Baby Formula

FDA announces a plan to prevent bacterial contamination in baby formula

The US Food and Drug Administration has a plan in place to increase its surveillance of infant formula for Cronobacter bacteria.

In a Tuesday statement, the agency stated that Cronobacter infections should be added to the US Centers for Disease Control and Prevention’s list of nationally notifiable diseases. This would require doctors to report any cases to public health officials.

Although rare, Cronobacter infections can be fatal in newborns. Cronobacter can be found in the environment. However, infants who have been diagnosed with this infection are often given powdered formula.

Minnesota is the only state that requires doctors to report Cronobacter infection to their state’s health department. Minnesota was the first state last year to alert federal regulators about a possible problem with powdered infant formula.

The FDA received four reports last year of Cronobacter infection in babies, with two deaths. All of the infants had consumed powdered formula made at an Abbott Nutrition facility in Sturgis (Michigan).

The lengthy FDA inspection and subsequent recall of infant formula products made there only exacerbated the national shortage of infant formula. Abbott closed the plant to make repairs. The Census data shows that many families still struggle to find baby formula even months after the facility was restarted.

Even though Cronobacter bacteria were detected in the plant by the FDA, genetic testing could not link it to the infants who were sickened.

Abbott stated in a written statement that “Since February’s voluntary recall, Abbott and the Centers for Disease Control and Prevention have conducted investigations including genetic sequencing, product samples, and product available from four complaints. They have not found any link between Abbott’s products and children’s illnesses.” Cronobacter was not found in any of the recalled products. In all four cases, the unopened formula containers in infant homes were negative for Cronobacter.

While the FDA statement is a significant weight in the push for Cronobacter to be added to the list of a notifiable diseases, it is ultimately decided by another group, the non-profit Council of State and Territorial Epidemiologists.

“If FDA supports and calls for it,” stated Mitzi Baum, chief executive officer at Stop Foodborne Illness, which is a non-profit organization that advocates for victims of food poisoning.

Stop Foodborne Illness sent a March letter to FDA and CDC urging them to take action to add Cronobacter to their list.

Baum stated that there are many interesting ideas in FDA’s outline. However, there is no timeline attached to it so she considers it a half-measure.

She said that the issue lacks urgency and is not focused on the most vulnerable populations. It’s not strong enough. It is, however, a step.

Tuesday’s FDA statement stated that the FDA is considering additional actions, including:

A dedicated food inspection team that would be able to focus on infant formula

Staff who inspect infant formula production facilities should receive additional training and education.

Revision and updating of guidelines and rules applicable to infant formula production facilities

To improve the safety of infant formula products, we are reviewing the testing requirements

Enhancing and developing consumer education about how to store and prepare infant formula safely

Supporting more research to fill gaps in scientific knowledge about Cronobacter

According to the agency, it will continue to refine its plans and meet with stakeholders over the coming months.

Similar action plans have been released by the FDA for foods with a history of contamination. The agency published plans in September to prevent salmonella infection from contaminated bulb onions, listeria, and wood ear mushrooms.

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