Food & Agriculture

First and Foremost, the Infant Formula Crisis is a Food Safety Crisis

By: Thomas Gremillion, Director of Food Policy

As the U.S. military airlifts baby formula into the country from Europe, and harried parents continue to encounter bare shelves, policymakers are understandably asking how we got into this mess. Corporate consolidation, regulatory barriers to entry, even import tariffs, all may deserve some reconsideration, but let’s not forget that a food safety failure lies at the heart of this crisis.

The closure of Abbot Laboratories’ Sturgis, Michigan plant, following the company’s Feb. 17 voluntary recall, represents the proximate cause of the infant formula shortage. Abbott controls 48% of the U.S. baby formula market, and Sturgis is the company’s main production facility. FDA was right to take the action it eventually did, but it should have acted much sooner.

Abbott issued its recall following reports that four infants who had consumed formula from the Sturgis plant were infected with Cronobacter sakazakii, with two of the infants eventually dying. Samples from a routine FDA inspection of the Sturgis plant in September of 2019 had turned up Cronobacter, and there were other grounds for suspecting food safety problems at the plant, but FDA did not return to inspect again until September 2021, two years later! That same month, the first of the four Cronobacter cases was reported. Following the infant deaths, and a whistleblower report alleging that the company had concealed other positive Cronobacter test results, FDA visited the Sturgis plant again on January 31st of this year, took samples that once again were positive for Cronobacter, and persuaded the company to issue a recall and shut down production.

Abbott has tweeted that “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses,” but the facts present a damning case against Abbott. According to the Department of Justice’s Complaint against the company, Abbott detected Cronobacter in finished product made on two different processing lines, in August of 2019 and June of 2020, as well as in multiple environmental samples. The FDA’s most recent inspection documented “310 water events including water leaks, moisture and condensation in dry powdered infant formula production areas.” And the whistleblower’s report, shared with FDA in October of 2021, alleges that the company falsified product safety records, released untested product, failed to fix labeling equipment that hampered traceback, and hid information from FDA auditors.

Why didn’t FDA act sooner to protect consumers?  In particular, after discovering Cronobacter in the Sturgis facility in September 2021, and receiving the first illness reports from Abbott formula fed infants in that same month, why did FDA take four months to revisit the plant? Why did FDA take two months to interview a whistleblower with credible information related to an ongoing foodborne illness outbreak? And why did FDA take two years to conduct a follow-up inspection in Sturgis—after finding Cronobacter in multiple samples from the plant—when your run-of-the-mill pepperoni processor gets a visit from a USDA government inspector every day?

FDA’s reluctance to take action against Abbott points to the need for fundamental reform that makes food safety a priority. What’s to be done?

Most importantly, Congress should pass legislation to create a single, independent food safety agency. The Safe Food Act, long supported by CFA, would bring coherence to our fragmented food regulatory system, which assigns food safety responsibilities to 15 different federal agencies and creates absurdities like disparate inspection frequencies between formula plants and pepperoni plants.

More immediately, Chronobacter infection should be added to the list of conditions that state and local health departments report to the Centers for Disease Control and Prevention’s National Notifiable Diseases Surveillance System. Currently, Minnesota is the only state in the nation that requires reporting of Cronobacter infections. That means that many illnesses are going underreported, with public health officials having fewer cases to go on when attempting to determine the root cause of an illness cluster, and less accountability for companies whose lax food safety practices cause babies to get sick.

Finally, at FDA, Commissioner Califf should restore the Deputy Food Commissioner that was eliminated during the Trump Administration. Doing so would unify FDA’s food program under one leader, with accountability to the commissioner and authority over the various food-related components of FDA.

As shortages of infant formula persist, the search for quick fixes to the crisis will only intensify. Unfortunately, ensuring a steady, safe supply of this vital commodity cannot occur in a vacuum. To avoid the next infant formula crisis, fix the food safety system.