INFORM January 2024

inform January 2024, Vol. 35 (1) • 29 REGULATORY REVIEW Updating infant formula compliance Regulatory Review is a regular column featuring updates on regulatory matters concerning oils- and fats-related industries.

On August 30, 2023, the US Food and Drug Administration issued warnings to three infant formula makers over violations of federal safety regulations. The agency instructed the manu facturers to correct their processes to better catch bacterial contamination. The warning letters were issued to ByHeart Inc, Reckitt Benckiser Group’s Mead Johnson Nutrition, and Perrigo’s Wisconsin unit for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Infant Formula regulations. They reflect findings from FDA inspec tions of these facilities over several months. At the time of each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls (in December 2022, February 2023 and March 2023) to remove product potentially contaminated with Cronobacter sakazakii from the marketplace. “The FDA is committed to identifying and acting on issues early to prevent any firms from reaching the level of concern that prompted last year’s large-scale recall and contributed to the infant formula shortage,” said Donald Prater, acting direc tor of the FDA’s Center for Food Safety and Applied Nutrition, in a statement. “Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities. These letters are a reflection of this enhanced oversight and are intended to help the industry continuously improve the safety of their manufacturing practices, so that parents and caregivers can be confident that the formula they feed their children is safe and nutritious,” he continued. EFFECT ON SUPPLY At the time, the FDA did not advise parents and caregivers to discard or avoid purchasing any specific infant formula. The agency did not believe that any distributed product was con taminated and considered the recalls effective in removing the potentially contaminated batches of product from the market. Additionally, the warning letters were not associated with any

recalls and did not impact the availability of infant formula on the market. “The FDA is issuing these letters now as part of its nor mal regulatory process and to reinforce to these firms the importance of instituting and maintaining appropriate correc tive actions when they detect pathogens to ensure compli ance with the FDA’s laws and regulations,” the agency said in a statement last summer. The letters mandated that the companies commit to extensive cleaning and sanitation regiments, conduct inves tigations into the contaminations and reevaluate company sanitation policies. The companies were given 15 working days to create corrective plans for FDA review. The agency