- The Reagan-Udall Foundation recently released a report summarizing lessons learned following investigations into 2025 and 2026 infant formula recalls due to the presence of Clostridium botulinum (C. botulinum). The
INFANT FORMULA
FDA Calls On Infant Formula Industry to Safeguard Against Contaminants Introduced Through Supply Chains
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- On July 13, 2026, FDA issued a letter to infant formula manufacturers and their supply chain partners in response to several serious public health events, calling on the industry
California AG Issues Warning Letter to Baby Food Manufacturers re Heavy Metal Testing Disclosures
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- On March 6, 2026, California Attorney General, Rob Bonta, issued an enforcement letter to baby food manufacturers, reminding industry of its obligations under AB 899, which requires that any
Agencies Declare Botulism Outbreak Over
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- On February 26, 2026, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) announced that the multistate outbreak of
FDA Calls on Infant and Children’s Food Brands to Improve Recall Communications
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- On July 9, 2025, FDA Commissioner Marty Makary published a letter encouraging manufacturers of infant formula, baby food, and foods intended for children to improve their product recall communications. The
FDA and HHS Announce Next Steps in “Operation Stork Speed”
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- FDA and the Department of Health and Human Services (HHS) have announced the next steps in “Operation Stork Speed,” a program intended to enhance the “quality, safety, and nutritional adequacy”
FDA Announces “Operation Stork Speed”
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- On March 18, 2025, FDA announced that, at the direction of Health and Human Services Secretary Robert F. Kennedy Jr., it is “taking steps to enhance its efforts to ensure
FDA Issues Draft Guidance on Infant Formula Manufacture Discontinuance or Disruption Notifications
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- On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which
NASEM Releases Report on Infant Formula Market Challenges
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- Last month, the National Academies of Science, Engineering, and Medicine (NASEM) released a 401-page report which analyzed the 2022 infant formula shortage, highlighted the vulnerabilities in the infant formula market,
Senators Propose Heavy Metal Legislation with Product Testing Requirements
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- Earlier this month, Senators Amy Klobuchar and Tammy Duckworth announced the introduction of legislation (the “Baby Food Safety Act of 2024”) intended to increase the safety of certain foods, including