CIRCULAR guiding the management of functional food products _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ To unify the management of the business functional food products on the market; health and safety for consumers and create favorable conditions for enterprises while trading, the Ministry of health guidelines on the management of functional food products (hereinafter referred to as functional food) are as follows: i. the CONCEPT and NAME of FUNCTIONAL FOOD: 1. Functional food is food that used to support the functions of the parts of the body able people, nutritional effects, give body to a comfortable situation, increased resistance and reduce the risk of disease.
 
2. functional foods, according to the use, quality and content of vi manual, also known as the following: a) food supplement micronutrients;
b) food supplements;
c) health protection food;
d) medical nutrition products.
 
II. conditions to DETERMINE the FUNCTIONAL FOOD: food products have additional nutrients such as vitamins, mineral salts and other biologically active substances if manufacturers are announce that product is functional food; be the competent State authorities of the country of origin or in the country to allow circulation certified with the law on food and have enough of these conditions shall be considered as functional foods: 1. for food supplement micronutrients: If the amount of micro-substances introduced into the body daily according to the user's Guide recorded on the label of the product at least one vitamin or mineral salts is higher than 3 times the value of the table of recommended nutritional needs 2002 RNI (Recommended Nutrient Intakes), attached herewith, then must have a certificate of the competent State authorities of the country of origin or in the country to allow circulation to confirm the safety of the product and must be clearly stated on the label or the label of the product side (for imported products) response level RNI effects of the micro-nutrients are added;
2. for functional foods containing bio-active substances: If the announced products that support the functions in the human body, increased resistance and reduce the risk of disease, they must have reported clinical trials about the effect of the products or documentation about the effect of components of products that have that function or certificate of authority the State has the authority of the country of origin or in the country to allow circulation with content validated the use of the product indicated on the label.
3. content labeling of functional food must meet the conditions specified by law regarding label and the following conditions: a) the content of the manuals for the products with special uses need to be recorded: name of Group products (food supplements, health protection food , functional food, food diet, nutritional food, medicine), the object of use, product uses, dosage, contraindications, the special note or the side effects of the product (if available);
b) for foods containing bio-active substances on the label or extra labels required to write the words "this food is not smoking, not work replace medicines";
c) On functional food product labels was not indicated for the treatment of any one particular disease or product has the effect of alternative medicine healing.
4. With regard to those products containing vitamins and mineral salts, not mentioned in the Panel recommendations on nutritional needs stipulated in clause 1 of this Section, the products are manufactured in the country but not food or drugs, products containing active substances not enough documents to prove the safety and effects of the active substances that , Bureau of food safety and hygiene is responsible for chairing and coordinating with Vietnam drug administration and Service of traditional medicine-the Health Ministry to review the classification and management.
 
III. Management For FUNCTIONAL FOOD 1.         Functional food has enough of the conditions specified in section II of this circular shall be administered and implemented under the provisions of the law on food. These products must be declared to the standard of food hygiene and safety in the food safety Bureau-Ministry of health in accordance with the regulations of the law on food before circulating on the market.
2. The information, advertising, product labeling is regarded as functional food must be made according to the regulations of the law on information, advertising, labeling and to ensure honest, accurate, apparently without causing damage to producers, consumers and business.
 
IV. IMPLEMENTATION 1.         The Bureau of food safety and hygiene-the Ministry of health is responsible for launch, directing, testing, inspection and monitoring of the implementation of this circular. 
2. The Department of health of the province, central cities, health departments are responsible for organizing, directing, inspection, testing and monitoring of production units, food business functions in the process of implementing the provisions of this circular.    
3. The units of production, functional food business is responsible for implementation of the provisions of this circular.
 
V. TERMS Of ENFORCEMENT 1.         This circular effect after 15 days from the date The report. Abolish circular No. 20/2001/TT-BYT of September 11, 2001 of the Ministry of health about the guidance of drug product administration – food.
2. During the implementation of this circular, if there are difficulties and obstacles, which reports to the Ministry of health (food safety Bureau) to consider and resolve.