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Cosmetics & Supplements
- How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
- Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
- Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
- Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
- Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products.
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
- Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?
- Do the regulations in your jurisdiction specify what can and cannot be put in supplement products? If so, what are some examples of these restrictions?
- Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
- Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards before being place in the market? If so, are there any exceptions/particular extra requirements for certain products?
- Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?
- Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
- Is the advertising and promotion of Supplements allowed in your jurisdiction? If so, under what conditions? Are there any specific requirements or regulations for advertising and promotion?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regards to the supply of supplements
- Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
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Beauty devices
- Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
- Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic devices and their safety placed on the market?
- Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
- Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
- Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products.Is there criminal liability for non-compliance?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
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Cosmetic (non-surgical) services
- Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
- Are there any rules in your national law which prevent an individual under the age of 18 (or other age as relevant) from receiving a particular non-surgical cosmetic service?
- Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
- Does the (national) law require that businesses and/or practitioners administering these services register with a centralised body? Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services?
- Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above.
- Are there any national laws or regulations which are relevant to the advertising of non-surgical cosmetic services? If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?
- Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
jurisdiction
Cosmetics & Supplements
1. How are cosmetic products classified in your jurisdiction and what key national laws/regulations apply?
- Health Products Act 2007 (“HPA”)
- Health Products (Cosmetic Products — ASEAN Cosmetic Directive) Regulations 2007 (“ACD Regulations”)
- Health Products (Good Manufacturing Practice Certificate — Cosmetic Products) Regulations 2011
- Health Products (Cosmetic Products — Import for Re-export and Manufacture for Export) Regulations 2019
- Health Products (Active Ingredients) Regulations 2023 (“Active Ingredients Regulations”)
The definition of a cosmetic product under the HPA read with the ACD Regulations comprises three parts: product composition, field of application, and function:
- Product Composition: Any substance or preparation.
- Field of Application: Intended to be placed in contact with various external human body parts, with the teeth, or the mucous membranes of the oral cavity.
- Function: There are 6 functions specified including to clean, perfume, change appearance, protect or keep in good condition such parts, as well as to correct body odours.
Products that are intended to be ingested, used to address a disease or its symptoms in humans, intended to be used on animals, have medicinal properties, or otherwise fall under one of the other categories of health products under the HPA would unlikely be classified as cosmetic products. Oral dental gums, which are defined under the HPA to include chewing gum or equivalents intended to promote dental health or oral hygiene, are also separately classified.
Products which are ingested and claim to have “cosmetic benefits”, for example, beauty dietary supplements, would likely fall under separate category of health supplements.
Products to treat/prevent or fight spots and acne are likely to be classified as therapeutic products, especially if their ingredients are found under the Register of Therapeutic Products.
Shampoos may be cosmetic or therapeutic products depending on the ingredients and the claims being made. Those mainly intended for general hygiene would likely be cosmetic products. However, if the shampoo claims and is intended to be used to treat or alleviate conditions such as dermatitis, the product would instead likely be a therapeutic product, especially if their ingredients are found under the Register of Therapeutic Products.
2. Does the law in your jurisdiction place restrictions on particular substances in cosmetic products?
Yes. The Third Schedule of the ACD Regulations prescribe a list of substances that are prohibited (Part I) or subject to restrictions or conditions (Part II). It also prescribes the list of colouring agents (Part III), preservatives (Part IV) or UV filters (Part V) that are allowed within a cosmetic product.
The above specify a variety of conditions, for example by prescribing a maximum authorised concentration of listed substances, other applicable limitations and requirements, as well as applicable warnings and precautions to be stated on product labels.
The Active Ingredients Regulations regulate certain active ingredients prescribed under the Schedule. Manufacturers must not manufacturer, import, supply, or procure or arrange for the manufacture, import or supply of, any adulterated, counterfeit or unwholesome active ingredient (sections 4 and 5). Licenses are required to manufacture, import or supply whole any active ingredient, and licensees are subject to various duties and obligations (Parts 3 and 4).
The ACD Regulations does not distinguish between products for home use as opposed to professional use. All such products fall under the umbrella term of “cosmetic products”.
3. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic products and their safety placed on the market?
Yes. The person responsible for introducing cosmetic products in the Singapore market will be required to ensure that the cosmetic product(s) complies with obligations under the ACD regulations including labelling, advertising, records retention, notification and reporting requirements (Parts II – IV of the Act).
Under the ACD Regulations, the person responsible for placing a cosmetic product in the Singapore market is the person located in Singapore who is instrumental in causing the cosmetic product to be available for sale in Singapore (Regulation 2).
