Singapore: HSA Health Supplements Regulatory Framework Updates

In short

In March 2022, the Health Sciences Authority (HSA) released its revised health supplement guidelines (“HS DirectivesThis is accompanied by sets of new guidance on (i) claims and their substantiation; (ii) labeling standards; and (iii) safety and quality standards, which were also published in March 2022.

Key points to remember

  • Although there are currently no registration or licensing requirements for the importation, manufacture or sale of dietary supplements, resellers must comply with various HSA guidelines before they can supply them in Singapore. The introduction of these new guidelines therefore offers a welcome clarification of the main obligations that must be fulfilled by retailers of health supplements.
  • The introduction of these new guidelines also signals a move towards a more comprehensive regulatory regime. This complements the HSA’s track record of monitoring and taking enforcement action against non-compliant health supplement retailers and products. We’ve covered examples of these efforts in our recent newsletters here and here.
  • Companies would therefore do well to carry out audits of their ingredients, efficacy, testing requirements and claims to ensure that their existing products, labels and advertisements comply with these new standards, while keeping these new guidelines. in mind for future products, labels and advertisements.

More in detail

In March 2022, the Health Sciences Authority (HSA) released its revised health supplement guidelines (“HS DirectivesThis is accompanied by sets of new guidance on (i) claims and their substantiation; (ii) labeling standards; and (iii) safety and quality standards, which were also published in March 2022.

Revised HS Directives

The HS Guidelines provide a high-level regulatory overview of the main requirements governing the import, manufacture and sale of dietary supplements in Singapore. In its latest round of revisions, the HSA has since offered greater clarity on the classification of health supplements containing vitamins and/or minerals. In a new flowchart appended to the HS Guidelines, the HS Guidelines list various factors that would determine the classification of a health supplement containing vitamins and/or minerals as a complementary health product, quasi-medical product or requiring classification. additional. request to send to the HSA. These factors include whether the product in question:

  • Contains vitamins and/or minerals as active ingredient
  • Contains an active ingredient intended to be a source of vitamin(s) and/or mineral(s)
  • Is labeled as a vitamin and/or mineral supplement
  • Contains health claims attributable to the vitamins and/or minerals present in the product
  • Contains at least a 50% proportion of vitamin(s) and mineral(s), calculated according to the number of active ingredients compared to the total number of ingredients present in the product

This, in turn, will determine whether a product must comply with other regulations. For example, resellers of dietary supplements that have been classified as quasi-medicinal products will need a valid license before publishing medical advertisements or conducting sales promotion activities.

New Guidelines for Claims and Substantiation of Claims for Traditional Medicines and Health Supplements (“Claims Guidelines”)

The Claims Guidelines aim to provide guidance on the scope of acceptable health claims that can be used in traditional medicines and dietary supplements in Singapore, and the evidence required to substantiate them.

They also provide a list of general principles that health claims must adhere to in order to ensure that products do not convey misleading messages that could lead to inappropriate use of the product or cause undue harm to the public. These general principles include, among others, restrictions on sellers of health supplements and traditional medicines of:

  • Make claims that are in any way misleading or otherwise imply that the product has properties and benefits beyond those of a traditional drug or health supplement
  • Using terms such as “Proven by Clinical Trials” or “Clinically Proven”, or scientific data to imply greater validity than the product can provide for the general population
  • Give the impression that claims represent advice or recommendations from medical professionals
  • Use medical professional testimonials, celebrity endorsements or endorsements, or appear to be receiving celebrity advice or endorsement
  • Using claims to instill fear or exploit public superstition
  • Insinuating that the product is infallible, miraculous or that it guarantees efficacy or harmlessness
  • Make claims that question the nutritional properties of foods or that consumption of the product can substitute for a healthy lifestyle
  • Refer to the prevention and reduction of stress; improvement in IQ or academic performance in studies; or effects on anti-aging, sexual function, or hormone levels

New Guidelines for Labeling Standards for Traditional Medicines and Health Supplements (“Labelling Guidelines”)

The labeling guidelines aim to guide companies on labeling standards for traditional medicines and dietary supplements in Singapore. To this end, the labeling guidelines distinguish between different categories of product labels (i.e. outer labels, inner labels, small labels and strip/blister labels) and provide a table indicating the information that must be included for each product. type of label and instructions.

New guidelines for safety and quality standards

Finally, the HSA has published a series of guidelines that collectively stipulate the safety and quality standards that health supplements and traditional medicines must meet. These include:

  • Guidelines for Establishing the Safety of Ingredients of Traditional Medicines and Health Supplements, which define the scope of authorized active ingredients and the requirements for substantiating the safety of said ingredients
  • Guidelines for manufacturing standards for traditional medicines and health supplements to ensure that products are consistently manufactured to the quality standards appropriate for their intended use
  • Guidelines for Physical Test Parameters Based on Dosage Forms of Traditional Medicines and Health Supplements
  • Guidelines for testing requirements of traditional medicines and health supplements to ensure products meet stipulated limits for heavy metals, microbes and poisons and are free of adulterants

A more comprehensive health supplement regulatory regime

The health supplements market in Singapore is expected to become a SGD 740 million industry by 2024.

For many years, the regulation of health supplements in Singapore was governed by a single set of guidelines. Therefore, the introduction of these new sets of guidelines represents a marked shift towards a regulatory regime with clearer do’s and don’ts; increased compliance requirements; and greater regulatory oversight.

As the COVID-19 pandemic and modern lifestyle continue to drive market demand for health supplements, and opportunities to market products on e-commerce platforms are increasing due to digital transformation, companies would do well to audit their ingredients, efficacy, testing requirements, and claims to ensure that their existing products, labels, and advertisements comply with these new standards. They should also keep these new guidelines in mind for future products, labels and advertisements.

The content is provided for educational and informational purposes only and is not intended and should not be construed as legal advice. This may qualify as “lawyer advertising” requiring notice in some jurisdictions. Prior results do not guarantee similar results. For more information, please visit: www.bakermckenzie.com/en/disclaimers.

Comments are closed.