It’s been about a month since Abbott Laboratories reopened its formula plant in Michigan, but the United States is still in dire need of infant formula. The plant shut down in February after some formulations were recalled for containing bacteria after infants became ill. Abbott holds a whopping 40% share in the fixture market within the United States. The production plant was supposed to resume operations in June but was postponed for a month due to flooding in the area. Certain states saw stock-out rates close to 60% in July, but the national average is currently 30%.
The White House secured 17 missions from Operation Fly Fly Formula and imported enough powder to make 61 million bottles. The Defense Production Act was repealed to remove some tariffs, but this was a temporary fix. Consumers in the United States require formula that is sufficient for 65 million bottles per week. Experts now believe the shortage will continue into the fall months.
The Food and Drug Administration (FDA) failed to act quickly. Some red tape and regulations are to blame. FDA commissioner Robert Califf testified in July, clearing the FDA of blame, saying they simply didn’t know. “There is no law requiring manufacturers of these products to notify the Food and Drug Administration when they become aware of conditions that may lead to a shortage of these products. Without this information, the agency may have little or no idea as to when a major shortage will occur, Califf said, preventing us from taking potential mitigation efforts until the crisis unfolds. He believed that the availability of the formula would return to normal within eight weeks.
An investigation showed that the Food and Drug Administration was first notified of the contamination of formula in December 2021. In fact, 128 complaints were filed between December 2021 and March 2022. The FDA was certainly aware of the contamination before it took action. The White House also took so long to respond that Biden did not call for the Defense Production Act until May 2022, when 40% of the formula was unavailable. This problem should have been resolved months ago, but it persisted due to the government’s incompetence.