4. Does the law in your jurisdiction require cosmetic products to adhere or pass certain safety assessment standards?
Yes. The Advisory for Suppliers – Assessing the Safety and Quality of Cosmetic Products (July 2024) provides for a general guide on assessing the safety and quality of cosmetic products. This includes:
- Sourcing reputable and reliable manufacturers, importers and distributers;
- Sourcing for products that do not have reported safety and quality issues;
- Reviewing of cosmetic products’ composition for compliance with the ACD Regulations; and
- Laboratory testing of cosmetic products for the presence of prohibited and restricted ingredients in cosmetic products to ensure that the presence or concentration of these ingredients comply with the ACD Regulations.
For completeness, the Health Sciences Authority (“HSA”), which is the local regulator overseeing the regulation of cosmetic products, offers a voluntary scheme for local manufacturers of cosmetic products to apply for a Good Manufacturing Practice (“GMP”) certification. Companies applying for the GMP certification would have to ensure compliance with the GMP Guidelines for Manufacturers of Cosmetic Products, go through a GMP certification audit, submit the necessary documentation and pay the necessary fees.
5. Are there any packaging requirements for cosmetics in your jurisdiction? What information must be included on packaging?
Yes. Under the ACD Regulations, the cosmetic product is required to have a label with the following information (Regulation 7):
- Name
- Function
- List of all ingredients
- Weight or volume
- Batch number
- Name and address of the person responsible for placing the cosmetic product in the Singapore market
- Country of origin for manufacturing
- Special precautions as required to be specified pursuant to the Third Schedule of the ACD regulations
- Date of expiry
- Date of manufacture
The above information on the label must appear in the following applicable manner (Regulation 7):
- On the outer packaging;
- On the immediate container or package (Where there is no outer packaging); and
- On the leaflet (Where the information cannot fit on the container or package, but excluding name and batch number which must be on the container or package).
6. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic products i.e., advertising regulations?
Yes. There are several prohibitions relating to the advertising of health products (the definition of which includes cosmetic products) under the HPA and the ACD Regulations which include:
- Advertising any registered health product (or causing any registered health product to be advertised) in a way to represent it as being usable for any purpose other than that for which it has been registered;
- Advertising any health product (or causing any health product to be advertised, whether registered or not) in a false or misleading way;
- Advertising any cosmetic product (or causing any cosmetic product to be advertised) with any express or implied claim that the cosmetic product has a therapeutic benefit or can be used for therapeutic purposes; and
- Advertising any cosmetic product (or causing any cosmetic product to be advertised) with any claim which is likely to create an erroneous impression regarding the formulation, composition, quality or safety of the cosmetic product.
The Guidelines on the Control of Cosmetic Products also prescribe that in general, any claims within advertisements for cosmetic products must be justified by scientific data / evidence and/or by the cosmetic formulation or preparation itself.
- Advertisements for cosmetic products must not claim to modify a physiological process or to prevent or treat a disease / medical condition.
- Advertisements for cosmetic products must also comply with the principles and guidelines listed in the Singapore Code of Advertising Practices.
Aside from the above, there are general advertising requirements that apply to all products, including cosmetic products.
7. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products.
HPA
A person who:
- supplies any health product (which includes cosmetic products) by wholesale (section 14):
- Without a valid wholesaler’s license;
- In contravention of the wholesaler’s license conditions;
- By using an unauthorised premise or facility; or
- In contravention of any prescribed requirements;
- supplies an unregistered health product (section 15);
- who supplies or procures or arranges for the supply of an unwholesome health product (section 16);
- supplies any health product in contravention of any other prescribed requirements (section 17); or
- supplies any health product, the presentation of which does not comply with prescribed requirements (section 18); may be subject to a maximum fine of S$50,000 (approx. USD$38,500) and/or maximum jail term of 2 years.
Section 16 of the HPA also states that a person who supplies or procures or arranges for the supply of an adulterated, counterfeit or tampered health product may be subject to a maximum fine of S$100,000 (approx. USD$77,000) and/or maximum jail term of 3 years.
Separately, a person who:
- Advertises any cosmetic product or causes it to be advertised as such if that product is not a cosmetic product (section 19);
- Advertises any registered cosmetic product or cause such product to be advertised in such a way as to represent the registered cosmetic product as being usable for any other purpose other than that for which it has been registered (section 19);
- Advertises any cosmetic product or cause it to be advertised in a false or misleading way (section 20); or
- Advertises any cosmetic product or cause it to be advertised that does not comply with prescribed requirements (section 21); may be subject to a maximum fine of S$20,000 (approx. USD $15,400) and/or a maximum jail term of 12 months for each of the offences stated above.
