Regulating Health Supplements in Singapore: Compliance Guidelines and Controls

Overview of Health Supplements Regulation in Singapore

Understand the requirements for importing, manufacturing, or selling health supplements in Singapore.

What is a Health Supplement?

A health supplement is defined as a product used to augment dietary intake and promote or mntn healthy bodily functions. They are not injections or sterile preparations like eye drops, nor are they food items like meals or beverages such as cookies or coffee. Health supplements must contn one or more ingredients including vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, other bioactive substances, natural sources derived from plants, animals, and minerals, or synthetic equivalents of these ingredients.

Health supplement examples include capsules, softgels, tablets, liquids, syrups, etc., but do not encompass products designed for animal use. Health supplements are subject to regulatory oversight by the Health Sciences Authority HSA rather than the Singapore Food Agency for food-like items.

CHP Classification Tool

For a quick decision on whether your product qualifies as a complementary health product e.g., Chinese Proprietary Medicine, Traditional Medicine, use our self-help tool. Get a printable summary of your classification outcome.

Controls on Health Supplements in Singapore:

• HSA does not require pre-market approval or licensing for the importation, manufacture, and sale of health supplements but prohibits the addition of medicinal ingredients like steroids.

• Dealers must ensure product safety and quality prior to distribution.

• Voluntary Notification: Companies can notify HSA about their products if they wish, providing evidence that their health supplements comply with necessary standards.

Safety Standards:

Dealers must confirm compliance with safety guidelines including:

1. Prohibitions on certn substances,

2. Limits for toxic heavy metals content,

3. Microbial limits,

4. Vitamin and mineral levels,

5. Quality standards, and

6. Clear labeling requirements.

Labeling Guidelines:

The health supplement label must be clear, prominent, and truthfully describe the product in English. It should include detls like:

• Product name including brand if applicable,

• Dosage form,

• Active ingredients with quantities,

• Indications or purpose,

• Usage instructions,

• Batch number and expiry date,

• Manufacturer country of origin,

• Local importer's name and address for overseas products, product owner's info for local ones,

• Contrndications, warnings,

• Storage conditions, and

• Pack size or net content.

Compliance with Health Supplement Clms:

Health supplements cannot clm therapeutic effects or be marketed to prevent diseases. Advertisements and promotions must not mislead users about the health benefits they provide.

Advertised Products:

Products classified as quasi-medical i.e., those contning only vitaminsminerals require review for advertising permits, except if it's uncertn regarding classification, use our online CHP Classification Tool.

For ads promoting quasi-medical products specifically, refer to guidelines on advertisement and promotion permit applications and requirements.

Last Updated: August 26, 2024
This article is reproduced from: https://www.hsa.gov.sg/health-supplements/overview

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