JThe Food and Drug Administration dodges questions about a voluntary recall of high-demand infant formula products, issuing emergency authorization without detailing how to get full approval after pulling it off the shelves.

The federal agency has approved the return of infant formula made at an Abbott Nutrition factory in Sturgis, Michigan, to the market in an emergency without define the return criteria at the request of the Washington Examiner. It’s unclear whether the agency provided the company with more detailed criteria, and Abbott did not return a request for comment.

“The plant remains closed as the company works to correct findings related to processes, procedures, and conditions that the FDA observed during its inspection of the facility from January 31 through March 18, 2022,” the statement said. agency pressed by the Washington Examiner on the criteria that the factory must meet in order to obtain approval.


The formula may be put back on the market although information on how to address the agency’s concerns remains unknown due to the urgent need for the product amid a national infant formula shortage.

“[The FDA is] do not object to Abbott Nutrition providing products to people in need of urgent and vital supplies of certain specialty and metabolic formulas on a case-by-case basis that have been put on hold at its Sturgis plant. In these circumstances, the benefit of allowing caregivers, in consultation with their health care providers, access to these products may outweigh the potential risk of bacterial infection,” the FDA said Tuesday.

The federal agency is trying to address the issue by streamlining the process of importing certain products “from foreign facilities with favorable inspection records” and speeding up the review process, a notable step because the U.S. typically produce about 98% of the formula milk they consume. , according to the White House.

But those mitigations don’t answer the question of how the bacteria were found at the factory, which will now put the formula back on the shelves. It’s not immediately clear why dangerous bacteria were inside the facility, but FDA inspectors found myriad problems at the manufacturing plant with sanitation procedures.

“You failed to ensure that all infant formula contact surfaces were maintained to protect infant formula from all sources of contamination,” inspectors wrote in FDA Form 483 for their review of the installation, which took place from January 31 to March 18. “Personnel working directly with infant formula, its raw materials, packaging or surfaces in contact with equipment or utensils were not wearing the necessary protective clothing.”

The investigation was prompted after four babies who consumed the company’s infant formula made at the Sturgis plant were hospitalized with infections believed to be caused by the bacteria Cronobacter sakazakii between September 2021 and January 2022. Two of the babies died, prompting the Centers for Disease Control and Prevention to quickly open and close an investigation after no additional cases were discovered.

Cronobacter sakazakii is known to live in dry foods such as powdered infant formula and powdered milk, according to the CDC. The bacteria can cause bloodstream infections and meningitis in which “the linings surrounding the brain and spinal cord swell,” according to the agency. On average, two to four cases of Cronobacter infections, which could be fatal to newborns, occur each year.

During the investigation of the factory, the inspectors discovered the Cronobacter during environmental testing of “product-free contact areas of the facility,” according to the company. The FDA noted that it had found five different strains of Cronobacter at Sturgis facilities.

However, Abbott maintained that none of the bacteria were linked to “a known childhood illness” and that none of its products tested positive for Cronobacter.

“Genetic sequencing of the two available samples from sick infants did not match the Cronobacter strains in our facility. The samples from sick infants did not match, meaning there was no connection between the two cases,” said the company said in a press release. “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.”

Yet, as a precaution, the company issued a voluntary recall in February of several of its powdered baby formulas with an expiration date of April 1 or later. The company also closed its Sturgis plant to address contamination concerns. The recall did not include liquid formulas or powder formulas produced at other Abbott factories.

Abbott said it has been working to revamp its procedures in line with FDA recommendations.

“Even before our official response, we had begun work to resolve these issues, implement improvements and take corrective actions. Some of these actions included reviewing and updating education, training and security measures for employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures in the facility. We immediately implemented corrections to address the issues raised by the FDA,” the company said in a statement Wednesday.


Prior to the recall, there were indications of health risks at the Sturgis plant. Some employees may have transferred bacterial contaminants to formula by failing to change gloves, inspectors who visited the facility last September said in an FDA report obtained by Bloomberg. The contaminated batch was not distributed, according to the report.

Abbott falsified records, released untested infant formula, undermined a 2019 FDA audit, had lax cleanup processes and struggled to adequately trace its products, according to a whistleblower document sent to officials. the FDA last October. The company also failed to maintain worn-out equipment connected to the drying process, creating risks that bacteria could enter the system, according to the report.

Factory supervisors expressed amazement that the FDA failed to find the microorganisms in some batches and welcomed after the 2019 audit cleared the company, according to the whistleblower document. The Sturgis site has received more certificates of analysis than any other facility for falsity and incompleteness, Food Safety News reported.

The tumult at Abbott has exacerbated the market reeling from pandemic-related supply chain issues and a surge in demand for infant formula. Abbott is one of three companies, along with Reckitt Benckiser and Nestle, that control about 95% of the U.S. infant formula market, according to the Nation. In 2008, Abbott held about 43% of the market, according to the Department of Agriculture.

In the first week of May, 43% of stores were out of stock of infant formula, a particularly alarming development for mothers of babies with special dietary needs, according to Datasembly, a data analytics firm on infant formula. consumer products. At least 42% of mothers start taking formula during their newborn’s first year, according to a Mamava survey.

According to Bridget Young, founder of BabyFormulaExpert.com, mothers concerned about giving their baby formula that has only been granted temporary approval can take precautionary measures.

“If parents are really worried about it, there are things they can do to make formula at home,” she told the Washington Examiner. “This will significantly reduce the potential, for example, [of] Contamination by Cronobacter sakazakii. They can follow the WHO guidelines for my parents’ formula, which involves boiling the water, cooling it to a very specific temperature that won’t degrade the formula but will kill the bacteria.


The company said it could restart production at the Sturgis plant within two weeks of receiving FDA approval.

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