John Patrick M. Santos | Jude Francis S. Rebosa
On 03 July 2025, the Philippine Food and Drug Administration issued FDA Circular No. 2025-003 (“Circular”), aimed at adopting the Codex Guidelines for Ready-to-Use Therapeutic Food (“RUTF”) to all Food Business Operators (“FBOs”), and ensuring the quality and safety of RUTF being distributed locally.
RUTFs are energy and micronutrient-dense food used in support of community-based management of acute malnutrition without medical complications. The Circular highlighted that there is currently no regulation of RUTF and no existing local reference standard that may be used as a basis to ascertain their safety. Therefore, to ensure the quality and safety of RUTF currently being distributed locally, the Codex Guidelines for RUTF (CXG 95-2022, Rev. 2023) (“Codex Guidelines”) are being adopted.
Particularly, the Circular aims to provide guidelines to all FBOs on the use of the revised Codex Guidelines. It also aims to set limits on consumption and quality factors, purity requirements, food additives, contaminants, hygiene, labeling, and methods of analysis and sampling.
Under the Circular, all FBOs shall secure a License to Operate (“LTO”) prior to application for Certificate of Product Registration (“CPR”) before engaging in the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising, or sponsorship of RUTF.
Among the specific guidelines enumerated in the Circular is the provision on accessibility which mandates that a copy of the Codex Guidelines for RUTF be made accessible on the FDA Website, with any amendments or updates announced through appropriate FDA advisories.
The Circular also emphasizes compliance with LTO application process under relevant administrative orders and their future amendments such as the Rules and Regulations on the Licensing of Food Establishments and Registration of Processed Food, and Other Food Products.
The Circular reiterates compliance with other relevant laws particularly Executive Order No. 51 or Milk Code of the Philippines, its Implementing Rules and Regulations, Administrative Order 2014-0030 entitled “Revised Rules and Regulations Governing the Labeling of Pre-packaged Food Products Distributed in the Philippines, and For Other Purposes.”
The Circular will take effect after fifteen (15) fifteen days following the publication in the Official Gazette or in a newspaper of general circulation and filing with the Office of the National Administrative Register of the University of the Philippines Law Center.
For further details or to view the complete text of the Circular, please refer to the official link:
https://www.fda.gov.ph/fda-circular-no-2025-003-adoption-of-codex-guidelines-for-ready-to-use-therapeutic-foods-rutf-cxg-95-2022-as-technical-regulation/
If you wish to know more about Ready-to-Use Therapeutic Foods and other regulatory matters, you may reach out to:
Patricia A. O. Bunye, Managing Partner
Email: po.bunye@cruzmarcelo.com
+632 8810 5858