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The U.S. Food and Drug Administration (US-FDA) issues import alerts to enforce food safety regulations for products in the US market, including food, pharmaceutical drugs, medical devices, cosmetics, tobacco products, biologics, and radiation-emitting devices from foreign countries.
Exported products from firms that have been included in the import alert will be subjected to Detention Without Physical Examination (DWPE) under which the US-FDA automatically detains the products even without the conduct of inspection, examination, or sampling. Once on an import alert or “red listed”, the US-FDA will continue to detain the affected products until the manufacturer, shipper, grower, or importer proves to the US-FDA that the violation has been corrected or “green listed”.
Companies included in the Red List should submit a petition to the US-FDA to either remove their company from the Red List or put them on the Green List. The company must prove that they have addressed the issues and have consistently shipped products that meet FDA rules. These cases are being reviewed by the US-FDA's Import Operations team.
The US-FDA updates and modifies the import alerts as needed. However, some companies may not be aware of their inclusion in the US-FDA’s import alert list. Philippine exporters to the US are advised to regularly check the US import alerts at this link. Philippine exporters listed on a US-FDA import alert are advised to immediately work with their respective US regulatory agent.
For more information, you may contact DTI-EMB Market Officers at MID@dti.gov.ph.