3. Compositional Aspects

Food Supplements
Philippines

This section provides the compositional requirements for the food category and/or food products in scope and information on permitted nutrients, ingredients, and additives.

3.1 Composition Requirements

“Foods supplements” should comply with Section 3.1 of the “General Foods” guidebook. Additionally, the below applies to foods supplements containing vitamins and minerals:

Vitamins and mineral preparations shall be considered food supplements based on the following criteria [1]:

1. The indication for the preparation is ‘Dietary Supplement’;
2. Strength or concentration per dosage form is <105% of Philippines RDA for fat-soluble and <150% for water-soluble vitamins;
3. It may be available in non-pharmaceutical or pharmaceutical dosage form except parenteral;
4. It may be present as purified or as a natural product; and
5. There are no additional pharmacologically active ingredients.

The Vitamin/Mineral product will be considered a drug based on the following criteria:

1. Has clinical therapeutic indication or claim in relation to a specific vitamin deficiency or disease;
2. The strength or concentration per dosage form is >105% of Philippines RDA for fat-soluble and >150% for water-soluble vitamins;
3. It is in a pharmaceutical dosage form or injectable form;
4. It is highly purified; and
5. Additional pharmacologically active ingredients are present.

3.2 Raw Material Requirements

The Philippine Authorities apply the ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Food Supplements [2].

Some common names on this negative list include Monkshood, Wormwood, Nimba, Sumatrana Amarissimus, Marijuana, Bitter apple, Sea squill, Vanish tree, Tea tree, etc.

3.3 Fortification

The Administrative Order No. 4-A s. 1995 [3] does NOT apply to food supplements.

Permitted mineral salts, amino acids, and vitamin compounds shall be referenced from Table 6 of Bureau Circular 2006 016.

Strength or concentration per dosage form is <105% of the Philippines RDA for fat-soluble and <150% for water-soluble vitamins.

There is no specific dosage threshold for minerals to be classified under "food supplement" or "drug".

3.4 Other Permitted Ingredients

Amino acids, herbs, or other dietary substances of botanical, animal, artificial, or natural origin have specific requirements [4].

3.5 Permitted Additives

There are no permitted additives requirements specific to “Foods supplements”. It should comply with Section 3.5 of the “General Foods” guidebook for the Philippines.

3.6 Permitted Flavors and Colors 

There are no permitted flavors and color requirements specific to “Foods supplements”. It should comply with Section 3.6 of the “General Foods” guidebook for the Philippines.

3.7 Permitted Processing Aids 

3.8 Additional Notes 

N/A

3.9 References

1. Officer Order No. 22 s. 1991 Guidelines for the Classification of Vitamins and Minerals as Drug or as Food

https://www.fda.gov.ph/wp-content/uploads/2021/05/Officer-Order-No.-22-s.-1991.pdf

2. ASEAN Guiding Principles for Inclusion into or Exclusion from the Negative List of Substances for Health Supplements 

https://asean.org/wp-content/uploads/2021/01/ASEAN-Guiding-Principles-for-Inclusion-Into-or-Exclusion-from-the-Negative-List-of-Substances-for-Health-Supplements-1.pdf

3. Bureau Circular No. 2006-016 Updated list of food additives

https://www.fda.gov.ph/wp-content/uploads/2021/05/Bureau-Circular-No.-2006-016.pdf

4. Clause 19 Section IV Administrative Order No. 2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and the Other Food Products, and for Other Purposes

https://www.fda.gov.ph/wp-content/uploads/2021/03/Administrative-Order-No.-2014-0029.pdf