The competent authority may order a person who has advertised a cosmetic product or cause it to be advertised in contravention of sections 19-21 to take corrective actions to: (a) stop the advertisement immediately; (b) take measures to remove any published advertisements; and/or (c) publish a corrective advertisement. Persons who do not comply with corrective orders may be subject to a maximum fine of S$20,000 (approx. USD $15,400) and/or a maximum jail term of 12 months.
ACD Regulations
Under Regulation 4 of the ACD Regulations,
- a person responsible for placing a cosmetic product in the market and supplies a cosmetic product, or cause that cosmetic product to be supplied on his behalf, in Singapore,
- without the prior submission of a notification to the Authority (“Product Notification”);
- despite the expiry of the Product Notification for that cosmetic product; or
- submits a Product Notification:
- that contains any statement or document that the person knows to be false or does not believe to be true; or
- that contains misleading information due to the intentional suppression of any material fact; or
- any other person who supplies a cosmetic product in Singapore without a Product Notification; may be subject to a maximum fine of S$20,000 (approx. USD $15,400) and/or a maximum jail term of 12 months.
Under Regulation 10 of the ACD Regulations, a person who:
- fails to keep, fails to produce records for inspection or fails to include any of the prescribed information within such records, in relation to any supply of a cosmetic product, may be subject to a maximum fine of S$10,000 (approx. USD $7,700) and/or a maximum jail term of 6 months for each of the offences stated above; and
- furnishes a false or misleading record may be subject to a maximum fine of S$20,000 (approx. USD $15,400) and/or a maximum jail term of 12 months.
Under Regulation 11 of the ACD Regulations, a person who, in relation to an event or other occurrence:
- that concerns any adverse effect arising from the use of the cosmetic product, does not within the prescribed period(s):
- inform the Authority of such event or occurrence; or
- submit a detailed report on the event of occurrence; or
- that reveals any defect in the cosmetic product, does not within the prescribed period(s):
- inform the Authority of such event or occurrence; or
- submit a detailed report on the event of occurrence; or
- furnishes a false or misleading report in relation to any of the situations above;
may be subject to a maximum fine of S$20,000 (approx. USD $16,000) and/or a maximum jail term of 12 months.
Enforcement powers include the ability to enter premises, inspect goods take them for testing, issue notices, obtain evidence, and request technical documents (Section 49 HPA).
8. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
As of September 2024, there are currently no anticipated foreseeable developments in relation to laws and regulations applicable to cosmetic products.
9. Supplements are often used alongside cosmetics as part of an everyday beauty routine. What is a “supplement” product classified as in your jurisdiction and what key regulations apply?
Depending on their function, a “supplement” may either be:
- a food supplement; or
- a health supplement.
Food Supplement
Food and supplements of food nature (“Food Supplements”) are regulated by the Singapore Food Agency (“SFA”).
Key Regulations for Food Supplements are the following:
- Sale of Food Act 1973 (“SF Act”)
- Food Regulations
The SF Act defines food to include the following (section 2A):
- any substance or thing of a kind used, capable of being used, or represented as being for use, for human consumption (whether it is live, raw, prepared or partly prepared);
- any substance or thing of a kind used, capable of being used, or represented as being for use, as an ingredient or additive in a substance or thing mentioned in paragraph (a);
- any substance used in preparing a substance or thing mentioned in paragraph (a) (other than a substance used in preparing a living thing);
- chewing gum or an ingredient or additive in chewing gum, or any substance used in preparing chewing gum;
- any substance or thing declared by the Minister by order in the Gazette to be food.
Importantly, “food” does not include any health product within the meaning of the HPA.
Under the Food-Health Product Classification Tree, a food supplement includes food that:
- is part of a daily diet; and
- has a conventional food presentation.
Part of a Daily Diet
The meaning of “part of a daily diet” means the product or substances of food nature that provide the nutrients (such as carbohydrates, protein, dietary fibre, vitamins and minerals) which contributes to a normal healthy diet. The product or substance may be used as part of a meal or taken to replace a meal.
Examples of substances that can be taken as part of a diet include, among other things, bee pollen, bird nest, ferment soybean, and wolfberry fruits.
Examples of products that can be taken as part of a diet include, among other things, energy food, essences (chicken, duck, fish, deer), general herbal teas and drinks, meal replacements, and sports supplements.
Conventional Food Presentation
The meaning of “conventional food presentation” refers to the external appearance of the product/substance which includes, among other things, drink beverages cans or bottles, soup containers, etc.
Health Supplement
Health supplements do not require approvals and licensing by the HSA for their importation, manufacture and sales.
