1 
 Regulations governing the labeling of formula for certain disease 
 
   
 
1. This standard is established under the provisions of Subparagraph 10 of Paragraph 1 
of Article 22 of the Act Governing Food Safety and Sanitation. 
2. Formula for certain disease shall have containers or packages labeled with the 
following information, as required in addition to general information requirements: 
(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" (text shall appear bold and be distinct from the 
background color). 
(5) Warning statement: "Increasing dosage will not help improve this type of 
disease", or words of similar meaning. 
(6) Precautions. 
(7) Others. 
 
3. In addition to the foregoing requirements, different categories of formula food for 
certain disease shall have the following additional information printed on the 
container or package: 
(1) Protein-adjusted formula: 
A. Contents of sodium, potassium, and protein. 
B. Protein efficiency ratio (P.E.R., it is not required if the nitrogen content of the 
product is below 1.8%). 
C. High protein foods shall be labeled with the words "High Protein Food," 
whereas low protein foods shall be labeled with the words "Low Protein 
Food." 
D. Warning statement: "To achieve balanced diet, please do not take this product 
on its own", or words of similar meaning. A product that provides the basic 2 
 calories and nutrients physiological needs for the patient, may be exempt 
from this label. 
(2) Amino acid adjusted formula: 
A. Contents of essential amino acids. 
B. Phenylalanine-free and low phenylalanine formulas must include a warning 
statement, "This product is not nutritionally complete " and "This product is 
only intended for patients with phenylketonuria (PKU), " or words of similar 
meaning. 
C. Warning statement: "This product is not for intravenous use." 
(3) Fatty acid adjusted formula: 
A. Percentage of essential fatty acids (linoleic acid, α-linolenic acid) and energy 
content. 
B. Product containing no essential fatty acids, must include a warning statement, 
"This product contains no essential fatty acids," on the label. Product 
containing no essential fatty acids linoleic acid or α-linolenic acid, must 
include a warning statement, "This product contains no essential fatty acids  
linoleic acid," or "This product contains no essential fatty acids α-linolenic 
acid," on the label. 
(4) Mineral adjusted formula: 
A. Contents of electrolyte (e.g. sodium, potassium, chlorine, calcium, 
magnesium, phosphate, etc.). 
B. Depending on the nature of the product, labels must state "low-sodium food," 
"sodium restricted food," or "oral rehydration product." 
C. Oral rehydration product must have osmolality and pH value labeled. 
D. Oral rehydration product must include a warning statement, "Conditions 
such as moderate to severe diarrhea or substantial losses of body fluid or 
electrolytes must be treated by a physician before taking this product" or 
words of similar meaning. 
(5) Allergen-reduced formula: 
A. The name of the allergen reduced or elimated. 
B. The name of the specific ingredient substituted for allergen reduced or 
elimated, if there is any substitute used. 3 
 (6) Weight control formula: 
A. The name and content of the sweetener used, if there is any sweetener used. 
B. The name and content of various nutrients (e.g. energy, protein, fat, 
carbonhydrate, vitamins, and minerals). 
C. "Excessive intake of this product leads to energy accumulation and does not 
help control body weight" or words of similar meaning. 
D. Other important labeling information (warnings) : "Not intended for children, 
teenagers and pregnant women," "Seeking advice and instruction from a 
doctor or registered dietitian before long-term use (or "Not to be taken 
continuously beyond a certain period of time"), "This product is intended to 
only replace __  meal(s) per day, and used in conjunction with a 
well-designed diet plan," and "Drink enough fluids each day." 
E. Instruction manual and a sample menu for at least one week. 
(7) Tube feeding formula: 
A. The name and content of various nutrients (e.g. energy, protein, fat, 
carbonhydrate, vitamins, and minerals). 
B. Osmolality. 
C. Warning statement: "This product is not for intravenous use."