The FDA has released extensive information about the status of its work to improve its monitoring of infant formula production and its handling of complaints about the safety of formula.

Problems with the Food and Drug Administration’s ability to watch for problems and respond to complaints about infant formula were brought to light during the 2021-22 outbreak of cronobacter infections in infants. The subsequent recall of Similac and other popular brands of infant formulas further showed internal failures in terns of the agency’s ability to respond to and contain such situations.

In a Dec. 13 update, the agency outlined steps it has taken to resolve the problems, which also included a supply crisis related to the recall of the formulas and the shutdown of the Abbott Nutrition plant that manufactured them.

During a May 2022 congressional hearing, members of the U.S. House of Representatives told FDA Commissioner Robert Califf to fix the problems related to infant formula as well as agency wide problems with communication and chain of command that the formula crisis revealed.

In response to those congressional demands, the FDA has stepped up inspection of infant formula production. During the federal fiscal year 2023, which ran from Oct. 1, 2022, through Sept. 30, 2023, the FDA conducted 47 routine annual inspections of foreign and domestic facilities that produce infant formula, including some that also produce medical foods.

Among the problems revealed by the 2021-22 infant formula outbreak and shortage was the handling of a whistleblower complaint received by the FDA in the fall of 2022. It was ultimately found that the complaint had been delayed from reaching proper authorities because of a variety of internal problems, including mailroom issues.

The complaint described numerous failures at the Abbott Nutrition manufacturing plant that made the formula, including the fact that the company’s internal testing showed contamination of some formula that was not reported to the FDA.

In September this year, the FDA released an update on its strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. According to the Dec. 13 update, some of the action includes:

  • Issuance of a letter to the powdered infant formula industry to share current safety information and a call to industry to take prompt action to improve processes related to the safe production of powdered infant formula.
  • Initiation of hiring to establish a dedicated group of investigators to conduct infant formula inspections.
  • Initiation of hiring of staff to support the new Office of Critical Foods.
  • Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, which was successfully adopted by the CSTE on June 29, 2023, and goes into effect in 2024. The FDA, along with CSTE and CDC, have been meeting regularly to discuss how best to support implementation of this new notification process.

The FDA’s update also says the agency continues to seek additional congressional authority through the FY24 budget request to require that manufacturers report to FDA final product positive test results for relevant pathogens, including those that have not left the manufacturer’s control.

The agency also wants the authority to conduct more frequent environmental monitoring in facilities to identify relevant pathogens and maintain the results of such testing for FDA inspection, either in person or remotely. 

“The combination of these new authorities would empower the FDA to work with firms in real time to resolve issues around product positive findings and better assure the safety of product entering the market,” according to the FDA update.

Operational improvements cited by the FDA include updates to its consumer complaint procedure to more quickly notify senior officials of complaints. Such complaints include the illnesses and/or deaths of infants.

The agency has also revised its procedures for handling complaints from whistleblowers and confidential sources. The FDA’s Office of Operations has initiated procedures to improve the tracking of accountable mail, which may include complaints, through the point of delivery to ensure that such mail is received and acted upon in a timely manner.

Also, the FDA’s Office of Regulatory Affairs (ORA) has expanded the agency’s ability to test for cronobacter to all seven ORA laboratories and all FDA labs have been given new procedures for escalating significant testing results to senior leaders. 

Other adjustments made by the FDA in relation to the safety of infant formula include increasing the staff at the Center for Food Safety and Applied Nutrition’s Office of Nutrition and Food Labeling by 66 percent to improve infant formula reviews.

Another change is the creation of the Office of Critical Foods (OCF), which will oversee and coordinate activities related to “critical foods,” which are defined as medical food and infant formula. The agency is hiring people to fill positions related to the OCF as well as other positions, which will help to support infant formula oversight and regulation. This has included the hiring of a Chief Critical Foods Officer, a Senior Advisor for Critical Foods Enforcement and Compliance, a Senior Regulatory Counsel for Critical Foods, and a Medical Officer for Critical Foods.

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