Parents across the US are trying to locate baby food due to supply disruptions and a massive recall from Abbott Nutrition regarding the Sturgis manufacturing facility.
Months of spot shortages at pharmacies and supermarkets have been exacerbated by the recall at Abbott, which had to close its factory in Sturgis – the largest formula plant in the US – in February over contamination concerns.
“We understand the situation is urgent — getting Sturgis up and running will help reduce this deficit,” Abbott officials said Wednesday. “Subject to FDA approval, we can restart the site in two weeks. We would start with the production of EleCare, Alimentum and Metabolic formulas first and then start with the production of Similac and other formulas. From the moment we restart the site, it will take six to eight weeks for the product to hit the shelves.”
An Abbott press release said the voluntary recall in February related to four complaints of Cronobacter sakazakii – a common environmental bacterium – in infants consuming infant formula produced at the Sturgis plant. Two babies got sick and two died.
“The facts about what has been learned about Cronobacter cases have not been widely communicated,” the press release said. “After a thorough review of all available data, there is no evidence to link our formulas to these teething problems.”
The company stated:
- Abbott performs microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella.
- All tests of the finished product by Abbott and the FDA during facility inspection were negative for Cronobacter and/or Salmonella. No Salmonella was found in the Sturgis facility.
- The Cronobacter sakazakii found during environmental testing during the study was located in non-product contact areas of the facility and has not been associated with any known teething problems. Specifically, genetic sequencing on the two available samples from sick babies did not match strains of Cronobacter in our plant. Samples from sick babies did not match, meaning there was no link between the two cases.
- In all four cases, the state, FDA and/or CDC tested samples of the Abbott formula used by the child. In all four cases, all unopened containers tested negative.
- In three out of four cases, open containers from the babies’ homes were also tested; two out of three tested negative. One positive came from an open container from the child’s home, and it tested positive for two different strains of Cronobacter sakazakii, one of which matched the strain causing the child’s infection, and the other matched a strain found on a bottle of distilled water in the house used to mix the formula. Again, neither species matched the ones found in our plant.
- The babies consumed four different kinds of our formula made over the course of nearly a year, and the illnesses occurred over several months in three different states.
“The FDA concluded its inspection with a letter of 483 to Abbott on March 18. This is a list of observations that indicate where Abbott has not followed our processes and where we can improve our systems and protocols,” the press release said. “We take this very seriously and we responded to the 483 on April 8th. Even before our formal response, we had started addressing these issues, implementing improvements and taking corrective action. Some of these actions include reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and facility cleaning and maintenance procedures. We immediately made corrections to address the issues raised by the FDA in the 483. We have also made upgrades to the factory, including installing non-porous, easy-to-clean and sanitary floors.”
For now, pediatricians and health professionals are urging parents who can’t find a formula to contact food banks or doctor’s offices. They warn against watering down the formula to stretch supplies or use DIY recipes online.
“For babies who aren’t breastfed, this is all they eat,” says Dr. Steven Abrams of the University of Texas, Austin. “So it has to contain all of their nutrition and, moreover, it has to be well prepared so that it is safe for the little ones.”
To keep the formula in stock, retailers, including CVS and Walgreens, have begun to limit purchases to three containers per customer.
Nationwide, about 40% of major stores are sold out, up from 31% in mid-April, according to Datasembly, a data analytics firm. According to the company, which collects data from 11,000 locations, more than half of U.S. states see out-of-stock levels between 40% and 50%.
Baby food is particularly vulnerable to disruption because only a few companies account for nearly all of the US supply.
Industry executives say restrictions started last year when the COVID-19 pandemic led to disruptions in ingredients, labor and transportation. Stocks were further pressured by parents stockpiling during the lockdowns.
Abbott said it is increasing production at its other facilities to fill the gap, including its air transport formula from a factory in Ireland.
The deficiencies are especially dangerous for infants who require special formulas because of food allergies, digestive problems, and other conditions.
“Unfortunately, a lot of those highly specialized formulas are only made in the United States at the factory that had the recall, and that caused a huge problem for a relatively small number of babies,” Abrams said.
After hearing concerns from parents, the FDA said last month that Abbott could begin releasing some special formulas unaffected by the “case-by-case” recalls.
Food safety advocates say the FDA made the right decision to release the formula, but parents should talk to their pediatrician before using it.
“There is still some risk from the formula because we know there are issues at the plant and the FDA has not identified a cause,” said Sarah Sorscher of the Center for Science in the Public Interest. “But it’s worth releasing because these babies could die without it.”