Legal Regulations on the Trading of Functional Foods in Vietnam

In the context of increasing public awareness and demand for healthcare, Vietnam’s functional food market has witnessed significant growth, with the active participation of both domestic and foreign enterprises. However, due to the specific nature of functional foods and their direct impact on consumer health, the importation and distribution of such products are subject to strict legal regulations under Vietnamese law. A clear understanding of the applicable legal framework is essential not only to ensure compliance but also to minimize potential legal risks that may arise during business operations. This article provides an overview of the current legal provisions governing the importation and distribution of functional foods in Vietnam, and highlights key legal considerations that enterprises must be aware of to operate effectively and sustainably. 

1. Importation of Functional Foods 

According to Clause 23, Article 2 of the Law on Food Safety 2010, functional foods are defined as: “foods used to support the functions of the human body, promote a sense of well-being, enhance resistance, and reduce the risk of illness, including dietary supplements, health protection foods, and medical nutritional foods.” In relation to this matter, the Law on Food Safety 2010 sets out specific provisions regarding the conditions for importing functional foods. In particular, Clauses 1 and 2, Article 38 of the Law on Food Safety 2010 stipulate that functional foods must: 

• Register a declaration of conformity with technical regulations at a competent state authority prior to importation; 

• Obtain a “Notification of Import Requirement Compliance for Food Products” for each shipment, issued by a designated inspection authority as prescribed by the relevant Ministry. In the case of functional foods, the competent authority is the Ministry of Health; 

• Provide a Certificate of Free Sale (CFS) or a Health Certificate (HC) issued by the Vietnam Food Administration under the Ministry of Health. 

Regarding the importation procedure for functional foods. As previously mentioned, prior to importation, functional foods must be registered through a declaration of conformity with technical regulations at a competent state authority. Once the goods arrive at the port, the importing entity must carry out the state inspection procedure for food safety (except for certain categories of food exempted under Article 13 of Decree No. 15/2018/ND-CP). After the state inspection is completed, the Ministry of Health will issue a “Notification of Import Requirement Compliance for Food Products.” This document must then be submitted to the customs authority to complete the customs clearance process. 

In addition, importers must comply with relevant legal provisions on labeling and specific regulatory requirements, including the following: 

• Regarding the expiration date displayed on the product label, depending on the type of product, it must be stated as “expiry date,” “use by,” or “best before” (Clause 1, Article 44 of the Law on Food Safety 2010). 

• The words “functional food” must be indicated clearly on the label, and the label must not contain any statements implying medicinal effects or suggesting that the product can replace medicine (Point a, Clause 2, Article 44 of the Law on Food Safety 2010). 

2. Legal Compliance in the Distribution and Sale of Functional Foods: What Should Businesses Be Aware Of? 

The functional food market in Vietnam is experiencing rapid growth, accompanied by increasingly stringent legal compliance requirements in business operations. One of the key factors for products to be legally circulating in the market is that businesses must ensure conformity with the declared technical regulations. This means that enterprises are not only required to regularly control product quality but also to conduct periodic testing and monitoring while properly using the conformity mark as prescribed by law. 

According to the Law on Food Safety 2010, functional foods, like other food products, must meet strict hygiene and safety conditions. Specifically, products must comply with applicable technical standards. They shall not exceed permissible limits for pathogenic microorganisms, pesticide residues, veterinary drug residues, heavy metals, or other contaminants that may harm consumer health. Additionally, businesses must comply with regulations related to the use of food additives, labeling, packaging, and product preservation throughout the distribution process. 

For functional foods—products that have a direct impact on health—the law imposes even stricter requirements. According to Article 14 of the Law on Food Safety, such products must be accompanied by scientific documentation proving the effects of the components responsible for the declared functions. In particular, for products being introduced to the market for the first time, additional test reports demonstrating the efficacy of their claimed benefits are required. 

An essential procedure is the application for a Certificate of Eligibility for Food Safety. The conditions for obtaining this certificate include: facilities and equipment that meet hygiene standards, direct employees must have health certificates, and have undergone training on food safety knowledge. The application dossier consists of an application form, a description of the facilities, health certificates, and certificates of food safety knowledge. Upon receiving a valid application, the competent authority will conduct an on-site inspection and issue the certificate within 15 working days. 

According to Article 37 of the Law on Food Safety, the Certificate of Eligibility for Food Safety is valid for a period of three years. Businesses must submit an application for renewal at least six months prior to the certificate’s expiration date if they wish to continue their operations. Additionally, it should be noted that certain special cases are exempted from obtaining this certificate under the provisions of Decree No. 15/2018/ND-CP. However, in the majority of cases involving the distribution of functional foods, holding this certificate remains mandatory. 

In response to the increasing demands for food safety and legal transparency, the business and distribution of functional foods in Vietnam require enterprises not only to comply with current regulations but also to proactively establish effective internal control systems. Every stage, from product declaration and periodic testing to obtaining operation licenses, must be conducted diligently and consistently to minimize potential legal risks that may arise during business operations. 

For new market entrants or businesses undergoing expansion, staying updated with legal policies, reviewing business conditions, and establishing standardized internal procedures are essential steps. Seeking support from experienced legal advisory firms in the food sector can help enterprises minimize errors and enhance proactive risk management. In this context, the presence of seasoned legal consultants specializing in the food industry, such as CDLAF, plays a vital role in assisting businesses to operate in compliance with regulations, procedures, and timelines. When the legal framework is approached systematically and applied consistently, enterprises not only reduce legal risks but also improve their stability and reputation in the eyes of consumers and market partners. 

Time of writing: 28/05/2025

The article contains general information which is of reference value, in case you want to receive legal opinions on issues you need clarification on, please get in touch with our Lawyer  at  info@cdlaf.vn

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