Dietary supplements in the Philippines are under the unified regulation of the Philippine Food and Drug Administration (PFDA), an agency under the Department of Health. Its core responsibilities include formulating regulations and standards for food and dietary supplements, conducting market access review and approval, and performing post-marketing supervision and law enforcement.
Official Website of the Regulatory Authority:https://www.fda.gov.ph/
Database Portal: https://verification.fda.gov.ph
Republic Act No. 9711 (2009)
Department Circular No. 2011-0101
Republic Act No. 10611 (2013)
Republic Act No. 8976 (2000)
Republic Act No. 7394
Dietary supplements are processed food products intended to supplement the diet. They contain one or more ingredients including vitamins, minerals, amino acids, herbs, and dietary substances of plant or animal origin, and are designed to increase total daily intake to meet nutritional needs.
They are usually presented in the form of capsules, tablets, liquids, gels, powders or pills, and shall not be used as a substitute for conventional food, the sole source of diet, or medicinal products.
Hold a valid Philippine License to Operate (LTO) and provide information of the designated contact person
Provide quality system certificates (GMP, ISO 22000 or HACCP)
Submit complete product ingredient formulas, compliant labels, and physical product photos taken from all angles and covering all packaging sizes
Provide scientific supporting evidence corresponding to product claims and registered trademark documents
Provide complete qualification information of relevant entities such as manufacturers and importers
Submit technical documents including product samples, finished product Certificate of Analysis (COA), stability data, and safety assessment data
Additional requirement: The sources of raw materials used in production and pre-packaged processed food shall be filed with the PFDA (in accordance with FDA Circular 2016-007).
English or Filipino
Clear and complete product label / packaging artwork (for all packaging specifications)
Photos of the product from all angles (in commercial packaging form)
Supporting documents for label declarations (such as nutrition labels, health claims, Halal / organic certifications, etc.)
Product samples in commercial packaging for food supplements
Certificate of Analysis (COA) for raw materials
The LTO is a mandatory qualification for local importers, distributors, traders and manufacturers of processed food in the Philippines. It authorizes enterprises to engage in commercial activities such as food manufacturing, import, export, sales and distribution.
LTO fees for general food distributors (importers / exporters / wholesalers):
Initial application: PHP 8,080 (valid for 2 years)
Renewal: PHP 20,200 (valid for 5 years)
1.Registration Flowchart
2.Official Review Timeline
Standard full process: 114 calendar days
Re-examination cycle for rejected applications: 57 calendar days
3.Official Fees
Initial registration fee for dietary supplements: PHP 1,000 per product (valid for 1 year)
Registration renewal fee for dietary supplements: PHP 5,000 per product (valid for 5 years)
Label modification fee: PHP 210 per time