In early March 2022, Singapore Health Sciences Authority (HSA) unveiled the new version of the Health Supplements Guidelines (Guidelines for short), which provides the regulatory information for enterprises dealing with health supplements in Singapore. It is noteworthy that this Guideline is just a collection of information and does not supersede any of prior national legislation.
This Guideline introduces the regulatory requirements of health supplements from the perspective of safety & quality (including prohibited ingredients, contaminants limits, use of vitamins and minerals, etc.), labeling, advertising, as well as product and dealer licensing control. Key points are listed below:
Market access approval
At present, health supplements are free of premarket approval or licensing by HSA for their importation, manufacture, and sales in Singapore.
Ingredients
Related enterprises must ensure the safety of their products. Besides, the Guideline includes the list of ingredients prohibited to be added in health supplements, such as substances listed in ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements, and Catalogue of Prohibited/Restricted Ingredients for Health Supplements (Annex A of the Guideline). It is worth noting that some ingredients were reported to have potential risk towards some target groups (listed in Annex B of the Guidelines). Therefore, enterprises should be aware of these risks and are encouraged to take risk mitigation measures if such ingredients are contained in their products.
When it comes to the vitamin and mineral limits, the indicators stipulated by Singapore government are almost the same as those specified in ASEAN General Principles for Establishing Maximum Levels of Vitamins and Minerals in Health Supplements.
Label & claims
In Singapore, enterprises can make general health claims or functional health claims for health supplements.
General health claims: refer to the general health benefits derived from supplementation beyond a person’s daily dietary intake.
Functional health claims: refer to the health benefits relating to the positive contribution to a function or biological activity of the body.
Claims for health supplements should be supported by substantial evidence. Additionally, the claims cannot involve any diseases treatment or prevention functions. Examples of diseases/conditions/disorders not allowed for health supplements are listed below.
Examples of Diseases/Conditions/Disorders Not Allowed for Health Supplements
Body system / organs | Examples of related claims not allowed |
Circulatory system | Hypertension, stroke, cholesterol disorders, reduces cholesterol, regulates platelet aggregation, coagulation defects, arteriosclerosis |
Eye, Ear, Nose | Blindness, cataract, deafness, inflammation |
Digestive system | Periodontitis, ulcers, gastritis, hepatitis, liver cirrhosis, fatty liver, diarrhoea, constipation, inflammation of the intestines/liver/pancreas |
Endocrine system | Diabetes, thyroid disorders, hypothyroidism, prostate diseases, thymus disorders, hormonal regulation |
Metabolic system | Obesity |
Respiratory system | Asthma, tuberculosis, bronchitis, sinusitis |
Skin, Hair, Nails | Fungal infection, eczema, ulcers, warts, moles, pigmentation disorders |
Immune system | Leprosy, AIDS, allergies, immunisation |
Muscular, connective tissues and skeletal systems | Osteoporosis, arthritis, sclerosis, autoimmune diseases, sclerosis, inflammation of joints |
Nervous system | Epilepsy, fits, paralysis, Alzheimer’s disease, Parkinsonism, dementia, neuropathies, drug addictions, depression, eating disorders |
Renal system | Kidney stones, renal failure, nephritis, urinary tract infection, incontinence, cystitis |
Reproductive system | Menstrual disorders, sexual dysfunction, infertility, frigidity, impotency, conception, pregnancy |
Others | Cancers, infectious diseases |
Please click here for the complete version of Singapore Health Supplements Guidelines (Revised March 2022).
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