Preliminary tests find germ that causes botulism in ByHeart baby formula
Preliminary tests showed that ByHeart baby food contained the type of bacteria that produces the toxin associated with baby food. botulism epidemicCalifornia health officials said this.
The outbreak has sickened at least 13 babies in 10 states. No deaths were reported.
“Consumers who possess this product should stop using it immediately,” the California Department of Public Health said in a statement late Saturday.
More testing of ByHeart Complete Nutrition Infant Formula is expected as state and federal health officials investigate the outbreak that began in mid-August. The New York-based company recalled two batches of the powder product this weekend.
Here’s what you need to know about the outbreak and infant botulism.
An outbreak of infant botulism has sickened babies between the ages of 2 weeks and 5 months since mid-August. They were all hospitalized after consuming the ByHeart powder formula, according to the U.S. Centers for Disease Control and Prevention.
Cases have occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
ByHeart officials agreed to recall two lots of the company’s Complete Nutrition Infant Formula, according to the U.S. Food and Drug Administration. The expiration date of the formula is December 2026.
California health officials tested a box of powdered formula given to a sick baby. The results “reveal the presence” of the strain of botulism toxin-producing bacteria that has been confirmed in other cases. It may take several days for results to be confirmed.
ByHeart officials said “more testing is needed” to know whether the type of bacteria that causes botulism is present. The company said it comes from a large family of bacteria, many of which occur naturally in the environment and do not cause disease.
“We take this very seriously,” it said in a statement on Sunday.
The FDA is investigating reports of 83 cases of infant botulism reported since August, including cases linked to Byheart infant formula.
Infant botulism typically affects fewer than 200 babies each year in the United States. It is caused by a type of bacteria that produces toxins in the large intestine. The bacteria spreads through resistant spores in the environment that can cause serious illness, including stroke.
Babies younger than 1 year old are particularly vulnerable and can become ill after exposure to spores in dust, dirt, or water, or by eating contaminated honey.
Symptoms can take weeks to develop and may include malnutrition, loss of head control, drooping eyelids, and a flat facial expression. Babies may feel “limp” and have difficulty swallowing or breathing.
Nutritionist from the University of Texas, Dr. Steven Abrams said no known outbreaks of infant botulism linked to powdered formula have been confirmed.
“That would be extremely rare,” he said.
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 only worldwide source.
BabyBIG works to shorten the length of hospital stay in babies with botulism and reduce the severity of the disease. Babies often need to be put on a ventilator because the infection can affect the ability to breathe.
The CDC said all children in the ByHeart outbreak received the drug.
There is no danger of baby food shortages due to this pandemic. Founded in 2016, ByHeart accounts for an estimated 1% of national formula sales, according to the CDC. The company sells the formula through its website and in retail stores nationwide.
This is different from the crisis caused by formula produced by Abbott being linked to infant deaths and illnesses in 2022.
This product was contaminated with a different microbe that can cause serious illness and death in babies. Since Abbott is one of the largest manufacturers of baby food in the United States, the closure of its manufacturing facility in Michigan led to major formula shortages across the United States.
In 2022, ByHeart recalled five batches of baby food after a sample at the company’s packaging facility tested positive for cronobacter sakazakii, the microbe at the heart of the Abbott crisis. In 2023, the FDA sent the company a warning letter detailing “areas that still require corrective actions.”
Federal health officials promise overhaul US food supply and we look from a new perspective baby food.
Surgeon General Robert F. Kennedy Jr. runs the Food and Drug Administration review Nutrients and other ingredients in the infant formula that fills the bottles of millions of American babies.
The study, called “Operation Stork Speed,” is the first in-depth look at the materials since 1998.
FDA officials are reviewing comments from industry, health experts and the public to decide next steps.
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