1 
 Regulations governing the labeling of special dietary food s for patients  
(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 certain dise ase 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 dosage in structions.  
(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 ." 
(6) Precaution s. 
(7) Others . 
 
3. In addition to the foregoing requirements , different categories of fo rmula food for 
certain disease shall have th e following additional information print ed on the 
container or packa ge: 
(1) Protein -adjust ed formula : 
A. Contents of  sodium, potassium, and protein content.  
B. Protein effici ency ratio (P.E.R. , it is not required if the nitrogen 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 ." A product that provide s the basi c calories and nutrients 2 
 physiological  need s for the patient, may be exempt from this lab el. 
(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 statement : "This product is not for intravenous use." 
(3) Fatty acid adjust ed formula : 
A. Percentage of essential fatty acids and energy content.  
B. Product contain ing no essential fatty acids (linolenic acid content less than  
0.5%), must include a warning statement , "This product contain s no essential 
fatty acids ," on the  label.  
(4) Mineral  adjust ed formula : 
A. Content s of electrolyte (e.g. sodium, potassium, chlorine, calcium, 
magnesium, phosphate , etc.). 
B. Dependi ng on the nature of the product , label s must state  "low-sodium foo d," 
"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 
electrolyt es 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, i f there is any substitute used.  
(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, protein, fat, 
carbonhydrate , vitamins , and minerals).  
C. "Excessive intake of this product lead s to energy accumulation and does not 
help control body weight " or words of similar meaning . 3 
 D. Other important labeling information (warning s) : "Not intended for childre n, 
teenagers and pregnant women ," "Seek ing advic e 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 di et 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. Osmol ality. 
C. Warning statement : "This product is not for intravenous use."