U.S. Senator Bill Cassidy, chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, has requested information from ByHeart regarding the sale of infant formula linked to 51 cases of infant botulism in 19 states.
“Ensuring that parents and their infants have access to safe formula is essential for us to protect our most vulnerable population,” wrote Dr. Cassidy. “There should never be any question about the quality of these products. The ongoing safety recall affecting ByHeart products undermines access to safe, quality infant formula by putting pressure on the overall supply of infant formula.”
The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) recommended a voluntary recall by ByHeart after an outbreak was connected to its powdered infant formula. Federal agencies are continuing their investigation into how the contamination occurred.
Cassidy’s letter highlights concerns over inspection reports that identified safety deficiencies at ByHeart facilities, such as not taking steps to prevent contamination or adulteration during manufacturing. He requested detailed responses from ByHeart regarding when it became aware of safety issues, how it is working with retailers and authorities to manage recalled products, its current safety processes including third-party reviews, and whether proactive inspections occur at its facilities in Allerton, Iowa; Portland, Oregon; or Reading, Pennsylvania.
The letter also asks for details about past FDA inspections between 2022 and March 2025 that found non-compliance with good manufacturing practices requirements—such as not maintaining sanitary conditions—and requests a list of deficiencies along with corrective actions taken by ByHeart.
As chair of the HELP Committee in the 119th Congress (source), Cassidy leads oversight efforts concerning federal health policy. The HELP Committee legislates on public health issues and oversees agencies like the FDA (source). It plays a key role in shaping regulations that affect health standards across the United States (source).
By January 14, 2025, Cassidy expects answers from ByHeart addressing all questions raised in his inquiry.
For more updates from HELP Republicans visit their official website or Twitter at @GOPHELP.
