FDA Says Infant Formula Maker Abbott Nutrition to Release Certain Products on a Case-by-Case Basis

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By Joel Brussels , Parent Herald May 02, 11:39 am

Photo: (Photo : Christopher Pearce/Getty Images)

The US Food and Drug Administration (FDA) issued an important statement, saying that Abbott Nutrition, a baby formula maker under investigation by federal agencies for reports of infant illness and consumer complaints, will consider distributing some of its products on a case-by-case basis soon.

The FDA and the US Centers for Disease Control and Prevention (CDC) are currently investigating the company's powdered infant formula products. Abbott Nutrition has recalled and held back Alimentum, EleCare, and Similac products produced at its facility in Sturgis, Michigan, while enhanced safety testing is being conducted.

The formula recalls have come at the worst possible time as it has compounded product shortages due to supply chain issues, according to CNN. The FDA said in its statement that it "has no objection" for Abbott Nutrition to immediately release products to individuals who are in urgent need of "life-sustaining supplies" of certain specialty and metabolic formulas on a case-by-case basis.

Baby formula products may carry risk of contamination

According to the FDA, the agency is concerned that the risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions and in some cases present life-threatening risks for individuals and infants who rely on these powdered formula products.

The FDA added that in these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these baby formula products may outweigh the potential risk of bacterial infection.

The FDA made it clear that products produced at the Michigan facility from late January through early March, prior to the agency's inspection, may carry a risk of contamination. According to Food Safety News, parents who are seeking the baby formula should talk to their child's doctor about whether the benefit of consuming the infant formula outweighs the risk of a bacterial infection in the circumstances of their child.

Abbott issued a statement on Friday, April 29 regarding this development, saying it "is releasing limited quantities of metabolic nutrition formulas at the request of FDA that were previously on hold" following the company's recall of some powder infant formulas from its facility in Sturgis, Michigan.

Abbott said that these products have already been tested and comply with all product release requirements before their distribution. The infant formula maker said that the lots being released were not included in the recall.

Abbott says products will be released free to patients

According to the FDA, parents seeking the product should directly contact Abbott to request it. Abbott Nutrition said that the products will be released free to patients, in coordination with healthcare professionals.

The specialty and metabolic formulas that may be released on a case-by-case basis by Abbott Nutrition are the following: Tyrex-1, Tyrex-2, Similac PM 60/40, Propimex-1, Propimex-2, ProViMin, Glutarex-1, Glutarex-2, Hominex-1, Hominex-2, Cyclinex-1, Cyclinex-2, I-Valex-1, I-Valex-2, Phenex-1, Phenex-2, Phenex-2 Vanilla, Ketonex-1, Ketonex-2, Pro-Phree, and Calcilo XD.

The formulas that were recalled earlier this year by Abbott have been linked to serious Salmonella and Cronobacter sakazakii infections in five infants. Two of the babies who had Cronobacter infections died, according to Politico.