Powdered whole milk may be culprit in botulism outbreak that sickened dozens of babies

Powdered whole milk used to make ByHeart infant formula could be the source of contamination that led to an outbreak of botulism that sickened dozens of babies.

The Centers for Disease Control and Prevention (CDC) reported the details on Friday.

Powdered whole milk may be culprit in botulism outbreak

What we know:

Testing by the U.S. Food and Drug Administration (FDA) found that bacteria in an unopened can of formula matched a sample from a sick baby — and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company, officials said. 

FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart — and it matched the germ in a finished sample of the company's formula.

What they're saying:

A ByHeart official said the finding helps shed light on what has become a "watershed moment" for the company.

"We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula," said Dr. Devon Kuehn, ByHeart's chief scientific and medical officer.

What we don't know:

While these results advance the agency’s understanding of the outbreak, the FDA said the findings are not conclusive, and the investigation continues "to determine the source of the contamination."

In addition, neither the FDA nor ByHeart named the supplier of the powdered whole milk.

Botulism outbreak sickens dozens of babies

The backstory:

New York-based ByHeart has been at the center of a food poisoning outbreak that has sickened 51 babies in 19 states since December 2023. 

No new cases in the outbreak have been identified since mid-December, the CDC said, and no deaths have been reported in the outbreak to date. 

On Dec. 10, the FDA reported 51 cases of confirmed or suspected illness across 19 states among babies who consumed ByHeart formula.

That was an increase from 39 cases across 18 states reported in the FDA’s previous update earlier that month.

Cases have been reported in Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington and Wisconsin. 

What is botulism?

Big picture view:

Botulism is a rare but serious disease that can cause paralysis and death. Symptoms can take weeks to develop.

Infant botulism typically affects fewer than 200 babies in the U.S. each year. It is caused by a type of bacteria that produces a toxin in the large intestine. The bacterium is spread through hardy spores present in the environment that can cause serious illness, including paralysis.

Infants are particularly vulnerable to infection because their gut microbiomes are not developed enough to prevent the spores from germinating and producing the toxin. They can be sickened after exposure to the spores in dust, dirt or water or by eating contaminated honey.

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Symptoms can take weeks to develop and can include poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel "floppy" and can have problems swallowing or breathing.

The only treatment is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California's Infant Botulism Treatment and Prevention Program developed the product and is the sole source worldwide.

All of the children in the ByHeart outbreak have received the medication, the CDC said.