Written by Robert Califf, Commissioner of the Food and Drug Administration
Over the past several months, the US Food and Drug Administration has worked 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 safety, nutrition, and quality standards. of the agency. This was no small task. Years of consolidation in the infant formula industry and with regard 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 prone to production disruptions when quality issues are identified.
Earlier this year, I asked Dr. Stephen Solomon, director of the Center for Veterinary Medicine, to conduct a top-down review of the agency’s activities and make decisions regarding the closure of the Abbott Sturgis, Michigan, infant formula facility in February 2022. Yesterday, Dr. Sulaiman chest The review results in a 10-page report, which includes information gleaned from interviews with Food and Drug Administration personnel directly involved in the agency’s response to infant formula shortages as a result of the Sturgis facility closure. I agree with the findings and recommendations outlined in the report, but it is important to note that I also requested a broader and more comprehensive evaluation of the FDA’s Food Program. this is evaluation It is conducted by an external group led by Dr. Jane Heaney 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 ongoing efforts to ensure that our most vulnerable populations have consistent access to infant and specialty dairy products in the future. Importantly, it also identifies the need for additional resources and powers that will ensure the agency can fulfill its role in consumer protection and gain significant insight into the supply chain with the goal of preventing these problems in the future.
Based on some of the findings in the report, we don’t need to wait for the Reagan-Udall Foundation’s broader assessment to begin implementing some changes. The agency has already updated some of the existing processes and procedures that will allow the agency to respond more quickly during a public health emergency. Immediate changes we were able to implement include improving the emergency response structure and simplifying the ways the public can contact the agency to report food product concerns. 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 power the FDA has to force many companies to “do the right thing” without interference. As domestic infant formula manufacturers have stepped up to meet the call to increase their production capacity and are working hard, the long-term resilience of the infant formula supply chain will depend on greater diversity of manufacturers, including new entrants to the U.S. market, and investment. in new manufacturing facilities by infant formula producers and the commitment of these companies to the ongoing and ongoing adherence to FDA quality and safety standards. Ultimately, these combined methods will protect the most vulnerable individuals.
I encourage those with an interest in enhancing the US food supply and supporting the Agency’s ongoing efforts to read this report.
We understand the impact of formula deficiency on parents, caregivers, children, and individuals who depend on these products. Rest assured that we are committed to implementing the changes needed to help us avoid supply shortages in the future and ensure that parents and caregivers have access to safe, nutritious infant formula when and where they need it.
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