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

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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 Health	Effective date:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
Official number:	10/2021/TT-BYT	Signer:	Truong Quoc Cuong
Type:	Circular	Expiry date:	Updating
Issuing date:	30/06/2021	Effect status:	Known Please log in to a subscriber account to use this function. Don’t have an account? Register here
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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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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Circular 10/2021/TT-BYT List of substances banned from use in dietary supplements

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