Regulatory overview of health supplements

Understand the requirements to import, manufacture or sell health supplements in Singapore.

What is a health supplement

A health supplement is a product that is used to supplement a diet with benefits beyond those of normal nutrients, and to support or maintain the healthy functions of the human body. It cannot be an injectable or a preparation that needs to be sterile, such as injections and eyedrops. It cannot be an item of a meal or diet.

A health supplement must also contain one or more, or a combination of the following ingredients:

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.

A health supplement must be administered in small unit doses in dosage forms such as the following:

Capsules
Softgels
Tablets
Liquids
Syrups

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.

If you are unsure of your product's classification, you can check using our Complementary Health Products (CHP) Classification Tool to assist you in the classification of common CHP.

Controls on health supplements

Health supplements are not subject to approvals and licensing by HSA for their importation, manufacture and sales. HSA prohibits the addition of medicinal ingredients such as steroids in health supplements. HSA also sets strict limits on toxic heavy metals in these products. Dealers (importers, manufacturers, wholesale dealers and sellers) have the obligation to ensure that their products are not harmful or unsafe, and that they conform with the following guidelines before supplying health supplements into Singapore.

Safety and quality standards

As a dealer of health supplements, you must ensure your products conform with our safety and quality standards.

Substances not allowed

Health supplements that are imported or sold must not contain the following:

Ingredients controlled and prohibited under the Poisons Act (Chapter 234) and Poisons Rules, Misuse of Drugs Act (Chapter 185) and its Regulations, Sale of Drugs Act (Chapter 282) and its Regulations and the ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements.
Ingredients derived from human parts.
Ingredients that may affect the human health (see Health Supplements Guidelines231 KB for more information).
Ingredients that contain agents that can lead to animal-transmissible diseases such as Transmissible Spongiform Encephalopathy (TSE). The guidelines on minimising the risk of TSE are available at: TSE guidelines107 KB
Ingredients regulated under the Endangered Species (Import & Export) Act, unless permitted. Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) import permit is needed from NParks.
Active substances that are not stated on the label.
Active ingredients documented to have inherent pharmacological properties that could lead to the use of the substance for a medicinal purpose to treat or prevent any disease or disorder.

Toxic heavy metal limits

Your product must not exceed the following heavy metal limits:

Heavy metal	Permissible limits
Arsenic	5 parts per million (ppm)
Cadmium	0.3ppm
Lead	10ppm
Mercury	0.5ppm

Note: For existing products imported or locally manufactured before 1 September 2019, dealers will have one year grace period to ensure compliance to the above revised limits. With effect from 1 September 2020, all products sold in Singapore should not exceed the revised limits.

Microbial limits

Your product must not exceed the following 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

Notwithstanding the limits stated above, it is the obligation of the dealers and sellers to ensure that the microbial content and heavy metals of the product is appropriate and safe when used according to the recommended conditions of use and target users. Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of Contaminants for microbial limits. The applicable guidelines is posted at: http://asean.org/asean-economic-community/sectoral-bodies-under-the-purview-of-aem/standards-and-conformance/policy-and-guidelines.

Vitamin and mineral limits

Vitamin limits

The following table specifies the limits of vitamins in health supplements for the general adult population.

Nutrient	Maximum Daily Limit
Biotin	0.9 mg
Folic acid	0.9 mg
Nicotinamide	450 mg
Nicotinic acid	15 mg
Vitamin A (Retinol)	1.5 mg (5000 IU)
Vitamin B1	100 mg
Vitamin B2	40 mg
Vitamin B5 (Pantothenic acid)	200 mg
Vitamin B6	100 mg
Vitamin B12	0.6 mg
Vitamin C	1000 mg
Vitamin D	0.025 mg (1000 IU)
Vitamin E	536 mg (800 IU)
Vitamin K1 / K2	0.12 mg

Mineral limits

The following table specifies the limits of minerals in health supplements for the general adult population.

Nutrient	Maximum Daily Limit
Boron	6.4 mg
Calcium	1200 mg
Chromium	0.5 mg
Copper	2 mg
Iodine	0.15 mg
Iron	15 mg*
Magnesium	350 mg
Manganese	3.5 mg
Molybdenum	0.36 mg
Phosphorus	800 mg
Selenium	0.2 mg
Zinc	15 mg

*For multivitamin and mineral supplements for pregnant women, a higher iron limit of 30mg/day may be considered.

Higher levels of vitamins and minerals in health supplements for use in specific adult population groups that require higher levels of supplementation must be justified with:

Credible authoritative references or expert opinion to show that supplementation over and above the established limits for the general adult population is needed
Medical professional’s assessment and recommendation on specific patient’s additional supplementation needs

Product intended for supplementation in patients with specific condition should be labelled with statements indicating:

the product must be used under recommendation by healthcare professionals
the product poses a health hazard when consumed by persons who do not have the conditions for which the product is intended

Examples of supplements intended for specific adult population groups that require higher levels of supplementation are:

Zinc for patients with wounds or metabolic conditions
Vitamin B2 for patients with certain genetic or metabolic disorders
Folic acid for pregnant women to prevent against recurrence of neural tube defects or for patients with folic acid deficiency
Iron for patients with low blood haemoglobin level

Labelling standards

Your product label should be prominent and conspicuous. Its information in English should be adequate and truthful. The label should contain the following:

Product name
Names and quantities of all active ingredients
Product indications/Intended purpose
Daily dosage
Directios 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

Note: Ingredient naming should be based on its internationally accepted, scientific names. The use of the common name of the ingredient name is optional. For minerals, common or chemical names may be used.

For products packed in small containers (such as unit dose sachets, blister strips) and there is limitation of label space, the product's name, batch number and expiry date must be on the product. The full product information should be on an accompanied outer container such as an outer box.

Quality standards

Your product needs to achieve acceptable standards of quality in terms of:

Product stability and shelf life
Storage conditions and distribution practices
Manufacturing, packaging and assembly conditions

Health supplement claims

Health supplements must not be labelled, advertised or promoted for any specific medicinal purpose. This includes claims that suggest treatment or prevention of any disease, disorder or their related conditions. Refer to our guide on health supplement claims for more information.

Advertisements and promotions

Advertisements and promotions of health supplements are not subject to permit approval, except for products which are classified as quasi-medicinal products (e.g. products containing only vitamins and minerals). If you are unsure of your product's classification, please use our Complementary Health Products (CHP) Classification Tool to assist you in the classification of common CHP.

Your advertisements must comply with our guide on health supplements claims. Advertisement and promotional messages must not contain misleading claims, lead to improper use of the product or bring undue harm to the public.

If your product is a quasi-medicinal product, please refer to our advertisements and promotions guidelines for more information on advertisements and sales promotion permit applications and requirements.

Last updated: 31 Dec 2018