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CDC closes infant formula outbreak investigation; The FDA continues to work to find the source; USDA working to address shortages




The CDC has said an outbreak of cronobacter infections in babies is over, but the Food and Drug Administration is continuing to investigate the manufacturer of the infant formula involved.

The FDA received four complaints of Cronobacter infections in infants beginning September 20, 2021 and through January 11, 2022. Two of the infected infants died. The parents of the four infants said they gave their children infant formula produced by Abbott Nutrition before they fell ill.

The Centers for Disease Control and Prevention worked with the FDA and state health departments to investigate the outbreak. The FDA has opened an investigation into the production facility in Abbotts Sturgis, MI, and the plant remains closed while the investigation continues. Although five strains of cronobacter were found in the production plant, none of them exactly matched the patient samples.

The situation has led to the recall of certain Similac products as well as products sold under the Alimentum and EleCare brands.

The FDA continues to advise consumers not to use the recalled Similac, Alimentum or EleCare powdered infant formula. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the containers. Products are included in the recall if they contain all three items below:

  • the first two digits of the code are from 22 to 37 and
  • the code on the container contains K8, SH or Z2, and
  • the expiry date is 4-1-2022 (April 2022) or a later date.

In addition to the products described above, Abbott Nutrition has recalled Similac PM 60/40 with lot code 27032K80 (box) / 27032K800 (case). Currently, Similac PM 60/40 with lot code 27032K80 (box) / 27032K800 (case) is the only type and lot of this specialty formula being recalled. Additional recall information for the initial recall is available on the FDA website. Recalls do not include liquid formula.

Shortage of formula

Due to the recalls, a shortage of powdered infant formula is being reported by parents and caregivers across the country. A U.S. House of Representatives subcommittee is due to begin a hearing on the situation on May 25.

In the meantime, President Biden, FDA officials and US Department of Agriculture administrators have all said publicly that they are working to address the shortages.

The FDA played down the shortage, reporting earlier this week that more infant formula was sold in April than in March. The agency created an Incident Management Group (IMG) on April 1 to work on supply chain and food safety issues.

On Friday, the USDA, which oversees the federal WIC program that provides food assistance to women and their infants and children, said it was working with states on flexible requirements for recipients.

We were acutely aware that the ongoing recall has left many parents and caregivers worried about access to formula and how they will feed their babies, said Agriculture Secretary Tom Vilsack. Our team is committed to the health and safety of all Americans and calls on states to act immediately to provide maximum flexibility, information, and support to WIC participants. During this time, the USDA will continue the work we began in February, working not just within our department but across the federal government, suppliers and partners to end this infant formula crisis as soon as possible. quickly as possible.

Within days of Abbott’s recall announcement on Feb. 17, the USDA began working with state WIC partners to ensure a sufficient supply of infant formula was available for program users. .

The USDA Food and Nutrition Service (FNS) immediately contacted the states to offer support and within days,announcementa continuation offlexibilitiesavailable, such as allowing states to widely offer other sizes, shapes and brands of formula and allowing stores to accept exchanges of purchased formula with WIC benefits, according to the USDA statement released Friday.

The USDA is also in communication with Abbott, with Secretary Vilsack today calling on the company to increase efforts to ensure WIC participants have access to safe formulas, especially those dependent on the specialty formulas produced. by Abbott.

Earlier this week, the FDA announced that it had cleared Abbott to begin marketing certain products on a case-by-case basis for infants with specific medical conditions.

Generally, there are rules about what products families can buy with WIC benefits and what stores can allow. The USDA has worked with states to relax these rules to deal with the effects of the shortage.

Nowadays,not all stateshave adopted all the flexibilities. with todayletterand ongoing technical assistance efforts, President Biden and the USDA urge all states to immediately take advantage of these flexibilities to ease burdens along the supply chain and stand ready to meet their demands, the USDA said on Friday.

The USDA has also asked WIC agencies to encourage families to redeem their recalled formula, issued reminders onreturn and exchange optionsrecalled products and posted several resources oninfant formula safetyincludingtips for parents and guardians.

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