On 29 October 2025, le Autorité des sciences de la santé (HSA) of Singapore published updated guidelines governing prohibited and restricted ingredients in health supplements (HS) and traditional medicines (TM). The update strengthens regulatory clarity and safety expectations for global companies involved in health supplement formulation, manufacturing, and distribution.
Overview of the Update
The revised HSA health supplement regulation outlines which substances are prohibited, which are restricted, and what obligations dealers must follow to ensure product safety. The guidelines apply to importers, manufacturers, wholesale dealers, and sellers of health supplements and traditional medicines worldwide that distribute in Singapore.
Details of the Updated Prohibited and Restricted Ingredient Rules
The guidelines confirm that prohibited substances include those defined under the Poisons Act 1938 et Misuse of Drugs Act 1973, as well as ingredients derived from human parts and substances regulated under the Endangered Species Act, unless specifically permitted.
The update also establishes strict conditions for restricted ingredients, such as maximum daily dosage limits et mandatory labeling requirements, which are detailed in Annex A.
Substances identified as having potential safety concerns require dealers to monitor consumer feedback and implement appropriate risk-mitigation measures, as listed in Annex B.
To comply, dealers must conduct safety assessments, maintain evidence of product safety, ensure proper labeling, and report adverse effects associated with products containing regulated substances.
Date limite de retour d'information
There is no feedback deadline associated with this regulatory update.
Date d'entrée en vigueur
The updated guidelines came into effect in October 2025.
Pourquoi c'est important
This update enhances transparency around health supplement ingredient restrictions, strengthens safety oversight for both supplements and traditional medicines, and provides consistent regulatory expectations for product formulation, labeling, and monitoring. The clearer framework supports safer product development and more predictable compliance processes without adding unnecessary operational burden.
Who Should Review This Update
This regulatory development is particularly relevant for Affaires réglementaires, Quality Assurance, manufacturers, importers, distributors, and compliance teams involved in health supplements, traditional medicines, and global health product safety assessments.
Prochaines étapes
Regulatory teams should assess the updated guidelines to identify affected products and determine whether updates are required for formulations, safety documentation, monitoring systems, or labeling. Companies must review Annex B substances, perform necessary safety assessments, and ensure systems are in place for adverse effect reporting and continuous monitoring.
As organizations evaluate their portfolios, this is a timely opportunity to strengthen ingredient monitoring and streamline global regulatory workflows. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that helps organizations navigate complex regulatory landscapes across more than 140+ countries. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights, supports ingredient compliance checks, and automates regulatory monitoring to accelerate global market access. Apprendre encore plus ou réservez une démo maintenant.
FAQ
What substances are prohibited under the updated HSA health supplement regulation?
Prohibited substances include those listed under the Poisons Act 1938, Misuse of Drugs Act 1973, human-derived materials, and substances regulated under the Endangered Species Act, unless explicitly permitted.
What are restricted ingredients in HSA health supplement guidelines?
Restricted ingredients are substances that may be used only under specific conditions, such as maximum daily dose limits ou labeling requirements, as set out in Annex A.
What obligations do dealers have under the new HSA guidelines?
Dealers must conduct safety assessments, report adverse effects, maintain evidence of product safety, ensure appropriate labeling, and monitor substances with potential safety concerns listed in Annex B.
How can RegASK assist companies impacted by HSA’s health supplement regulation update?
RegASK helps companies track regulatory changes, assess ingredient compliance, and automate global monitoring using agentic AI, supporting accurate and timely responses to updates like this HSA guideline revision.
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