Based on the HSA website and the Food-Health Product Classification Tree, a health supplement is:
- a product that is
- taken as a supplement to a diet; or
- taken for a medicinal purpose;
- has a pharmaceutical presentation; and
- has defined dosages.
Diet Supplement or taken for a Medicinal Purpose
A product that is taken as a supplement to a diet means that it is taken to provide additional nutrients that cannot be obtained (whether adequately or otherwise) through normal dietary means and for certain benefits to the body.
Examples of substances that can be taken as a supplement of a diet include, among other things, glucosamine, extracts (ginger, green tea, guarana, tea tee), milk thistle, probiotics, and soyabean isolates.
A product that is taken for a medicinal purpose would be, for example, to treat, prevent or diagnose diseases or carry medicinal claims.
Examples of substances that can be taken for a medicinal purpose include, among other things, black cumin, Vitamin K, Synthetic Caffeine, and Charcoal.
Pharmaceutical Presentation
The meaning of “pharmaceutical presentation” refers to the external appearance of the product/substance which includes, among other things, tablets, capsules, soft gels, gelcaps, liquids, syrups.
10. Do the regulations in your jurisdiction specify what can and cannot be put in supplement products? If so, what are some examples of these restrictions?
Food Supplements
The “incidental constituents” heading of Part III of the Food Regulations state that a person must not import, sell, advertise, manufacture, consign or deliver any food containing an incidental constituent except as otherwise permitted by the Food Regulations.
Incidental constituents include, but are not limited to, the following:
- Pesticide residues;
- Heavy metals, arsenic and lead;
- Mercury;
- Tin;
- Cadmium;
- Residues of antimicrobial agents;
- Veterinary drug residues;
- Mycotoxins;
- Melamine; and
- Microbiological standards.
Health Supplements
Although health supplements in general are not regulated by the HSA, such supplements cannot contain prohibited ingredients in general, such as the following:
- Prohibited substances including, but not limited to,
- Ingredients under the Poisons Act 1938, Misuse of Drugs Act 1973 and ASEAN List applicable to Health Supplements.
- Toxic heavy metals, such as Arsenic, Cadmium, Lead and Mercury (with permissible limits);
- Microbial limits, such as yeast and mould (with permissible limits), and Escherichia coli, salmonellae and staphylococcus aureus (completely prohibited); and
- Vitamins with maximum daily limits.
11. Does the law in your jurisdiction require a person or entity to be responsible for the supplements and their safety placed on the market?
Food Supplements
Yes. A person must not carry on a non‑retail food business except in accordance with a licence issued to the person by the Director‑General under Part 4 of the SF Act (section 21).
The Food Regulations state that no person shall import, advertise, manufacture, sell, consign or deliver any prepacked food if the package of prepacked food does not bear a label containing all the particulars required by the Food Regulations (Regulation 5).
Labelling requirements include, but are not limited to, the name and address of the manufacturer, packer or local vendor in the case of a food of local origin, and the name and address of the local importer, distributor or agent and the name of the country of origin of the food in the case of an imported food.
A telegraphic or code address or an address at a post office shall not be sufficient.
The name appearing on the label shall be presumed to be the name of the manufacturer, packer, local vendor or importer of the food unless proven otherwise. If more than one name appears, the names shall be presumed to be that of the manufacturer, packer, local vendor or importer of the food unless proven otherwise.
Health Supplements
No. However, the HSA states that dealers may voluntarily notify them of any health supplements that are supplied in Singapore (see here).
12. Does the law in your jurisdiction require supplements to adhere or pass certain safety assessment standards before being place in the market? If so, are there any exceptions/particular extra requirements for certain products?
Food Supplements
If supplements comply with SG law (including the SF Act and the Food Regulations), they are permitted for sale. It is the responsibility of the manufacturer, importer or retailer of the supplements to ensure that they comply with the law.
Specific requirements (on prohibitions, dosage, etc) can be found under the Food Regulations depending on the type of ingredients that are included in the food supplement.
Health Supplements
Although health supplements in general are not regulated by the HSA, such supplements cannot contain prohibited ingredients in general.
Please see the response to Question 10 above for a non-exhaustive list of prohibited ingredients within health supplements.
13. Does the law in your jurisdiction require the responsible entity to keep records in relation to supplements made available to customers? If so, what are these records?
Food Supplements
Currently, the SF Act and its regulations do not appear to prescribe record keeping requirements applicable to supplements made available to customers.
