This English version is an operational reference translation and is not an official legal translation. Circular 10/2021/TT-BYT is an important reference for businesses producing, importing or trading health supplements in Vietnam. The operational risk is usually linked to ingredient formula, scientific names, test reports and market circulation dossiers.

QUICK SUMMARY

Scope

Regulates the list of prohibited substances for production and trading of health supplements in Vietnam.

Effective date

Issued on 30 June 2021 and effective from 01 September 2021.

Immediate action

Review ingredient formula, supplier COA/test report, Vietnamese labels and market circulation dossiers before import or distribution.

DOCUMENT INFORMATION

Document number

10/2021/TT-BYT

Issuing body

Ministry of Health

Issued date

30/06/2021

Effective date

01/09/2021

Status

In force according to the national legal database

Impacted scope

Health supplements, ingredients, formula dossiers and testing records

Field	Content
Document title	Circular 10/2021/TT-BYT on the list of prohibited substances used in production and trading of health supplements
Document number	10/2021/TT-BYT
Issuing body	Ministry of Health
Issued date	30/06/2021
Effective date	01/09/2021
Legal status	In force according to the national legal database
Signer	Trương Quốc Cường
Scope	Prohibited substances in health supplement production and trading

KEY POINTS FOR IMPORT/EXPORT COMPLIANCE

Issue	Operational note
Scope	Applies to organizations and individuals involved in production, trading and related activities concerning health supplements in Vietnam.
Prohibited lists	Article 3 refers to multiple legal lists and an appendix of 80 substances attached to the Circular.
Effective date	The Circular takes effect on 01 September 2021.
Dynamic reference rule	If cited legal documents are amended, supplemented or replaced, the new document must be applied.

AFFECTED BUSINESSES AND GOODS

Affected party	Required review
Importers and trading companies	Review formula, COA, test reports, labels and market circulation dossiers before import.
Manufacturers / brand owners	Control ingredient formula and prohibited substances before production or placing orders.
Logistics providers / customs brokers	Check document consistency before ETA and avoid describing goods only by trade name.
Distributors	Maintain dossiers for post-clearance audit and market circulation inspection.

IMPORT/EXPORT AND LOGISTICS IMPACT

Ingredient formula, COA, test report, label and declaration dossier should be checked before shipment and before ETA.
The goods description should not be locked only by commercial product name; the active ingredient and scientific name matter.
Incomplete dossiers may create storage, demurrage, additional testing or post-clearance risks.

Legal document	Role
Food Safety Law 55/2010/QH12	General legal basis for food safety management.
Decree 15/2018/ND-CP	Details implementation of certain provisions of the Food Safety Law.
Decree 54/2017/ND-CP	Drug/medicinal ingredient control list cited by Article 3.
Decree 73/2018/ND-CP	Narcotic substances and precursors list cited by Article 3.
Circular 20/2017/TT-BYT, 06/2017/TT-BYT, 42/2017/TT-BYT and 30/2017/TT-BYT	Related controlled pharmaceutical and toxic medicinal material lists.

VIEW / DOWNLOAD ORIGINAL DOCUMENT

Government legal portal National legal database Original signed PDF

FULL LEGAL TEXT – OPERATIONAL REFERENCE AND ORIGINAL PDF

This English version is an operational reference translation and is not an official legal translation.

MINISTRY OF HEALTH

SOCIALIST REPUBLIC OF VIET NAM
Independence – Freedom – Happiness

No. 10/2021/TT-BYT

Hanoi, 30 June 2021

CIRCULAR
Providing the list of prohibited substances used in the production and trading of health supplements

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

Pursuant to Decree No. 15/2018/ND-CP dated 02 February 2018 detailing the implementation of a number of articles of the Law on Food Safety;

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

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

The Minister of Health promulgates this Circular providing the list of prohibited substances used in the production and trading of health supplements.

Article 1. Scope of regulation and subjects of application

1. This Circular provides the list of prohibited substances used in the production and trading of health supplements.

2. This Circular applies to Vietnamese organizations and individuals; foreign organizations and individuals in Vietnam engaged in the production and trading of health supplements; and organizations and individuals whose activities are related to health supplements in Vietnam.

