FDA Committed to Strengthening U.S. Infant Formula Supply; Review Provides Roadmap to Support Ongoing Efforts

The following is attributed to FDA Commissioner Robert M. Califf, M.D.

SILVER SPRING, Md., Sept. 20, 2022 /PRNewswire/ -- For the past several months, the U.S. Food and Drug Administration has been working around the clock with our U.S. government partners, including the U.S. Department of Health and Human Services and the U.S. 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 been no small undertaking. Years of consolidation in the infant formula industry and concerning food safety processes and general procedures at some of the facilities producing these products have resulted in a fragile supply chain that is susceptible to production disruptions when quality issues are identified.

Earlier this year I asked Dr. Steven Solomon, director of the Center for Veterinary Medicine, to conduct a top-down review of agency activities and decision-making related to the shutdown of Abbott's Sturgis, Michigan, infant formula facility in February 2022. Today, Dr. Solomon released the results of the review in a 10-page report, which includes information gleaned from interviews with FDA staff 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 identified in the report, but it is important to note that I have also requested a broader and more comprehensive evaluation of the FDA's Foods Program. This evaluation is being done by an external group led by Dr. Jane Henney and supported by the Reagan-Udall Foundation that will review various aspects of the Foods Program, including structure, function, funding and leadership.

The report released today highlights detailed findings and recommendations that will support the agency's ongoing efforts to ensure that our most vulnerable population has consistent access to infant and specialty formula products in the future. Importantly, it also identifies the need for additional resources and authorities that will ensure the agency can fulfill our consumer protection role and gain important visibility into the supply chain with the aim of preventing these issues in the future.

Based on some of the findings in the report, we don't need to wait for the broader Reagan-Udall Foundation evaluation to begin implementing some changes. The agency has already updated some existing processes and procedures that will allow the agency to respond more quickly during a public health emergency. Immediate changes that we've been able to implement include improving our emergency response structure and streamlining the ways in which the public can contact the agency to report concerns with food products. We have also developed a sophisticated data system to track production, distribution and purchase of infant formula. There is more work to do, but this is a start.

The situation at the Abbott Sturgis facility has highlighted just how little authority the FDA has to compel many companies to "do the right thing" without intervention. While domestic infant formula manufacturers have stepped up to meet the call to increase their production capacity and are working diligently, the long-term resiliency of the infant formula supply chain will rely on greater diversification of manufacturers, including new entrants to the U.S. marketplace, investment in new manufacturing facilities by infant formula producers and a commitment by these companies to consistently and continuously adhere to the FDA's quality and safety standards. Ultimately, these combined approaches will protect the most vulnerable individuals.

I encourage those who have an interest in strengthening the U.S. food supply and supporting the agency's ongoing efforts to read this report.

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

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration