US FDA admits the shortage of infant formula, shared a roadmap for strengthening its supply

The US is facing a serious shortage of infant formula. The Commissioner of the Food and Drug Administration, Robert M. Califf, stated in the announcement that the stringent restrictions applied on the infant formula market have resulted in supply chain disruptions. FDA has increased the regulations, making them more strict to improve the quality of infant formula and to maintain the safety of consumers. Abbott’s events with its manufacturing plant in Michigan have resulted in making these regulations even more strict, thus disrupting the supply chain. These stringent regulations have greatly reduced consumer access to infant formulas. On Feb 17, 2022, Abbott announced a recall request for Similac, Alimentum, and EleCare infant formulas in response to the four complaints filed against these products. As per the complaint, the infant formulas prepared at the Abbott plant in Sturgis, Michigan contained bacteria such as Cronobacter sakazakii or Salmonella. Four children were hospitalized after consuming these powder formulas, one of them died due to bacterial infection. Because of this, Abbott recalled all the units of Similac, Alimentum, and EleCare infant formulas manufactured at this plant. Abbott has since then shut down its manufacturing plant in Sturgis, Michigan. This plant was not only responsible for fulfilling the local demand, but also the international demand. But its impact on the US infant formula market was significant enough to cause a shortage of baby formula in the country since Abbott is one of the largest producers of infant formula in the world. An analytical study conducted by Dr. Steven Solomon, director of the Center for Veterinary Medicine, to address the FDA’s decision-making related to Abbott’s case, showed many flaws in how the US FDA handled the situation. The study highlighted the lack of clarity while commencing emergency management in FDA. As per the study, the US FDA lacks standard processing, especially when it comes to food safety product-related emergencies. The lack of clarity in roles and responsibilities caused the disruptions of supply chains related to infant formula, resulting in its shortage. COVID-19 restrictions also played a key role in delaying an active response to the filed complaints against Abbott’s infant formulas. Another major finding of this study was that the FDA investigators who handled Abbott's case had minimum expertise specifically related to the management of infant formula analysis. The reason stated for this in the study was the lack of funding. Lack of funding has caused stalling of the FDA’s food program, thus failing the FDA staff to keep up with the rapidly developing food industry, its complex supply chain, and the technological developments in the food manufacturing industry. FDA responded that the study highlighted how little authority the FDA poses to make the companies stick to ethical manufacturing and production practices. The FDA further assured that the local and domestic manufacturers of the infant formula have agreed to actively follow the manufacturing practices to meet the required standards. The new entrants in the infant formula industry and the rising investments are supposed to result in a rise in production volume in the coming period.