On January 9, 2024, the Philippines FDA unveiled a draft document titled 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". All concerned stakeholders may submit comments via email to email@example.com before January 26.
The new draft aims to provide guidelines to all Food Business Operators (FBOs) on the classification of vitamins and minerals as food/dietary supplements, and set updated limit of vitamins and minerals that are classified as food/dietary supplements.
1. Differences Between Food and Food/Dietary Supplement
Food refers to any substance or product 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 treatment.
Food/dietary supplements refer to processed food products 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 whose amounts conform to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. They are usually in the form of capsules, tablets, liquids, gels, powders or pills and are not represented for use as a conventional food, the sole item of a meal or diet, or a replacement for drugs and medicines.
2. General Requirements for Food/Dietary Supplement
The intended use of the product shall be as food/dietary supplement.
The product shall be in form of capsules, tablets, liquids, gels, powders or pills and is not represented for use as a conventional food. It shall not be in parenteral forms, sublingual, and among other routes of administration not taken directly into the mouth.
The product doesn't contain additional active pharmaceutical ingredients or drug ingredients.
The product doesn't carry clinical therapeutic indication or claims.
Products containing vitamins and minerals shall supplement the diet but will not correct nutritional deficiencies.
Levels of vitamins and minerals shall be reviewed/revised as per the safe levels established by the latest generally accepted scientific evidences based on national food consumption surveys and population exposure assessment.
3. Limit of Vitamins and Minerals
Table 1 sets the maximum level of vitamin and minerals for adults that are classified as food/dietary supplement, including 26 varieties of vitamins or minerals.
Table 1 Maximum Level of Vitamin and Minerals for Adults that are Classified as Food/Dietary Supplement (Excerpt)
Vitamin A (Retinol)
1,500 mcg RE/day
536 mg/day (800 IU/day)
4. Labeling Requirements
The label of food/dietary supplement shall contain advice to the consumer to avoid exceeding the maximum recommended use per day. It should not be attached with any statement or implication that supplements can be used for the replacement of meals or a varied diet.
5. Transitional Provisions
Once the draft is approved, for affected food and dietary supplements with valid Certificates of Product Registration (CPRs) that will expire within five years from the guidelines' effective date, stakeholders must file an initial application before the expiration. CPRs with less than a year of validity upon guideline implementation may be renewed for a maximum of two years, allowing time for reformulation. If existing label stocks are still available during CPR filing and approval, a request for exhaustion may be filed, with a maximum allowance of six months for exhaustion.