I. FOOD SUPPLEMENTS
Food Supplements are defined in 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) as “a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, 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 usually is in the form of capsules, tablets, liquids, 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 replacement of drugs and medicines.”
The Phillipines FDA has published an order on the classification of Vitamins and Minerals as food or drug (Officer Order No. 22 s. 1991 Guidelines for the Classification of Vitamins and Minerals as Drug or as Food).
Vitamins and mineral preparations shall be considered food supplements on the basis of the following criteria;
(i) Indication for the preparation is ‘Dietary Supplement’
(ii) Strength or concentration per dosage form is <105% for fat soluble and <150% for water soluble vitamins
(iii) It may be available as non-pharmaceutical or pharmaceutical dosage form except parenterals.
(iv) It may be present as purified or as natural product
(v) And, there are no additional pharmacologically active ingredients.
The Vitamin/Mineral product will be considered a drug in the case of;
(i) Clinical therapeutic indication or claim in relation to a specific vitamin deficiency or disease
(ii) The strength or concentration per dosage form is >105% for fat soluble and >150% for water soluble vitamins.
(iii) It is in a pharmaceutical dosage form or injectable form
(iv) Additional pharmacologically active ingredients are present
Accordingly, food supplements are considered foods and more specifically processed foods in the Philippines. Foods are subdivided over 3 categories according to their microbiological risk (Annex A of Administrative Order No. 2014-0029): low risk food; medium risk food and; high risk food. The categorization influences the authorization process and the FDA’s priority for inspection.
Food supplements containing vitamins and minerals and/or amino acids are considered medium risk foods, while food supplements containing herbs and botanicals and/or products with other nutritional substance are considered high risk food.