However, the SF Act states that the Minister may make regulations that, among other things (section 56):
- set out requirements and procedures for document control and recording by food businesses to achieve the safety and suitability of food and to support a secure and reliable supply of food, including:
- the information that must be collected about food or a food contact article;
- the periods for which the information must be kept; and
- how, when and to whom that information must be reported; and
- set out requirements that apply to imported food or food contact articles to ensure that the food or food contact article is safe and suitable and to support a secure and reliable supply of imported food in Singapore, including keeping of records in relation to the source or traceability and handling of the food or food contact article imported.
Health Supplements
As health supplements in general are not regulated by the HSA, there are no record-keeping requirements applicable to health supplements.
14. Are there any labelling or packaging requirements for supplements in your jurisdiction? What information must be included on the labelling/packaging?
Food Supplements
Under the Food Regulations, every prepacked food shall, unless otherwise provided in the Food Regulations, bear a label, marked on or securely attached in a prominent and conspicuous position to the package, containing the following particulars, statements, information and words in English (Regulation 5):
- the common name, or a description (in the case where a suitable common name is not available) sufficient to indicate the true nature of the food;
- the appropriate designation of each ingredient in the case of food consisting of two or more ingredients and unless the quantity or proportion of each ingredient is specified, the ingredients shall be specified in descending order of the proportions by weight in which they are present;
- certain statements in specification of ingredients in the case of a food which contains the synthetic colouring, tartrazine;
- the net quantity of the food in the wrapper or container expressed in volume (liquid foods), weight (solid foods), or either volume or weight (for semi-solid or viscous foods);
- the name and address of the manufacturer, packer or local vendor in the case of a food of local origin; and the name and address of the local importer, distributor or agent and the name of the country of origin of the food in the case of an imported food;
- certain ingredients or food known to cause hypersensitivity, including but not limited to eggs, fish, peanuts, soybeans, milk, tree nuts, crustacea, and cereals containing gluten;
- a statement for any food containing aspartame; and
- such other particulars as are required by the Food Regulations to be given in the case of any particular food.
“Prepacked” means packed or made up in advance ready for sale in a wrapper or container, and where any food packed or made up in a wrapper or container is found on any premises where such food is packed, kept or stored for sale, the food shall be deemed to be prepacked unless the contrary is proved, and it shall not be sufficient proof of the contrary to show that the food had not been labelled in accordance with the provisions of the Food Regulations. The definition of “prepacked” is broad and would likely include food supplements (Regulation 2).
Health Supplements
Although health supplements in general are not regulated by the HSA, the HSA has released the Guidelines for Labelling Standards of Health Supplements and Traditional Medicines (Guidelines Version 4), which states that health supplements dealers should have prominent and conspicuous labels containing the following adequate and truthful information in English:
- Product Name (including Brand Name, if any);
- Dosage Form;
- Name and Quantity of Active Ingredients;
- Product Indications / Intended Purpose;
- Dosage and Directions of Use;
- Batch Number;
- Expiry Date;
- Country of Manufacture;
- Name and Address of Local Importer (for overseas manufactured product) or Product Owner (for locally manufactured product);
- Contraindications, if any;
- Other Warnings, if any;
- Storage Condition; and
- Pack Size / Net Content.
15. Is the advertising and promotion of Supplements allowed in your jurisdiction? If so, under what conditions? Are there any specific requirements or regulations for advertising and promotion?
Food Supplements
Under the Food Regulations, no person shall, among other things, advertise any prepacked food if the package of prepacked food does not bear a label containing all the particulars required by the Food Regulations (Regulation 5).
Additionally, an advertisement for food, other than a label, must not contain any statement, word, brand, picture, or mark that is prohibited by regulation 9 of the Food Regulations, other than to the extent permitted under regulation 9A or 9B of the same (Regulation 12).
Regulation 9 states that no written, pictorial, or other descriptive matter appearing on or attached to, or supplied or displayed with food is to include any claim or suggestion whether in the form of a statement, word, brand, picture, or mark purporting to indicate the nature, stability, quantity, strength, purity, composition, weight, origin, age, effects, or proportion of food or its ingredients that is false, misleading or deceptive, or is likely to create an erroneous impression regarding the value, merit or safety of the food.
Furthermore, unless permitted under regulations 9A or 9B, a label must not include any claim or suggestion in relation to food:
- that implies the food has therapeutic or prophylactic action;
- that implies the food will prevent, alleviate or cure any disease or condition affecting the human body;
- that implies that health or an improved physical condition may be achieved by consuming the food; or
- that may be interpreted as advice of a medical nature from any person whatsoever.
Finally, there are also specific advertisement restrictions for certain types of substances that may be present within food supplements, including but not limited to, food additives, anti-caking agents, anti-foaming agents, antioxidants, and colouring matter.
Health Supplements
The advertising of health supplements (except for quasi-medicinal products) are not subject any permit approval under the HPA or its regulations.
