FDA Releases Action Plan on Imported Goods

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The plan would improve collaboration, data management, and resource allocation.

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The Food and Drug Administration (FDA) announced this week an action plan designed to promote the safety of imported food, drugs, and other products. The plan follows on the heels of an Inspector General’s audit that found that the FDA was not doing enough to protect consumers.

As food and drug imports into the US are increasing dramatically, import safety has become more salient for federal regulators.  In 2009, 18.5 million lines of products were imported into the US compared to 7.9 million lines in 2002. Many supply chains now include stops in multiple countries, each with different standards for quality control.

The FDA could also do more to work with major exporting countries, including China and India. The action plan, which takes account of the agency’s increased regulatory authority after the FDA Food Safety Modernization Act, attempts to tackle these developments.

The plan consists of four primary components: collaboration, data, risk management, and resource optimization.

The FDA plans greater collaboration with foreign regulatory agencies to develop compatible regimes focused on safety results, rather than harmonious regimes focused simply on developing similar systems. As part of this effort, the FDA will work to develop an international body to coordinate food safety efforts.

The FDA also plans to develop a global information system that inspectors and other regulators can access and update in real time.

In an effort to manage complex data and quickly identify areas of risk, the FDA will use risk analysis and modernize its technical infrastructure.

In addition, the FDA will – for the first time – employ third-party investigators to inspect imports.  The agency will also consider using public-private partnerships in which companies would be responsible for conducting their own inspections.

The agency also says that in all its efforts it will focus public resources on products identified as riskiest.