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Infant-formula crisis linked restructure announced by FDA

Infant-formula crisis linked restructure announced by FDA
Infant-formula crisis linked restructure announced by FDA


US regulator the Food and Drug Administration (FDA) has revealed details of the restructure of its food division in the wake of the 2022 infant-formula crisis.

The government body said a planned new structure to oversee human food supply chains and agricultural products more efficiently, and which will allow it to be “more efficient, nimble and prepared for the ever-changing and complex industries” it regulates, will come into force on 1 October.

The FDA was criticised for its slow response to the infant-formula crisis, which was sparked by a recall by Abbott Laboratories due to the presence of salmonella at the baby-food maker’s plant in Sturgis, Michigan.

Shortages ensued as the company shut down the site, prompting emergency government measures to bring in supplies from abroad, including allowing more overseas manufacturers access to the restricted US market.

Last August, the regulator named James Jones as its first deputy commissioner for human foods to oversee the creation of the Human Foods Program (HFP).

Now the details of that restructure have been announced.

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The HFP will take over the roles of the Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response, along with key functions from the Office of Regulatory Affairs, which will be renamed the Office of Inspections and Investigations.

In a statement issued yesterday (30 May), the FDA described the move as a “significant milestone”.

FDA commissioner Robert Califf, to whom Jones reports, said: “This is a distinctive moment for the FDA. I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganisation of the agency in recent history come to life this fall.

“This reorganisation has been a major undertaking for the FDA, and I am proud of what we will be able to accomplish more efficiently and collaboratively to better meet our public health mandate.”

The FDA said the creation of the HFP will leave it “better positioned to uphold the safety of the nation’s food supply and respond to food-related emergencies, such as the 2022 infant-formula shortages”.

It added that the restructuring will enable its field operations unit to focus on inspections, investigations and imports as its core mission.

The changes were made in line with the recommendations made in a 2022 independent review by the Reagan-Udall Foundation, which assessed how the agency could improve its oversight of the food sector.


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