Top FDA officials are calling on manufacturers of infant formula to clean up their act.

In a letter this week Robert M. Califf, FDA Commissioner, and Susan T. Mayne, Director of the Center for Food Safety and Applied Nutrition, addressed concerns about infant formula along the food chain, speaking to manufacturers, packers, distributors, exporters, importers and retailers.

“FDA is sharing this information with you with the expectation that you will act to mitigate potential food safety risks in powdered infant formula in accordance with FDA regulations while further striving to improve operations, especially given the critical nature of these products,” a letter from the FDA leaders states.

“. . . The FDA has reviewed conditions during recent inspections of powdered infant formula manufacturers, including routine surveillance inspections, for-cause inspections to follow up on consumer complaints and other interactions with manufacturers.”

The letter is part of the FDA’s response to a series of Cronobacter spp. illnesses among infants associated with feeding Similac and other brands of powdered infant formula produced by an Abbott Nutrition plant in Michigan.

An inspection of the facility found Cronobacter spp. within the production environment, as well as other insanitary conditions, leading to a nationwide recall. The recall and months-long shutdown of the plant were a major contributing factors to the infant formula shortage experienced across the U.S. in 2022.

“In response, the FDA developed a strategy to prevent future Cronobacter spp. illnesses associated with powdered infant formula and is issuing this letter to share current information to assist industry in improving the microbiological safety of powdered infant formula,” according to the letter.

In a statement put out with the release of the letter, Califf and Mayne said the FDA has reviewed food safety and operating conditions during ongoing inspections of powdered infant formula manufacturers. In addition, during the past two months, food safety staff have been meeting regularly with the powdered infant formula manufacturers to further develop the prevention strategy to help prevent Cronobacter illness associated with consumption of powdered infant formula.

As part of the steps suggested by the FDA, the agency wants companies to “voluntarily notify the agency any time a product sample is found to be positive for Cronobacter spp. or Salmonella, even if the affected lot(s) have not been distributed.”

The FDA isn’t happy with the manner in which companies monitor the presence of bacteria and indicators of Cronobacter in their facilities, according to the letter from Califf and Mayne.

“Manufacturers of powdered infant formula must establish a system of process controls covering all stages of processing that are designed to ensure that the product does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” the FDA leaders say in their letter.

“. . . The presence or absence of EB (Enterobacteriaceae) on environmental surfaces is not a reliable indicator for the presence of Cronobacter spp. In other instances, when responding to the detection of Cronobacter spp. in a product sample, some facilities immediately initiated sanitation activities on suspected environmental or equipment surfaces and then collected samples from these surfaces to verify sanitation effectiveness. 

“This approach limited their ability to determine whether those surfaces contributed to the contamination event. FDA encourages firms conducting an RCI (root cause investigation)  to thoroughly investigate the potential sources of contamination by collecting environmental samples before performing sanitation activities, in addition to other RCI activities such as evaluating incoming ingredients and reviewing production records,” according to the letter.

The FDA leaders are calling on the manufacturers to ensure that the raw materials used to make infant formula are free of pathogens, or put in place methods to kill pathogens, before using raw ingredients.

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