Circular No. 08/2004/TT-BYT guiding the management of health food products

CIRCULAR

Guidelines for managing functional food products

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To unify the management of the business of functional food products in the market; to ensure health safety for consumers and create favorable conditions for businesses during their operations, the Ministry of Health provides guidelines for managing functional food products (Hereinafter referred to as functional foods) as follows:

I.         CONCEPT AND NAMES OF FUNCTIONAL FOODS:

1.         Functional foods are foods used to support the functions of various parts of the human body, with nutritional effects that make the body comfortable, increase resistance, and reduce the risk of disease.

2.         Depending on their functions, micronutrient content, and usage instructions, functional foods may also be called:

a)        Micronutrient-supplementing foods;

b)        Supplementing foods;

c)        Health-preserving foods;

d)        Medical nutrition products.

II.         CONDITIONS FOR DETERMINING FUNCTIONAL FOODS:

Food products that supplement nutrients such as vitamins, mineral salts, and biologically active substances if declared by the manufacturer as functional foods; certified by the competent state authority of the producing country or the country allowing circulation as complying with food laws and meeting the following conditions shall be considered as functional foods:

1.         For micronutrient-supplementing foods: If the daily intake of micronutrients according to the usage instructions on the product label exceeds three times the Recommended Nutrient Intake (RNI) 2002 value (as issued together with this Circular), then there must be a certificate from the competent state authority of the producing country or the country allowing circulation confirming the safety of the product, and the RNI levels of the supplemented micronutrients must be clearly stated on the label or secondary label (for imported products).

2.         For functional foods containing biologically active substances: If the product is declared to have supportive functions in the human body, increasing resistance, and reducing the risk of diseases, then there must be a clinical trial report on the product's effects or documentation proving the effects of the product's components with such functions, or a certificate from the competent state authority of the producing country or the country allowing circulation confirming the product's effects as stated on the label.

3.         The labeling content of functional foods must comply with the provisions of the law on labeling and the following conditions:

a)        Usage instructions for products with special purposes must include: Product group name (micronutrient-supplementing food, health-preserving food, functional food, dietary food, medical nutrition), target users, product function, dosage, contraindications, special warnings or side effects of the product (if any);

b)        For products containing biologically active substances, the label or secondary label must compulsorily state the phrase "This product is not a medicine and does not replace medicinal treatment";

c)        The label of functional food products must not indicate specific disease treatments or claim that the product can replace medicinal treatment.

4.         For products containing vitamins and mineral salts not mentioned in the Recommended Nutrient Intake table specified in Clause 1 of this Section, domestic products that are unclear whether they are food or medicine, and products containing biologically active substances without sufficient documentation to prove their safety and efficacy, the Food Safety Agency is responsible for organizing and coordinating with the Vietnam Drug Administration and the Department of Traditional Medicine under the Ministry of Health to classify and manage them uniformly.

III.         MANAGEMENT OF FUNCTIONAL FOODS

1.         Functional foods meeting the conditions stipulated in Section II of this Circular will be managed and implemented according to the regulations of the food law. These products must declare their food hygiene and safety standards at the Food Safety Agency under the Ministry of Health in accordance with the food law before being circulated in the market.

2.         Information dissemination, advertising, and labeling of products considered as functional foods must be carried out in accordance with the law on information dissemination, advertising, and labeling, and must ensure truthfulness, accuracy, clarity, and not cause damage to producers, traders, and consumers.

IV. IMPLEMENTATION

1.         The Food Safety Agency under the Ministry of Health is responsible for organizing the implementation, directing, inspecting, auditing, and supervising the implementation of this Circular.

2.         Provincial and municipal health departments under the central government, and health departments of relevant sectors are responsible for organizing the implementation, directing, auditing, inspecting, and supervising units producing and trading in functional foods during the implementation of this Circular.

3.         Units producing and trading in functional foods are responsible for implementing this Circular.

V. IMPLEMENTATION PROVISIONS

1.         This Circular takes effect fifteen days after its publication in the Official Gazette. The Circular No. 20/2001/TT-BYT dated September 11, 2001, of the Ministry of Health on guiding the management of drug-food products is hereby abolished.

During the implementation of this Circular, if there are difficulties or obstacles, units shall report to the Ministry of Health (Food Safety and Hygiene Department) for consideration and resolution.