The Philippines does not have a complete transparent regulatory system for dietary/food supplement. Dietary/food supplement 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 (RDAs). It is usually in the dosage form of capsules, tablets, liquid, 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. Currently no therapeutic claim is allowed in any form of advertisement, promotion and/or sponsorship activities or material for dietary/food supplement.
Vitamin and mineral products can be classified as drug or food supplement
based upon specific criteria such as strength or concentration per dosage unit, indication or
claims made, dosage form, etc. There is no explicit classification for the majority of
other ingredients in terms of drug or food supplement categories. Product
details need to be evaluated by BFAD to determine the category of product based on the nature of ingredient(s), dose, claim, dosage form, etc.
The local company that wants to import health supplements must obtain the License to Operate (LTO) from FDA before applying for product registration.
For dietary/food supplement registration, documents detailing product formulation, quality, stability, safety and manufacturing protocols are required to be submitted to BFAD for evaluation. For drug products, the importer must submit GMP Evidence Dossier together with application forms to BFAD to obtain GMP clearance for the foreign manufacturer before product can be registered. GMP inspection reports from regulatory authorities of PIC/S member countries is accepted but BFDA reserves the right to request any further relevant information and conduct an on-site inspection. Bioavailability/bioequivalent and toxicology studies may also be required.
NHP Consulting will provide all regulatory documentation to achieve market compliance for the Philippines marketplace.