Home HEALTH FDA leader updates status of infant formula

FDA leader updates status of infant formula


By Robert Califf, FDA Commissioner

For the past several months, the US Food and Drug Administration has been working around the clock with our US government partners, including the US Department of Health and Human Services and the US Department of Agriculture, to expand consumer access to infant formula products, while also ensuring that these products meet the agency’s safety, nutrition, and quality standards. This has not been a small company. Years of consolidation in the infant formula industry and in relation to food safety processes and general procedures at some of the facilities that produce these products have resulted in a fragile supply chain that is susceptible to production disruptions when identified. quality problems.

Earlier this year I asked Dr. Steven Solomon, director of the Center for Veterinary Medicine, to conduct a top-down review of the agency’s activities and decision-making related to the closure of the infant formula facility in Abbott in Sturgis, Michigan, in February 2022. Yesterday, Dr. Solomon released The review results in a 10-page report, which includes information obtained from interviews with FDA personnel directly involved in the agency’s response to infant formula shortages as a result of the closure of the Sturgis facility. I agree with the findings and recommendations identified in the report, but it is important to note that I have also requested a broader and more comprehensive evaluation of the FDA Food Program. East evaluation it is being conducted by an outside group led by Dr. Jane Henney and supported by the Reagan-Udall Foundation that will review various aspects of the Food Program, including structure, function, funding, and leadership.

The report released yesterday highlights detailed findings and recommendations that will support the agency’s continued efforts to ensure that our most vulnerable population has consistent access to infant formula and specialty products well into the future. Importantly, it also identifies the need for additional resources and authorities that will ensure the agency can fulfill its consumer protection role and gain significant visibility into the supply chain in order to prevent these issues in the future.

Based on some of the report’s findings, we don’t need to wait for the Reagan-Udall Foundation’s broader assessment to start making some changes. The agency has already updated some existing processes and procedures that will allow it to respond more quickly during a public health emergency. The immediate changes we were able to implement include improving our emergency response structure and simplifying the ways the public can contact the agency to report concerns about food products. We have also developed a sophisticated data system to track the production, distribution and purchase of infant formula. There is more work to be done, but this is a start.

The situation at the Abbott Sturgis facility has highlighted how little authority the FDA has to force many companies to “do the right thing” without intervention. While domestic infant formula manufacturers have scrambled to meet the call to increase their production capacity and are working diligently, the long-term resilience of the infant formula supply chain will depend on further diversification of manufacturers, including new entrants to the U.S. market, investment in new manufacturing facilities by infant formula producers, and the commitment of these companies to consistently and continuously adhere to FDA quality and safety standards . Ultimately, these combined approaches will protect the most vulnerable people.

I encourage those with an interest in strengthening the US food supply and supporting the agency’s ongoing efforts to read this report.

We recognize the impact that formula shortages have had on parents, caregivers, and children and those who depend on these products. Rest assured, we are committed to making the necessary changes to help us avoid future supply shortages and ensure that parents and caregivers have access to safe and nutritious infant formula when and where they need it.

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