On February 29, 2024, the Philippines Food and Drug Administration (PFDA) published a draft of supplemental Guidelines aimed at enhancing the management and conduct of product recalls for prepackaged processed food products. In accordance with the provisions of the Food Safety Act of 2013, the Guidelines is designed to ensure the safety and compliance of food products in the market. All comments in MSWord format can be sent via email to ojolaurenana@fda.gov.ph no later than March 15.
Existing Guidelines
PFDA previously issued FDA Circular No. 2016-012 Guidelines on Product Recall, which provided general guidelines for conducting product recalls, including the basic principles, roles and responsibilities of the regulator and the marketing authorization holder (MAH), as well as other important provisions for the implementation of product recalls.
New supplemental Guidelines
To further enhance the recall process and align with modern practices, the FDA recently developed a new draft supplemental Guidelines. On the basis of providing oversight on the development of a recall system, this Guidelines aims to establish an electronic system for notifying recalls, and promote the use of new electronic means for reporting food safety concerns.
Key points of the new Guidelines
Recall strategy: Manufacturers, traders, and distributors of processed food products are required to develop a recall strategy that outlines the procedures for conducting recalls.
Health hazard evaluation: The recall strategy must include a health hazard evaluation to determine the risk associated with the product and the need for a recall.
Recall team: Companies are required to create a recall team responsible for investigating, taking action, and reporting on product recalls.
Traceability activities and depth of recall: Companies must conduct traceability activities to determine the root cause of the risk event and the implicated distributors/retailers. The depth of recall should depend on the product distribution scope confirmed by traceability.
Recall notification: Companies must promptly notify all distributors, retailers, and consumers of the recall in all modes of communication, including phone call, letter, electronic mail, and other media platforms. They also need to provide clear instructions for returning the affected products.
Recall effectiveness check: Companies must conduct recall effectiveness checks for all distributors/retailers to verify that all affected products have been covered. Multiple effectiveness checks methods shall be used, such as mail, telephone calls, company visit, online platform, and combinations of these methods.
Product disposal: The disposal of recalled products must follow FDA Circular No. 2016-012 Guidelines on Product Recall and may require the presence of an FDA representative.
E-recall notification: Companies can use an electronic system to notify the FDA of product recalls, including mock recalls. The notification shall provide information on the details of the recalling company, manufacturer (as applicable), recall coordinator, product for recall, reason for recall, and summary of the health hazard evaluation. Other attachments may also be required, such as test reports, label, package inserts and/or directions for use.
Annexes: Annex A provides a sample worksheet for recall strategy, which may be used by MAH as a guidance document in preparing recall strategy. Annex B demonstrates the notification procedure of the food product recall, applying to both actual recall and mock recall.
We provide full-scale global food market entry services (including product registration, ingredient review, regulatory consultation, customized training, market research, branding strategy). Please contact us to discuss how we can help you by 
