- 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”
INFANT FORMULA
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FDA Issues Draft Guidance on Infant Formula Manufacture Discontinuance or Disruption Notifications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- On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which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
FTC Releases Report on Infant Formula Market
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- Earlier this month, the Federal Trade Commission (FTC) released a report which analyzes market factors contributing to the infant formula market disruptions that occurred in 2022 following the recall of
FDA Releases Infant Formula Risk Management Plan Fact Sheet
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- On November 22, 2023, FDA released a one-page fact sheet answering questions regarding the redundancy risk management plan requirement in the Food and Drug Omnibus Reform Act of 2022. The
FDA Deputy Commissioner for Human Foods Expresses Commitment to Human Foods Program Framework
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- James Jones, the newly appointed Deputy Commissioner for Human Foods, released a statement on October 19 outlining his commitment to Commissioner Robert Califf’s framework for the proposed Human Foods Program
FDA Updates Compliance Program for Infant Formula
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- FDA updated its infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program comprehensively outlines the agency’s approach towards inspections, sample collection, sample analysis, and compliance
FDA Provides Update on the Cronobacter Prevention Strategy in Powdered Infant Formula
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- Continuous collaboration with industry,