Over Three Dozen Babies Sickened by Contaminated Formula

More than three dozen infants have been affected by an outbreak of infant botulism linked to contaminated formula, according to federal health officials. The Food and Drug Administration (FDA) reported that as of November 19, 2023, there are 37 confirmed or suspected cases of illness in babies who consumed ByHeart formula since August 2023. This outbreak was officially announced on November 8, with no fatalities reported thus far.

In response to the outbreak, ByHeart, a New York-based manufacturer of organic infant formula, recalled all its products sold in the United States on November 11. The FDA has since conducted inspections at the company’s production facilities located in Allerton, Iowa, and Portland, Oregon. Although ByHeart holds a mere 1% share of the U.S. infant formula market, it had been distributing approximately 200,000 cans of its product each month.

Infant botulism can take up to 30 days for symptoms to manifest, which include poor feeding, loss of head control, and drooping eyelids. According to medical experts, infants between the ages of 2 weeks to 9 months have been hospitalized following consumption of the contaminated formula. A sample from an open can of ByHeart formula that was fed to an infant who later fell ill tested positive for the bacteria responsible for the disease. The FDA noted that the brand is disproportionately represented among the affected infants.

The illness was reported to have begun between August 9 and November 19, with cases emerging in states including Arizona, California, Idaho, Illinois, Kentucky, Maine, Massachusetts, Michigan, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin.

Families of infants treated for botulism after using ByHeart formula have initiated lawsuits against the company. These lawsuits, filed in federal courts, allege that the formula is defective and that ByHeart was negligent in its sale. Plaintiffs are seeking financial compensation for medical expenses, emotional distress, and other damages.

Typically, fewer than 200 cases of infant botulism occur each year in the U.S. The Centers for Disease Control and Prevention (CDC) reported that by September 20, 2023, there had been 133 documented cases. Last year, 145 cases were recorded. The infection is caused by a specific type of bacteria that releases a toxin in the large intestine, posing a significant risk to infants due to their underdeveloped gut microbiomes.

Infants are susceptible to the illness through exposure to the bacterial spores found in dust, dirt, or contaminated honey. Symptoms can take weeks to develop and may result in severe complications, such as paralysis. Treatment is limited to an intravenous medication known as BabyBIG, which is derived from the pooled blood plasma of adults immunized against botulism. Developed by California’s infant botulism program, BabyBIG is the only treatment available globally and can help reduce hospital stays and the severity of the illness.

The current situation contrasts sharply with the formula shortages experienced in late 2021 and 2022, which were sparked by contamination issues at Abbott Nutrition, resulting in illnesses and deaths. Following those incidents, the FDA closed Abbott’s Michigan plant, leading to widespread formula shortages.

In 2022, ByHeart also faced scrutiny when five batches of its infant formula were recalled after a sample tested positive for cronobacter sakazakii. In 2023, the FDA issued a warning letter to the company regarding ongoing issues, including findings of mold and insect presence in its facilities.

In light of these incidents, federal health officials are prioritizing a comprehensive review of the U.S. food supply, particularly focusing on infant formula. Health Secretary Robert F. Kennedy Jr. has instructed the FDA to assess the nutrients and ingredients in infant formula for the first time since 1998. This initiative, referred to as “Operation Stork Speed,” aims to address the safety and quality of products that are essential for infants across the nation. The FDA is currently evaluating feedback from industry stakeholders and health experts to determine future actions.