On the Heel on Infant’s Death Due to Listeria Infection, FDA Will Test Infant Formula After Botulism Outbreak Sickens Dozens of Babies

The FDA is testing infant formula and key dairy ingredients after a botulism outbreak hospitalized at least 51 babies, renewing concerns over food safety, oversight, and the risks facing infants and pregnant individuals.

After the New Mexico Department of Health (NMDOH) officials confirmed an infant’s death due to Listeria infection, the US Food and Drug Administration (FDA) plans to begin testing infant formula amid growing concern that contamination could be putting babies at risk of botulism.

The move came after a ByHeart infant formula outbreak involving the hospitalization of at least 51 infants. No deaths were reported. But babies who consumed the formula suffered alarming symptoms, which included difficulty feeding, extreme lethargy, and loss of head control.

Kyle Diamantas, FDA deputy commissioner for human foods, told Bloomberg that the regulatory body will test products such as milk powder, whey protein concentrate, and finished infant formula. The tests will establish whether botulism-related contamination is “a foreseeable hazard that companies could test for.”

Botulism is a rare but potentially fatal illness.

Central to the test, Diamantas said, is whether the health risk could have been detected earlier.

Health officials say the planned testing will try to close gaps in infant formula safety and prevent similar outbreaks.

Warnings over unpasteurized dairy resurface

The agency’s action followed state health officials’ renewed warnings about the risks of unpasteurized dairy products, particularly for pregnant individuals and newborns.

“Individuals who are pregnant should only consume pasteurized milk products to help prevent illnesses and deaths in newborns,” Dr. Chad Smelser, deputy state epidemiologist at the New Mexico Department of Health, said in a statement.

Raw milk, if not heat-treated to kill harmful bacteria, could carry pathogens such as Listeria, Brucella, Salmonella, Campylobacter, E. coli, tuberculosis-causing bacteria, Cryptosporidium, and even avian influenza viruses.

New Mexico Agriculture Secretary Jeff M. Witte said pasteurization is “a vital part” of dairy safety. He urged the public to avoid unpasteurized products.

Food safety experts and the Centers for Disease Control and Prevention (CDC) repeatedly warned against consuming unpasteurized milk. But Health and Human Services Secretary Robert F. Kennedy Jr. continues to promote its purported health benefits, heightening concerns among public health officials as infant food safety comes under renewed scrutiny.

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