Abbott: Sturgis facility could restart within two weeks

Parents throughout the U.S. are scrambling to find baby formula because of supply disruptions and a massive safety recall from Abbott Nutrition in regard to its Sturgis manufacturing facility.

Months of spot shortages at pharmacies and supermarkets have been exacerbated by the recall at Abbott, which was forced to shutter its Sturgis facility — the largest U.S. formula manufacturing plant — in February due to contamination concerns.

“We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage,” Abbott officials said Wednesday. “Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.”

An Abbott press release stated the February voluntary recall involved four complaints of Cronobacter sakazakii — a common environmental bacteria — in infants who consumed infant formula produced at the Sturgis plant. Two infants became sick and two died.

“The facts about what was learned about the cases of Cronobacter have not been widely communicated,” the release stated. “After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.”

The company stated:

• Abbott conducts microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.

• All finished product testing by Abbott and the FDA during inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility.

• The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Specifically: Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.

• In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative.

• Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it 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. Again, 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.

“The FDA concluded its inspection with a 483 letter to Abbott on March 18. This is a list of observations that point out where Abbott did not follow our processes and where we can improve our systems and protocols,” the release stated. “We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We've also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.”

For now, pediatricians and health workers are urging parents who can’t find formula to contact food banks or doctor's offices. They warn against watering down formula to stretch supplies or using online DIY recipes.

“For babies who are not being breastfed, this is the only thing they eat," said Dr. Steven Abrams, of the University of Texas, Austin. "So it has to have all of their nutrition and, furthermore, it needs to be properly prepared so that it’s safe for the smallest infants.”

Trying to keep formula in stock, retailers including CVS and Walgreens have begun limiting purchases to three containers per customer.

Nationwide about 40% of large retail stores are out of stock, up from 31% in mid-April, according to Datasembly, a data analytics firm. More than half of U.S. states are seeing out-of-stock rates between 40% and 50%, according to the firm, which collects data from 11,000 locations.

Baby formula is particularly vulnerable to disruptions because only a few companies account for almost the entire U.S. supply.

Industry executives say the constraints began last year as the COVID-19 pandemic led to disruptions in ingredients, labor and transportation. Supplies were squeezed further by parents stockpiling during lockdowns.

Abbott said it is increasing production at its other facilities to fill the gap, including air-shipping formula from a plant in Ireland.

The shortages are especially dangerous for infants who require specialty formulas due to food allergies, digestive problems and other conditions.

“Unfortunately, many of those very specialized formulas are only made in the United States at the factory that had the recall, and that's caused a huge problem for a relatively small number of infants," Abrams said.

After hearing concerns from parents, FDA said last month that Abbott could begin releasing some specialty formulas not affected by the recalls “on a case-by-case basis." The company is providing them free of charge, in coordination with physicians and hospitals.

Food safety advocates say FDA made the proper call in releasing the formula, but that parents should talk to their pediatrician before using it.

“There’s still some risk from the formula because we know there are problems at the plant and FDA hasn’t identified a root cause,” said Sarah Sorscher of Center for Science in the Public Interest. ”But it’s worth releasing because these infants might die without it."

This article originally appeared on Sturgis Journal: News