Health Supplements are called by some English phrases such as Health Supplements or Dietary Supplements. These products are used as a supplement to the daily diet to maintain, strengthen, and improve the functions of the human body, reducing the risk of disease. Health Supplements may contain one or more of the following substances, including: (i) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances; (ii) Substances derived from animals, minerals, plants in the forms of extracts, isolates, concentrates or metabolites; (iii) Sources of the substances mentioned in two points above. The special point of identification for this group is that they are presented in processed form such as capsules, tablets, tablets, nuggets preparations, powders, liquids and other dosage forms and are dosed (for use) into smaller doses1.
The name of the group of Health Supplements was first mentioned in Circular No. 08/2004/TT-BYT on the management of functional foods. However, this legal document only recognized Health Supplements as another name for Functional Foods depending on the product’s uses, micronutrient content and instructions for use2. Thus, for a long time, the phrase “Health Supplements” was just an alternative name, without a clear definition describing this group of products. In fact, during that period, most of the products in this group were registered for circulation under the name of the group “Functional Foods”.
In 2010, when the Law on Food Safety 2010 was issued and came into effect, this Law recognized Health Supplements as a group of foods under the Functional Foods. However, the definition of Health Supplement group has not been specifically given3.
Since February 02, 2018, Decree No/ 15/2018/ND-CP guiding the Law on Food Safety 2010 came into effect, Health Supplements group is officially recognized as a separate food group, with a descriptive definition of it, fully regulated legal procedures that traders must comply with to register product quality in advance when putting products into circulation on the market.
Although Decree No. 15/2018/ND-CP has stipulated in more detail the group of Health Supplements, however, the process of developing a dossier of product quality announcement to register it with the competent authority has not been regulated, providing specific guidance on how to develop the required indicators, the limit that quality and safety indicators need to meet to have a uniform basis for application. In fact, the settlement of registration dossiers shows that products belonging to this group are often guided to prepare registration dossiers for each specific case and according to the unique guidance of registration dossier appraisal experts. Safety limits are applied almost similarly to those of some other product groups. This causes many inadequacies and difficulties for the traders when building dossiers and carrying out procedures for registering their products.
On July 18, 2024, the Ministry of Health issued Circular No. 12/2024/TT-BYT, whereby, promulgating the National Technical Regulation QCVN 20-1:2024/BYT on the limit of contaminants for Health Supplements/Dietary Supplements. QCVN 20-1:2024/BYT is going to take effect from August 01, 2025. Health Supplements group is very close to drug products. The legal and regulatory corridor for this group of products needs to be built in a transparent and clear way for uniform application. However, this is the first time that the Health Supplements group has issued a separate regulation to apply and ensure the food safety for this product group.
(1) Article No. 3.1 Decree No. 15/2018/ND-CP – Điều 3.1 Nghị định 15/2018/NĐ-CP.
(2) Section I Circular No. 08/2004/TT-BYT – Mục I Thông tư 08/2004/TT-BYT.
(3) Article No. 2.23 Law on Food Safety 2010 – Điều 2.23 Luật An Toàn Thực Phẩm 2010.
See more:
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Revocation of Certificate of Food Safety Compliance for Establishments
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Conditions of importing food from abroad and some related matters should be noted
Disclaimers:
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