FDA Investigating Report of Baby’s Death After Consuming Abbott Baby Formula

The Food and Drug Administration is investigating a new report of another child’s death after consuming

Abbott Laboratories

’ baby formula, the agency said Wednesday.

The FDA said it learned about the death, which occurred in January, from a consumer complaint it received on June 10. The FDA said its investigation is in preliminary stages, and it will provide an update as it learns more.

The FDA didn’t say which Abbott formula the baby had consumed or where the formula was produced.

An Abbott spokesman said at this time there is no evidence to suggest a causal relationship between Abbott’s formulas and this newly reported case.

A nationwide baby-formula shortage has some desperate parents driving hours in search of supplies. Dr. Steven Abrams, a pediatrician at the University of Texas at Austin, explains what parents should and shouldn’t do amid the crisis. Photo illustration: Laura Kammermann

The spokesman said Abbott was provided with limited product and clinical information to evaluate the case. The company will investigate further if additional information becomes available, he said.

Disclosure of the investigation is likely to intensify scrutiny of Abbott, one of the leading sellers of baby formula in the U.S. The company makes formula brands such as Similac, which along with Enfamil, made by

Reckitt Benckiser Group

PLC, have dominated the U.S. market for years.

Abbott and the FDA already have come under fire in recent months from Republican and Democratic lawmakers criticizing what they said was a slow response to problems at the company’s key formula plant in Sturgis, Mich.

Previously, the FDA has said there were four cases of a bacterial infection in infants who consumed formula from Abbott’s Sturgis plant, including two babies who died. These prior cases were reported to the FDA between September 2021 and February.

The FDA said it hasn’t been able to rule in or rule out a definitive link between the four cases and the conditions of Abbott’s plant.

The FDA found what it described as unsanitary conditions at Abbott’s Sturgis plant, including the presence of cronobacter bacteria, in an inspection in the winter. Cronobacter can be deadly to infants.

The FDA’s inspection of Abbott’s plant led to a production halt and product recall of Abbott’s Similac and other formula in February.

The shutdown worsened shortages of baby formula around the U.S. that were triggered by pandemic-related supply-chain disruptions.

The federal government has been taking steps to alleviate the shortages, including allowing Abbott to reopen the facility under the FDA’s supervision.

The FDA also has been investigating complaints tied to Abbott formula. Since January 2021, the agency said, it has reviewed and investigated 129 complaints tied to Abbott formula. Of these, 119 complaints were reported after Abbott’s recall in February, it said.

The FDA said it has previously reviewed complaints related to nine infant deaths, but that only two were associated with an investigation of Abbott’s plant in Sturgis.

The Wall Street Journal has reported that a former Abbott employee alleged problems at the Sturgis plant in a complaint filed under the U.S. Labor Department’s Occupational Safety and Health Administration’s whistleblower-protection program in February 2021, earlier than had been publicly known.

Abbott, of Abbott Park, Ill., restarted formula production at the plant in early June, but had to shut it down again last week after storms caused flooding. The company said the flooding would probably delay production and distribution of new products for a few weeks.

Write to Peter Loftus at peter.loftus@wsj.com and Jesse Newman at jesse.newman@wsj.com

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