Nutraceutical Regulations and Registration in Vietnam (MoH)

Nutraceuticals market in Vietnam reached USD 2.0 billion in 2024 and is projected to grow at a CAGR of ~4.5% through 2033.

The demand for nutraceuticals and dietary supplement market is growing. Unlike medicines, they can be taken by any individual. So, it is important to regulate them. The Vietnam Food Administration (VFA) of the Ministry of Health, Vietnam is the primary authority that oversees the dietary supplements in Vietnam.

Continue to read more about Vietnam food regulation, food supplement registration in Vietnam, health supplement registration process, labelling requirements & more.

Nutraceutical Regulatory Framework Vietnam

The regulation and registration of nutraceuticals and dietary supplements in Vietnam falls under the purview of several government agencies, primarily the Ministry of Health (MOH) and the Ministry of Agriculture and Rural Development (MARD). These agencies are responsible for overseeing the safety, labeling, and advertising of nutraceutical products to protect consumer interests.

There are also legal documents set forth to regulate dietary supplements in Vietnam. Some of them are as follows:

• Decree Number – 15/2018/ND-CP
• Law Number – 97/2015/QH13
• Circular Number – 75/2020/TT-BTC
• Circular Number – 117/2018/TT-BTC
• Circular Number – 43/2014/TT-BYT

Health Supplement Product Classification in Vietnam:

As per Circular No. 43/2014/TT-BYT, the health supplements also known as the dietary supplements/ food supplements are so called if they are in the form of pills, capsules, granules, tablets… and contain the mixture of or any one of the following:

• Vitamins
• Minerals
• Amino acids
• Fatty acids
• Enzymes
• Probiotics
• Substances having other activities
• Elements of natural origin that are biologically active. Natural origin like animals, plants and minerals and is in the form of metabolite, concentrated form, extracts or subdivisions.

Nutraceutical classification as per the ASEAN guidelines are as follows:

1. Dietary supplements
   • Vitamins and minerals
   •  Herbal
     • i) Ayurvedic extract
     • ii) Plant extract
     • iii) Algae extract
   • Protein Supplements
     • i) Protein powder
   • Probiotics and others
2. Functional F&B
   • Functional foods
     • i) Probiotic fortified
     • ii) Omega fatty acid fortified
     • iii) Protein bars and others

• • Functional beverages
    • i) Sports drink
    • ii) Energy drink
    • iii) Fortified juices

Health Supplement Registration Process In Vietnam:

The health supplement registration process typically concludes within 3 to 4 weeks upon submission. Upon approval, the Ministry of Health (MOH) Circular 43/2014/TT-BYT issues an enduring certificate.

Organizations and individuals that are trading and producing health supplements must register product declaration as per Decree Number 15/2018/ND-CP. For domestically produced products, the product declaration registration dossier must include the following:

• Product Declaration as specified in the Form no: 2 of Appendix I of the above-mentioned Decree.
• Free Sales Certificate or Export Certificate or Health Certificate that is issued by the competent authorities of the country of origin or export.
• Product’s food safety testing results within 12 months from the submission date of application. It must be issued by the designated testing laboratory or a testing laboratory that is recognized in accordance with ISO 17025. (Original or certified copy)
• Scientific evidence backing up the effectiveness of the ingredients or the product.
• Certificate of food safety eligibility, when applicable
• Certificate of food safety qualified facility that meets GMP requirements.

All these documents must be submitted in Vietnamese language and in case of foreign language, it should be translated and notarized. Valid must be every document at the time of submission of product declaration registration dossier.

For Imported Health Supplements in Vietnam:

Here are the Vietnam requirements for importing health supplements—MoH approvals

• Declaration form
• Original notarized copy of product’s food safety testing result issued by a designated or ISO 17025-compliant laboratory, dated within 12 months before submission
• Scientific evidence of product or ingredient effects, either original or authenticated copy. If ingredient effects are used, their daily dose must be equal to or exceed 15% of the content mentioned in the document
• Certificate of Good Manufacturing Practice (GMP) or equivalent, mandated from July 1, 2019 (authenticated copy).

Documents required for nutraceutical registration Vietnam:

The application dossier should include several documents such as:

• Certificate of Free Sale or Health Certificate.
• Licenses of a Vietnamese importer consisting of.
• Investment registration certificate (IRC).
• Enterprise registration certificate (ERC).
• Product samples.
• Product label.
• Certificate of Good Manufacturing Process (GMP).

Nutraceutical Claims, Vietnam

The health supplement claims are of 2 types, nutrient content claims and health claims.

• Nutrient content claims

As per Circular No: 43/2014/TT-BYT, the content of vitamins and minerals must be at least 15% of RNI (Recommended Nutrient Intake) as specified in the Appendix 1 of this circular. The maximum content of vitamins and minerals must not exceed permissible maximum content as mentioned in Appendix 2 of the same circular.

It also states that the key ingredients that give the effect of the product must be listed first along with full name and the contents. All other ingredients should be listed next by their weight in descending order. In case Vietnam does not have RNI, CODEX provisions or provisions of other relevant international organizations are applicable.

• Health Claims

The health claims should reflect the nature of the product. Moreover, the claims of effects of ingredients giving main or combined effects must be made only upon scientific evidence. No claims are possible if the contents of vitamins, minerals and active ingredients are lower than that specified in scientific documents. Claims are allowed if the contents are the same as those in the scientific documents given that the dose and suitable users are specified. Whatever the claims may be it must align and be in conformity with documents.

