We know the infant formula shortage has created stress and concern for parents and caregivers. The situation is urgent – and we’re committed to doing whatever it takes to relieve it.
Abbott has agreed to enter into a consent degree, a legal agreement, with the U.S. Food and Drug Administration (FDA) related to our Sturgis, Mich. infant formula plant that sets out the steps necessary to resume production and maintain the facility. This is a major step towards re-opening the Michigan facility to get families the high-quality infant formula they need.
Once the FDA confirms the initial requirements for start-up have been met, Abbott could restart the site within two weeks. We will begin production of EleCare®, Alimentum® and metabolic formulas first and then begin production of Similac and other formulas. From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves. We will communicate a more definitive timeline as soon as we can.
We continue to work to mitigate the shortage through efforts at our other FDA-registered facilities. These efforts include:
- Air shipping millions of Similac® Advance® cans from our site in Cootehill, Ireland
- Prioritized infant formula production at our Columbus, Ohio, facility, converting adult nutrition manufacturing lines into Similac and Alimentum liquid ready-to-feed.
- Releasing metabolic formulas that were on hold earlier this month at FDA's request on an urgent case by case basis to those who need these unique formulas.
- For WIC parents, we are providing rebates for competitive products in states where Abbott holds the WIC contract, when Similac is not available and we’ve committed to continue that through August 31.
We understand the voluntary recall has raised questions and concerns about the safety of our products. After a thorough investigation by FDA, Centers for Disease Control and Prevention (CDC) and Abbott, and review of all available data, there is no conclusive evidence to link Abbott's formulas to these infant illnesses. Specifically:
- The CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
- Abbott conducts testing on products prior to distribution and no sealed Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
- All retained product tested by the FDA and Abbott during the inspection of the Sturgis, Michigan facility came back negative for Cronobacter sakazakii and/or Salmonella. No Salmonella was found at the facility.
- The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the Michigan facility and has not been linked to any known infant illness.
- Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter sakazakii found in our plant. Samples from ill infants did not match each other, which means there was no connection between the two cases.
- Open containers of formula from the homes of the infants were also tested in three of the four cases; two of the three tested negative. One tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Neither strain matched strains found in our plant.
- The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.
Cronobacter sakazakii is naturally occurring and found nearly everywhere in the environment. However, Abbott has no tolerance for Cronobacter sakazakii in its production environment, and no Abbott product was distributed with Cronobacter sakazakii contamination.
We will do everything we can to ensure parents and caregivers have what they need to feed their babies. We know getting your baby high-quality infant formula is your priority – please know it is ours, too.