regulatoryguidance-health supplements guidelines (jan2010)

7/28/2019 RegulatoryGuidance-Health Supplements Guidelines (Jan2010)

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HEALTH SUPPLEMENTS GUIDELINES

JANUARY 2010


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HEALTH SCIENCES AUTHORITY HEALTH PRODUCTS REGULATION GROUP Page 2 of 15

These guidelines provide information for the trade in the dealing with healthsupplements in Singapore. The information provided in these guidelinesserves to supplement understanding and application of the Laws andRegulations and is not at any time meant to supersede or replace any of thelegislation.

Legislation

2. Information on the current legislative control of health supplements and relatedproducts may be found in the following legislation:

A. Medic ines Act 1975 & its Subsidiary Legis lat ion especial ly:i. Medicines (Prohibi tion of Sale & Supply) Order;ii. Medicines (Traditional Medicines, Homoeopathic Medicines and Other

Substances) (Exemption) Order;iii. Medicines (Non-Medicinal Products)(Consolidation) Order;iv. Medicines (Labelling) Regulations;

v. Medicines (Medical Advertisements) Regulations;vi. Medicines (Licensing, Standard Provis ions & Fees) Regulations

B. Medicines (Advertisement & Sale) Act: (note section 9: The Schedule ofDiseases and Conditions)

C. Sale of Drugs Act & its Regulations especially:i. Sale of Drugs (Prohibi ted Substances) Regulations;ii. Sale of Drugs (Prohibi ted Drugs) (Consolidation) Regulations;iii . Sale of Drugs (Rhodamine B) Regulations 1993

D. The Poisons Act & The Poisons Rules.

Working Definition

3. Health Supplement is currently not defined in the legislation. However, it includesthe following categories of products defined in the Medicines Act and its subsidiarylegislation:

a. "Quasi-medicinal products" (includes "medicated beverages", "Vitamins andnutritional preparations from natural sources under the legislation Medicines(Traditional Medicines, Homoeopathic Medicines and other Substances) (Exemption)

Order,

b. "Traditional Medicines" (other than CPM, Jamu, Ayurvedics, Homoeopathics)including herbal preparations under the legislation Medicines (Traditional Medicines,Homoeopathic Medicines and other Substances) (Exemption) Order,

c. "Health Foods with vague and general medicinal claims" under the legislationMedicines (Non-Medicinal products)(Consolidation) Order.


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4. A working definition of Health Supplement that may be useful to dealers isdescribed below:

Health Supplements refers to a product that has the following purpose,ingredients and dosage forms:

A product that is used to supplement a diet, with benefits beyond those ofnormal nutrients, and / or to support or maintain

the healthy functions of thehuman body.

Health Supplements contain one or more, or a combination of the followingingredients:

a. Vitamins, minerals, amino acids (natural and synthetic);b. Substances derived from natural sources, including non-human animal and

botanical materials in the forms of extracts, isolates, concentrates; andc. Are presented in any of the following dosage forms to be administered in

small unit doses: eg capsules, softgels, tablets, liquids, syrups, and anyother dosage forms as may be approved by the Licensing Authority.

5. Exceptions

:

Health Supplements shall not

include any of the following:

a. Any product as a sole item of a meal or diet;b. Any product that is defined otherwise in the legislation; andc. Any injectable and sterile preparation.

Safety & Quality Requirements

6. Currently, health supplements are not subjected to premarket approvals andlicensing for their importation, manufacture and sales in Singapore. The onus ofresponsibility for the safety and quality of health supplements rests with the dealers(importers, manufacturers, wholesale dealers) and sellers. They must ensure thattheir products comply with the safety and quality requirements provided in thisGuide.

7. Health supplements (HS) shall:

i) not

contain any other substances except those stated on the label;

ii) not

contain any human part or substance derived from any part of thehuman body;

iii) not

contain substances listed in the Schedule of the Poisons Act;

iv) not

exceed the limits for microbial contamination and toxic heavy metals asspecified in Tables 1 and 2;


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v) not

contain any substance above the limit specified in the List of RestrictedSubstances, such as for Vitamins and Minerals shown in Table 3;

vi) not

contain any substance specified in the List of Prohibited Substancesshown in Table 4;

vii) not

contain any active substance which is a chemically-defined isolatedconstituent of plants, animals or minerals, or a combination of any one ormore of these;

viii) not

contain any substance that may adversely affect the health of the persontaking the product;

ix) not

make any claim to directly or indirectly refer to the lists of conditions,diseases and disorders shown in Tables 5 and 6;

x) be of acceptable standards of quality in terms of product stability under local

climatic conditions, have adequate shelf-life period, proper packaging andlabeling; and are manufactured and/or assembled under proper conditions;and

xi) require the Convention on International Trade in Endangered Species ofWild Fauna and Flora (CITES) import permit if they contain substances (e.g.Hoodia, etc) listed under the Endangered Species (Import & Export) Act.Dealers should contact the Wildlife Regulatory Branch, Agri-Food &Veterinary Authority (AVA) at 5 Maxwell Road #02-03 Tower Block, MNDComplex, Singapore 069110, Tel: +65 62270670, Fax: +65 63257646 toobtain the necessary permit or to obtain further information.

