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FDA responds to OIG Recall Critique

In August 2016, the Office of Inspector General (OIG) found that the Food and Drug Administration (FDA) did not have an efficient and effective food recall initiation process that helps ensure the safety of the nation’s food supply. Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly.

Today, FDA Commissioner Scott Gottlieb announced improvements in the recall process.  According to Dr. Gottlieb, “the OIG reviewed a selective sample of 30 food recalls initiated from 2012 to 2015, including some very challenging ones, which occurred over this 3-year period.”

Gottlieb noted that the FDA does have mandatory recall authority, but allowed that “often the fastest and most efficient way to ensure unsafe foods are recalled quickly is by working directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on.”  On the significant step, which has been advocated by consumer groups for some time:

The FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product. “If we’re able to disclose this information, consumers would have an easier time knowing if they might have or have been, exposed to a recalled product that could cause potential risks if it were consumed,’ the commissioner said.

In addition, in April of 2017 a team of FDA senior leaders, called the SCORE team (which stands for “Strategic Coordinated Oversight of Recall Execution”) were gathered.  In Gottlieb’s view, the Score team has made recalls quicker in the following situations:

  • Lead contamination of a dietary supplement,
  • Salmonella contamination of powdered milk,
  • E. coli O157: H7 in soy nut butter, and
  • Listeria in hummus, soft cheese, and smoked fish.

Scott Gottlieb

The SCORE team also “initiated or helped to expedite the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food to the marketplace.”

Further, the Score team in 2017 “developed a new strategic plan that outlines actions to improve FDA’s recall management.” According to Gottlieb, the plan helps to standardize how the FDA assesses a company’s recall efforts and provides additional training to our staff involved in recall efforts so they can properly monitor and assess the effectiveness of a recall.

Finally, the commissioner announced that in 2018 the FDA will take additional policy steps “as part of a broader action plan to improve our oversight of food safety and how we implement the recall process.”

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