However, the HSA has released an informal guide on health supplement claims for advertisers of health supplements to comply with.
For quasi-medicinal products, a medicinal advertisement and sale promotion permit would be require pursuant to the Medicines Act and the Medicines (Medical Advertisements) Regulations.
Under the HPA, “quasi-medicinal product” includes, among other things, any medicated beverage and any vitamin or nutritional preparation from any natural source (First Schedule).
Aside from the above, there are general advertising requirements that apply to all products, including food and health supplements.
16. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regards to the supply of supplements
Food Supplements
The SF Act states that any person who contravenes any provision of Part 3 of the SF Act, which apply to various offences including ones concerning foods containing prohibited substances, and labelling and advertising food, shall be guilty of an offence.
There are specific penalties prescribed within the SF Act. For general penalties, the SF Act states that any person who is guilty of an offence under this Act for which no penalty is expressly provided shall be liable on conviction to a maximum fine of S$5,000 (approx. USD $4,000) and, in the case of a second or subsequent conviction, to a maximum fine of S$10,000 (approx. USD $ 8,000) and/or a maximum jail term of 3 months (section 49).
Part 6 of the SF Act prescribes the relevant enforcement mechanism, where a District Court and a Magistrate’s Court have jurisdiction to try any offence under the SF Act and have the power to impose the full penalty or punishment in respect of any offence under the SF Act (section 29).
Health Supplements
As health supplements in general are not regulated by the HSA, there are no applicable enforcement mechanisms.
For quasi-medicinal products, the Medicines (Medical Advertisements) Regulations state that any person who, among other things, issues a medical advertisement or conduct any sale promotion in relation to a medicinal product (which includes a quasi-medicinal product) without a permit shall be guilty of an offence and shall be liable on conviction to a maximum fine of S$5,000 (approx. USD $4,000) and/or a maximum jail term of 12 months (Regulation 15).
17. Do you expect any future developments in this field in your jurisdiction i.e. key areas of reform?
As of September 2024, there are currently no anticipated foreseeable developments in relation to laws and regulations applicable to food and health supplements.
Beauty devices
1. Does your jurisdiction regulate cosmetic devices separately from cosmetic products?
In general, cosmetic devices that are intended for modification of appearance or anatomy (e.g. treatment of wrinkles; improving skin texture; skin rejuvenation; body contouring; and hair removal) are not regulated unless they fall under paragraph 1(b) of the definition of “medical device” as set out in First Schedule of the HPA:
- any implant for the modification or fixation of any body part; (e.g. gluteal implants, breast implants)
- any injectable dermal filler or mucous membrane filler; (e.g. collagen/ hyaluronic dermal fillers, lip fillers)
- any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means. (e.g. lipoplasty/ liposuction equipment)
The HSA is responsible for managing cosmetic devices in Singapore.
The National Environment Agency (“NEA”) imposes licensing requirements for individuals or facilities handling ionizing/non-ionizing radiation emitting equipment under the Radiation Protection Act (“RPA”). Under the Radiation Protection (Non-Ionising Radiation) Regulations, sun lamps for tanning beds need to adhere to certain labelling requirements. Only licensed workers can operate high-power lasers, and only registered medical practitioners are permitted to use class 4 high-power lasers on humans at approved premises. Suppliers and dealers must ensure they do not supply these devices to unregistered individuals, such as beauticians.
However, IPL devices, which use non-laser high intensity emission from a high output flash lamp are not regulated by NEA under the RPA.
2. Does the law in your jurisdiction require a person or entity to be responsible for the cosmetic devices and their safety placed on the market?
If the cosmetics device is considered a medical device under the HPA, the entity importer or manufacturer will be required to ensure that the medical device complies with the obligations under the relevant regulations.
3. Does the law in your jurisdiction require cosmetic devices to adhere or pass certain safety assessment standards?
Some key safety concerns specific to medical devices for modification of appearance or anatomy will have to be addressed as part of the device validation. Documentary requirements, including but not limited to biocompatibility studies; mechanical testing (e.g. elongation, rupture resistance test, fatigue test); raw material certificate of analysis, electrical safety and functional testing of the device may be required by the HSA.
4. Are there any laws in your jurisdiction with respect to the marketing/promotion of cosmetic devices i.e., advertising regulations?
If the device is considered a medical device under the HPA, then there are certain laws that need to be followed. At a high level these are:
Section 19: Regulates the advertisement of health products, ensuring that advertisements comply with specific standards and guidelines.
Section 20: Prohibits false or misleading advertisements related to health products. Advertisements must not contain any information that could deceive consumers about the safety, efficacy, or quality of the health product. This section aims to ensure that all promotional materials are truthful and not exaggerated.
