Formula Company Halts 2023 Pennsylvania Production Amid Botulism Outbreak

The production of baby formula at ByHeart’s Pennsylvania facility has been suspended following a botulism outbreak affecting infants. The outbreak has sickened at least 23 babies, raising serious health concerns regarding ByHeart’s products.

FDA Findings and Company Response

In August 2023, the U.S. Food and Drug Administration (FDA) reported significant violations at ByHeart’s plant in Berks County. Inspections revealed the presence of mold and a disturbing number of dead insects within the facility.

In response to these findings and the health crisis, ByHeart issued a recall of its products in early November. The company later expanded the recall to include all of its baby formula products. It emphasized its commitment to infant safety while collaborating with the Centers for Disease Control and Prevention (CDC) and the FDA during the investigation.

Impact of the Botulism Outbreak

• 84 infants in the U.S. were treated for botulism between August 1 and November 10, 2023.
• Of those, 36 were exposed to infant formula, with 15 having consumed ByHeart products.
• The FDA highlighted that ByHeart products accounted for a disproportionate number of cases, despite representing only 1% of U.S. infant formula sales.

History of ByHeart’s Facility

ByHeart acquired the Berks County facility in 2019 and announced it was FDA-registered in April 2022. The facility has faced scrutiny over safety issues, particularly the detection of cronobacter sakazakii, a potentially lethal bacterium for infants.

In December 2022, ByHeart voluntarily recalled several batches of formula due to cross-contamination concerns. Recent inspections have only intensified scrutiny, uncovering serious hygiene issues that have led the FDA to classify the inspection findings at the highest level of concern.

State Support and Funding

The Pennsylvania government has supported ByHeart through substantial financial aid aimed at bolstering production and safety at the Exeter Township facility. The company has received $18 million in grants through the Redevelopment Assistance Capital Program, although none of it has been disbursed yet, pending specific construction milestones.

Additional Funding Request

ByHeart is currently seeking an additional $15 million grant for constructing a new state-of-the-art manufacturing facility. The company’s leadership has expressed gratitude for state support, emphasizing their commitment to producing safe infant formula.

Official Reactions and Future Steps

Members of the Pennsylvania legislature, while refraining from comments on the outbreak, remain involved in discussions regarding ByHeart’s operations. U.S. Rep. Rosa DeLauro has requested comprehensive inspection records for all three of ByHeart’s facilities as part of a broader interest in food safety.

As the investigation continues, ByHeart maintains that safety is its top priority, vowing to adhere to compliance protocols and improve quality assurance measures. The company’s actions will be closely monitored as it navigates this challenging situation.