Health Sciences Authority
11 Biopolis Way #11-03 Helios
Singapore 138667
Tel: 65 6866 3400 Fax: 65 6478 9027
Website: www.hsa.gov.sg
Please quote our reference in your reply
HSA-1308-03094
30 August 2013
JEUNESSE GLOBAL SINGAPORE PTE LTD
Attn: Mr Scott A Lewis
DID: 65 68663499
FAX: 65 64789039
Dear Mr Lewis
FINITI™
Please refer to your enquiry on the above product.
2 From the information supplied, please be advised that this product presently does not need to be registered and can be imported and sold without a licence from this Authority provided the requirements stated in Annex 1 are complied with.
3 As the product contains the ingredient Coenzyme Q10, Coenzyme Q10 is subject to the following conditions which dealers are reminded to strictly adhere to:
a) A maximum daily dosage of 150mg
b) No medicinal claims are to be associated with the substance and
c) A cautionary label, prominently displayed on the packaging, which states: “Do not take while on Warfarin therapy without medical advice” or any other wordings with the same meaning.
4 As the above product can affect the health of consumers, the onus of responsibility for the safety and quality of this product and compliance with the Guidelines for Health Supplements rests with you as the importer/manufacturer/seller/dealer. Moreover, it is imperative that you also possess adequate knowledge on the products dealt by your company.
5 More information on health supplements, including the above guidelines, can be found at
[http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/complementary_medicines/supplements.html].
Page 1 of 3
6 Please note that this letter is not to be construed as an endorsement/approval of the product in question nor of any claim made for it and is not to be used in the advertisement/sales promotion of the product.
7 This advice is given without prejudice to any future legislative and administrative change on the control of the product concerned. It may not be applicable or may be superseded as and when new information on the product is subsequently obtained.
Yours sincerely
Kwok Yu Ning (Ms)
Regulatory Specialist
Complementary Health Products Branch
Health Products Regulation Group
Encl. Annex 1
Page 2 of 3
Annex 1
1 Presently, there are no licensing requirements for the import, manufacture and local sales of these products.
2 However, dealers must ensure that:
(a) the products do not contain any substances controlled under the Poisons Act, which is available as reference from the Singapore National Library.
(b) the products do not contain prohibited substances including amygdalin, pangamic acid, danthron, suprofen and rhodamine B;
(c) the products do not contain any other substances except those stated on the labels;
(d) the heavy metal contents of the products do not exceed the following limits: Arsenic (5 ppm), Copper (150 ppm), Lead (20 ppm) and Mercury (0.5 ppm).
(e) the compositions and quantities of all the ingredients of the products are printed in English Language on the product labels and cartons;
(f) the products must not be labelled, advertised or promoted for any medicinal purpose, e.g. treatment or prevention, implied or otherwise, of any disease or medical condition, including the 19 diseases/conditions specified in the Medicines (Advertisement and Sale) Act, namely blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy or fits, hypertension, insanity, kidney diseases, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency, frigidity, conception and pregnancy.
3 For products containing materials (including those for making capsule shells) derived from ruminants e.g. cattle, buffalo, sheep, goat, deer and antelope, please refer to our guidelines on Transmissible Spongiform Encephalopathy (TSE). The guidelines can be downloaded from our website at:
[http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/complementary_medicines/files_1.Par.2923.File.tmp/CMB%20TSE%20Guidelines-08V2.pdf].
4 Dealers should contact the Agri-Food and Veterinary Authority (AVA) if the products contain substances listed under the Endangered Species (Import and Export) Act:-
For products of animal origin, please contact:-
Wildlife Section
5 Maxwell Road, Tower Block MND Complex, #02-03
Singapore 069110
Tel: (65) 6325 7281/ 7549
Fax: (65) 6325 7646
For products of plant origin, please contact:-
Plant Section
Sembawang Research Station
Lorong Chencharu
Singapore 769193
Tel: (65) 6751 9815
Fax: (65) 6752 0170
For more information, please refer to the AVA’s website at http://www.ava.gov.sg/AnimalsPetSector/CITESEndangeredSpecies/
Page 3 of 3
11 Biopolis Way #11-03 Helios
Singapore 138667
Tel: 65 6866 3400 Fax: 65 6478 9027
Website: www.hsa.gov.sg
Please quote our reference in your reply
HSA-1308-03094
30 August 2013
JEUNESSE GLOBAL SINGAPORE PTE LTD
Attn: Mr Scott A Lewis
DID: 65 68663499
FAX: 65 64789039
Dear Mr Lewis
FINITI™
Please refer to your enquiry on the above product.
