Circular 10/2021/TT-BYT List of substances banned from use in dietary supplements

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ATTRIBUTE

Circular No. 10/2021/TT-BYT dated June 30, 2021 of the Ministry of Health providing the List of substances banned from use in the production and trading of health protection food
Issuing body: Ministry of HealthEffective date:
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Official number:10/2021/TT-BYTSigner:Truong Quoc Cuong
Type:CircularExpiry date:Updating
Issuing date:30/06/2021Effect status:
Known

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Fields:Food and drug , Medical - Health

SUMMARY

List of substances banned from use in manufacturing and trading dietary supplements

The Ministry of Health issues the Circular No. 10/2021/TT-BYT prescribing the List of substances banned from use in manufacturing and trading dietary supplements on June 30, 2021.

Specifically, the List includes 80 types of substances banned from use in manufacturing and trading dietary supplements such as: Aminotadalafil; Beclomethasone; Budesonide; Cetilistat; Dapoxetine; Dexamethasone; Ibuprofen; Mometasone, etc.

The Vietnam Food Administration shall assume prime responsibility for, and coordinate with relevant units in, disseminating, guiding and implementing this Circular; direct units participating in testing dietary supplements to develop a plan, mobilize on human resources and testing equipment to satisfy requirements on testing substances in the List.

This Circular takes effect on September 01, 2021.

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TTXVN

THE MINISTRY OF  HEALTH

 

THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness

No. 10/2021/TT-BYT

 

Hanoi, June 30, 2021

 

CIRCULAR

Providing the List of substances banned from use in the production and trading of health protection food [1]

 

Pursuant to the June 17, 2010 Law on Food Safety;

Pursuant to the Government’s Decree No. 15/2018/ND-CP of February 2, 2018, detailing the implementation of a number of articles of the Law on Food Safety;

Pursuant to the Government’s Decree No. 75/2017/ND-CP of June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Vietnam Food Administration;

The Minister of Health promulgates the Circular providing the List of substances banned from use in the production and trading of health protection food.

Article 1. Scope of regulation and subjects of application

1. This Circular provides the List of substances banned from use in the production and trading of health protection food.

2. This Circular applies to Vietnamese organizations and individuals; Vietnam-based foreign organizations and individuals engaged in the production and trading of health protection food; and organizations and individuals carrying out health protection food-related activities in Vietnam.

Article 2. Principles of formulating the List of substances banned from use in the production and trading of health protection food

1. Ensuring compliance with regulations and having a scientific basis.

2. Being conformable with international practice and food safety management practice in Vietnam.

3. Promptly updating, modifying or supplementing the List to meet health protection and state management requirements.

4. Substances on the List are those likely to cause harms to the health or life of users or those other than categories permitted for use in food.

Article 3. List of substances banned from use in the production and trading of health protection food

Substances banned from use in the production and trading of health protection food include those on the following lists:

1. Appendix V “List of drugs and drug materials banned from import or production” to the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, detailing a number of articles of, and measures to implement, the Law on Pharmacy.

2. List I “Narcotic substances strictly banned from use in medicine and social life. The use of these substances in analysis, testing, scientific research and criminal investigation must comply with special regulations of competent authorities”; List II “Narcotic substances permitted for limited use in analysis, testing, scientific research, criminal investigation or in the medical field under regulations of competent authorities”; List III “Narcotic substances permitted for use in analysis, testing, scientific research, criminal investigation or in the field of health and animal health under regulations of competent authorities”; List IVA “Essential precursors found in chemical structure of narcotics” promulgated together with the Government’s Decree No. 73/2018/ND-CP of May 15, 2018, providing lists of narcotic substances and precursors.

3. Appendix I “List of addictive pharmaceuticals” to the Minister of Health’s Circular No. 20/2017/TT-BYT of May 10, 2017, detailing a number of articles of the Law on Pharmacy, and the Government’s Decree No. 54/2017/ND-CP of May 8, 2017, on drugs and drug materials subject to special control.

4. List of toxic drugs and toxic drug materials promulgated together with the Minister of Health’s Circular No. 06/2017/TT-BYT of May 3, 2017, providing the List of toxic drugs and toxic drug materials.

