The Food and Drug Administration is sidestepping questions about a voluntary product recall of highly demanded baby formula, issuing an emergency authorization without detailing how to achieve full approval after its removal from shelves.
The federal agency approved returning baby formula manufactured at an Abbott Nutrition plant in Sturgis, Michigan, to the market on an emergency basis without defining the criteria for the return when asked by the Washington Examiner. It is unknown whether the agency provided the company with more detailed criteria, and Abbott has not returned a request for comment.
“The plant remains closed as the company works to correct findings related to the processes, procedures, and conditions that the FDA observed during its inspection of the facility from January 31–March 18, 2022,” the agency said when pressed by the Washington Examiner about the criteria the plant should meet to gain approval.
HERE'S WHAT'S CAUSING THE BABY FORMULA SHORTAGE
The formula can be returned to the market even though information about whether the agency's concerns were addressed remains unknown due to the urgent need for the product amid a nationwide baby formula shortage.
"[The FDA is] not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility. In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection," the FDA said Tuesday.
The federal agency is attempting to address the problem by streamlining the import process for certain products "from foreign facilities with favorable inspection records" and expediting the review process, a noteworthy step because the United States typically produces about 98% of the baby formula it consumes, according to the White House.
But those mitigation actions don't address the question of how bacteria was found at the plant, which will now return formula to shelves. The reason hazardous bacteria were inside the facility is not immediately clear, but inspectors from the FDA found myriad problems at the manufacturing plant with sanitation procedures.
"You did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source," inspectors wrote in the FDA Form 483 for their review of the facility, which took place from Jan. 31 to March 18. "Personnel working directly with infant formula, its raw materials, packaging, or equipment or utensil contact surfaces did not wear necessary protective apparel."
The investigation was sparked after four babies who consumed the company's baby formula manufactured at the Sturgis facility were hospitalized with infections believed to have been caused by Cronobacter sakazakii bacteria between September 2021 and January 2022. Two of the babies died, prompting the Centers for Disease Control and Prevention to open and quickly close an investigation after no additional cases were found.
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 blood infections and meningitis in which the "linings surrounding the brain and spinal cord swell," according to the agency. An average of two to four cases of Cronobacter infections, which could be fatal to newborns, occur every year.
During the investigation of the plant, inspectors discovered the Cronobacter during environmental testing of "non-product contact areas of the facility," according to the company. The FDA noted it found five different strains of Cronobacter at the Sturgis facility.
However, Abbott maintained that none of the bacteria was linked to "any known infant illness" and that none of its products tested positive for Cronobacter.
"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," the company said in a press release. "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."
Still, as a precaution, the company issued a voluntary recall in February of several of its powder baby formulas with an expiration date of April 1 or later. The company also closed its Sturgis plant to address the contamination concerns. The recall did not include liquid formulas or powder formulas produced at other Abbott plants.
Abbott said it has been hustling to revamp its procedures in compliance with FDA recommendations.
"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," the company said in a statement Wednesday.
BIDEN IRKS PARENTS ONCE AGAIN WITH BABY FORMULA SHORTAGE
Prior to the recall, there were some indications of health risks at the Sturgis plant. Some employees might have transferred bacterial contaminants to the baby 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 an FDA audit in 2019, had lax cleaning processes, and struggled to trace its products adequately, a whistleblower document sent to FDA officials last October alleged. The company also failed to maintain worn-down equipment connected to the drying process, creating risks that bacteria could enter the system, the report alleged.
Supervisors at the plant expressed amazement that the FDA failed to find the microorganisms in some batches and congratulated one another after the 2019 audit cleared the company, the whistleblower document alleged. The Sturgis site had more certificates of analysis returned than any other facility for falseness and incompleteness, Food Safety News reported.
Tumult at Abbott has exacerbated the market reeling from pandemic-related supply chain problems and an increase in demand for baby formula. Abbott is one of three companies, alongside Reckitt Benckiser and Nestle, that control roughly 95% of the U.S. baby formula market, according to the Nation. In 2008, Abbott had a roughly 43% share of the market, according to the Department of Agriculture.
During the first week of May, 43% of stores were out of stock on baby formula, a particularly alarming development for mothers of babies with special dietary needs, according to Datasembly, a consumer products data analytics firm. At least 42% of mothers begin supplementing with formula during their newborn's first year, according to a survey by Mamava.
Mothers concerned about giving their babies formula that has been granted only a temporary authorization can take precautionary measures, according to Dr. Bridget Young, the founder of BabyFormulaExpert.com and professor of pediatrics at the University of Rochester School of Medicine.
“If parents are really worried about it, there’s things that they can do when preparing formula at home,” she told the Washington Examiner. “That will dramatically reduce the potential, for example, [of] Cronobacter sakazakii contamination. They can follow the WHO guidelines for formula preparation, which involves boiling the water, cooling it to a very specific temperature that won’t degrade the formula but will kill the bacteria, then adding the formula powder and mixing.”
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
The company said it can restart its production at the Sturgis plant within two weeks of garnering FDA approval.