2 From the information supplied, please be advised that this product presently does not need to be registered and can be imported and sold without a licence from this Authority provided the requirements stated in Annex 1 are complied with.
3 As the product contains the ingredient Coenzyme Q10, Coenzyme Q10 is subject to the following conditions which dealers are reminded to strictly adhere to:
a) A maximum daily dosage of 150mg
b) No medicinal claims are to be associated with the substance and
c) A cautionary label, prominently displayed on the packaging, which states: “Do not take while on Warfarin therapy without medical advice” or any other wordings with the same meaning.
4 As the above product can affect the health of consumers, the onus of responsibility for the safety and quality of this product and compliance with the Guidelines for Health Supplements rests with you as the importer/manufacturer/seller/dealer. Moreover, it is imperative that you also possess adequate knowledge on the products dealt by your company.
5 More information on health supplements, including the above guidelines, can be found at
[http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/complementary_medicines/supplements.html].
Page 1 of 3
6 Please note that this letter is not to be construed as an endorsement/approval of the product in question nor of any claim made for it and is not to be used in the advertisement/sales promotion of the product.
7 This advice is given without prejudice to any future legislative and administrative change on the control of the product concerned. It may not be applicable or may be superseded as and when new information on the product is subsequently obtained.
Yours sincerely
Kwok Yu Ning (Ms)
Regulatory Specialist
Complementary Health Products Branch
Health Products Regulation Group
Encl. Annex 1
Page 2 of 3
Annex 1
1 Presently, there are no licensing requirements for the import, manufacture and local sales of these products.
2 However, dealers must ensure that:
(a) the products do not contain any substances controlled under the Poisons Act, which is available as reference from the Singapore National Library.
(b) the products do not contain prohibited substances including amygdalin, pangamic acid, danthron, suprofen and rhodamine B;
(c) the products do not contain any other substances except those stated on the labels;
(d) the heavy metal contents of the products do not exceed the following limits: Arsenic (5 ppm), Copper (150 ppm), Lead (20 ppm) and Mercury (0.5 ppm).
(e) the compositions and quantities of all the ingredients of the products are printed in English Language on the product labels and cartons;
(f) the products must not be labelled, advertised or promoted for any medicinal purpose, e.g. treatment or prevention, implied or otherwise, of any disease or medical condition, including the 19 diseases/conditions specified in the Medicines (Advertisement and Sale) Act, namely blindness, cancer, cataract, drug addiction, deafness, diabetes, epilepsy or fits, hypertension, insanity, kidney diseases, leprosy, menstrual disorders, paralysis, tuberculosis, sexual function, infertility, impotency, frigidity, conception and pregnancy.
3 For products containing materials (including those for making capsule shells) derived from ruminants e.g. cattle, buffalo, sheep, goat, deer and antelope, please refer to our guidelines on Transmissible Spongiform Encephalopathy (TSE). The guidelines can be downloaded from our website at:
[http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/complementary_medicines/files_1.Par.2923.File.tmp/CMB%20TSE%20Guidelines-08V2.pdf].
4 Dealers should contact the Agri-Food and Veterinary Authority (AVA) if the products contain substances listed under the Endangered Species (Import and Export) Act:-
For products of animal origin, please contact:-
Wildlife Section
5 Maxwell Road, Tower Block MND Complex, #02-03
Singapore 069110
Tel: (65) 6325 7281/ 7549
Fax: (65) 6325 7646
For products of plant origin, please contact:-
Plant Section
Sembawang Research Station
Lorong Chencharu
Singapore 769193
Tel: (65) 6751 9815
Fax: (65) 6752 0170
For more information, please refer to the AVA’s website at http://www.ava.gov.sg/AnimalsPetSector/CITESEndangeredSpecies/
Page 3 of 3
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