Medical Advertisement Control

8. Certain categories of health supplements are subjected to medical advertisementcontrol. These include:

a. Vitamins and Minerals preparations (for supplementation and orprevention of vitamin and mineral deficiency diseases);

b. Some herbal traditional medicines (intended for medicinal purposes basedon traditional usage); and

c. Others such as "medicated beverages" and "medicated oil and balm".

Safety & Quality Specifications

9.The safety and quality levels are specified in the following tables. These limits maybe subjected to revisions from time to time, when new information is available.


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The above limits are not applicable to probiotics or products derived fromfermentation rocesses.

Table 1: Limits of Heavy Metals

Substance1. Arsenic 5 parts per million

Quantity (by weight)

2. Copper 150 parts per mil lion

3. Lead 20 parts per mil lion4. Mercury 0.5 parts per mil lion

For health supplements derived from herbs without extraction and heat processing,compliance with microbial count is required.

Table 2: Microbial Contamination Limits

Total aerobic microbial count: Not more than 105 per gram or mlYeast and mould: Not more than 5 x 102 per gram or ml

Escherichia coli, Salmonellae andStaphylococcus aureus: Nil in 1 gm or ml of the product

10. The following table specifies the limits above which Vitamins and Mineralspreparations may be registrable and licences are required for their manufacturing,importation and sale.


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Table 3

1) IronMINERALS:

2) Iodine

3) Potassium

4) Copper

1)VITAMINS:

Vitamin A

Betacarotene

(acetate or palmitate)

2) Nicotinic acidNiacin

3)Cholecalciferol (Vit D3)

Vitamin D

Ergo-calciferol (Vit D2)

4)alpha tocopheryl acetateVitamin E

alpha tocopheryl succinatealpha tocopherol

5)Thiamine (Aneurine)Vitamin B1

(Hydrochloride or mononitrate)

6)Pyridoxine HydrochlorideVitamin B6

7) Vitamin B12CobalaminCyanocobalaminMecobalamin

8) Vitamin KPhylloquinone, Menadione etc

Yes; if product contains more than 30mg ofelemental iron per unit dose.

Yes; if product contains more than 300mcgof elemental iodine per unit dose.

Yes; if product contains more than 200mg ofelemental potassium per unit dose.

Yes; if product contains more than 3mg ofelemental copper per unit dose.

Yes; if product contains more than 10,000iu

of vitamin A activity per unit dose.

No; if the vitamin is added in a nutritionalsupplement.Yes, if product is for specific therapeutictreatment.

Yes; if product contains more than 1,000iuof vitamin D activity per unit dose.

Yes; if product contains more than 800iu ofvitamin E activity per unit dose.

Yes; if product contains more than 50mgvitamin B1 per unit dose and also containsvitamin B6 and/or vitamin B12 together.

Yes; if product contains more than 50mgvitamin B6 per unit dose and also contains

vitamin B1 and/or vitamin B12 together.

Yes; if product contains more than 100mcgvitamin B12 per unit dose and also containsvitamin B1 and/or vitamin B6 together.

Yes


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11. The following is a list of ingredients that should not be used in Health Supplements,unless used under the restricted conditions stated below.

Table 4: List of ingredients containing prohibited/restricted ingredients for HealthSupplement products

Ingredients Constituent(s) of concern Restrictions & Control inHealth Supplements

1. Aconitum napellus(Monkshood, Aconite)Other spp: A carmichaeli, A.kusnezoffii, A. coreanum

Aconite alkaloids Controlled under Poisons Act

2. Aristolochia spp Aristolochic Acids Controlled under Poisons Act

3. Artemisia absinthium(Wormwood)

Artemisinin Controlled under Poisons Act

4. Atropa Belladonna

(Deadly nightshade)

