Health supplements play a significant role in supporting human body functions and maintaining well-being. However, navigating through the regulations and guidelines concerning their use, manufacturing, and distribution is essential.
Defining Health Supplements
A health supplement, as per Singapore regulations, serves as a dietary addition supporting, enhancing, or improving bodily functions without being an injectable or sterile preparation. Items utilized for animals and those packaged as food or beverages, like biscuits, cookies, coffee, and juice, do not fall under the category of health supplements.
Ingredients and Dosage Forms
Health supplements contain specific ingredients and are available in distinct dosage forms such as capsules, softgels, tablets, liquids, and syrups. These products encompass various ingredients like vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances. These could be sourced naturally or synthetically, offering a wide range of benefits to consumers.
Regulatory Oversight
The Singapore Food Agency (SFA) oversees food-related supplements, distinguishing them from health supplements regulated separately. Health supplements don't require Health Sciences Authority (HSA) approval or licensing for importation, manufacture, or sales. However, strict guidelines govern their safety, quality, and permissible ingredients. The dealers can carry out voluntary notification process for Health Supplements (HS).
Safety Measures
HSA prohibits the inclusion of medicinal ingredients, like steroids, in health supplements. Moreover, strict limits on toxic heavy metals exist, ensuring product safety. Importers, manufacturers, wholesalers, and sellers bear the responsibility of guaranteeing product safety before supplying health supplements in Singapore.
Labelling Standards
Health supplement labels must adhere to specific guidelines. Information should be accurate, truthful, and prominently displayed in English. The label includes details like product name, dosage form, active ingredients, intended purpose, dosage and usage directions, batch number, expiry date, country of manufacture, and local importer or product owner details. It's imperative that these labels are conspicuous and adequately informative.
* May be omitted if the product is supplied with an outer label
** May be omitted if the accompanying product leaflet provides this information
*** The small label, strip or blister pack label should minimally display the product name, batch number and expiry date.
Claims and Advertisements
Health supplement claims are statements or representations made regarding a product's benefits, actions, or indications, found in various materials such as product labels, advertisements, point-of-sale materials, and brochures. These claims fall into two categories: general claims and specific claims.
Permissible claims for health supplements include those supporting or maintaining overall health, well-being, or physiological processes. General claims focus on aspects like supporting good health and growth, enhancing body strength, or relieving tiredness. Specific claims target particular body functions or structures, such as supporting healthy joints or aiding in managing mild discomfort associated with menopausal symptoms.
Examples of permissible general claims include support for good health and growth, strengthening the body, and relieving general tiredness.
Specific claims might involve support for healthy joints, immune system, or blood circulation, or assisting in maintaining joint mobility.
However, health supplements must not be labeled, advertised, or promoted for medicinal purposes, including implications of treating or preventing diseases or disorders. Prohibited claims include any suggestion of the product's use for disease treatment or prevention. This prohibition extends to implied claims related to the treatment or prevention of illnesses or disorders.
Voluntary Notification Process for Health Supplements
Only locally registered companies under the Accounting and Corporate Regulatory Authority (ACRA) are eligible to submit product notifications. There are no fees associated with the submission of a product notification. CorpPass authentication is necessary for the submission process. The submission requires a complete notification form, accompanying declarations, and documents attesting that the product meets the prescribed quality and safety standards.
To complete the notification process, various documents must be submitted to HSA_TMHS@hsa.gov.sg, including a copy of the form, manufacturer's license, certificate of analysis, product label, product leaflet, laboratory test reports, and relevant undertaking forms. Detailed guidelines for testing requirements and a checklist for submission are provided by HSA for reference.
Upon submission, the turn-around-time for processing new product notifications is 60 working days. This timeline excludes the duration required by the company to respond to any requests for additional information or clarifications (company's stop-clock).
HSA reserves the right to refuse notifications for products with non-compliance records or those under HSA's investigation. Products failing to meet notification conditions risk removal from the list of notified products.
Understanding Singapore's stringent regulations and guidelines for health supplements is crucial for manufacturers, importers, and sellers to comply with safety, quality, and labelling standards. Adherence to these guidelines ensures consumers receive safe and accurately labeled health supplements.
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