- 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:
- Modern information technology that allows for the access and
exchange of data in real time to all the people involved in
- Sufficient staffing, training, equipment, and regulatory
authorities to fulfill the FDA's mission.
- Updated emergency response systems that are capable of handling
multiple public health emergencies occurring simultaneously.
- Increased scientific understanding about Cronobacter,
its prevalence and natural habitat, and how this translates into
appropriate control measures and oversight.
- Assessment of the infant formula industry, its preventive
controls, food safety culture and preparedness to respond to
- Modern information technology that allows for the access and exchange of data in real time to all the people involved in response.
- 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
- 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.
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