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Health Supplements: Regulatory Overview and Guidelines in Singapore
Understand the requirements for importing, manufacturing, or selling health supplements in Singapore.
Definition of Health Supplements
A health supplement is a dietary product designed to supplement nutrition and promote the health functions of the body. It does not include injectables or sterile preparations like injections and eye drops. Additionally, it excludes food items meant as meals or diets. A health supplement must contn one or more substances from these categories: vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, other bioactive substances; ingredients derived from natural sources including animal, mineral, and botanical materials in extract form; and synthetic equivalents of aforementioned components.
Key Components
Health supplements are consumed in small doses through various forms like capsules, softgels, tablets, liquids, and syrups. They do not cover products used for animals, or dietary food items such as biscuits, cookies, coffee, or juice.
Distinguishing Health Supplements from Complementary Health Products CHPs
Answer a series of questions on our self-help tool to determine if your product qualifies as a complementary health product e.g., Chinese Proprietary Medicine, Health Supplement, Traditional Medicine in Singapore.
Controlling Health Supplements
Health supplements do not require approvals or licensing by the Health Sciences Authority HSA. HSA prohibits the inclusion of medicinal substances like steroids and sets rigorous limits on toxic heavy metals. Dealers including importers, manufacturers, wholesale dealers, and sellers must ensure their products are non-harmful and comply with established safety and quality standards before entering Singapore.
Voluntary Notification
Dealers may voluntarily notify the HSA about health supplements in circulation within Singapore. Companies need to furnish documents demonstrating that their products meet necessary safety and quality benchmarks. For more detls, visit our notification page.
Safety Quality Standards
As a dealer of health supplements, you are tasked with ensuring your product adheres to these guidelines:
Prohibited Substances
Limits on Toxic Heavy Metals
Microbial Contamination Guidelines
Vitamin and Mineral Levels
Quality Criteria
Labelling Requirements
Your label must prominently carry all relevant information in English, meeting the following standards:
Product Name including Brand Name if applicable
Dosage Form
Active Ingredients Detls
Indications or Purpose of Use
Directions for Administration
Batch Number and Expiry Date
Country of Manufacture
Name and Address of Importer for overseas products Owner for local products
Warning Information including contrndications, if any
Recommations on Storage Conditions
Net ContentPackage Size
Refer to the detled labelling guidelines for comprehensive information.
Health Supplement Clms
Products cannot be advertised or promoted with clms suggesting specific medicinal purposes. This includes assertions about disease prevention or treatment effects. Consult our guide on health supplement clms for further clarity.
Advert and Promotion Compliance
All advertisements for health supplements must comply with HSA's guidelines, except those classified as quasi-medicinal products e.g., vitamin and mineral-only items. If unsure of your product's classification, utilize the Complementary Health Products Classification Tool.
For products like quasi-medicinals, refer to our Advertisements and Promotions Guidelines for detls on advertising permit applications and requirements.
Adverse Event Reporting
If you suspect any adverse effects associated with a health supplement, kindly report these incidents through our dedicated reporting mechanism.
International Cooperation
HSA collaborates globally to monitor the worldwide safety of health supplements.
CHP Classification Tool
Use this interactive tool to classify common complementary health products like Chinese Proprietary Medicine and Traditional Medicine for Singapore regulations.
Last updated: 26 August 2024
This article is reproduced from: https://www.hsa.gov.sg/health-supplements/overview
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