Globalization forces FDA to prioritize global food safety

Within its 50-page strategy document, Strategic Priorities 2011 – 2015: Responding to the Public Health Challenges of the 21st Century, comes the frank admission: “The growing challenges of globalization have far outstripped the FDA’s resources for inspection and quality monitoring, and the inability to maintain adequate oversight means potential risk to consumers grows every year.​

Stopping threats​

“Addressing these challenges will require a paradigm shift — to a focus on prevention, on stopping threats before they ever become reality. The border must be viewed as a final checkpoint for preventive controls, rather than the primary line of defense against unsafe imports.”​

An increasingly globalized world means that “… ensuring the safety of food, drugs, and devices for the American people is a global endeavor that integrates products and people across borders,”​ according to the strategy document.

To support its view, FDA highlighted the growing volume and complexity of imported products, national security threats, greater opportunities for economic adulteration and intentional fraud, corporations lacking accountability and enforcement tools that do not reflect today’s commercial practices.

More than 20m import lines of food, devices, drugs, and cosmetics arrived at US ports of entry in Fiscal Year (FY) 2010; more than three times the number of imports 10 years ago.

To guard against the threat this brought, FDA stressed the need for more information about product supply chains and the importance of monitoring information throughout the product life cycle.

It further highlighted the need for regulatory standards to foster corporate responsibility to identify, protect, and control risks together with coordination among foreign, federal, and state counterparts.

Adequate funding​

The administration called for updated compliance and enforcement tools and new adequate funding to allow for inspections, examinations and sample collections and analysis, and updated systems, including IT support. “These changes are essential if we are to protect product safety in a way that Americans expect and deserve,”​ it said.

Within the Department of Health and Human Services (HHS), FDA is responsible for ensuring the safety and effectiveness of products that account for about 20 cents of every dollar spent by American consumers each year.

That includes 80 percent of the food supply, biological products, medical devices, cosmetics, radiation-emitting products, and tobacco products plus human and animal drugs.

Margaret Hamburg, FDA commissioner, pledged her administration to science-based decision-making. “Science underlies everything we do,” she said. “To serve the public health, we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies​.”