How The Baby Formula Shortage Is Sparking Massive Changes To Food Safety Protocol

The U.S. Food and Drug Administration (FDA) has major responsibilities that include ensuring that foods are "safe, wholesome, sanitary, and properly labeled." In addition, it must ensure that human and veterinary drugs, including vaccines, medical devices, and other products are safe and effective. The agency is also responsible for the safety and proper labeling of cosmetics, and the regulation of tobacco products.

The baby formula shortage in 2022, sparked by a recall on several brands and supply chain issues, uncovered weaknesses with how the agency handles crises. As a result, FDA Commissioner Robert M. Califf, M.D., teamed with the Reagan-Udall Foundation to evaluate the agency's Human Foods Program. The foundation published a lengthy report that noted, among other things, "during the aforementioned infant formula foodborne-illness outbreak and subsequent product shortage, a review of events indicates that lack of communication and engagement across the Agency accounted, in part, for missteps."

In addition, the report states the FDA's current approach, which is "primarily focused on identifying and reacting to acute outbreaks of foodborne illness and death is unacceptable."

The lack of a clear vision and mission, along with the lack of strong leadership, contributed to the problems the FDA experienced during the pandemic, the report explains. As a result, the foundation suggests restructuring the Human Foods Program. It also suggests that the FDA utilize its mandatory recall authority more often, noting that a "process should be in place to assure that accommodations are made for life-sustaining products that are the only source of nutrition for certain populations." Other changes recommended include a Federal Food Administration that operates independently of a Federal Drug Association. 

FDA Commissioner Robert M. Califf, M.D., released a statement in which he states that he is committed to creating a "world-class Human Foods Program," and adds that the Human Foods Program is a top priority for the agency. He says he plans to form a group of leaders to advise him going forward with any other decisions. He says that the FDA will provide public updates on the agency's new vision by the end of February 2023.