FDA Found To Lack Recall Efficacy

In an ongoing audit of FDA's food recall program, the U.S. Health and Human Services (HHS) found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the nation's food supply. Specifically, the HHS report said, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. As a result, consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.

HHS, thus, suggests that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for (1) FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.

In response to the published report, FDA stated:

"Public health is our top priority and the U.S. Food and Drug Administration works hard to ensure the U.S. food supply remains among the safest in the world.

During a nearly three-year period recently reviewed by the HHS Office of Inspector General (OIG), the FDA oversaw thousands of food recalls, with an average time for recall initiation of less than a week. A small number of these recalls fell well outside of that average, with months passing before all impacted products were taken off shelves, even though the FDA notified the companies involved of a contamination as soon as it had evidence.

These delays are unacceptable. While some food recalls are more complicated than others due to the nature of the product(s), contamination, and investigation, the recall process should be as swift as possible and the FDA is already taking concrete steps to address the OIG’s concerns. These steps include the establishment of a rapid-response team made up of agency leaders, and the introduction of new technologies to make the process even swifter.

The FDA will continue to work with the OIG and other stakeholders to make our food safety programs even stronger."
Download the HHS report.

Read the FDA blog on the steps the FDA is taking to address the OIG’s concerns.