(x) Name and address of dealers (or Importer, wholesale dealer where appropriate)

(xi) Precautionary label/statement (where appropriate)

V.         NUTRITIONAL HEALTH CLAIMS AND FUNCTIONAL HEALTH CLAIMS

A claim refers to any message or representation made on a product in relation to its indications, benefits or action. Claims may be stated directly or inferred indirectly through, but not limited to, the following:

• Graphics or logos on product packaging
• Product and/or Brand Name
• Media advertisements (print, sound and light & sound)
• Point of sales materials
• Product brochures or information sheets distributed with/separately from the product

A Health Supplement may make Nutritional (General) Health Claims or Functional Health Claims (See point 16 of the Guidelines for Health Supplement). Point 17 contains a list of prohibited claims, particularly claims relating to treatment or reduction of disease or disorder. Point 18 contains a list of general principles which need to be respected.

In general, the claims made must be consistent with the definition of Health Supplements i.e. a product that is used to supplement a diet, with benefits beyond those of normal nutrients, and / or to support or maintain the healthy functions of the human body. The claims made should not imply that the product is necessary or play a role in diseased states.

Scientific substantiation is required for the use of claims based on authoritative references, documented history of use, scientific opinion from scientific organizations or regulatory authorities and good quality scientific evidence from human studies. It is the responsibility of dealers to hold evidence to support these claims, and provide the evidence to the Authority when required to do so.