FDA Unveils Plan Aimed at Preventing Outbreaks of Deadly Bacteria in Baby Formula

Baby formula shelved in a Walmart Supercenter in Houston, Texas on July 8, 2022. Brandon Bell/Getty Images

The U.S. Food and Drug Administration (FDA) on Nov. 16 said it is developing a new plan which aims to prevent outbreaks of Cronobacter bacteria in instant baby formula.

In a statement, the agency said it would review and update current guidance and rules regarding the manufacturing of infant powdered formula and is considering whether to establish a dedicated group of investigators to conduct inspections of infant formula.

The agency said it would also look into realigning staff across two divisions: the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs, to better support “regulatory oversight” of infant formula, and review and update the Infant Formula Compliance Program to reflect current science on Cronobacter.

It would also ensure that FDA officers have the tools and resources they need to conduct comprehensive inspections of infant formula manufacturing facilities.

Additionally, the FDA plans to provide additional education and training to FDA regulatory staff regarding inspections of powdered infant formula manufacturing facilities and evaluate the testing requirements of instant formula to see if improvements can be made to enhance the safety of the finished product.

The agency would also like to see Cronobacter added to the Centers for Disease Control and Prevention’s (CDC) list of national notifiable diseases, under which doctors, healthcare providers, laboratories, and hospitals would be required to report cases to public health authorities.

Currently, only the state of Minnesota requires Cronobacter cases to be reported to public health authorities in the state.

Cronobacter, also known as Enterobacter sakazakii, is a germ that can live in very dry places, including in dry foods like powdered infant formula, powdered milk, herbal teas, and starches, according to the (CDC).

The Abbott Laboratories facility where dozens of recalled types of powdered baby formulas were made leading to production being halted at the location, in Sturgis, Mich., on May 20, 2022. Eric Cox/Reuters

Infections in Infants Can Be Deadly

While Cronobacter infections are rare, they can be deadly when they occur in infants. According to the CDC, infections in infants less than 12 months old are often linked to powdered infant formula.

Cronobacter infections in infants typically occur in the first days or weeks of life. However, infections can also occur in vulnerable individuals, such as the elderly, or those aged 65 years and older,  and those who have weakened immune systems, such as individuals with HIV, organ transplants, or cancer.

Roughly two to four cases of Cronobacter infections are reported to the CDC every year, although the agency says that the actual figure may be higher.

Symptoms in infants typically begin with a fever and poor feeding, along with excessive crying and decreased energy. Some infants may also have seizures, according to the CDC.

The FDA’s plan comes after four infants were hospitalized between September 2021 and February 2022 for infections related to Cronobacter bacteria after consumption of powdered infant formula. The bacterial infection may have contributed to two deaths, according to the FDA.

“After learning that each of these infants consumed powdered infant formula products manufactured by Abbott Nutrition in Sturgis, Michigan, the FDA initiated an onsite inspection at the facility and commenced an investigation that revealed unsanitary conditions, including the presence of five different strains of Cronobacter sakazakii within the facility,” the FDA said in Tuesday’s statement.

The shutdown of Abbott’s Michigan plant exacerbated a nationwide shortage of baby formula. The plant was later restarted in July.