Regulatory overview of health supplements

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 Guidelines and Guidelines for Establishing Safety of Ingredients 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 guidelines

• 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.

Some substances have the potential to cause adverse health effects or safety concerns when used in health supplements and traditional medicines, and hence should be used with specific restrictions or conditions such as maximum daily dose limits or labelling specifications.

Please refer to the Guidelines on Prohibited and Restricted Ingredients in Health Supplements and Traditional Medicines for more information.

Your product must not exceed the following:

Your product must not exceed the following microbial limits:

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).

Oral liquid CHPs must not exceed the following:

Vitamin limits

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

Mineral limits

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

*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

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: 

• Physical test parameters based on dosage forms

• Testing requirements (A reference list of laboratories accredited for testing is found in the guidelines)

• Manufacturing standards

• ASEAN Guidelines on Stability and Shelf-life of Health Supplements at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11)

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 guidelines for more information.

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.