FDA Gives Guidance To Manufacturers Of Baby Formula

The FDA recently provided guidance to baby formula manufacturers. That guidance comes after baby formula was recalled in 2022 due to Cronobacter sakazakii and Salmonella Newport infections.

The FDA inspected the manufacturing plant which was associated with the infections and found Cronobacter bacteria in the production environment, along with additional unsanitary conditions, leading to the recall. The plant’s temporary shutdown and the recall contributed significantly to a shortage of infant formula which the United States experienced in 2022.

The guidance letter the FDA provided baby formula manufacturers with included a strategy to prevent future bacterial infections associated with baby formula and was intended to help the industry improve the safety of baby formula.

FDA Calls On Baby Formula Manufacturers To Act

The FDA asked baby formula manufacturers to take five steps to protect infants:

1. Evaluate all processing stages involved in the production system, from acceptance and receipt of raw materials, components and ingredients through the distribution and storage of finished products, and make sure adequate controls are implemented at any stage, step or point in the process of production where it is necessary to have control to prevent infant formula from being adulterated;
2. Make sure all regulations are complied with;
3. Consider concerns in the letter when evaluating the production system as well as in-process controls, including during the process of taking corrective action;
4. Make sure the notification requirement regarding misbranded or adulterated infant formula is adhered to whenever products leave the facility;
5. Voluntarily notify the FDA whenever product samples are found to test positive for Cronobacter or Salmonella bacteria, even when the affected product has not been distributed.

FDA Found Five Areas Of Concern At Infant Formula Manufacturing Plants

The FDA recently inspected infant formula manufacturing plants, reviewing conditions during the inspections. The agency identified five areas of improvement for the infant formula industry:

1. Controlling Water In Areas Of Dry Production

The FDA called reducing water’s presence in dry production environments “essential” for controlling contamination of the production environment. The FDA, when inspecting several infant formula manufacturing plants, observed the presence of water in production areas which were supposed to be dry. The water came from condensation, equipment leaks and leaks from roofs or other features of the exterior facilities.

The FDA noted that one water source in the dry production environments was poorly maintained equipment which leaked.

The FDA also noted that cleaning equipment can introduce large amounts of water to the surfaces of equipment, stressing the importance of making sure equipment is fully dried following cleaning procedures.

2. Verifying Control Effectiveness By Monitoring The Environment

The FDA noted that it is “important” to monitor the environment to make sure hygiene and sanitation controls effectively prevent pathogens from ending up in or persisting in production areas which are supposed to be dry.

The FDA found that some plants heavily relied on monitoring for the presence of Enterobacteriaceae (EB) within production areas, while limiting the collection of samples for Cronobacter. The agency stated that while the presence of EB can be a useful indication that water is present in a dry environment or that hygiene control may have broken down, they aren’t aware of enough data which demonstrates a correlation between populations of EB and Cronobacter presence on surfaces in the environment. The agency stated they encourage directly testing for the presence Cronobacter in infant formula plants.

3. Implementing Corrective Action After Pathogens Are Isolated

The agency stated infant formula manufacturers must implement corrective action once testing detects pathogens such as Salmonella or Cronobacter.

The agency noted that some manufacturing plants tested for EB following the detection of Cronobacter, again noting that reliable data doesn’t exist indicating a correlation between the presence of EB and the presence of Cronobacter.

The agency also noted that some plants immediately sanitized the environment and equipment, then performed tests to determine if sanitation was effective, after detecting Cronobacter. The agency noted this limited the plants’ ability to figure out if those surfaces were a contributing factor to contamination. The agency encouraged plants to investigate the root cause of contamination events prior to sanitizing equipment and environments.

The agency found during their inspections that manufacturing activities sometimes went on for “extended” time periods between sanitation activities.

The agency also recommended that plants use whole genome sequencing to conduct root cause investigations when pathogens are detected in products or the environment.

4. Implementing Supply Chain Controls Regarding Biological Hazards

The FDA noted that some infant formula manufacturing plants use raw materials and ingredients in a way which doesn’t apply treatments to them which would kill bacteria like Salmonella or Cronobacter. The agency encouraged plants to evaluate hazards associated with ingredients and raw materials, determine if they need supplier-level control, and, if necessary, establish supply chain programs for them.

The agency also found that supply chain programs at manufacturing plants didn’t always completely characterize the risk of bacterial pathogens. The agency stated that it is the manufacturer’s responsibility to verify if raw materials or ingredients are sanitary and inform suppliers what the intended use of the ingredients or raw materials is.

5. Identifying Any Biological Hazards Which Are Relevant

The FDA reminded the infant formula industry that while Cronobacter has seen a lot of attention lately, there are other biological hazards associated with infant formula. The agency encouraged manufacturers to consider Cronobacter, Salmonella and Clostridium botulinum when designing and implementing control measures for the safe manufacturing of infant formula as well as products designed for children aged 12 to 36 months.

Baby Formulas Recalled In 2022

Similac, Alimentum and EleCare formulas were recalled in 2022 due to the presence of Cronobacter and Salmonella bacteria. The FDA said that two infants died and four infants were hospitalized due to the formula contamination.

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