Section 21: Imposes additional requirements for the advertisement of health products to ensure they are not deceptive or harmful.
Aside from the above, there are general advertising requirements that apply to all products, including cosmetic devices.
5. Please describe the enforcement mechanism for compliance with regard to the regulations discussed in Q1 in your jurisdiction with regard to the supply of cosmetic products.Is there criminal liability for non-compliance?
For cosmetic devices that are considered medical devices, under the Health Products (Medical Devices) Regulations 2010 in Singapore, the HSA is responsible for investigating allegations of non-compliance and prosecuting serious offences. Enforcement powers include the ability to enter premises, inspect goods take them for testing, issue notices, obtain evidence, and request technical documents (Section 49 HPA).
The penalty for failure to comply with the enforcement powers of an officer under section 49(2) of the HPA includes a maximum fine of $10,000 (approx. USD $8,000) and/or a maximum of 6 months imprisonment.
6. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
As of September 2024, there are currently no anticipated developments in relation to laws and regulations applicable to cosmetic devices.
Cosmetic (non-surgical) services
1. Is the administration of any/all of the cosmetic (non-surgical) services above regulated in your jurisdiction? If so, what national laws apply?
Yes.
Under the HPA, a “medical device” includes:
- any injectable dermal filler or mucous membrane filler (e.g Collagen or hyaluronic dermal fillers, lip fillers, wrinkle filers);
- any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for, among other things, diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury (which may include whole body cryotherapy); and
- any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means (e.g. weight loss injections, mesotherapy).
Per the HSA website and the Guidelines on the Control of Cosmetic Products, aesthetic or beauty devices, which likely includes the following, would not be regulated as cosmetic products:
- Tools that assist with dermarolling and dermaplaning;
- IPL skin treatments;
- Laser, LED and IPL skin treatments (hair removal, skin rejuvenation, weight loss);
- Devices that facilitate:
- micro dermabrasion;
- professional skin lightening;
- Infrared skin treatments; and
- semi-permanent make up;
Additionally, the following cosmetic (non-surgical) services would unlikely be classified as cosmetic products:
- Vitamin drips and injections;
- Microneedling;
- Chemical Skin peels; and
- Vampire facials/platelet-rich plasma (PRP).
If the ingredients in relation to the products used within the abovementioned cosmetic (non-surgical) services fall under the Register of Therapeutic Products, the product concerned would be a therapeutic product and regulated under the HPA and its regulations.
The aesthetic / beauty devices, as well as the abovementioned cosmetic (non-surgical) services (which do not use products that are therapeutic products), are unlikely to be subject to any registration, permit or notifications requirements under the relevant statutes relating to health or cosmetic products.
However, aesthetic / beauty devices and devices used to facilitate the abovementioned cosmetic (non-surgical) services may still be regulated generally (under import, customer protection and other applicable laws).
Separately, as Clostridium botulinum, the main ingredient in botulinum toxin, is found under the Register of Therapeutic Products, botulinum toxin would be a therapeutic product and regulated under the HPA and its regulations.
2. Are there any rules in your national law which prevent an individual under the age of 18 (or other age as relevant) from receiving a particular non-surgical cosmetic service?
No. However, parental consent is usually required as the minimum age of contractual capacity in Singapore is 18 years.
Accordingly, an individual under the age of 18 would not be able to receive a particular non-surgical cosmetic service without the presence of a parent or legal guardian to sign the relevant agreements (i.e. terms and conditions, waivers) on the behalf of the underaged individual.
3. Is botulinum toxin (BT) a prescription only drug in your jurisdiction? If so, who can prescribe BT in your jurisdiction i.e., what expertise or qualification is required to prescribe and/or administer BT?
Yes, aside from being a therapeutic product, BT, when contained in preparations intended for treatment of human ailments (e.g. when used as botox for aesthetic purposes), is classified as a poison since it falls under the Poisons List in the Schedule of the Poisons Act 1938 (“PA”).
As a poison, a person would be required to have a licence under the PA to import, possess for sale, sell or offer for sale BT.
There are additional prohibitions and regulations with respect to the sale of BT as a poison (section 6 PA). However, such additional prohibitions and regulations do not apply to, among other things:
- a medicine which is supplied by a medical practitioner for the purposes of medical treatment of his own patients;
- a medicine which is dispensed by a license pharmacist on the premises specified in his licence; and
- to a poison forming part of the ingredients of a medicine, except a patent or proprietary medicine, which is supplied by a licensed pharmacist on the premises specified in his licence;
- if certain labelling and supply records requirements are complied with (section 7 PA).
