FDA Globalization
In today's world, other countries produce significant portions of the food and medical products that U.S. consumers and patients use in their daily lives. In fact 300,000 foreign facilities from more than 150 countries export FDA-regulated products to the United States. U.S. imports include:
- 10-15 percent of the U.S. food supply,
- 50 percent of fresh fruits, 20 percent of vegetables, and 80 percent of seafood,
- 40 percent of listed finished drugs, and
- medical devices that constitute over 35 percent of the U.S. medical equipment market.
FDA faces ever-greater challenges in determining whether a product has been properly manufactured, distributed and stored and even in determining who has handled the product. The manufacture of a single product can now involve multiple parties from different countries that are engaged at various steps throughout the process. Along the way, there are opportunities for the product to be improperly formulated or packaged, contaminated, diverted, counterfeited or adulterated.
Further information on FDA work overseas can be found at the agency's Office of Global Regulatory Operations and Policy Web page.
FDA has mobilized diverse approaches as part of its strategy to address the complex issues posed by globalization, including efforts to:
- develop new enforcement and regulatory tools
- conduct more foreign inspections
- increase collaboration with foreign regulators and other stakeholders
- develop internationally-harmonized standards and standards convergence
- educate foreign industry about FDA requirements, and
- increase transparency and accountability in the supply chain
To learn more:
- Meeting the Challenges of Globalization and Strengthening International Collaboration for Improved Health and Safety (Dr. Hamburg, November 2014)
- New Realities of Globalization -- Implications for Health, Medicine and the Role of the Regulator (Dr. Hamburg, March 2014)
- Blog: In a country full of differences, common ground
- Global Engagement Report
- Office of International Programs
- Animal Feed and Drugs International Program
- Cosmetics International Activities
- Food International Activities
- Medical Devices International Activities
- Vaccines, Blood and Biologics International Activities
Beginning in 2008, FDA established foreign offices, posting staff in strategic locations around the world, including China, Europe, India and Latin America. FDA offices overseas work closely with foreign governments, industry, and other stakeholders to enable FDA to more effectively protect U.S. consumers.
FDA has made globalization one of the Agency’s five cross-cutting strategic priorities for 2014-2018. FDA’s strategy involves developing an international operating model comprised of four pillars:
- Information-sharing
- Data-driven risk analytics
- Enhanced intelligence
- The smart allocation of resources through partnerships
To learn more:
Globalization Contacts
Office of Global Regulatory Operations and Policy
10903 New Hampshire Avenue
Building 1
Silver Spring, MD 20993
Office of International Programs
10903 New Hampshire Avenue
Building 31/32
Silver Spring, MD 20993
Phone: 301-796-4600
Fax: 301-595-7937