Vietnam Health Supplement Regulation

1. Definition

Under Vietnam’s regulation, health supplement is supervised as a subcategory of functional food. It is used as a supplement to the daily diet to maintain, improve and strengthen the functions of the human body and reduce the risk of disease. They may contain one or a mixture of the following substances:

Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances;
Substances derived from animals, minerals, plants in the form of extracts, isolates, concentrates or metabolites.
Sources of the substances mentioned in Point a and b above.

Health supplements may be in the form of soft gels, pellets, tablets, granules, powder, liquid and other formulations, and are dosed into small units for consumption.

Notes:

Functional foods in Vietnam include:

Supplemented food, whose nature is ordinary food with healthy micro-nutrients and elements, such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and substances with other biological activities;
Heath protection food (health supplement/food supplement/dietary supplement);
Medical nutrition food, also known as food for special medical purpose, or medical food;
Food for special dietary use, intended for individuals on special diets, the elderly, and other specific groups as defined by the Codex Alimentarius Commission (CODEX).

2. Competent authority

Competent authority	Responsibility
Ministry of Health (MOH), especially the Vietnam Food Administration (VFA) under MOH	Food safety management of health supplement Formulation of technical regulations and relevant requirements Product registration Novel food additive registration Advertisement review
MOH & Ministry of Industry and Trade (MOIT)	Post-Market supervision
General Department of Vietnam Customs	Customs inspection, quarantine, and declaration

3. Market access approval

3.1 Overall import conditions

Health supplement products intended to be exported to Vietnam must adhere to relevant regulations established by the Vietnamese authorities. One of the primary regulations entails obtaining a registration conformity declaration from the Ministry of Health before the exportation to the country. (Read details in 3.2 Product registration: Registration of product conformity declaration) If health supplement products comply with these requirements, they are permitted to be exported to Vietnam.

Please note:

Overseas manufacturers producing health supplement and the corresponding exporting countries are not required to get listed with Vietnam authorities.
Different from some food categories, health supplement manufacturers are not required to obtain the Certificate of Satisfaction of Food Safety Condition since they are required to have one of the following certificates: Good Manufacturing Practice (GMP), HACCP, ISO 22000, IFS, BRC, FSSC 22000 or an equivalent certificate; and they are dealing with prepackaged foods.
Health supplement manufacturers shall satisfy GMP requirements in accordance with instructions from the Ministry of Health.

3.2 Product registration: Registration of product conformity declaration

Stakeholders should finish the registration of health supplement product before entering the market by submitting materials to MOH. If the submitted materials meet the requirements, the authority will verify the application and issue a Certificate of Registered Product Conformity Declaration within 21 working days.

Submitted materials should include:

Declaration form;
A legalized Certificate of Free Sale/Certificate of Exportation/Health Certificate issued by the authority of the exporting country;
The testing results, completed within 12 months up to the date of the document submission, issued by recognized laboratories or ISO 17025 accredited laboratories;
A documentation proving the scientific evidence of the product or ingredients’ effects;
A Certificate of GMP or an equivalent certificate for health supplements; and
Original Label (in color) and sub-label (in Vietnamese).

3.3 Inspection and quarantine

Unless there is a safety warning, health supplement products are exempted from the state inspection of imported food safety since they are with Certificate of Registered Product Declaration.

4. Product compliance

Manufacturers of dietary supplements shall satisfy general food safety conditions specified in Food Safety Law 2010 and Decree No. 15/2018/ND-CP of the Government: Detailing the Implementation of a Number of Articles of the Law on Food Safety (partly amended by Decree 155/2018/ND-CP Amendments to Some Articles Related to Business Conditions Under State Management of the Ministry of Health).

Besides the Food Safety Law and its supporting regulation, it is important to follow some specialized regulations for health supplements as well as some safety and hygiene requirements.

5. Label

The Food Safety Law and its implementation rules have specified basic requirements for labelling. In addition, Decree No. 43/2017/ND-CP on Goods Labels is the most important regulation for stakeholders to learn, since it is a specialized regulation for product labeling. In 2021, some articles of Decree No. 43/2017 were amended and supplemented by Decree 111/2021/ND-CP. At last, health supplement enterprises shall also refer to Circular 43/2014/TT-BYT Regulating the Management of Functional Foods for labeling requirements, including content claim and health claim.

Recommended material:

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Tags: Vietnam Health Supplement Registration Regulation & Standard