Atropine Controlled under Poisons Act

5. Catharanthus roseus, Vincarosea(Periwinkle Madagascar, OldMaid)

Vincristine Controlled under Poisons Act

6. Chaparral Not suitable to be used inHealth Supplements.

7. Cimicifuga racemosa (Blackcohosh)

Link with liver adversereactions. The following

cautionary label is requiredWarning: This productcontains Black cohoshwhich may harm the liver insome individuals

8. Coenzyme Q10Ubidecarenone

Restricted to 150mg per day.The following cautionary labelis required Do not takewhile on Warfarin therapywithout medical advice

9. Colchicum autumnale Colchicum alkaloids Controlled under Poisons Act

10. Corydalis ambigua, C.bulbosa, C. amurensis, C.decumbens, C. pallida, C.racemosa, C. turschaninorii,C. yanhusuo

Corydaline, corydine,tetrahydropalmatine

Controlled under Poisons Act

11. Corynanthe yohimbi,Pausinystalia yohimbe,(Yohimbe)

Yohimbine Controlled under Poisons Act


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12. Danthron, Suprofen Danthron, Suprofen Controlled under Poisons Act

13. Datura stramonium(Jimsonweed, Devils-Apple,Green Dragon, Zombies

Cucumber, Moon Weed,Trumpet Lily, Stinkweed)

Atropine, Hyoscyamine,Hyoscine


14. Dehydroepiandrosterone(DHEA)

Dehydroepiandrosterone(DHEA)


15. Dimethyl sulphoxide(DMSO)

Dimethyl sulphoxide (DMSO) Controlled under Poisons Act

16. Dimethylaminoethanol(DMAE)

Deanol Controlled under Poisons Act

17. Ephedra sinica (Ma huang)Sida cordifolia extract

Ephedrine1% and above is not allowedin Health Supplements


18. Hydrastis Canadensis(Golden Seal), Berberisvulgaris (Barberry), Berberisaquifolium (Oregon Grape),Coptis Chinensis (Chinesegoldthread), Coptis Teeta,Chelidonium majus,

Mahonia aquifolium, Mrepens, M nervosa,Phellodendron amurense, Pchinense

Berberine Controlled under Poisons Act

19. Hyoscyamus niger(Henbane, Henblain,Jusquaime)

Atropine, Hyoscine,Hyoscyamine


20. Piper Methysticum (Kava,Kava-kava)

Piper methysticum (kava-kava); kava pyrones(kavalactones)


21. Lobelia inflata, L. tupa(Lobelia)

Lobelia alkaloids0.1% and above is not allowedin Health Supplements


22. Mucuna pruriens(Mucuna prurita)(Cowhage, Cowage)

Dopamine, Nicotine,Physostigmine


23. N-acetyl cysteine(NAC)

Acetyl cysteine Controlled under Poisons Act


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24. Nux vomica(Strychnos nux-vomica)

StrychnineBrucine


25. Pilocarpus jaborandi, P.microphyllus, P. pinnatifolius

Pilocarpine Controlled under Poisons Act

26. Pituitary gland, Somatropin,Human Growth hormone,Suprarenal gland, Thyroidgland, Sex hormones,Pregnenolone,Androstenedione etc

Pituitary gland Controlled under Poisons Act

27. Podophyllum peltatum(Mayapple, AmericanMandrake)

Podophyllin resin Controlled under Poisons Act

28. Pomegranate (except bark)(but not present in Polygalaspecies)

Pomegranate, alkaloids Controlled under Poisons Act

29. Rauvolfia serpentina(Rauwolfia, Indiansnakeroot, Snakeroot)

Reserpine, Rescinnamine Controlled under Poisons Act

30. Red Yeast Rice(Sole ingredient controlledas a CPM)

Lovastatin1% and above is not allowedin Health Supplements.


31. Sanquinaria anadensis(Bloodroot, Indian Paint)

Berberine Controlled under Poisons Act

32. Solanum dulcamara(Bittersweet nightshade)

Solanaceous alkaloids Controlled under Poisons Act

33. Spigelia marilandica(Worm grass)

Strychnine Controlled under Poisons Act

34. Symphytum peregrinum,Symphytum officinale

(Comfrey)

Not suitable to be used inHealth Supplements

35. Vitamin B15 Pangamic Acid / DMG ordimethylglycine

Prohibited under Sales ofDrugs Act

36. Vitamin B17 Amygdalin / Laetrile/Nitrilosides

Prohibited under Sales ofDrugs Act

37. Vinca minor(Periwinkle, Myrtle)

Vincristine, Vinblastine,Vinpocetine



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Please note:i) The above list is not exhaustive and will be updated from time-to-time, as newinformation becomes available.

ii) Where the routes of administration are other than by oral route, and otherconsiderations such as sterility, bioavailability and quality control become important

in the overall safety of the final product, pre-market authorization (i.e. approval &licence) is likely to be required.

