FDA report on baby formula shortage outlines delayed response by agency

STURGIS, Mich. — The U.S. Food and Drug Administration (FDA) admits its response to the formula shortage was slowed by delays within the agency.

A new 10-page internal report gives more insight into those problems and shows outdated technology, inadequate staffing and training, and poor visibility within the agency are all factors that lead to the formula shortage some families struggled with.

In that report, some major shortfalls were discovered. This comes after the country was forced to airlift millions of pounds of powdered baby formula from overseas.

Looking back at the timeline leading up to the shortage, on September 20, 2021, the FDA learned a child had an infection caused by a type of bacteria which can cause brain damage leading to death.

That same day, FDA inspectors arrived at the Abbott Plant for an inspection.

During that inspection, they found the plant was not meeting certain cleanliness standards.

On October 20, 2021, the FDA received a report from former Abbott employee that alleged the company falsified records, hid issues from inspectors and released untested formula to consumers.

As that was happening, the FDA was made aware of four infants who developed bacterial infections between September 2021 and February 2022. Two of those babies died as a result.

According to the House Appropriations Committee, the FDA did not interview the whistleblower until December 2021 and din't inspect the plant again until late January 2022.

Abbott issued recalls of formula on February 17, 2022 after the FDA recommended the Sturgis plant stop production.

On June 5, 2022, Abbott reopened its plant.

Production stopped again on June 15, 2022 because of weather damage.

As of July 9, 2022, production has been running at the plant.

The report details the slow response to the whistleblower is due to mail delays, according to the FDA.

Then, shipping delays are to blame for late arrival of collected bacterial samples.

The first inspection and testing at the plant was also delayed because of COVID-19 cases among staff.

The report found five new resources Congress would need to authorize to improve inspections and standards.

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

Right now, families are seeing some relief as formula supply improves throughout the country.

According to IRI, a market research firm, in-stock rates hit above 80% last week which is around 11% from mid-July.