The Safe Food Coalition delivered a letter to Secretary Kennedy, Department of Health and Human Services, Commissioner Makary, U.S. Food and Drug Administration, and Acting Director O’Neil, Centers for Disease Control and Prevention, urging immediate steps towards ensuring infant formula safety following the outbreak of Clostridium botulinum infections linked to infant formula manufactured by ByHeart, Inc. The letter states, swift action is needed to avoid future outbreaks and further disruptions to the supply of this critical product. The ongoing infant botulism outbreak linked to infant formula, with 37 confirmed cases so far, has exposed dangerous deficiencies in the inspection and regulatory systems that should ensure the safety of the nation’s youngest and most vulnerable consumers.