"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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Today, the Food and Drug Administration published a draft guidance explaining how the agency plans to publish the names of retailers involved in food recalls. This information, long advocated for by CSPI, is necessary for consumers to understand whether they have purchased food that may be dangerous. Until now, the FDA has only released retailer information rarely and without a clear policy.
The Food and Drug Administration should publish the names of retailers who received romaine lettuce covered in the recent Fresh Express recall. The romaine was implicated in a Cyclospora outbreak traced to McDonald’s salads. So far, according to the Centers for Disease Control and Prevention, 286 people in 15 states have become ill in the outbreak. There have been 11 hospitalizations and no deaths.
