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 and to support or maintain, enhance and improve 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:

a. Vitamins, minerals, amino acid, fatty acids, enzymes, probiotics and other bioactive substances;

b. Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates; and

c. Synthetic sources of ingredients mentioned in (a) and (b).

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.

Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree1517 KB for more information.

Is my product a complementary health product (CHP)?

Answer a few questions in our self-help tool to find out if your product is considered a complementary health product (e.g.  Chinese Proprietary Medicine, Health Supplement, Traditional Medicine) in Singapore.

 

You can also get a print-out of your product classification outcome from the tool.Let's go

Want to know more about CHP product classification? Click here for our FAQ.

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.

Voluntary notification of health supplements

Dealers may voluntarily notify HSA of their health supplements supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards. Click here for more information.

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:

  • Ingredients controlled and prohibited under the Poisons Act (Chapter 234) and Poisons Rules, Misuse of Drugs Act (Chapter 185) and its Regulations, and the ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).
  • Ingredients derived from human parts.
  • Ingredients that may affect the human health (see Health Supplements Guidelines447 KB and Guidelines for Establishing Safety of Ingredients269 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 guidelines236 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

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

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 the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).

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
 Biotin0.9 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 recommendations 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

Quality standards

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

Please refer to the following guidelines for more information: 

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 (including Brand Name, if any)
  • Dosage Form
  • Name and Quantity of Active Ingredients
  • Product Indications / Intended Purpose
  • Dosage and Directions of Use
  • Batch Number
  • Expiry Date 
  • Country of Manufacture
  • Name and Address of Local Importer (for overseas manufactured product) or Product Owner (for locally manufactured product)
  • Contraindications, if any
  • Other Warnings, if any
  • Storage Condition
  • Pack Size / Net Content

Please refer to the labelling standards guidelines288 KB for more information.

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.

You may refer to the QM classification flowchart129 KB for self-help in the classification of health supplements containing vitamin(s) and/or mineral(s).

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.