FDA Commits to Strengthening U.S. Infant Formula Supply; The review provides a roadmap to support ongoing efforts

The following is attributed to the Commissioner of the FDA Robert M. CaliffMD

SILVER SPRING, MD., September 20, 2022 /PRNewswire/ — Over the past few months, the U.S. Food and Drug Administration has worked 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 Health. Agriculture, to expand consumer access to infant formula, while ensuring that these products meet the agency’s safety, nutrition and quality standards. It was no small feat. Years of consolidation in the infant formula industry and regarding food safety processes and general procedures at some of the facilities producing these products have resulted in a fragile supply chain that is likely to interrupt production when problems arise. of quality are identified.

Earlier this year, I asked Dr. steven solomondirector of the Center for Veterinary Medicine, to conduct a top-down review of agency operations and decision-making related to Abbott’s closure Sturgis, Mich.infant formula establishment February 2022. Today Dr. Solomon published the results of the review in a 10-page report, which includes information from interviews with FDA personnel directly involved in the agency’s response to infant formula shortages following the Sturgis closure of the establishment. 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 dietary program. This Evaluation is carried out by an external group led by Dr. Jane Henney and supported by the Reagan-Udall Foundation which will examine various aspects of the food 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 our most vulnerable population has consistent access to infant and specialty formula in the future. Importantly, it also identifies the need for additional resources and authorities that will enable the agency to fulfill its consumer protection role and gain significant supply chain visibility in an effort to prevent these problems in the future.

Based on some of the report’s findings, we don’t need to wait for the broader Reagan-Udall Foundation assessment to begin implementing 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. Immediate changes we were able to implement include improving our emergency response structure and streamlining the ways the public can contact the agency to report food-related issues. We have also developed a sophisticated data system to track the production, distribution and purchase of infant formula. There is still work to be done, but it is a start.

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

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

We recognize the impact formula shortages have had on parents, caregivers, children and people who depend on these products. Rest assured that we are committed to implementing 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. .

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer requests: 888-INFO-FDA

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.

SOURCE US Food and Drug Administration

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