5. Appendix I “List of toxic medicinal materials of plant origin”; Appendix II “List of toxic medicinal materials of animal origin”; and Appendix III “List of toxic medicinal materials of mineral origin” to the Minister of Health’s Circular No. 42/2017/TT-BYT of November 13, 2017, providing the List of toxic medicinal materials for use as drugs, except those marked with an asterisk (*) that have been processed by processing methods specified by the Minister of Health in Circular No. 30/2017/TT-BYT of July 11, 2017, guiding methods of processing traditional medicaments ensuring food-making safety.

6. The List of substances is provided in the Appendix to this Circular.

Article 4. Effect

1. This Circular takes effect on September 1, 2021.

2. In case the legal documents referred to in this Circular are amended, supplemented or replaced, the amending, supplementing or replacing documents prevail.

Article 5. Organization of implementation

1. The Vietnam Food Administration (the Ministry of Health) shall:

a/ Assume the prime responsibility for, and coordinate with related units in, disseminating, guiding and organizing the implementation of this Circular;

b/ Direct units participating in testing of health protection food in working out methods, investing in human resources and testing equipment to meet requirements on testing of substances on the List of banned substances specified in this Circular.

2. Provincial-level Departments of Health and Food Safety Management Boards shall organize the implementation of this Circular. Provincial-level Departments of Health shall direct provincial-level Food Safety and Hygiene Branches and related units in inspecting and supervising organizations and individuals engaged in the production and trading of health protection food in their localities.

Any problems arising in the course of implementation of this Circular should be reported to the Ministry of Health (the Vietnam Food Administration) for consideration and settlement.-

For the Minister of Health
Deputy Minister
TRUONG QUOC CUONG

 

APPENDIX

LIST OF SUBSTANCES

(To Circular No. 10/2021/TT-BYT of June 30, 2021)

No.

Substance name

Scientific name

1

1-3-dimethylamylamine

4-methylhexan-2-amine

2

Aildenafil

5-[5-[(3S,5R)-3,5-dimethylpiperazin-1-yl]sulfonyl-2-ethoxyphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d] pyrimidin-7-one

3

Aminotadalafil

(2R,8R)-6-amino-2-(1,3-benzodioxol-5-yl)-3,6,17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione

4

Aromatase inhibitor

Aminogluteth imide

3-(4-aminophenyI)-3-ethylpiperidine-2,6-dione

Formestane

(8R,9S,10R,13S,14S)-4-hydroxy-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthrene-3,17-dione

Anastrozole

2-[3-(2-cyanopropan-2-yl)-5-(1,2,4-triazol-1-ylmethyl) phenyl]-2-methylpropanenitrile

Letrozole

4-[(4-cyanophenyl)-(1,2,4-triazol-1-yl)methyl]benzonitrile

Vorozole

6-[(4-chlorophenyl)-(1,2,4-triazol-1-yl)methyl]-1-methylbenzotriazole

Exemestane

6-Methyleneandrosta-1,4-diene-3,17-dione (8R,9S,10R,13S,14S)-10,13-dimethyl-6-methylidene-7,8,9,11,12,14,15,16-octahydrocyclopenta[a]phenanthrene-3,17-dione

5

Beclomethasone

(8S,9R,10S,11S,13S,14S,16S,17R)-9-chloro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16- octahydrocyclopenta[a]phenanthren-3-one

6

Benproperine

1-[1-(2-benzylphenoxy)propan-2-yl]piperidine

7

Benzamidenafil

N-[(3,4-dimethoxyphenyl)methyl]-2-(1-hydroxypropan-2-ylamino)-5-nitrobenzamide

8

Benzyl sibutramine

1-(1-(4-chlorophenyl)cyclobutyl)-N,N-dimethyl-2-phenylethan-1- amine

9

Betamethasone

(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one

10

Budesonide

(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-8-(2-hydroxyacetyl)-9,13-dimethyl-6-propyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one

11

Buformin

2-butyl-1-(diaminomethylidene)guanidine

12

Cetilistat

2-hexadecoxy-6-methyl-3,1-benzoxazin-4-one

13

Chlorpheniramine

3-(4-chlorophenyl)-N,N-dimethyl-3-pyridin-2-ylpropan-1-amine

14

Chlorpromazine

3-(2-chlorophenothiazin-10-yl)-N,N-dimethyIpropan-1-amine

15

Chlorzoxazone

5-chloro-3H-1,3-benzoxazol-2-one

16

Cinnarizine

1-benzhydryl-4-[(E)-3-phenylprop-2-enyl]piperazine

17

Clobetasol propionate

[(8S,9R,10S,11S,13S,14S,16S,17R)-17-(2-chloroacetyl)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] propanoate

