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

Substances not allowed

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

Toxic heavy metal limits

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

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

 

 

 

Labelling standards

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. 

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