Singapore Health Supplement Regulation
Mar 02, 2020
Lennie Tao
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CONTENTS

1.   Definition


In Singapore, health supplements fall under the scope of "complementary health products" and are regulated as "health products". A health supplement is a product that is used to supplement the diet, and to support or maintain the healthy functions of the human body. It cannot be an injectable/a preparation that needs to be sterile, such as injections and eyedrops; or any type of general food.

A health supplement must also contain one or more, or a combination of the following ingredients, and it must be administered in small unit doses in dosage forms such as capsules, softgels, tablets, liquids, syrups.

  • Vitamins, minerals, or amino acids (both natural and synthetic).

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

Products used on animals, as well as products presented in the form of food and beverages, such as biscuits, cookies, coffee, and juice are not health supplements.

2.   Supervision System


2.1 Competent Authorities

Health Sciences Authority ("HSA"), under the Ministry of Health, is the regulatory authority that manages the national regulatory frameworks for pharmaceuticals, complementary medicines, medical devices and other health products.

2.2 Supervision Management of Imported Health Supplements

Health supplements can be imported and sold without a license from HAS and they are not subjected to pre-market approval regulations, but dealers are required to comply with the Health Supplement Guidelines released by HSA.

What's more, instead of the pre-market approval, HSA will conduct post-market surveillance to monitor the safety of health supplements and to initiate timely product recalls - This includes random sampling of products in the market and adverse reaction monitoring, which draws on HSA's network of healthcare professionals and international regulatory partners to pick up signals of adverse reactions to products. Products found to be unsafe will be withdrawn from the market.

2.3 Related Legislation

The current legislative control that may apply to health supplements may be found in the following legislation:

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

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

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

d) Poisons Act (Chapter 234) & Poisons Rules.

3.   Compliance Requirements


3.1 Technical requirements

3.1.1 Prohibited ingredient

a)            

Substances listed in:

b)            

Ingredients derived from human parts

c)            

Ingredients that may affect the human health

d)            

Ingredients that contain agents that can lead to animal-transmissible diseases such as Transmissible Spongiform Encephalopathy (TSE).

e)            

Ingredients regulated under the Endangered Species (Import & Export) Act, unless permitted. A Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) import permit is needed from NParks.

f)             

Active ingredients that are not stated in the label

g)            

Active ingredients documented to have 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

3.1.2 Heavy Metals Limits

Heavy metal

Permissible limits

Arsenic

5 parts per million (ppm)

Cadmium

0.3ppm

Lead

10ppm

Mercury

0.5ppm

3.1.3 Microbial Limits

Microbe

Microbial count (colony-forming units (CFU) per g or ml of product)

Total aerobic microbial count

Not more than 105

Yeast and mould

Not more than 5 x 102

Escherichia coli, salmonellae and staphylococcus aureus

Absent

Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of Contaminants for microbial limits. 

3.1.4 Vitamins and Mineral Limits

Nutrient  

 Maximum Daily Limit

Nutrient  

 Maximum Daily Limit

 Biotin

0.9 mg

 Vitamin B5 (Pantothenic acid)

200 mg

 Folic acid

0.9 mg

 Vitamin B6

100 mg

 Nicotinamide

450 mg

 Vitamin B12

0.6 mg

 Nicotinic acid

15 mg

 Vitamin C

1000 mg

 Vitamin A (Retinol)

1.5 mg (5000 IU)

 Vitamin D

0.025 mg (1000 IU)

 Vitamin B1

100 mg

 Vitamin E

536 mg (800 IU)

 Vitamin B2

40 mg

 Vitamin K1 / K2

0.12 mg

3.2 Product Labeling

The information on the product label should be adequate and truthful to enable consumers to make informed decisions and use the product correctly. The information must be in English and must be printed in a clear and legible manner. Information that should be included in the product label are shown below.

  • Product name

  • Names and quantities of all the active ingredients

  • Product indications/ Intended purpose

  • Daily dosage

  • Directions of use

  • Pack Size

  • Batch Number

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

  • Cautionary label or statement, where necessary

  • Name and address of the local manufacturer or local importer

  • Name of the country of manufacture for imported products

3.3 Health Supplement Claims

3.3.1 Definition of “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.

Claims for health supplements should be substantiated by good quality evidence that is relevant to the claims. Evidence may be based on finished products or ingredient(s) if justifiable. The evidence used to substantiate claims should be 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.

3.3.2   General Health Claims

Health supplements may make general health claims or functional health claims. General health claims refer to the general health benefits derived from supplementation beyond a person’s daily dietary intake. It include claims that are intended for:

  • General health maintenance and well-being.

  • Vitamin and/or mineral supplementation. Such claims are permitted only when the relevant vitamin and mineral used in the product amounts to

  • >30% the RDA value.

  • Supplementation beyond normal nutritional value from food.

Examples of general health claims include:

  • Support good health and growth

  • Supplementation for growth and development

  • Strengthen the body

  • Relieve general tiredness, weakness

3.3.3 Functional Health Claims

Functional health claims refer to the health benefits relating to the positive contribution to a function or biological activity of the body.

Examples of functional health claims include:

  • Support healthy functions of the human body such as maintaining healthy joints, support natural physiological processes e.g. immune system, circulation, etc.

  • Manage mild discomfort associated with menopausal symptoms.

  • Assist in maintaining joint mobility.

3.3.4 Prohibited Claims

Health supplements must not be labelled, advertised or promoted for any specific medicinal purpose, i.e. treatment or prevention, implied or otherwise, of any disease or disorder, including its related conditions.

3.4 Advertisements and Sales Promotion Control

Vitamins and minerals as well as some other health supplements (e.g. melatonin products) are subject to medical advertisements and sales promotion permit control.

View more at the HSA guideline.