Health Supplements Claims Guidelines

12. In general, the health claims made must be consistent with the definition ofhealth supplements.

13. Health supplements must not be advertised or promoted for any specificmedicinal purpose, i.e. treatment or prevention, implied or otherwise, of any diseaseor disorder. A list of prohibited diseases and disorders is provided in Table 5.


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Table 5

Examples of Diseases/Conditions/Disorders Not Allowed for Health Supplements 1. Cardiovascular diseases & disorders incl.

Hypertension, stroke, cholesterol disorder,reduces cholesterol, etc.

2. Dental & Periodontal diseases and disorders3. Diseases & disorders of the eye, ear or nose

likely to lead to severe impairment, blindness ordeafness, cataract, etc.

4. Diseases of the liver, biliary system or pancreasincl. Hepatitis, fatty liver, liver cirrhosis, hepatitis,etc.

5. Endocrine diseases & disorders, incl. diabetes,thyroid disorders, thymus disorders, prostaticdisease, etc.

6. Gastrointestinal diseases & disorders incl. ulcers,gastritis, diarrhoea, constipation, etc.

7. Haematological diseases e.g. increases orreduces platelets, etc8. Immune disorders & diseases incl. AIDS,

allergies, etc.9. Immunisation e.g. vaccines, protects body

against diseases (all types), etc10. Infectious diseases, incl. sexually transmitted

diseases, bacterial or viral infection, leprosy, etc11. Mental diseases, disorder & conditions incl.

Substance abuse, addiction, depression, eatingdisorder, etc.

12. Metabolic disorders incl. obesity, etc.

13. Musculoskeletal diseases & diseases of joint,bone, collagen incl. rheumatic diseases,osteoporosis, anti-inflammatory, etc.

14. Neoplastic disease incl. all types of cancers15. Nervous system and neurological disorders incl.

epilepsy, fits, paralysis, Alzheimers disease,dementia, etc.

16. Physiological processes, enhance or depress,e.g. immunity, enzyme deficiency, anti-aging,hormonal imbalances, hormone releasestimulants, etc.

17. Renal diseases, diseases of the genito-urinary tracts incl. urinary tract infection,symptoms of nephritis, etc.

18. Respiratory diseases incl. asthma,tuberculosis, etc.

19. Skin diseases & disorders incl. eczema,fungal infection, ulcers, warts, mole,pigmentation disorder, etc.

20. Reproductive disease, disorders &conditions incl. sexual dysfunction,conception and pregnancy, infertility,menstrual disorders, impotency, frigidity,etc.

Examples of Misleading Claims:1. Anti-aging, longevity

2. Sexual powers

3. Arousal, libido

4. Enhancement of sexual organs

5. Breast enhancement, enlargement, growth

6. Height growth

7. Enhance intelligence

8. Enhance immunity

9. Anti-stress

10. Hormone Releaser

(The above list is not exhaustive and may be revised from time to time when new informationis available)

14. For Traditional Medicines, no claim is allowed for serious medicinal diseases,disorders and conditions. Any therapeutic claim must be based on traditional usage,as documented in approved traditional medicine literature.

15. In addition, health supplements are not allowed to make any claim, which cannotbe adequately substantiated by scientific evidence. Anyone found to be makingfalse, misleading and deceptive claims, and those who make direct or indirectreferences to any of the following 19 diseases and conditions listed in the Schedule


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of the Medicines Act, extracted and shown in Table 6, may be charged with anoffence and be liable to legal punishment.

Table 6: List of Prohibited 19 Diseases and Conditions

Types and Evidence of Claims for Health Supplements

A. Nutr it ional (General) Health Claims

a. Nutritional Health claims are permissible for products provided that theycontain well-documented ingredients, where the function of each ingredient issupported and documented in standard reference texts.

b. Nutritional Health claims include Nutrient-Support claims and General Healthclaims that are intended for:

i) General health maintenance and well-being.ii) Vitamin and/or mineral supplementation, such claims are permitted

only when the relevant vitamin and mineral used in the productamounts to >30% the RDA value.

iii) Nutritional supplementation beyond normal nutritional value from food.

c. The dealers must hold evidence to support these claims, and provide this tothe Authority when required to do so.

d. Examples include:i) Relieve general tiredness, weaknessii) Enhance good health and growthiii) Supplementing nutritioniv) Nourish the bodyv) Strengthen the body (without reference to body organs).

