1 
 Regulations Governing the L abeling of Special Dietary Food s for Patients  
(Revised Draft)  
   
 
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 cert ain disease  shall have containers or packag es 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 d osage 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 distin ct from the 
background  color ). 
(5) Warning statement : "Increasing dosage will not help improve this type of 
disease ", or words of similar meaning . 
(6) Precaution s. 
(7) Others . 
 
3. In addition to the foregoing requirements , different categories of for mula food for 
certain disease shall have the following additional information print ed on the 
container or packa ge: 
(1) Protein -adjust ed formula : 
A. Contents of  sodium, potassium, and protein.  
B. Protein effici ency ratio (P.E.R., it is not required if the nitroge n content  of the 
product  is below 1.8%). 
C. High p rotein foods sh all be labeled with the words "High Protein Food," 
whereas low protein foods sh all 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 provide s the basi c 2 
 calories and nutrients physiological need s for the patient, may be exempt 
from this label . 
(2) Amino acid adjust ed formula : 
A. Content s of essential amino acids.  
B. Phenylala nine-free and  low p henylalanine 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 stat ement : "This product is not for intravenous use ." 
(3) Fatty acid adjust ed formula : 
A. Percentage of essential fatty acids  (linoleic acid, α-linolenic acid)  and energy 
content.  
B. Product contain ing no essential fatty acids , must include a warning statement , 
"This product contain s no essential fatty acids ," on the  label.  Product 
conta ining 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-linole nic 
acid," on the label . 
(4) Mineral  adjust ed formula : 
A. Content s of electrolyte (e.g. sodium, potassium, chlorine, calcium, 
magnesium, phosphate , etc.). 
B. Depending on the nature of the product, labels must state  "low-sodium foo d," 
"sodium restricted food," or "o ral rehydration product ." 
C. Oral rehydration product must have osmolality and p H value  labeled.  
D. Oral rehydration product  must include a warning statement , "Conditions 
such as moderate to severe di arrhea or substantial losses of body fluid or 
electrolyte s must be treated by a physi cian before taking this product"  or 
words of similar meaning.  
(5) Allerg en-reduced formula:  
A. The name of the allerg en reduce d 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 fo rmula : 
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, pr otein, fat, 
carbonhydrate , vitamins , and minerals).  
C. "Excessive intake of this product leads  to energy accumulation and do es not 
help control body weight"  or words of similar meaning . 
D. Other important labeling information ( warning s) : "Not intended for childre n, 
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," an d "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. Osmola lity. 
C. Warning statement : "This product is not for intravenous use ."