Philippines Consults on Cosmetics Recall Guidelines

On December 22, 2023, Philippines Food and Drug Administration (FDA) released a draft of Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration (the Guidelines). This Guidelines is drafted to develop an updated framework for the recall of health products, including cosmetics, in pursuit of public health and safety. Any comments can be sent to [email protected] no later than January 24, 2024.¹

In 2016, the FDA introduced Circular (FC) No. 2016-012 to prescribe guidance on product recalls. However, since its implementation, global trade has evolved, facilitating the flow of goods. The FDA has also expanded its regulatory scope and digitized its administrative processes. In this background, the Guidelines is formulated to repeal the Circular, further enhancing public health protection and consumer awareness. Comprising 11 sections, it details precise procedures for product recalls, and specifies the responsibilities of the marketing authorization holder (MAH) in this process.

Procedures for Product Recalls

Health products that fail to meet FDA standards on safety, efficacy, and/or quality, or pose a significant risk of injury, illness, and/or deception to end-users, are subject to recalls. Based on the decision maker of the recall, recalls are categorized as MAH-initiated/voluntary recall, and FDA-ordered/mandatory recall. Regardless of the recall type, once the MAH decides/agrees to proceed with the recall, the following procedures and timelines must be adhered to:

MAH's Responsibilities

The overall responsibility for conducting a recall lies with the MAH, primarily including maintaining a comprehensive recall system and conducting the recall, along with the compliance with required communication and reporting activities.

1. An operational recall system

The MAH shall have a recall system as one of risk management tools to prevent product-related incidents that may trigger recall. This system enables the activation and operation of recall activities by a qualified management team. It also incorporates procedures for thorough monitoring and evaluation of the recall's effectiveness, and be able to trace affected products and communications with other partners in the supply chain.

2. Communication requirements

The MAH shall notify all concerned parties in the supply chain of recall activities. The communications shall be clear, consistent, and accurate to ensure a comprehensive understanding of the risks associated with the recall and its steps to minimize such risks.

In the initial recall report, the MAH is required to submit a communication plan as part of the product recall strategy. This plan shall include the following information:

Identification of communication channels;
Template documents, which shall at least contain information on product details, the reason for recall, a warning to halt further distribution of the recalled product in the supply chain, and guidance for end-users.

3. Reporting obligations

The MAH bears reporting obligations through the entire recall process. As indicated in the above-mentioned procedures of product recall, the MAH is obligated to report all relevant information to the FDA after making the recall decision. During the recall, the MAH shall check and monitor the recall's effectiveness, and submit recall status reports to the FDA. These reports shall be filed at [email protected], and copied to the Office of the Director General at [email protected]. The minimum information to be gathered in these reports is detailed in the table below.

No.

Report Type

Purpose

Required Information

Initial recall report

To provide information to adequately identify the product, and to outline the product recall strategy

i. Identity of the MAH and the person responsible for the recall;

ii. Product details;

iii. Reason for recall;

iv. Results of the health hazard evaluation/risk assessment;

v. Recall strategy;

vi. Distribution details;

vii. Other relevant information.

Recall status reports

To present updates on the monitoring of recall effectiveness, or to report the recalls completion

i. Details of notified parties and notification records

ii. Details of parties that respond to the recall communication, and the quantity of products on their hand at the time of receiving the recall notice;

iii. Details of parties with no response;

iv. Details of products returned/accounted by each party communicated;

v. Results of effectiveness checks;

vi. Estimated completion time of the recall;

vii. Quarantine management of the recalled product;

viii. Details of the media announcement for specific classification of recalls (applicable only to the initial status report)

ix. Details of the final disposition of the recalled products, and a final inventory (applicable only to the final status report)