INFORM January 2024

30 • inform January 2024, Vol. 35 (1)

NEW SAFETY STANDARDS On October 6, 2023, the agency updated its infant formula compliance program for FDA investigators, laboratory ana lysts, and compliance officers. In a statement, the agency said its latest compliance program comprehensively outlines the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the US food supply are safe and nutritious. And that this effort is part of the FDA’s ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry. In September 2022, the FDA released its internal eval uation of the infant formula response which recommended that the agency review and update its infant formula com pliance program to ensure that it reflected the latest science on Cronobacter and offered consistency and clarity on inspec tion and compliance activities. In November 2022, as part of the Cronobacter prevention strategy, the agency committed to completing that review and update. The FDA has now published its updated compliance pro gram, which builds on lessons learned over the last several years to elaborate on its approach to inspections, sampling, laboratory analysis, and imported infant formula products. For example, updates include instructions for annual environ mental sampling of Cronobacter and Salmonella at powdered infant formula facilities. The compliance program provides instructions for FDA notification should a sample test positive for Cronobacter or Salmonella , or if a sample is found to have nutrients that are above or below required levels per the FDA’s infant formula regulation. The compliance program also includes instructions for product or environmental positive tests for contamination during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program. More generally, additional background on the risks asso ciated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022. The FDA will continue its regulatory oversight and engage ment with industry to enhance infant formula safety, includ ing continuing to conduct annual inspections of infant formula facilities, maintaining a dialogue with infant formula manu facturers on these issues, and furthering prevention-based research and activities. For more on the updates related to the FDA’s oversight of infant formula visit the FDA’s Infant Formula webpage (https:// www.fda.gov/food/resources-you-food/infant-formula).

also planned to evaluate the “adequacy” of the companies’ responses when it next inspected their facilities. The health warnings came after a year of shortages in the baby formula market in 2022. That year the Abbott Laboratories’ Michigan unit shut down its infant formula man ufacturing plant. The FDA said stock rates of baby formula have been at about 85 percent nationwide ever since the beginning of 2023. THE DANGER TO INFANTS Cronobacter sakazakii occurs naturally and is found in most home settings, where it lives on countertops, sinks, and other hard surfaces. Most people are not susceptible to harmful infections from Cronobacter , but for premature or very young infants, the pathogen can cause septicemia (blood poisoning), necrotizing enterocolitis (tissue death in the colon and intes tine), and meningitis (swelling of the protective layer around the brain and spinal cord). Cronobacter infection is extremely rare, but is fatal in 40 to 80 percent of cases; survivors gener ally experience severe neurological disorders, including devel opmental delays and motor impairment. Powdered infant formula is considered the primary source of Cronobacter in the food supply, but Cronobacter testing for non-infant formula products is rare and not required. A 2009 study tested 233 samples of food and environmental products for Cronobacter . One powdered infant formula of the 76 tested samples was positive, and 26 of the remaining 28 positive tests were from samples of herbs, spices, teas, and packaged instant foods. (Two positive samples were from household dust.) These non-formula food products are not routinely tested for Cronobacter . The FDA says parents and caregivers should follow man ufacturer instructions for preparing powdered infant formula. For babies less than 2 months old, born prematurely, or with weakened immune systems the US Center for Disease Control recommends, if possible, using ready-to-feed liquid infant formula. Liquid infant formula is made to be sterile and is the safest option for infants not receiving breast milk. However, parents and caregivers can also take extra steps to prepare powdered formula for these infant groups by heating water to at least 158°F/70°C to help protect against Cronobacter , adding the powdered infant formula and mixing, and then cooling the for mula to body temperature (98.6°F) before feeding. However, certain metabolic and specialty products include statements on their packaging warning consumers against heating because heating the product above 100°F could result in a loss of vitamins and nutrients. Therefore, caregivers should be especially mindful of the manufacturer’s instruc tions included on the packaging for metabolic and specialty formulas.