U.S. Food and Drug Administration (FDA) Global Initiative

import_border_photos06_960Global production of FDA-regulated products has quadrupled over the last decade and continues to grow.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities. Fifty percent of fresh fruits, 20 percent of vegetables, and 80 percent of seafood consumed in America comes from abroad.  Similarly, 40 percent of finished drugs come from overseas, and 80 percent of active ingredients manufacturers are located outside the US.  Further, half of all medical devices are imported. The growth in imports has been rapid and promises to accelerate. As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.

Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission.  Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment.

The agency is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by industry, and enhancing collaboration with international regulatory counterparts and other third parties.

As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.

http://www.fda.gov/aboutfda/globalinitiative/default.htm

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import_border_photos03_960FDA inspectors struggle to keep up with flood of imports

The Food Safety Modernization Act, passed in 2011, gives the FDA a new mandate to make certain food is safe for U.S. consumers. Among the requirements are stricter rules for imported foods and more inspections. The law places more responsibility for food safety on foreign manufacturers. And it calls for the FDA to inspect at least 600 foreign food facilities within 2012 and double those inspections every year for the next five years. That would mean 19,200 foreign inspections in year six.

Photo: Does it pass the “smell test” … ? Organoleptic specialist Stephen Angold uses his professional nose to sniff for filth or decomposition on imported mahi-mahi fillets inside the U.S. FDA’s $40 million testing laboratory in Irvine, CA.

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