1. Definition & classification

In Singapore, health supplements fall under the category of “complementary health products”, which also includes items such as Proprietary Medicines and traditional medicines. Health supplement is used to supplement a diet and to maintain, enhance and improve the healthy functions of the human body. It cannot be a preparation required to be sterile such as injections and eye drops. It cannot be an item of a meal or diet.

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

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

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

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

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

2. Competent authority

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. Some of HSA’s key responsibilities include the registration and licensing of certain health products like medical devices and therapeutic goods. It also establishes and enforces standards for product safety, quality and labelling claims.

3. Market access requirements

3.1 Supervision management

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

HSA conducts post-market surveillance to monitor the safety of health supplements and to initiate product recalls timely. 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 Products found to be unsafe will be withdrawn from the market.

3.2 Voluntary notification

HSA introduces a voluntary notification initiative for companies dealing with health supplements. This initiative allows companies to submit voluntary declarations on their health supplements to show that they comply with the published guidelines. Only compliant products will be published on the list of notified products. This publication of notified products should not be misconstrued as HSA’s endorsement of these products.

4. Product Compliance

4.1 Product requirements

Health supplement companies have the obligation to ensure that their products are safe and not harmful. Health supplements must not contain the prohibited ingredients listed in the table below.

Prohibited ingredients

a)

Substances listed in:

• Poisons Act (Chapter 234) & Poison Rules

• Misuse of Drugs Act (Chapter 185) & its Regulations

• ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements

b)

Ingredients derived from human parts.

c)

Ingredients that may affect the human health (see Annex A of the Health Supplement Guidelines).

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.

f)

Active ingredients that are not stated on the label.

g)

Active ingredients documented to have inherent pharmacological properties that could lead to the usage for medicinal purpose of treatment or prevention of any disease or disorder, including its related conditions.

In addition, companies are encouraged to take note of the list of ingredients highlighted in Annex B of the Health Supplements Guidelines that reportedly have potential to affect the health of some individuals.

HSA specifies heavy metals and microbial limits for health supplements. The details can be found in the table below.

Item

Quantity

Heavy metal (by weight)

Arsenic

5 ppm

Cadmium

0.3 ppm

Lead

10 ppm

Mercury

0.5 ppm

Microbe (colony-forming units (CFU)) per g/ml of product

Total aerobic microbial count

Not more than 105

Yeast and mould count

Not more than 5 x 102

Escherichia coli, salmonellae and staphylococcus aureus

Absent

Please note that the above limits for total aerobic microbial count, as well as yeast and mould count may not be applicable to certain products such as probiotics or products derived from fermentation processes.

HSA also specifies the limits for vitamins and minerals in health supplements intended for the general adult population. Some examples are listed in the table below.

Nutrient

Maximum Daily Limit

Nutrient

Maximum Daily Limit

Biotin

0.9 mg

Boron

6.4 mg

Folic acid

0.9 mg

Calcium

1200 mg

Nicotinamide

450 mg

Chromium

0.5 mg

Nicotinic acid

15 mg

Copper

2 mg

Vitamin A (Retinol)

1.5mg (5,000IU)

Iodine

0.15 mg

Vitamin B1

100 mg

Magnesium

350 mg

Vitamin B2

40 mg

Manganese

3.5 mg

For a comprehensive list of vitamins and minerals limits for the general adult population, as well as situations such as higher levels of vitamins and minerals in health supplements for specific adult population groups, please refer to the Health Supplements Guidelines.

4.2 Label

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

• 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

In addition, health supplements may make general health claims or functional health claims. Examples of general and functional health claims can be found in the List of Health Claims for Health Supplements and Traditional Medicines.

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. A list of examples of prohibited diseases and disorders is provided in Table 5 of the Health Supplements Guidelines.

For more labeling requirements for health supplements in Singapore, please check the guidelines below:

• Guidelines for Labelling Standards of Health Supplements and Traditional Medicines

• Guidelines for Claims and Claims Substantiation of Health Supplements and Traditional Medicines

* Global Food Compliance Service

Chemlinked provide various market entry services to help stakeholders better understand exporting requirements, establish business, and secure a competitive place to facilitate trade development.

Covered Countries

China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand, etc.

Our Services

• Food Ingredient Review

• Label Review

• Product Registration

• Regulatory Consultation

• Monitoring, Training and Customized Report

Please feel free to contact us via [email protected] if you need any help.