Health Supplement Labelling Requirement In Vietnam:

To distinguish it from ordinary foods and medicines, a phrase “Health Supplements’’ must be shown. In general, a label should be put on the package of the health supplement and contain the following mandatory information:

• Name of the product.
• Composition.
• Quantity of product.
• Manufacturing date.
• Usage and preservation instructions.
• Shelf life.
• Country of origin.
• Name and address of manufacturer/responsible party.
• Nutritional information.
• Warnings
• The phrase “Caution: These products are not medicines and do not substitute curative medicines” must be written right below the label’s section for writing claims of the products or in the same place with other recommendations, if any.

Health Supplement Registration Timeline in Vietnam:

Here is the timeline for the food supplements registration in Vietnam

• Document Preparation: this phase could take 1 to 2 months.
• Submission and Review. The review phase may take around 2 to 3 months.
• Testing and analysis: laboratory testing could take an additional 1 to 2 months.

Within 21 working days from the date of receipt of complete dossier of product declaration registration the Ministry of Health will issue a certificate of Product Declaration in Form no:3, Appendix I of Decree Number – 15/2018/ND-CP after dossier assessment.

In case of any disagreement of the dossier, the dossier receiving agency can request for supplementation or amendment and must have a document stating the reason and legal basis for the request. A written report is issued after assessing the revised and supplemented dossier within 7 days from its date of receipt.

Health Supplement/nutraceutical Registration Fees:

As per Circular No: 75/2020/TT-BTC, the fee structure regarding the health supplement registration are as follows:

Type	Fee in VND
Processing of applications for product declaration registration of health supplements	1,500,000/ application/ product
Processing the application for the certificate of satisfaction for food safety requirements: for health supplement producers as per GMP requirement	22,500,000/ application/ applicant

**Kindly note that these fees are not fixed and are subject to change. Before making any payment kindly refer to the Ministry of Health, Vietnam official website.**

A detailed fee structure is described in Circular No: 75/2020/TT-BTC and other relevant circulars published by the Ministry of Finance, Vietnam.

Health Supplements Intake Levels, Vietnam

As per the Vietnamese regulations, there are certain limits to which each supplement can be taken per day. Some of them are as follows:

Vitamins	Daily Adult Dose
A	M: 600 mcg F: 500- 600mcg
D	10-15 mcg
E	12 mg
K	M: 59 mcg F: 51 mcg
C	70 mg
B1	M: 1.2 mg F: 1.1mg -1.2 mg
B2	M: 1.3 mg F: 1.1 mg
B3	M: 16 mg F: 14 mg
B6	M: 1.3 mg- 1.7 mg F: 1.3 mg – 1.5 mg
B9	400 mcg
B12	2.4 mcg
M- Male, F – Female
Minerals	Maximum Level/ Day
Boron	20 mg
Copper	10,000 mcg
Fluoride	10 mg
Iodine	1100 mcg
Iron	45 mg
Magnesium	350 mg
Manganese	11 mg
Molybdenum	200 mcg
Nickel	1mg
Selenium	400 mcg
Zinc	40 mg

Post Marketing Surveillance Of Dietary Supplements in Vietnam

Dietary Supplements will be under surveillance even after its release into the Vietnamese market. This is to ensure that it still follows and is in compliance with all the relevant regulations. It is important to make sure of this as it is the evidence of safe and quality product marketing and consumption by the consumers.

As per the article published in the International Journal of Drug Regulatory Affairs, the post market control required by Vietnam are given below:

• Monitoring Adverse Effects
• Labelling, packaging and advertisement monitoring
• Post market surveillance

These activities are conducted to keep in check any misleading, conflicting or any evidence that can be generated relating to safety or quality issues. In such cases, the health authority has the power to warn, recall or even withdraw the supplements from the market.

Recall Of Health Supplements

Health supplements can be recalled if they fail to meet the requirements. Conditions of the recall of health supplements are given below:

• They have expired.
• Do not conform to the technical regulations or food safety regulations of the Ministry of Health.
• Marketed without regulation confirmatory certificates or written certificates of conformity with the food safety regulations.
• Information of the products that are marketed are inconsistent with contents that are certified by the agency or violate food safety or other regulations.
• Competent agencies of related countries or international organizations warning that the product is unsafe and this has been confirmed by the VFA (Vietnam Food Administration).

Navigating the regulations can lead to an expedited market entry. However, marketing health supplements can be challenging specially for foreign manufacturers. Since most of Vietnam documents are in Vietnamese it is difficult to comprehend the regulations. Vietnam also requires submitted documents to be in Vietnamese as well.

Artixio is here to help you with the registration of health supplements in Vietnam. Our regional regulatory experts can guide you through the product registration and associated activities. Connect with us through info@artixio.com

FAQ’s

Q. Who governs nutraceuticals in Vietnam?

A. In Vietnam 3 different ministers regulate nutraceuticals. The Ministry of Health (MOH), the Ministry of Industry and Trade (MOIT) & the Ministry of Agriculture and Rural Development (MARD) are those authorities governing.

Q. What must be a mandatory notice while advertising health supplements?

A. A notice conveying that “This product is not a medicine and is not a substitute for medicines” must be stated in all advertisements regarding health supplements on audio visual media. Under normal conditions, the words and letters must be easy to read and hear.

Q. Are there any requirements for stating that this product is not a medicine and not a substitute on the label of health supplements?

A. Yes and it is that the colour of the phrase must be in contrast to the background colour of the label. The letter height must be 1.2mm. It must be at least 0.9mm if one side of the package is less than 80 cm.sq. In addition to this, it must be written just below the label section for writing product utilities or in the space where any recommendations are included.

Q. What is the timeline for reviewing the application?

A. The time for application review is calculated from the time the application has been submitted on the online public service system. For applications submitted directly or submitted via post, the time is calculated as per the date stamp of the receiving agency.