Health supplements sold in Singapore are not subject to pre-market approval, and product notification introduced in 2022 remains voluntary. As of June 30, a total of 664 products have been voluntarily notified, according to HSA data.
This week, the authority announced a proposed regulatory framework for Complementary Health Products which would cover health supplements, traditional medicines, homeopathic medicines, medicated oils, balms, plasters and topical antiseptics.
Complementary Health Products are generally defined as self-care products containing ingredients with a long history of safe use, intended to support or enhance general health or relieve symptoms of minor, self-manageable conditions.
One of the more significant features of the newly proposed framework is the introduction of mandatory product listing for Complementary Health Products—requiring compliance with specific safety, quality, labeling, record-keeping, safety reporting and advertising requirements.
Products that have not undergone mandatory notification would not be allowed on the market, and information on all notified products would be published on HSA’s pubicly accessible website.
HSA emphasized that mandatory notification does not constitute product approval or endorsement.
Traceability as key purpose
The central aim of mandatory product notification is to ensure visibility into the market.
“The key purpose of the mandatory notification framework is for product traceability, so that in the event of any product recalls, the authorities will have quick access to the required information on the product manufacturers, etc.,” said Wai Mun Poon, regulatory affairs consultant at Wong SJ Asia.
To promote traceability, the person responsible for making the product notification—whether brand owner, manufacturer of importer—would need to provide their name, address, contact details and the name and address of the manufacturer and local importer, if any. Other key information required includes product name, dosage form, product type and identity and quantity of active ingredients.
The proposed framewok also requires record-keeping of adverse effects and product defects, in addition to manufacturing and supply records.
“All local manufacturers, importers, wholesalers and retailers remain responsible for compliance with relevant requirements applicable to their business activity,” the HSA proposal stated. “This enables traceability and appropriate risk-mitigation actions to be taken when necessary.”
The packaging or labeling of the notified products would also be required ot include information such as the batch number, the name and address of the local person responsible for placing the product on the market, and key product information, including active ingredients, intended purpose and the presence of sensitizing ingredients.
Overall, Poon believes that the new framework could provide better safeguards for consumers.
“The proposed framework gives legal clarity to the legal definition of health supplements and also gives consumers greater confidence in products sold in the market,” she said.
Changes to advertising regulations
Another key feature of the proposal is that advertisements for Consumer Health Products would no longer have to undergo a pre-publication permit requirement.
Instead, advertisers would be required to comply with a set of advertising restrictions, with post-market surveillance conducted to ensure compliance. Examples of proposed advertising restrictions include making false, misleading or unsubstantiated claims, advertisements for un-notified Consumer Health Products and advertisements that encourage self-diagnosis, excessive use or discourage medical consultation or treatment.
The public consultation on the proposal began on July 1 and will run until July 29.
Timeline, process and penalties
The proposed framework will be rolled out in phases, starting in the third quarter of 2028 with requirements for record-keeping, safety reporting and advertisement controls.
A two-year grace period will be provided for the implementation of product notification and other new requirements, with full implementation slated for the third quarter of 2030.
Poon noted that mandatory notification of health supplements represents a natural progression from the current voluntary notification process. However, the two frameworks may not be identical in terms of process, as details of the mandatory notification regime have yet to be finalized.
“A potential challenge of the mandatory notification could be the administrative process, but I think it is just a matter of getting used to it,” she said.
The new proposal comes amid the transfer of regulatory controls for various subsets of health products, including health supplements currently regulated under the Medicines Act (MA), to the Health Products Act (HPA).
“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,” the HSA noted. “It also provides HSA with stronger enforcement tools and harsher penalties to deter non-compliance.”
