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FDA lays out plan to combat bacterial contamination of baby formula

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By Brenda Goodman, CNN

The US Food and Drug Administration is charting a plan to enhance its surveillance of infant formula for Cronobacter bacteria.

The agency said in a statement Tuesday that it would like to see Cronobacter infections added to the US Centers for Disease Control and Prevention's list of national notifiable 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 doctors 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 manufactured at an Abbott Nutrition production facility in Sturgis, Michigan.

A lengthy FDA inspection of the plant and subsequent recall of products manufactured there exacerbated a nationwide infant formula shortage that only got worse when Abbott shut down the plant to make needed repairs. Census data shows that families are still struggling to find baby formula months after the facility restarted.

Ulitmately, although the FDA detected Cronobacter bacteria in the plant, genetic testing couldn't link that bacteria to the sick infants.

In a written statement to CNN, Abbott said "Since our voluntary recall in February, investigations conducted by the FDA, the Centers for Disease Control and Prevention (CDC) and Abbott, including genetic sequencing, retained product samples and available product from the four complaints, did not find any definitive link between the company's products and illnesses in children. No retained samples of recalled product tested positive for Cronobacter. And, in all four cases, unopened containers of formula in the infant homes tested negative for Cronobacter sakazakii."

Although the FDA's statement adds important weight to the push to add Cronobacter to the list of notifiable diseases, ultimately, the decision is made by a different group: the nonprofit Council of State and Territorial Epidemiologists.

"If FDA supports it and calls for it, I think that provides a lot of support to move the issue forward with the State and Territorial Epidemiologists," said Mitzi Baum, chief executive officer of Stop Foodborne Illness, a nonprofit group that advocates on behalf of the victims of food poisoning.

Stop Foodborne Illness wrote a letter to the FDA and the 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 outline, but because there's no timeline attached to the plan, it strikes her as only a half measure.

"It lacks 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 is a step."

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

  • Creating a dedicated team of food inspectors that would focus on infant formula
  • Providing additional education and training for staff who inspect infant formula production facilities
  • Reviewing and updating guidance and rules for infant formula production facilities
  • Re-evaluating testing requirements to enhance safety of finished infant formula products
  • Developing and improving consumer education on how to safely prepare and store infant formula
  • Conducting and supporting more research to fill in gaps in the scientific knowledge of Cronobacter

The agency says it will meet with stakeholders and continue to refine its plans over the next few 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 wood ear mushrooms.

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