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FDA Circular    
No. _________   
   
 
SUBJECT:  Guidelines for the Classification of Vitamins and Minerals for 
Food/Dietary Supplements under Processed Food  Product  
Repealing the Provisions for Food in the Office Order No. 22 s. 
1991 entitled “ Guidelines for  the Classification of Vitamins and 
Minerals as Drug or as Food ” 
 
I. RATIONALE  
 
It is a policy of the State as embodied in Article II, Section 15 of the 1987 Constitution 
to protect and promote the right to health of the people and instill health consciousnes s 
among them . It is also stated under  Section 12, Article XIII of the same document that 
an effective food and drug regulatory system shall be established and maintained to 
undertake appropriate health manpower development and research, responsive to the 
country’s health needs and problems.  
 
The FDA issued Office Order No. 22 s. 1991 on 18 October 1991 that sets the limit 
for vitamins and minerals to be classified as food supplements. After thorough review 
and evaluation, and to keep pace with the advances in energy and nutrient 
requirements , the FDA shall use the different international references in setting the 
limits of vitamins and minerals such as Association of Southeast Asian Nations 
(ASEAN), Codex Alimentarius Commission, Food and Agriculture 
Organiz ation/World Health Organization (FAO/WHO), European Food Safety 
Authority (EFSA), USFDA, among others.  
 
The establishment of limit of vitamins and minerals in food/dietary supplements aims 
to ensure that the manufacturers use safe levels of vitamins and minerals in their 
products. Thus, use of the products under the instruction or direction for use provided 
by the manufacturers will be safe for the consumers  
 
Accordingly, with the aim to provide coherence in the regulation of food/dietary 
supplements cont aining vitamins and minerals under the FDA -Center for Food 
Regulation and Research, the issuance of this Circular is deemed imperative.  
 
II. OBJECTIVES  
 
This Circular aims to : 
  
A. provide  guidelines to all Food Business Operators (FBOs) on the 
classification of vitamins and minerals as food/dietary supplements; and  
 
B. set updated limit of vitami ns and minerals to be classified  as food/dietary 
supplements under processed food products . Page 2 of 6 
  
III. SCOPE  
 
This Circular shall cover all  local and imported food/dietary supplements intended to 
be manufactured, used, imported, distributed and offered for sale in the Philippines . 
 
 
IV. DEFINITION OF TERMS  
 
For purposes of these Guidelines, the following definitions shall apply:   
 
A. Food refers to any substance or pr oduct whether processed, partially processed or 
unprocessed that is intended for human consumption. It includes drinks, chewing 
gum, water and other substances which are intentionally incorporated into the food 
during its manufacture, preparation and treat ment.  
 
B. Food/Dietary Supplements means a processed food product intended to 
supplement the diet that bears or contains one or more of the following dietary 
ingredients: vitamin, mineral, amino acid, herb, or other dietary substance of 
botanical, animal, artificial or natural origin to increase the total daily intake in 
amounts conforming to the latest Philippine recommended energy and nutrient 
intakes or internationally agreed minimum daily requirements. It is usually in the 
form of capsules, tablets, liq uids, gels, powders or pills and is not represented for 
use as a conventional food or as the sole item of a meal or diet or a replacement for 
drugs and medicines.  
 
C. Nutrient  means any substance normally consumed as a constituent of food:  
1. which provides energy; or  
2. which is needed for growth, development and maintenance of 
life; or  
3. a deficit of which will cause characteristic bio -chemical or 
physiological changes to occur.  
D. Philippine Dietary Reference Intakes (PDRI)  is the collective term comprising 
refere nce value for energy and nutrient levels of intakes.  
E. Recommended Energy/Nutrient Intake (REI/RNI) refers to the level of intake 
of energy or nutrient which is considered adequate for the maintenance of health 
and well -being of healthy persons in the popula tion. 
 
 
V. GENERAL GUIDELINES  
 
A. The intended use of the product shall be as food/dietary supplement.  
 
B. The product to be classified  as food/dietary supplement shall be in form of 
capsules, tablets, liquids, gels, powders or pills and is not represented for use as a Page 3 of 6 
 conventional food. It shall not be in parenteral forms, sublingual, and among other  
routes  of administration not taken di rectly into the mouth.  
 
C. There is  no additional  active pharmaceutical ingredients or drug ingredients . 
 
D. There is no clinical therapeutic indication or claims . 
 
E. Food/dietary supplements with vitamins and minerals shall supplement the diet but 
these will not  correct nutritional deficiencies.  
 
F. Levels of vitamins and minerals shall be reviewed/revised based on safe levels 
established by latest generally accepted scientific evidence based on national food 
consumption surveys and population exposure assessment.  
 
 
VI. SPECIFIC GUIDELINES  
 
A. The following maximum level for adults shall be applied to vitami ns and minerals 
to be classified  as food/dietary supplement:  
      
Maximum amounts of vitamins and minerals in food/dietary supplements shall be 
set, taking the follow ing criteria into account:  
 
i. Maximum levels based on Upper Levels of Vitamins and Minerals ( see 
Table 1 ), considering sensitivities of individuals to certain 
vitamins/minerals  
ii. The daily intake of vitamins and minerals from other dietary sources.  
 
