Highlights “systemic vulnerabilities” and changes to address them.
Infant formula supplies in the U.S. have been improving recently, with in-stock rates reaching 80 percent last week, up from 69 percent in July.
A report from an internal investigation and review of the Food and Drug Administration’s actions leading up to the infant formula crisis found a number of shortfalls that exposed “systemic vulnerabilities” that delayed the agency’s response.
The review, led by Director Steven Solomon of the FDA’s Center for Veterinary Medicine, found that delays in processing whistleblower complaints, lack of staffing and training for its food inspectors, outdated technology, and insufficient manufacturing processes all exacerbated the formula shortage. President Biden’s administration sourced millions of pounds of infant formula from overseas as a result.
“There is no single action to explain the events that occurred, rather the report identifies 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,” wrote Dr. Solomon. “As we implement these changes, we must ensure that they address the issues that led to the shortage of a safe, wholesome food supply for our most vulnerable populations.”
The 10-page report detailed that the agency would need “considerable” resources to modernize its systems and hire and train more staff to keep it on pace to address evolving public health threats. It also underscored errors that were outside of the agency’s control, including that the FDA does not have the authority to require manufacturers of “infant formulas or certain medical foods” to notify it when a problem arises that could lead to a shortage.
“Access to this information in a timely manner could help the FDA take steps to potentially ensure continued availability of these products for consumers who need them,” the report read.
As the Lord Leads, Pray with Us…
- For Commissioner Califf as he oversees the authorizations, approvals, and reviews of the plethora of food and drug items his agency handles.
- For FDA officials as they evaluate and determine which substances and items are safe for public consumption or exposure.
- For parents and guardians of infants who are still experiencing the shortage of formula.
Sources: Washington Examiner, The Hill