18

Colchicine

N-[(7S)-1,2,3,10-tetramethoxy-9-oxo-6,7-dihydro-5H-benzo[a]heptalen-7-yl]acetamide

19

Cortisone

(8S,9S,10R,13S,14S,17R)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,12,14,15,16-decahydrocyclopenta[a]phenanthrene-3,11-dione

20

Cyproheptadine

1-methyl-4-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,9,11,13- heptaenylidene)piperidine

21

Dapoxetine

(1S)-N,N-dimethyl-3-naphthalen-1-yloxy-1-phenylpropan-1-amine

22

Deflazacort

[2-[(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04, 8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] acetate

23

Desisobutyl-benzylsibutramine

1-[1-(4-chlorophenyl)cyclobutyl]-N,N-dimethyl-2-phenylethanamine

24

Desmethyl carbodenafil

5-[2-ethoxy-5-(4-methylpiperazine-1-carbonyl)phenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one

25

Desmethylsibutramine

1-[1-(4-chlorophenyl)cyclobutyl]-N,3-dimethylbutan-1-amine

26

Desmethylsildenafil

5-(2-ethoxy-5-piperazin-1-ylsulfonylphenyl)-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one

27

Dexamethasone

(8S,9R,10S,11S,13S,14S,16R,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one

28

Diclofenac

[2-[(2,6-dichlorophenyl)amino]phenyl]acetatic acid

29

Diclofenac Sodium

Sodium2-[(2,6-dichlorophenyl)amino]phenyl]acetate

30

Didesmethylsibutramine

1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutan-1-amine

31

Dimethylacetildenafil

5-[5-[2-[(3S,5R)-3,5-dimethylpiperazin-1-yl]acetyl]-2-ethoxyphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7- one

32

Dithiodesmethylcarboden afil

5-[2-ethoxy-5-(4-methylpiperazine-1-carbothioyl)phenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidine-7-thione

33

Doxepin

(3E)-3-(6H-benzo[c][1]benzoxepin-11-ylidene)-N,N-dimethylpropan-1-amine

34

Ephedrine alkaloids

ephedrine

(1R,2S)-2-(methylamino)-1-phenylpropan-1-ol

pseudoephedrine

(1S,2S)-2-(methylamino)-1-phenylpropan-1-ol

norephedrine

(1S,2R)-2-amino-1-phenylpropan-1-ol

norpseudoephedrine

(1S,2S)-2-amino-1-phenylpropan-1-ol

35

Fenfluramine

N-ethyl-1-[3-(trifluoromethyl)phenyl]propan-2-amine

36

Flibanserin

3-[2-[4-[3-(trifluoromethyl)phenyl]piperazin-1-yl]ethyl]-1H-benzimidazol-2-one

37

Fludrocortisone

(8S,9R,10S,11S,13S,14S,17R)-9-fluoro-11,17-dihydroxy-17-(2- hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

38

Fluocinolone

(6S,8S,9R,10S,11S,13S,14S,16R,17S)-6,9-difluoro-11,16,17-trihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one

39

Fluocinonide

[2-[(1S,2S,4R,8S,9S,11S,12R,13S,19S)-12,19-difluoro-11-hydroxy-6,6,9,13-tetramethyl-16-oxo-5,7dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] acetate

40

FluoromethoIone

(6S,8S,9R,10S,11S,13S,14S,17R)-17-acetyl-9-fluoro-11,17-dihydroxy-6,10,13-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one

41

Fluoxetine

N-methyl-3-phenyl-3-[4(trifluoromethyl)phenoxy]propan-1-amine

42

Fluticasone

S-(fluoromethyl) (6S,8S,9R,10S,11S,13S,14S,16R,17R)-6,9-difluoro-11,17-dihydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a] phenanthrene-17- carbothioate

