October 4, 2022

Volume XII, Number 277

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October 03, 2022

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FDA Publishes Internal Evaluation of Infant Formula Response

  • In May, FDA Commissioner Robert M. Califf, M.D., requested an internal agency review of the FDA’s actions related to multiple reports of Cronobacter in infants, the temporary shutdown of Abbot Nutrition’s facility in Sturgis, Michigan, and confounding issues that led to a shortage of infant formulas. On September 20, the FDA released the report, “FDA Evaluation of Infant Formula Response,” which includes information obtained from more than 40 interviews with over 60 FDA staff and leadership involved with the events.

  • The report identifies five major areas of need in order to ensure the safety of the food supply:

    1. Modern information technology that allows for the access and exchange of data in real time to all the people involved in response.

    2. Sufficient staffing, training, equipment, and regulatory authorities to fulfill the FDA’s mission.

    3. Updated emergency response systems that are capable of handling multiple public health emergencies occurring simultaneously.

    4. Increased scientific understanding about Cronobacter, its prevalence and natural habitat, and how this translates into appropriate control measures and oversight.

    5. Assessment of the infant formula industry, its preventive controls, food safety culture and preparedness to respond to events.

  • The report highlights that there is no single action to pinpoint as the cause of the events that occurred. Rather, it was “a confluence of systemic vulnerabilities that demonstrate the need to focus on continued modernization and investment in the expertise and tools needed to better anticipate and address future public health challenges in this area.” The report also identifies several areas in which FDA lacks authority, and how additional authorities and resources could enhance the agency’s capabilities.

  • In addition to this internal agency review, Commissioner Califf also requested an evaluation by an external group led by Dr. Jane Henney and supported by the Reagan-Udall Foundation that is intended to review various aspects of the Foods Program, including structure, function, funding, and leadership.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 264
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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