1. Definition & classification
As per 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), food/dietary supplement refers to 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. It is usually 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 a replacement for drugs and medicines.
Besides, the Philippines adopts risk-based classification of food products, which influences the authorization process and FDA’s priority of inspection. The classification of food supplements are as follows:
Medium risk foods: food/dietary supplements containing vitamins and minerals and/or amino acids
High risk foods: food/dietary supplements containing herbs and botanicals and/or products with other nutritional substance.
2. Competent authority
Competent authority | Responsibility |
DOH is the executive department of the government of the Philippines responsible for ensuring the access to basic public health services by all Filipinos through the provision of quality health care, and the regulation of all health services and products. | |
PFDA is a health regulatory agency under DOH responsible for licensing, monitoring, and regulating of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for their safety, efficacy, and quality in the Philippines. |
3. Market access approval
3.1 License to operate (LTO)
Under Administrative Order No.2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes, companies involved in the importation, exportation, trading, and distribution of processed food in the Philippines need to obtain a License to Operate (LTO). The LTO application procedure and requirements can be found at Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration.
3.2 Certificate of product registration (CPR)
Under Administrative Order No.2014-0029 Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products, and For Other Purposes, all processed food products including food additives, food supplements and bottled water are required to secure a Certificate of Product Registration (CPR) before they are put on the market, offered for sale or use, distributed or supplied. Notably, when applying for CPR for food supplements, a sample in actual commercial presentation shall be submitted. The CPR application procedure can be found at FDA Circular No. 2016-014 Procedure for the Use of Electronic Registration (E-Registration) System for Prepackaged Processed Food Products.
4. Product compliance
4.1 Product requirements
As stipulated in Office Order 22 s.1991, to be classified as food supplement, the maximum limit is 150% Philippine Recommended Energy and Nutrient Intake (RENI) for Water Soluble Vitamins and 105% RENI for Fat Soluble Vitamins. For minerals, PDRI 2015 and ASEAN regulations can be used as reference for the maximum limit. For herbals and botanicals, related ASEAN regulations are applicable.
Besides, available food additives that can be used in food supplements are regulated in Updated List of Food Additives. Food supplements is a separate category under the list with reference number 13.6.
4.2 Label
The labelling of prepacked foods, including food supplements, is regulated by Administrative Order No. 2014-0030 (The Rules and Regulations Governing the Labeling of Prepackaged Food Products Distributed in the Philippines).
The use of nutrition and health claims in food labeling and the advertisement of food products is regulated by Guidelines in the Use of Nutrition and Health Claims in Food. Besides, food supplements shall not have curative claims or therapeutic claims. Other claims shall be in accordance to the existing and relevant labeling guidelines.
In addition, as per No. 2, s. 1999, the phrase "No approved therapeutic claim" shall be indicated in the labels of all food supplements to inform consumers that food/dietary supplements have no approved curative effects.
* Global Food Compliance Service
We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.
Covered Countries
China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.
Our Services
Food Ingredient Review
Label Review
Product Registration
Regulatory Consultation
Monitoring, Training and customized report
Please feel free to contact us via food@chemlinked.com if you need any help.
