FDA Releases Internal Review of Agency Actions Related to U.S. Infant Formula Supply

Dr. Steven Solomon, director of the Food and Drug Administration's (FDA) Center for Veterinary Medicine, released the results of a top-down review of agency activities and decision-making related to the shutdown of Abbott’s Sturgis, Mich., infant formula facility in February 2022.

The 10-page report, released Sept. 20, 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. It focuses on aspects of the response that are within the agency’s purview; other factors, including the limited number of infant formula manufacturers, needed improvements in the ingredient supply chain and better control of product distribution, must be addressed by other external stakeholders, said Solomon.

For the past several months, FDA has been working with 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 ensuring that these products meet the agency’s safety, nutrition and quality standards, said Robert M. Califf, M.D., FDA commissioner of food and drugs.

“This has been no small undertaking,” said Califf. “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.”

Califf said he agrees with the findings and recommendations identified in the report, but he has requested a broader and more comprehensive evaluation of FDA’s Foods Program. This evaluation is being completed 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.

“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,” said Califf. “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 have been implemented include improving FDA’s 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,” said Califf. “There is more work to do, but this is a start.”

The situation at the Abbott Sturgis facility has highlighted how little authority FDA has to compel companies to “do the right thing” without intervention, Califf said.

“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,” he said. “Ultimately, these combined approaches will protect the most vulnerable individuals.”