Response from FDA to Safe Food Coalition letter RE: ByHeart infant formula outbreak

"Thank you for your December 8, 2025, letter regarding infant formula safety in light of the ongoing Clostridium botulinum outbreak linked to ByHeart infant formula. The Food and Drug Administration (FDA or “We”) share your commitment to protecting our nation's most vulnerable consumers and appreciate your recommendations for strengthening FDA’s inspection and regulatory oversight of infant formula. Ensuring that the infant formula supply is safe and wholesome for children and their families who rely upon these products is a top priority for the Department of Health and Human Services (HHS) and FDA. Operation Stork Speed, announced in March 2025, reaffirms our commitment to ensuring the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply."

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