1. Blindness 10. Tuberculosis2. Cataract 11. Cancer3. Dangerous drug addiction 12. Conception and pregnancy4. Diabetes 13. Deafness5. Frigid ity 14. Epilepsy or Fits6. Infertil ity 15. Hypertension7. Impotency 16. Insanity8. Leprosy 17. Kidney diseases9. Paralysis 18. Menstrual disorder

19. Sexual function


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B. Functional Health Claims

a. Functional Health claims must be adequately substantiated throughingredient-based evidence. The dealers must hold evidence to support theseclaims, and provide this to the Authority when required to do so.

b. Functional Health claims include:

i) General enhancement / maintenance of healthy functions.ii) Supports healthy function of the human body such as maintaining healthy

joints, support natural physiological processes e.g. immune system,circulation, etc.

c. The claims made should not imply that the product is necessary or play a rolein diseased states.

C. Permiss ible Health Claims

a. Permissible Health claims refer to specific health claims allowed by theAuthority, and may include the relief of mild symptoms associated with milddiseases and disorders. Please check with the Health Supplements Unit onthe allowed statements of claims.

b. The claims must be substantiated by ingredient-based and product-basedevidence. The dealers must hold evidence to support these claims, andprovide this to the Authority when required to do so.

c. The claims must not include the diseases and conditions listed in Tables 5and 6.

d. Examples of such claims include:i) Relieve the discomfort associated with cold or flu symptomsii) Relief of mild coughiii) Soothes sore throativ) Relieve the discomfort associated with menopausal symptomsv) Assist in maintaining joint mobility.

e. Permissible Health claims allowed for health supplements are limited to thosefor the prevention or treatment of vitamin and mineral deficiency diseases.These should be well-documented in authorized reference literature.

Labelling Guidelines

16. Labelling must be prominently and conspicuously displayed on the product atthe point of sale. Where the size, shape or nature of the final product or packagedoes not permit the full listing of labelling information, the use of inserts, leaflets,hang tags, in appropriate format, will be allowed. However, the name of the healthsupplement product, the recommended dosage, the batch reference and relevantprecautionary statements must be displayed on the final product or package, as thecase may be.


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Other information on label / packaging:8) Expiry date (or Use by , Use before or words with similar meaning)9) Batch Number10) Name and address of the manufacturer & packer (or local Assembler)11) Name and address of dealers (or Importer, Wholesale dealer where

appropriate)

12) Mandatory Precautionary Label / Statement, where necessary

17. The types of information to be provided on the label are shown in Table 7. Theyshould be adequate and truthful. The information shall be in English and shall beprinted in a clear and legible manner.

Table 7

Examples of Information Useful to Enable Consumers to make InformedDecisions

The names of the ingredients on the label may be the Scientific names, Latinbotanical names or Common names. Companies should use acceptable internationalnomenclature for ingredient names.

18. Further information on the regulatory control of other health products may beobtained from the following website:

http://www.hsa.gov.sg

Please be reminded that the onus of responsibility to ensure safety andquality of health supplement products rests on you as the importer/

manufacturer / seller.

Health Supplements Unit, Complementary Health Products Branch, Pre-MarketingDivision, Health Products Regulation Group, Health Sciences Authority, 11 BiopolisWay #11-01, Helios, Singapore 138667, Tel: +65 6866 3467, Fax: +65 64789 039,Email: [email protected].

The above information shall be updated or revised from time-to-time as other newlegislation is implemented or as current legislation is revised. For any new, addition,amendments or deletion of the legislation, please refer to the latest copy of theGovernment Gazette.

Basic Supplemental Facts1) Name of the health supplement product2) Names and quantities of all the active ingredients3) Names of inactive ingredients including sweeteners, preservatives, colorants

and other addictives, if present4) Recommended daily allowance (RDA) based on approved local s tandards or

authoritative international standards (to specify the standard used)5) Recommended daily dosage

6) Instruct ions on proper usage7) Pack Size


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Contact Officers:

Aidah SulaimanHealth Supplements UnitComplementary Health Products BranchPre-Marketing DivisionHealth Products Regulation GroupHealth Sciences Authority

11 Biopolis Way, #11-01 HeliosSingapore 138667www.hsa.gov.sgT: (65) 6866 3467

F: (65) 6478 9039

Amy PehHealth Supplements Unit

Complementary Health Products BranchPre-Marketing DivisionHealth Products Regulation GroupHealth Sciences Authority

11 Biopolis Way, #11-01 HeliosSingapore 138667www.hsa.gov.sgT: (65) 6866 3468F: (65) 6478 9039

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