Federal health officials have expanded their investigation into an outbreak of infant botulism associated with ByHeart baby formula, now encompassing all products manufactured by the company since its inception in March 2022. The U.S. Food and Drug Administration (FDA) announced that it “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever produced.
As of now, the outbreak includes at least 51 infants across 19 states, with the latest case reported on December 1, 2023. The new criteria for identifying cases, as defined by the U.S. Centers for Disease Control and Prevention (CDC), includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release.” Previously, health officials had reported 39 suspected or confirmed cases since August 2023, highlighting a significant rise in cases linked to ByHeart products.
ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its U.S. products on November 11, 2023. The company, which holds approximately 1% of the U.S. infant formula market, had been distributing about 200,000 cans monthly. Concerns regarding the long-term safety of ByHeart products have left families distressed, particularly those who have had infants hospitalized due to botulism.
Andi Galindo, a mother from Redondo Beach, California, shared her experience after her five-week-old daughter, Rowan, was hospitalized in December 2023 following consumption of ByHeart formula. Galindo, who chose ByHeart based on recommendations for its natural composition, expressed her frustration, stating, “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”
The FDA has conducted inspections at ByHeart facilities located in Allerton, Iowa, and Portland, Oregon, but has yet to release inspection results. Preliminary lab tests revealed contamination in 36 samples from three different lots of ByHeart formula. Furthermore, inspection documents indicate a history of contamination issues, with a previous recall in 2022 due to a positive test for cronobacter sakazakii.
Infant botulism is a rare but serious condition, affecting fewer than 200 infants in the U.S. annually. It occurs when infants ingest spores that germinate in their intestines, producing a toxin that can severely impact their nervous system. Babies are particularly vulnerable until about one year of age due to their underdeveloped gut microbiomes. Symptoms may take up to 30 days to appear and can include constipation, poor feeding, loss of head control, and breathing difficulties.
The primary treatment for infant botulism is known as BabyBIG, an intravenous medication derived from the blood plasma of adults immunized against the toxin. Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital, emphasized the ongoing risk for affected infants, advising families to discontinue use of the recalled formula.
In light of the outbreak, several families have initiated legal action against ByHeart, alleging that the formula was defective and the company acted negligently in its distribution. The lawsuits aim to secure compensation for medical expenses, emotional distress, and other damages.
As the situation develops, health officials continue to monitor cases and provide guidance to families regarding safe feeding practices. The CDC and FDA are committed to ensuring that affected infants receive the necessary care while addressing the broader implications of food safety regulations in the infant formula industry.
