FDA Announces Recall of ByHeart Whole Nutrition Infant Formula Due to Outbreak of Infant Botulism

WASHINGTON, D.C. - Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, issued the following statement in response to an announcement by the Department of Health and Human Services (HHS) of a decision to recall ByHeart Whole Nutrition Infant Formula due to an outbreak of infant botulism, which is currently being investigated.

"The Committee has a history of conducting oversight of infant formula matters to ensure adequate supply is safe and readily available for families and children. President Trump's FDA has also done important work through Operation Stork Speed to address these issues, and I am pleased to see his Administration take swift action to restore confidence for caretakers when it comes to their little ones' nutritional needs," said Chairman Guthrie. "I am grateful to HHS Secretary Kennedy and FDA Commissioner Makary for furthering our commitment to protecting children and mothers through improving the safety and availability of the domestic infant formula supply."

Background:

• The Committee has conducted extensive oversight of the Biden Administration's mishandling of the infant-formula shortage and challenged the U.S. Food & Drug Administration (FDA) on its preparedness, inspection practices, and responsiveness to early warnings about the formula crisis.
• On May 25, 2022, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations held a hearing titled "Formula Safety and Supply: Protecting the Health of America's Babies" during the infant-formula shortage to examine supply, safety, and what further action was needed.
• Following the hearing, the Committee sent a letter to then FDA Commissioner, Robert M. Califf, directing the Biden Administration to provide access to the memos and reports sent to the White House and demanding that the administration be completely transparent with parents who deserve answers.
• On September 21, 2022, Energy and Commerce Republicans convinced Committee Democrats to join in passing a bipartisan resolution requesting that the Biden administration turn over documents related to the baby formula shortage. H.Res.1287 was reported out of the committee by a vote of 54-0.
• Chairman Guthrie has also introduced legislation to help prevent future baby formula shortages-the More Options for Infants and Parents Act-and signed on as a cosponsor to the Improving Newborn Formula Access for a Nutritious Tomorrow (INFANT) Act, to enhance testing of infant formula for contaminants and improve resilience of supply.

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