U.S. Food and Drug Administration officials hope enhanced oversight and guidelines will better ensure the safety of infant formula. The agency has announced adoption of its draft guidelines and an updated Infant Formula Compliance Program will be released shortly.

Among announced initiatives underway is increased staffing of both investigators to “establish a dedicated cadre of investigators to conduct infant formula inspections” and “staff to support the new Office of Critical Foods.” The hirings are part of reorganization and realignment efforts.

To better support regulatory oversight of infant formula, the FDA explains: “Infant formula activities will be housed within the new Office of Critical Foods within the proposed Nutrition Center of Excellence and with continued support from the proposed Office of Microbiological Food Safety.”

Relevant rules and testing requirements are currently under review. The agency is also working with Congress, exploring legal authority to require companies to notify the FDA if any product tests positive for Cronobacter sakazakii.

Authorities want to avoid a formula shortage like the one that followed four cases of illness and death as a result of Cronobacter sakazakii  in 2022. Concerns over possible bacterial investigations prompted an investigation into possible bacterial contamination, which led to the shuttering of one of the nation’s largest baby formula manufacturing plants.

Baby Formula Recalls Highlighted Need for More Oversight

Between September 2021 and February 2022, the FDA received reports of four babies who were ill or died after consuming infant formula tracked to Abbott Nutrition’s Sturgis, Michigan plant. FDA investigators found unsanitary conditions in the facility.

Five different strains of the deadly Cronobacter pathogen were found inside the plant. None of the strains found at the plant matched the strain identified in the sickened babies, however.

Babies who suffer from a Cronobacter infection can have bloodstream or central nervous system infections including sepsis or meningitis. Other complications could include brain abscess, developmental delays, motor impairments or death, according to the FDA.

A massive baby formula recall was issued and the plant was closed, causing a significant shortage in 2022. Families struggled to find baby formula across the country. 

Some parents turned to types of formula incompatible with their children’s specific dietary needs because they were what was available. Some parents even tried risky options such as nutritionally questionable homemade formula recipes circulating on social media that landed some infants in the hospital for malnutrition.

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FDA Letters to Baby Formula Companies

In August 2023 the FDA sent warning letters to three formula makers. The letters noted violations of the Federal Food, Drug and Cosmetic Act and the FDA’s Infant Formula regulations that were found during inspections over the past several months.

“Infant formula manufacturers are responsible for ensuring they make safe products, and the agency has remained in ongoing discussions with the infant formula industry to address the agency’s concerns,” Donald Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition stated. “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.” 

Letters were sent to ByHeart Inc., Mead Johnson Nutrition/Reckitt and Perrigo Wisconsin, LLC. Such letters are now part of the regulatory process according to the FDA. 

“Over the last year the FDA has continued to increase our oversight of powdered infant formula facilities,” Prater explained. “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.”

Concerns Over Baby Formula and NEC

Contributing to public concerns over the safety of baby formula products are reports of necrotizing  enterocolitis. Unrelated to the Cronobacter sakazakii cases, some premature babies developed NEC after consuming cow’s milk-based baby formulas. 

NEC is a severe gastrointestinal condition that primarily impacts premature babies. NEC-related illnesses and deaths have led to lawsuits against manufacturers Mead Johnson and Abbott Laboratories. 

The plaintiffs are parents of injured infants. Their baby formula lawsuits claim that manufacturers failed to warn medical providers and the public about the risk of NEC associated with their baby formulas.