Table 1 . Maximum level of vitam in and minerals for adults to be classified  as 
food/dietary supplement.  
Vitamins/Minerals  Maximum Level  
Vitamin A 
(Retinol)  1500 mcg RE/day  
Vitamin D  25 mcg/day  
Vitamin E  536 mg/day (800 IU/day)  
Vitamin K  120 mcg/day  
Vitamin C  1000 mg/day  
Vitamin B1  100 mg/day  
Vitamin B2  40 mg/day  
Vitamin B6  100 mg/day  
Folic acid  0.9 mg/day  or 1500 mcg DFE/day  
Vitamin B12  600 mcg/day  
Biotin  0.9 mg/day  
Nicotinic acid  15 mg/day  
Nicotinamide  450 mg/day  
Pantothenic acid  200 mg/day  
Calcium  1200 mg/day  
Phosphorous  800 mg/day  
Magnesium  350 mg/day  Page 4 of 6 
 Boron  6.4 mg/day  
Chromium  0.5 mg/day  
Copper  2 mg/day  
Iodine  150 mcg/day  
Iron 15 mg/day  
Manganese  3.5 mg/day  
Molybdenum  0.36 mg/day  
Selenium  200 mcg/day  
Zinc 15 mg/day  
 
B. As food/dietary supplements forms only part of the diet of consumers, the levels  of 
vitamins and minerals shall not reach the maximum levels for food supplements as 
other sources of nutrients from the diet are expected to contribute to nutrient intakes. 
This is to ensure safety and protect consumers as the amount beyond the Upper 
levels of vitamins and minerals will pose adverse health effects.  
 
C. A recent (within 24 months  from the date of application ) Certificat e of Analysis  
reflecting quantitative vitamin s and minerals assay, validated reference methods of 
analysis, the limit of detection for the method used in the analysis, and complete 
name and signature of Competent T echnical Analyst/S taff, and Stability Data of the 
finished product with at least six (6) months result shall be submitted as part of the 
registration requirements , from an accredited laboratory of the FDA and Philippine  
Accreditation Board/Office (PAB/PAO) or from the country of origin .  
 
D. The percent (%) REI/RNI from  the PDRI 2015 prescri bed by the DOST -FNRI shall 
be used in the nutrition information in replacement of the 2002 Recommended 
Energy and Nutrition Intake ( RENI ). 
 
E. For the Vitamin K , the form shall only be Vitamin K1 and/or Vitamin K2 , and the 
intended use shall be in oral form o f multivitamin or mineral preparations for adults 
and not as a single ingredient . Also, a precaution  “Consult a health care practitioner 
prior to use if you are on anticoagulant therapy or taking blood thinners such as 
warfarin”  shall be reflected on the l abel.  
 
F. For nutrients  not included in the Table 1, and  that have no established hazards at 
high intakes, their maximum intake levels with sufficient evidence of safety 
(observed safe level) established by scientific risk assessment based on generally 
accepted scientific data shall be submitted.  
 
G. The process for registration and other requirements  not mentioned in this Circular  
shall follow the Administrative Order 2014 -0029 and FDA Circular 2020 -033 or 
their latest revisions.  
 
H. The label shall contain advice to the consumer not to exceed the maximum 
recommended use per day.  
 
I. The label should not state or imply that supplements can be used for the replacement 
of meals or a varied diet.  
 
J. The labeling shall be in accordance with Administrative  Order No. 2014 -0030,  Page 5 of 6 
 Bureau Circular 02 s. 1999,  other related issuances and their latest revisions.  
 
K. All nutrients that will exceed the maximum level as prescribed in Table  1 shall  be 
denied for reg istration application.  
 
 
VII. TRANSITORY PROVISION  
 
Affected manufacturers, traders, importers and distributors of food/dietary supplement 
products distributed in the Philippines are given a transition period as follows:   
 
A. All affected food/dietary supplements that needs to reformulate and has a valid 
CPRs expiring within five (5) years from effectivity of this Circular shall file for 
initial application in compliance to this issuance before the date of expiration . 
 
B. Those CPR wi th less than a year of validity upon effectivity of this Circular  shall 
be renewed for a maximum of two (2) years , provided they are qualified for 
renewal,  to give time for r eformulation, after which, an initial  application shall be 
filed.   
 
C. In cases where there are still existing stocks of labels on the current CPR and stocks 
may be still available by the time of filing of new CPR and its approval, a request 
for an  exhaustion  may be filed  (inventory of remaining stocks shall be declared) , 
and once approved the exhaustion may be allowed within maximum of six (6) 
months.  
 
VIII.  REPEALING CLAUSE  
 
The provisions for Food in Office  Order No. 22 s. 1991 entitled “Guidelines for the 
Classification of Vitamins and Minerals as Drug or as Food ”, and other  FDA issuances 
inconsistent with this Circular are hereby repealed accordingly.  
 
 
IX. MONITORING AND REVIEW CLAUSE   
 
This FDA Circular shall be reviewed and evaluated within three (3) years of its 
implementation to determine whether the policy’s objectives, impact, and effectiveness 
are achieved.   
 
 
X. SEPARABILITY CLAUSE  
 
If any provision of this Circular be declared as invalid or unenforceable, the validity 
and enforceability of the remaining portions or provisions shall remain in full force and 
effect.   
 
 
 
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 XI. EFFECTIVITY  
 
This Circular shall take effect fifteen (15) days after its publication in the Official 
Gazette or in any newspaper of general circulation and upon filing with the University 
of the Philippines Law Center Office of the National Administrative Register.  
 
 
 
 
DR. SAMUEL A. ZACATE  
                                                                                                  Director General  
 
 
DTN 20231019152551  
 
Office  CFRR  PPS LSSC  
Initial   
 
PILAR MARILYN M. 
PAGAYUNAN, MBA  
        Director IV   
 
IRENE FLORENTINO -
FARIÑAS, RPh, MD, MNSA  
                  Director III   
 
ATTY. EMILIO L. POLIG. JR.  
                     Director III  
Date     Page 1 of 1