4. Does the (national) law require that businesses and/or practitioners administering these services register with a centralised body? Does this centralised body responsible handle complaints in relation to non-surgical cosmetic services?
For services which require a medical practitioner (which includes ), the Medical Registration Act 1997 (“MRA”) states that the Registrar must maintain and keep, among other things, a register called “The Register of Medical Practitioners” which contain the details of persons registered as fully registered medical practitioners and the details of persons registered as medical practitioners with conditional registration (section 19 MRA).
Individuals with the necessary degrees or certificates that satisfy requirements imposed by the Medical Council may apply to be a fully registered medical practitioner (section 20 MRA).
THE MRA provides that a complainant to make a complaint (section 40 MRA):
- relating to:
- the conduct of a registered medical practitioner in his professional capacity; or
- a registered medical practitioner’s improper act or conduct which brings disrepute to his profession; or
- that the professional services provided by a registered medical practitioner are not of the quality that is reasonable to expect of him.
Complaints in relation to non-surgical cosmetic services that are provided by a registered medical practitioner in their professional capacity will be received by the Medical Council who will direct it to the Complaints Panel which will in turn involve any one or more of the following committees as required: the Inquiry Committees, Complaints Committees, Review Committees, Disciplinary Tribunals and Interim Orders Committees (Part 7, Div 2 MRA).
Separately, there are also registration requirements (with their respective disciplinary or complaints panels) for the following types of healthcare professionals:
- Pharmacists: Pharmacists Registration Act 2007 (“PRA”)
- Traditional Chinese Medicine (TCM) Practitioners: Traditional Chinese Medicine Practitioners Act 2000 (“TCMPA”)
5. Please set out at a high level the key enforcement mechanism and/or consequences for non-compliance in relation to the regulations discussed above.
For health products under the HPA, please see our response to Question 7 Part 1 (i.e. Cosmetics & Supplements).
Under the PA, offences include:
- Section 16: General contraventions of provisions of the PA (including prohibited importation and sale of poisons under the PA) – maximum fine of S$10,000 (approx. USD $8,000) and/or maximum of 2 years imprisonment.
- Section 19: Sale of poisons to persons below 18 years old – maximum fine of S$1,000 (approx. USD $800) and/or maximum of 6 months imprisonment.
Under the MRA,
- Section 17: any unauthorised person acting as a medical practitioner may be subject to:
- for their first conviction, a maximum fine of S$100,000 (approx. USD $80,000) and/or maximum of 12 months imprisonment; and
- for their second or subsequent conviction, a maximum fine of S$200,000 (approx. USD $160,000) and/or maximum of 2 years imprisonment.
- Section 19: a medical practitioner who does not inform the Registrar in writing of any change to his/her name or residential address may be liable to a maximum fine of S$1,000 (approx. USD $800).
- Regarding complaints raised to the Medical Council, please see here for a broad overview of the enforcement process
There are various offences in relation to unauthorised or improper practices within the practice of pharmacy (Part 4 PRA).
Similar penalties apply to Pharmacists (section 15 PRA) and TCM Practitioners (section 12 TCMPA) for failure to inform the Registrar in writing of changes to personal details under the Registrar.
The complaints process for Pharmacists and TCM Practitioners under the PRA and TCMPA respectively largely mirror the process that applies under the MRA.
6. Are there any national laws or regulations which are relevant to the advertising of non-surgical cosmetic services? If so, are third party booking platforms which allow consumers to book non-surgical cosmetic services also caught by these advertising laws or regulations?
For advertising of health products under the HPA, please see our response to Question 6 Part 1 (i.e. Cosmetics & Supplements).
The HPA defines “advertisement”, in relation to a health product, to means the publication, dissemination or conveyance of any information for the purpose of promoting, whether directly or indirectly, the sale or use of that health product by any means or in any form, including the following (section 2):
- publication in a newspaper, magazine, journal or other periodical;
- display of posters or notices;
- circulars, handbills, brochures, pamphlets, books or other documents;
- letters addressed to individuals or bodies corporate or unincorporate;
- photographs or cinematograph films;
- sound broadcasting, television, the Internet or other media;
- public demonstration of the use of the health product; or
- offer of trials of the health product to members of the public.
Based on the above, advertisements on third party booking platforms would likely be caught under section 2(f) of the HPA.
7. Do you expect any future developments in this field in your jurisdiction i.e., key areas of reform? If so, please provide a high-level description of the proposed reforms and when they are likely to be introduced.
As of September 2024, there are currently no anticipated foreseeable developments in relation to laws and regulations applicable to food and health supplements.