FDA outlines plan to tackle bacterial illnesses in infant formula


The United States Food and Drug Administration is developing a plan to improve its monitoring of infant formula for Cronobacter bacteria.

The agency said in a statement Tuesday that it would like to see Cronobacter infections added to the U.S. Centers for Disease Control and Prevention’s list of national reportable diseases, which would mean doctors would be required to report cases to public health officials.

Cronobacter infections are rare, but they can be serious and even fatal, especially in newborns. Cronobacter lives in the environment, but when these infections are diagnosed in infants, they are often linked to powdered formula.

Only one state, Minnesota, now requires physicians to report Cronobacter infections to the state health department. Because of this requirement, Minnesota was the first state to alert federal regulators to a potential problem with powdered baby formula last year.

Ultimately, the FDA received four reports of Cronobacter infections in babies last year, including two deaths. The infants had all consumed powdered formula made at an Abbott Nutrition production facility in Sturgis, Michigan.

A lengthy FDA inspection of the plant and subsequent recall of products made there exacerbated a national infant formula shortage that only worsened when Abbott closed the plant to make necessary repairs. Census data shows families are still struggling to find infant formula months after the facility restarted.

Ultimately, although the FDA detected Cronobacter bacteria in the plant, genetic testing could not link this bacteria to sick infants.

In a written statement to CNN, Abbott said, “Since our voluntary recall in February, investigations by the FDA, Centers for Disease Control and Prevention (CDC) and Abbott, including genetic sequencing, stored product samples and available products of the four complaints, found no definitive link between the company’s products and childhood illnesses. No retained samples of the recalled product have tested positive for Cronobacter. And, in all four cases, unopened containers of infant formula in nursing homes tested negative for Cronobacter sakazakii. »

Although the FDA statement adds significant weight to the desire to add Cronobacter to the list of reportable diseases, ultimately the decision is made by a different group: the nonprofit Council of Epidemiologists for state and territories.

“If the FDA backs it up and calls it out, I think that provides a lot of support to move the issue forward with state and territory epidemiologists,” said Mitzi Baum, chief executive of Stop Foodborne Illness, a nonprofit group. nonprofit that advocates on behalf of food poisoning victims.

Stop Foodborne Illness wrote a letter to the FDA and CDC in March urging them to move the ball forward to get Cronobacter added to the list.

Baum said there are several interesting ideas in the FDA’s plan, but because there’s no timeline attached to the plan, it only seems like a half measure to him.

“There is a lack of a sense of urgency associated with this issue, which is really focused on the most vulnerable population,” she said. “It’s just not a strong enough step. But it’s a step. »

The FDA said Tuesday it is also considering other actions, including:

  • Create a dedicated team of food inspectors that would focus on infant formula
  • Provide additional education and training to personnel who inspect infant formula production facilities
  • Review and update of guidelines and rules for infant formula production facilities
  • Reassess testing requirements to improve the safety of finished infant formula
  • Develop and improve consumer education on how to safely prepare and store infant formula
  • Conduct and support more research to fill gaps in scientific knowledge about Cronobacter

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

The FDA has released similar action plans for other foods that have a history of certain types of contamination. In September, the agency released plans to prevent salmonella infections caused by contaminated bulb onions and listeria and salmonella infections linked to ear fungus.


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