Stakeholder Consultation on the Proposed Regulation for Complementary Health Products under the Health Products Act

Introduction

The Health Sciences Authority (“HSA"), a statutory board of the Ministry of Health (“MOH”), invites feedback on the proposed regulatory framework for Complementary Health Products (“CHP”). The consultation period will be from 1 July 2026 to 29 July 2026.

2       CHP are self-care health products containing ingredients with a long history of safe use and are intended for supporting or enhancing general health or alleviating symptoms of minor conditions that consumers can manage themselves. These products include health supplements, traditional medicines (which exclude  traditional Chinese medicines¹), homeopathic medicines, medicated oils, balms and plasters and topical antiseptics.

Current Controls of CHP

3       Given their inherently lower risk safety profile and health claims, CHP are currently regulated with a light touch approach under the Medicines Act (“MA”). CHP are not subject to pre-market product evaluation and licensing of manufacturers, importers and suppliers, although HSA imposes relevant safety and quality requirements on CHP, including prohibiting the addition of medicinal ingredients such as steroids, and setting strict limits on toxic heavy metals.  Post-market surveillance to monitor the safety and quality of marketed CHP includes sampling and testing, and monitoring of adverse events reported by healthcare professionals.

Proposed CHP Regulatory Framework under the Health Products Act

4       The regulatory controls for various subsets of health products under the MA, including CHP, are being moved to the Health Products Act (“HPA”) in phases. The HPA was introduced in 2007 to consolidate the regulatory controls of various categories of health products under a single Act. Unlike the MA (which was enacted in 1975), the HPA provides flexibility for different levels of control to be applied to different types of products.  It also provides HSA with stronger enforcement tools and harsher penalties to deter non-compliance. HSA intends to port over the regulatory controls for the remaining medicinal products that fall under the scope of CHP from the MA to the HPA by the end of 2028. This provides an opportunity for enhancements to be made to the regulatory framework for CHP.

5       The proposed regulatory framework for CHP under the HPA is intended to safeguard public health, strengthen regulatory oversight, support industry innovation, and ensure consumer protection through mandatory product traceability.

6       HSA proposes to strengthen the requirements relating to product safety, quality and labelling, as well as duties and obligations to be imposed on manufacturers, importers and suppliers, while maintaining the regulatory approach of light-touch pre-market regulatory controls.  HSA also proposes to require a person who is instrumental in placing a CHP in the market locally to notify HSA of key information relating to the product, to facilitate post-market surveillance by HSA and to enable timely regulatory actions where any safety issue is detected.

7       The areas being consulted include:

A) Product Notification Requirements;

B) Product Safety and Quality Requirements;

C) Product Labelling Requirements;

D) Record Keeping and Safety Reporting Requirements;

E) Advertisement Controls; and

F) Implementation Timeline.

Please see Annex A for details of the key regulatory controls for CHP under the HPA, as well as the implementation timeline.

Views Sought

8       HSA welcomes feedback on the proposed regulatory controls for CHP. Please provide your feedback using the following online form ↗ (opens in new tab) during the consultation period. Please provide your name, name of the organisation you represent (if applicable) and email address. We may contact you to clarify your feedback if necessary. 

9       Please note that the contents of any written feedback submitted, and the respondent profile (e.g. CHP business, medical practitioner, academia), may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence if the information is proprietary, confidential, or commercially sensitive. HSA will not publish such feedback publicly and will respond to you, if needed, in confidence.

¹Traditional Chinese medicinal products will be regulated under a separate framework from that for CHP, to be implemented under the Health Products Act from early 2027.

Annex A ↗ (opens in new tab)