On November 24, 2014, the Ministry of Health issued the Circular No. 43/2014/TT-BYT on prescribing the functional foods management including supplemented foods, health protection foods, medical foods and foods used for special dietary uses; not apply to nutritional formula for children.
At this Circular, the Ministry of Health requires that there must be a declaration of conformity and registration of declaration of conformity at the Ministry of Health for imported and domestically produced functional foods that are regulated by technical regulations before they are put on the market. And there must be a declaration of compliance to food safety regulations and registration of declaration of compliance to food safety regulations at the Ministry of Health for imported and domestically produced functional foods that are not regulated by any technical regulations before they are put on the market. Any pharmaceutical manufacturer that has obtained the Certificate of Good Manufacturing Practices (GMP) in producing functional foods shall be exempt from obtainment of the Certificate of Food safety. There must be a separate area in the pharmacy where functional foods are sold.
Besides complying with regulations on labeling packaged foods with the name, the composition and the mandatory label contents, labeling functional foods for each specific food groups must also warn of risks, if any and the name of the product and the information on the label must be consistent with the claims and materials attached to the declaration document.
Particularly, labels of health supplements must have the phrase: “Attention: This product is not a medicine, and is not a substitute for medicines” right after the product’s effects or with other recommendations (if any). This phrase must have a contrasting color to the background color of the label and the letters must be at leapt 1.2 millimeters. The letters must be at least 0.9 millimeters if one side of the package is smaller than 80 square centimeters. In main side of the label of medical foods and foods for special dietary, there must be a phrase expressing the food group as “dietary products (for specific users)” to distinguish ordinary foods from foods for special dietary uses.
This Circular takes effect on January 15, 2015 and replaces Circular No. 08/2004/TT-BYT dated August 23, 2004.
