Outbreak of Infant Botulism Linked to ByHeart Formula Affects 37 Babies

More than three dozen infants have been affected in an outbreak of infant botulism associated with contaminated ByHeart formula, according to the Food and Drug Administration (FDA). As of November 19, 2023, federal health officials confirmed or suspected 37 cases among babies who consumed the powdered formula since August. The outbreak was announced on November 8, and while no fatalities have been reported, all affected infants have required hospitalization.

The New York-based company, ByHeart, recalled all its products sold in the United States on November 11. The FDA has dispatched inspectors to the company’s production facilities located in Allerton, Iowa, and Portland, Oregon. ByHeart holds a modest share of the U.S. infant formula market, accounting for approximately 1%, with monthly sales of around 200,000 cans.

The outbreak has primarily affected infants aged between two weeks and nine months. All hospitalized infants had consumed ByHeart powdered formula, and health officials in California confirmed that a sample from an open can linked to an ill infant contained a bacteria associated with botulism. Preliminary lab tests have validated that some samples were indeed contaminated.

The FDA is currently investigating the increase in infant botulism cases reported since August. The agency noted that “ByHeart brand formula is disproportionately represented among sick infants in this outbreak.” The illnesses have occurred between August 9 and November 19, 2023, with cases identified across several states including Arizona, California, Illinois, and Texas.

Families of affected infants have initiated lawsuits against ByHeart, claiming that the formula was defective and that the company acted negligently in its distribution. The lawsuits, filed in federal courts, seek compensation for medical expenses, emotional distress, and other damages.

Infant botulism typically impacts fewer than 200 babies annually in the U.S. According to the Centers for Disease Control and Prevention (CDC), there were 133 reported cases as of September 20, 2023, compared to 145 cases reported throughout 2022. This condition is caused by a type of bacteria that produces a toxin in the intestines, with spores commonly found in the environment. Infants, due to their underdeveloped gut microbiomes, are particularly susceptible to this infection, which can lead to serious complications such as paralysis.

Symptoms of infant botulism may take weeks to manifest and can include poor feeding, loss of head control, drooping eyelids, and a “floppy” appearance. In severe cases, infants may experience difficulty swallowing or breathing, necessitating support from ventilators.

Previously, baby formula has been linked to isolated cases of illnesses, but no known outbreaks of infant botulism related to powdered formula had been confirmed until now. Treatment for this condition involves BabyBIG, an intravenous medication derived from the plasma of adults immunized against botulism. This product, developed by California’s infant botulism program, is the only known treatment available globally.

Despite the outbreak, experts indicate that there is minimal risk of infant formula shortages, as ByHeart represents a small segment of the market. This situation stands in stark contrast to the significant formula shortages experienced in late 2021 and 2022, which were linked to contamination issues at Abbott Nutrition’s facilities. In that crisis, four infants fell ill due to a different germ, leading to two fatalities.

In response to the recent outbreak, federal health officials are committed to overhauling the U.S. food supply. Health Secretary Robert F. Kennedy Jr. has directed the FDA to conduct a comprehensive review of the nutrients and ingredients in infant formula, marking the first in-depth examination since 1998. This initiative, named “Operation Stork Speed,” aims to enhance safety and quality standards in infant nourishment.

As investigations continue, the FDA is engaging with industry stakeholders, health experts, and the public to determine the best course of action moving forward.