The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or cosmetics into the United States or are part of the import supply chain for food, drugs devices or cosmetics may wish to review the report to learn how FDA currently plans to rely on foreign posts to accomplish its mission, and what the foreign posts have accomplished so far.
FDA currently has thirteen foreign posts: three in China, two in India, four in Latin America, three in Europe, one in South Africa to serve the Sub-Saharan Africa region, and one in Jordan to serve the Middle East and North Africa. FDA has requested permission to establish an additional post in Brazil but has no current plans for additional posts. Decisions to establish foreign posts are based on the volume of imported products, the magnitude of problems associate with imported products, the value derived from leveraging activities and resources of foreign counterpart regulatory authorities, the ability of FDA to contribute to promoting U.S. public health priorities, the stability of political and security environments in the foreign country, and the political relationships and receptiveness of the foreign country to the presence of FDA staff. FDA staff are deployed to U.S. embassies or consulates. In Europe, FDA also has senior technical experts embedded in the European Medicines Agency and in the European Food Safety Authority.
The purpose of the foreign posts is “to engage more proactively and consistently with various stakeholders in strategic areas abroad to help prevent unsafe products from reaching U.S. borders and to help FDA centers and border officials make the best informed decisions possible about product entry into the United States.” The objectives of the offices are as follows:
1. Relationship building with foreign counterparts
2. Obtaining information on regulation, production, manufacture, and transport of products
3. Providing information on FDA policies, laws, regulations, standards and expectations
4. Engaging in technical cooperation and capacity-building to strengthen regulatory data and information systems
5. Conducting inspections and investigations of overseas facilities
6. environmental scanning for conditions and events that might affect FDA-regulated products, and
7. Cooperation with other U.S. agencies that have complimentary missions.