Formula for Certain Disease is intended for the dietary management of patients who have an impaired capacity to ingest, digest, absorb, or metabolize ordinary foods or certain nutrients, or who, for any medically proven reason, have special dietary requirements that cannot be easily met by rebalancing their daily diet. Products in this category are specifically formulated to meet these needs. The Ministry of Health and Welfare has implemented a pre-market review and registration of Formula for Certain Disease.

Beginning January 1, 2025, “Formula for Certain Disease” shall appear prominently and conspicuously on the principal display panel of the container or external packaging, in order to clearly differentiate these products from regular foods.

Additionally, for approved Formula for Certain Disease products, the outer packaging must comply with general labeling requirements for packaged foods and must include the following information: (1) The applicable subjects (2) Storage instructions before and after the package is opened (3) Usage and dosage instructions (4) Warning statement: “This product is a formula food for certain disease. It is not suitable for the general population and must be taken under the instruction of a doctor or registered dietitian.” (5) Warning statement: “Increasing the dosage will not help improve this type of disease,” “This product is not for intravenous use,” or similar statements.