Article 2. Principles for developing the list of prohibited substances used in the production and trading of health supplements

1. Ensuring conformity with legal regulations and scientific basis.

2. Ensuring conformity with international practice and food safety management practice in Vietnam.

3. Timely updating, amending and supplementing the list to meet health protection requirements and state management requirements.

4. Substances included in the list are substances that may harm the health or life of users, or substances that are not intended for use in food.

Article 3. List of prohibited substances used in the production and trading of health supplements

Prohibited substances used in the production and trading of health supplements include substances in the following lists:

1. Appendix V “List of drugs and medicinal ingredients banned from import and production” issued together with Decree No. 54/2017/ND-CP.

2. Lists I, II, III and IVA issued together with Decree No. 73/2018/ND-CP prescribing lists of narcotic substances and precursors.

3. Appendix I “List of narcotic pharmaceutical substances” issued together with Circular No. 20/2017/TT-BYT.

4. The List of toxic drugs and toxic medicinal ingredients issued together with Circular No. 06/2017/TT-BYT.

5. Appendices listing toxic medicinal herbs issued together with Circular No. 42/2017/TT-BYT, except where they are processed in accordance with Circular No. 30/2017/TT-BYT.

6. The list of substances in the Appendix issued together with this Circular.

Article 4. Effectiveness

1. This Circular takes effect from 01 September 2021.

2. Where legal documents cited in this Circular are amended, supplemented or replaced, the provisions of the new documents shall apply.

Article 5. Implementation

1. The Vietnam Food Administration under the Ministry of Health shall preside over dissemination, guidance and implementation; and direct testing units to develop methods and invest in testing human resources and equipment.

2. Departments of Health and Food Safety Management Boards of provinces and centrally-run cities shall organize implementation, inspection and supervision of organizations and individuals producing and trading health supplements in their localities.

FOR THE MINISTER
DEPUTY MINISTER
Truong Quoc Cuong

Open the appendix table of 80 prohibited substances

Appendix – List of substances attached to Circular 10/2021/TT-BYT

Substance names and chemical/scientific names are kept as in the source appendix for technical comparison.

No.	Substance name	Scientific name / substance group in the appendix
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	Aminoglutethimide; Formestane; Anastrozole; Letrozole; Vorozole; Exemestane
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-dimethylpropan-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]acetic acid
29	Diclofenac Sodium	Sodium 2-[(2,6-dichlorophenyl)amino]phenylacetate
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	Dithiodesmethylcarbodenafil	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; pseudoephedrine; norephedrine; norpseudoephedrine
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-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-8-yl]-2-oxoethyl] acetate
40	Fluorometholone	(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-Desmethylvardenafil	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-octahydrocyclopenta[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

ORIGINAL PDF OF CIRCULAR 10/2021/TT-BYT – DIRECT PREVIEW

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FAQ

When did Circular 10/2021/TT-BYT take effect?

It took effect on 01 September 2021.

Which products are affected?

Health supplements and related ingredients, formulas, production, trading and market circulation activities in Vietnam.

Can businesses rely only on the commercial product name?

No. The formula, ingredient names, scientific names and test reports must be reviewed.

What should be checked before ETA?

Invoice, Packing List, B/L or AWB, C/O, COA, test reports, labels, formula and declaration dossiers.

Is this an official translation?

No. It is an operational reference only. The Vietnamese legal text and original PDF prevail.

What should be retained after customs clearance?

Shipment dossiers, product declaration, test reports, labels, formula data and import documents.

OPERATIONAL SUPPORT FROM TGIMEX

TGIMEX supports businesses in reviewing legal scope, import dossiers, shipment documents and post-clearance retention for health supplement imports.

Legal review

Identify scope, effective status, cited lists and dossier-triggered risks.

Document control

Cross-check Invoice, Packing List, B/L/AWB, COA, test reports, labels and formula.

Operational coordination

Plan timeline before ETA and coordinate customs, port/warehouse and logistics milestones.

Post-clearance retention

Maintain batch dossiers for audit, market circulation and post-clearance review.

LEGAL DOCUMENTS, MINISTRY OF HEALTH

Circular 10/2021/TT-BYT – Prohibited substances in health supplements

CIRCULAR 10/2021/TT-BYT: LIST OF PROHIBITED SUBSTANCES IN HEALTH SUPPLEMENT PRODUCTION AND TRADING