Regulations governing the labeling of special dietary foods for patients 
(Draft) 

   
 
1. Formula for certain disease shall have co ntainers or packages labeled with the 
following information, as required in Su bparagraph 10 of Paragraph 1 of Article 22 
of the Act Governing Food Safety and Sanitati on, 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 form ula food for certain disease, it is not 
suitable for the general population and mu st be taken under the instruction of a 
doctor or registered dietitian" (text sh all appear bold and be distinct from the 
background color). 
(5) Warning statement: "Increasing dosage  will not help improve this type of 
disease." 
(6) Precautions. 
(7) Others. 
 
2. 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 content. 
B. Protein efficiency ratio (P.E.R., it is no t required if the nitr ogen content of the 
product is below 1.8%). 
C. High protein foods shall be labele d 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." 
(2) Amino acid adjusted formula: 
A. Contents of essential amino acids. 
B. Phenylalanine-free and low phenylalan ine formulas must include a warning 
statement, "This product is not nutritionally complete " and "This product is 
only intended for patients with phenyl ketonuria (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 and energy content. 
B. Product containing no essential fatty acids (linolenic acid content less than  
0.5%), must include a warning statement, "This product contains no essential 
fatty acids," on the label. 
(4) Mineral adjusted formula: 
A. Contents of electrolyte (e.g. so dium, potassium, chlorine, calcium, 
magnesium, phosphate, etc.). 
B. Depending on the nature of the produc t, labels must state "low-sodium food," 
"sodium restricted food," "low-sodium sa lt," "low-sodium soy sauce," or "oral 
rehydration product." 
C. For "low-sodium salt" and "low-sodium soy sauce," labels must include name 
and content of the substitute used. 
D. Oral rehydration product must ha ve osmolality and pH value labeled. 
E. 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 physic ian 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. 
(6) Weight control formula: 
A. The name and content of the sweetene r used, if there is any sweetener used. 
B. The name and content of various nu trients (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 (w arnings) : "Not inte nded for children, 
teenagers and pregnant women," "Seek ing 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 samp le menu for at least one week. 
(7) Tube feeding formula: 
A. The name and content of various nu trients (e.g. energy, protein, fat, 
carbonhydrate, vitamins, and minerals). 
B. Osmolality. 
C. Warning statement: "This product is not for intravenous use."