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FDA creates TWG to handle seized counterfeit, unregistered health products

Published Nov 27, 2023 07:03 am

The Food and Drug Administration (FDA) has established a technical working group (TWG) to ensure the proper handling, storage, and disposal of seized counterfeit and unregistered health products.

In a statement on Nov. 24, the FDA said the creation of the TWG, called “Oplan Katharos” and established last April, is part of its commitment to protecting public health.

The TWG is tasked with developing and implementing guidelines for the proper handling, storage, and disposal of seized health products.

“Oplan Katharos” is in line with national and international environmental conservation and recovery standards, which demonstrates FDA's commitment to these principles.

“The FDA is unwavering in its dedication to safeguarding public health against the proliferation of counterfeit, adulterated, misbranded, and unregistered processed food, devices, drugs, cosmetics, household hazardous substances, and other health products,” the FDA said in establishing the TWG.

Under Oplan Katharos, FDA’s field regional regulatory offices have taken proactive measures to seize and collect all reported counterfeit goods, employing rigorous procedures to ensure proper documentation and disposal of these items in the interest of public health.

It said FDA Order No. 2023-2223 titled, “Guidelines Governing the Transport, Receipt, Handling, Storage, and Disposal of all Health Products, Pertinent Equipment or Documents, Other Finished and Unfinished Materials, Containers, and Labeling Materials that are Collected or Seized,” was issued to provide comprehensive guidance to the concerned FDA Centers and Offices on the correct protocols for managing the transportation, receipt, handling, storage, and disposal of collected or seized health products, equipment, documents, containers, and labelling materials, provided in Republic Act No. 3720, and other pertinent laws and their respective implementing rules and regulations.

FROO Memorandum No. 2023-014 titled, “Implementation of FDA Order No. 2023-2100,” was also instituted to address the custody and storage of seized health products, particularly those posing danger or imminent threat to public health and the environment, within the regional field offices.

The FDA advised the public to buy registered or notified health products only from establishments operating with valid License to Operate.

It also encouraged prompt and timely reporting of sale distribution of unregistered and/or counterfeit health products.

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Technical Working Group FDA
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