FDA to focus on improving infant formula industry’s accountability
Outdated technology, inadequate processes when handling whistleblower complaints and confusion about staff roles and responsibilities are just part of the findings published in FDA’s internal review of the agency’s handling of this year’s infant supply shortage.
Carried out by Dr. Steven Solomon, director of the Center for Veterinary Medicine, the top-down review looks closer at agency activities and decision-making related to the shutdown of Abbott Nutrition’s, Sturgis, Michigan infant formula facility in February 2022. A broader, more complex evaluation of the FDA Foods Program is also in the works, the agency said.
Formula industry-specific actions
Dr. Solomon has identified five major areas for improvements, submitting 15 findings in total. The five ‘areas of need’ are to do with modern information technology that allows for the access and exchange of data in realtime; availability of sufficient staffing, training, equipment and regulatory authorities; updated emergency response systems; increased understanding about cronobacter; and an assessment of the infant formula industry and its food safety culture and preventive controls.
The review found that the conditions observed at the Abbott Nutrition facility ‘were not consistent with a strong food safety culture,’ with Dr. Solomon stating that the FDA should re-evaluate its New Era of Smarter Food Safety initiative to include steps and procedures relevant to the infant formula industry.
He concluded that the formula industry ‘employs dated technology and record-keeping practices that can cause delay in collecting critical information’ that could aid the process and scope of product recalls, recommending that the agency defines best practices for product sampling, environmental monitoring and traceability among others.
He also found that consumer education regarding the safe handling and preparation of infant formula was ‘limited’, suggesting that the FDA should team up with other bodies and health providers to spread the word about the risks associated with powdered infant formula.
No authority, expertise or resources
The report has also identified serious gaps in the agency’s preparedness to face a crisis of this proportion. In one particularly damning verdict, Dr. Solomon wrote that the agency had no ‘authority, expertise or resources’ to manage supply chain issues of critical food products and that FDA agents who inspect infant formula plants ‘receive limited infant formula-specific training’. “The FDA should determine the resources needed to develop a specialized training program for investigators and other personnel charged with inspection and oversight of infant formula and other medical foods manufacturing facilities, request those resources from Congress, and develop and implement a specialized training program,” he recommended.
Dr. Solomon also criticized the agency’s lack of mechanisms to engage with other key regulatory and public health authorities ‘to avoid confusion about roles and responsibilities’. He also found the agency lacks means of coordinating staff on response activities beyond a typical foodborne outbreak response.
The FDA is set to implement the recommendations during the fall and release its own report in a year’s time on what has been achieved.
Responding to the findings, FDA commissioner of food and drugs, Robert M. Califf, has agreed with the recommendations. He stated: “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 fulfil 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.”
