FDA Launches Investigation After Receiving Complaint of Another Infant Death Related to Abbott Baby Formula

The Food and Drug Administration (FDA) is looking into another youngster who died after drinking Abbott Laboratories' newborn formula.

According to an Abbott spokeswoman, the firm received minimal product and clinical information to analyze the situation, and there are "no conclusions" and no evidence to establish a causative association between Abbott goods and the reported newborn mortality at this time.

Infant Death Report Comes After FDA Approves Abbott's Reopening

The investigation comes less than a month after the FDA approved Abbott's reopening of its manufacturing in Sturgis, Michigan. The facility is the largest infant formula manufacturer in the United States. Following a bacterium infection in four newborns, two of whom died, the institution was closed in February. According to the investigation, Abbott goods were not the likely source of the illnesses in the previous cases.

The Sturgis factory was forced to close again more than a week ago after violent thunderstorms and heavy rains damaged the facility. The firm stated that it will require time to examine the damage and re-sanitize the plant before reopening.

Meanwhile, the United States is still dealing with a countrywide formula shortage. The Biden administration stated on Wednesday that it will provide logistical support for the import of around 16 million 8-ounce infant formula bottles from Mexico beginning this weekend.

The action is part of President Joe Biden's Operation Fly Formula program, which aims to alleviate supply shortages and delays caused by the Abbott plant's shutdown. According to a customer complaint submitted to the FDA on June 10, the most recent newborn mortality happened in January, Daily Mail reported.

Two of those people died, and the FDA claimed it couldn't prove if Abbott's formula was to blame for their illnesses or deaths. According to the corporation, there is no proof linking their formula to the illnesses or fatalities. In any case, the move exacerbated a scarcity among many manufacturers that began with pandemic supply chain concerns, prompting criticism of the Biden administration for being sluggish to recognize and respond to the situation.

Abbott Claims Baby Deaths Are Not Related to Their Products

Finally, the president used the Defense Output Act, which gives the government additional control over industrial production during emergencies, to urge formula ingredient suppliers to prioritize delivery to formula producers.

He also launched Operation Fly Formula, which instructed the Department of Health and Human Services to import foreign formulas. At least six countries contributed supplies.

It stated that the agency had already announced its investigation into nine newborn fatalities. Only two newborn fatalities were linked to the Abbott Nutrition Sturgis factory probe; and after considerable study, the data does not rule in or rule out a conclusive relationship between these infant deaths and the product manufactured at Abbott Nutrition's Sturgis plant, as per Independent.

The reports of the infants' deaths were among 128 customer complaints gathered by the FDA from its consumer complaint system between December and March. The babies' identities have not been made public, and they are only known by their case numbers. Abbott Nutrition asserted that no causal association between Abbott's products and any of the reported deaths had been found.

Attorney Sam Geisler is representing over two dozen families who claim their children became ill after drinking Abbott's formula. He stated the papers show systematic issues at the Sturgis site. The Centers for Disease Control and Prevention confirmed the presence of germs at the facility and conducted testing, but the cause of the infection - whether it was the formula or something else - could not be identified, according to The Sun.