43

Furosemide

4-chloro-2-(furan-2-ylmethylamino)-5-sulfamoylbenzoic acid

44

Hydrochlorothiazide

6-chloro-1,1-dioxo-3,4-dihydro-2H-1lambda6,2,4-benzothiadiazine-7-sulfonamide

45

Hydrocortisone

(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one

46

Hydroxyhomosildenafil

5-[2-ethoxy-5-[4-(2-hydroxyethyl)piperazin-1-yl]sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one

47

Hydroxyacetildenafil

5-[2-ethoxy-5-[2-[4-(2-hydroxyethyl)piperazin-1-yl]acetyl]phenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one

48

Ibuprofen

2-[4-(2-methylpropyl)phenyl]propanoic acid

49

Indomethacin

2-[1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic acid

50

Ketoprofen

2-(3-benzoylphenyl)propanoic acid

51

Lorcaserin

(5R)-7-chloro-5-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine

52

Metformin

3-(diaminomethylidene)-1,1-dimethylguanidine

53

Methocarbamol

[2-hydroxy-3-(2-methoxyphenoxy)propyl] carbamate

54

Methylprednisolone

(6S,8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-6,10,13-trimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one

55

Mometasone

(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one

56

Naproxen

(2S)-2-(6-Methoxynaphthalen-2-yl)propanoic acid

57

N-Desmethyl tadalafil

(2R,8R)-2-(1,3-benzodioxol-5-yl)-3,6,17-triazatetracyclo[8.7.0.03,8.011,16]heptadeca-1(10),11,13,15-tetraene-4,7-dione

58

N-Desmethyl-N-benzyl sildenafil

5-[5-(4-benzylpiperazin-1-yl)sulfonyl-2-ethoxyphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one

59

N-Desmethylyardenafil

2-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one

60

Nefopam

5-methyl-1-phenyl-1,3,4,6-tetrahydro-2,5-benzoxazocine

61

Orlistat

[(2S)-1-[(2S,3S)-3-hexyl-4-oxooxetan-2-yl] tridecan-2-yl](2S)-2-formamido-4-methylpentanoate

62

Phenformin

1-(diaminomethylidene)-2-(2-phenylethyl)guanidine

63

Phenytoin

5,5-Diphenylimidazolidine-2,4-dione

64

Piperadino vardenafil

2-[2-ethoxy-5-(piperidine-1-sulfonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f]-[1,2,4]triazin-4-one

65

Piroxicam

4-hydroxy-2-methyl-1,1-dioxo-N-pyridin-2-yl-1lambda6,2- benzothiazine-3-carboxamide

66

Prednisolone

(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one

67

Prednisone

(8S,9S,10R,13S,14S,17R)-17-hydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,12,14,15,16-otahydrocyclopenta[a]phenanthrene-3,11-dione

68

Propranolol

(2RS)-1-[(Propan-2-yl)amino]-3-[(naphthalen-1-yl)oxy]propan-2-ol

69

Salbutamol

(1RS)-2-[(1,1-Dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanol

70

Salmeterol

2-(hydroxymethyl)-4-[1-hydroxy-2-[6-(4-phenylbutoxy)hexylamino]ethyl]phenol

71

Sildenafil

5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one

72

Sulfoaildenafil

5-[5-[(3S,5R)-3,5-dimethylpiperazin-1-yl]sulfonyl-2-ethoxyphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidine-7-thione

73

Sulfohydroxyhomosildenafil

5-[2-ethoxy-5-[4-(2-hydroxyethyl)piperazin-1-yl]sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidine-7-thione

74

Tadalafil

(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1’,2’:1,6]-pyrido[3,4-b]indole-1,4-dione

75

Terazosin hydrochloride

1-(4-Amino-6,7-dimethoxyquinazolin-2-yl)-4-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine hydrochloride

76

Testosterone

(8R,9S,10R,13S,14S,17S)-17-hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one

77

Thioaidenafil

5-[5-[(3S,5R)-3,5-dimethylpiperazin-1-yl]sulfonyl-2-ethoxyphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidine-7-thione

78

Thiosildenafil

5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidine-7-thione

79

Triamcinolone

9α-Fluoro-11β,16α,17α,21-tetrahydroxypregna-1,4-diene-3,20-dione

80

Vardenafil

1-{[3-(3,4-Dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f]-as-triazin-2-yl)-4-ethoxyphenyl]sulfonyl}-4-ethylpiperazine

     

 


[1] Công Báo Nos 677-678 (24/7/2021)

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