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The Daily Intake

Legal and Regulatory updates for the food and supplement industry

INFANT FORMULA

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FDA and HHS Announce Next Steps in “Operation Stork Speed”

Posted on May 13, 2025
  • 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”
… Continue Reading FDA and HHS Announce Next Steps in “Operation Stork Speed”

FDA Announces “Operation Stork Speed”

Posted on March 31, 2025
  • 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
… Continue Reading FDA Announces “Operation Stork Speed”

FDA Issues Draft Guidance on Infant Formula Manufacture Discontinuance or Disruption Notifications

Posted on December 3, 2024
  • On December 2, 2024, FDA issued draft guidance to assist the infant formula industry in complying with section 424 of the Food, Drug, and Cosmetic Act (FD&C Act), which
… Continue Reading FDA Issues Draft Guidance on Infant Formula Manufacture Discontinuance or Disruption Notifications

NASEM Releases Report on Infant Formula Market Challenges

Posted on August 14, 2024
  • 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,
… Continue Reading NASEM Releases Report on Infant Formula Market Challenges

Senators Propose Heavy Metal Legislation with Product Testing Requirements   

Posted on May 22, 2024
  • 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
… Continue Reading Senators Propose Heavy Metal Legislation with Product Testing Requirements   

FTC Releases Report on Infant Formula Market

Posted on March 27, 2024
  • 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
… Continue Reading FTC Releases Report on Infant Formula Market

FDA Releases Infant Formula Risk Management Plan Fact Sheet

Posted on November 27, 2023
  • 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
… Continue Reading FDA Releases Infant Formula Risk Management Plan Fact Sheet

FDA Deputy Commissioner for Human Foods Expresses Commitment to Human Foods Program Framework

Posted on October 23, 2023
  • 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
… Continue Reading FDA Deputy Commissioner for Human Foods Expresses Commitment to Human Foods Program Framework

FDA Updates Compliance Program for Infant Formula

Posted on October 11, 2023
  • 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
… Continue Reading FDA Updates Compliance Program for Infant Formula

FDA Provides Update on the Cronobacter Prevention Strategy in Powdered Infant Formula

Posted on September 20, 2023
  • Continuous collaboration with industry,
… Continue Reading FDA Provides Update on the Cronobacter Prevention Strategy in Powdered Infant Formula

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  • FDA and HHS Solicit Comments on Deregulation
  • FDA Announces Plans for Post-Market Review of Chemicals in Food
  • Texas Launches Another Investigation into Healthy Claims in Cereals
  • FDA and HHS Announce Next Steps in “Operation Stork Speed”
  • FDA and NIH Launch Joint Nutrition Regulatory Science Program

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Keller and Heckman, founded in 1962, has a broad practice in the areas of regulatory law, public policy, and litigation, serving both domestic and international clients. Our firm is a pioneer in the use of interdisciplinary approaches to problem-solving. Since 1971, we have had an in-house scientific staff that works closely with the firm’s attorneys on matters of technical complexity. Many of our attorneys also have government experience and expertise in multiple areas of the law.

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