Federal report suggests ways to improve infant formula safety oversight

To avoid a repeat of the infant formula shortage that for months had families scrambling, the U.S. Food and Drug Administration needs to fix its recall and complaint reporting processes, a new report says.

To avoid a repeat of the infant formula shortage that for months had families scrambling, the U.S. Food and Drug Administration needs to fix its recall and complaint reporting processes, a new report says. (Zoë Petersen, Deseret News)

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SALT LAKE CITY — To avoid a repeat of the infant formula shortage that for months had families scrambling, the U.S. Food and Drug Administration needs to fix its recall and complaint reporting processes.

That's among the findings of a new report issued this month by the Office of Inspector General in the U.S. Department of Health and Human Services.

The FDA lacked or had inadequate policies and procedures to identify risk to the formula supply and respond effectively, the report says. "For example, FDA had not developed an organizational structure or assigned responsibility to handle whistleblower complaints in an efficient and effective manner and took more than 15 months to address" such a complaint from February 2021 about the Abbott formula manufacturing plant in Sturgis, Michigan.

From the time the complaint was forwarded to the FDA by the Department of Labor to the time it really caught the FDA's attention, 15 months had passed, the report said.

Another whistleblower complaint that arrived in October 2021 wasn't elevated to senior leadership at the company, creating a four-month lag before company leaders knew of it.

The FDA did not have a system to create timeframes for "mission critical inspections," so the inspection related to one complaint didn't happen for 102 days. Nor did the agency have the policies and procedures it needed to initiate a baby formula recall under its "FDA-required recall authority," the report says.

The audit found that the FDA did follow its rules for inspection and recall in accordance with federal requirements. But the report said improvements are needed to keep the baby formula supply safe.

The new report is not the first time the Office of Inspector General has found problems with the FDA's domestic food facilities inspections and food recall oversight. It is, however, specifically focused on baby formula and how to prevent the kind of crisis that had other countries producing formula for the U.S., the president involved and families recruiting friends and even strangers to comb store shelves to help them feed their babies.

A baby formula crisis

As Deseret News reported extensively, many parents of very young children spent much of late winter 2021 and early spring 2022 searching for infant formula after the nation's largest formula manufacturing plant, the Abbott facility in Michigan, stopped making formula there and issued a voluntary recall of many of its products, including Similac, Alimentum and EleCare.

There had been consumer complaints of infants ill with Cronobacter sakazakii, a germ that can live in dry foods like powdered infant formula. At the time, Abbott produced about 40% of the U.S. market's baby formula. And about 40% of what the company made was manufactured there. Then the bacteria was found in the facility, though it was never found directly in baby formula and the FDA was not able to match the positive samples from the factory to the illnesses being experienced by using genome sequencing.

In May 2022, Abbott signed a consent decree with the FDA and Justice Department, promising to take specific action to make sure safe powdered formula is produced at the facility. That also beefed up inspections.

Meanwhile, the combination of panic buying by parents when they did find some, the recall, the temporary shuttering of the plant and supply chain issues kept the heat on parents, but also on politicians to do something. Congress made it easier for manufacturers outside the country to provide formula in the U.S. The Biden administration arranged airlifts of formula and diverted needed supplies under the Defense Production Act.

Even a year later, the shortage could be felt, per Deseret News.

And recent formula recalls likely put some parents on edge.

Fixing formula oversight

Among the Inspector General report's recommendations:

  • Cross-train staff on whistleblower policy and procedures and national consumer complaint coordinator duties, including monitoring the whistleblower email inbox.
  • Formalize the requirement to regularly update senior FDA leadership on the status of whistleblower complaints.
  • Create policies and procedures the FDA can use in future public health emergencies to identify how and when to conduct mission-critical inspections in a timely manner.
  • Facilitate reporting consumer complaints "in real time" to investigators who are conducting an active inspection of a facility mentioned in the complaint.
  • Find a way to identify data entry inaccuracies.
  • Formalize written policies and procedures so that reports of adverse events that should be forwarded to national consumer complaint coordinators actually reach them.
  • Continue to seek authorization to require formula manufacturers to notify and provide samples of any Cronobacter or salmonella detected in a formula product, even if that product has not been distributed. And update the databases with that information.

FDA steps taken

Food Safety Magazine reports that "a massive reorganization of FDA's Human Foods Program is underway, and is expected to be fully implemented by the beginning of Fiscal Year 2025 (Oct. 1). The reorganization is intended to address many of the pain points in FDA's current structure and processes that hinder its handling of food safety incidents, which were brought to public awareness by the agency's ineffective response to the 2022 infant formula crisis."

In a response to the Office of Inspector General report, the FDA said it agrees with the report and will implement the recommendations and some of it is already underway. For example, it has asked alongside its latest budget proposal for authority to get infant formula manufacturers to notify the FDA of any products found to contain pathogens, whether the product has been destroyed or not.

Food Safety News quoted Brian Ronholm, food policy director at Consumer Reports: "The Inspector General's report confirms what we've known for years about how the FDA's structure has interfered with its ability to ensure our food is safe. The problems highlighted by the infant formula crisis have plagued the FDA for years and have hampered its ability to protect the public on many food safety issues."

Added Ronholm, a former U.S. Department of Agriculture deputy undersecretary over food safety, "Fortunately, the FDA has begun making the kinds of changes that can help avoid a recurrence of the infant formula debacle, although significant work remains to be done. We look forward to continuing to work with the FDA to ensure its plan to reorganize its human foods program is implemented effectively so that it can carry out its critical mission to protect the public from food safety risks."

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Lois M. Collins
Lois M. Collins covers policy and research impacting families for the Deseret News.


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