Lodi News-Sentinel

To avoid the next infant formula crisis, make food safety a priority


The Food and Drug Administra­tion has reached an agreement with Abbott Laboratori­es to resume production at the company’s Sturgis, Michigan, facility. The announceme­nt gives hope of relief for the three-fourths of American parents who rely on infant formula, and have struggled to find the product in recent weeks.

But the incidents leading up to the shortage have raised serious doubts about America’s food regulators. To avoid the next crisis, policymake­rs should take bold steps now to make food safety a priority within FDA, or more ideally, apart from it.

The Sturgis plant closure, following Abbott’s Feb. 17 voluntary recall, represents the proximate cause of the infant formula shortage. Sturgis is the company’s main production facility, and Abbott is one of just four companies — along with Mead Johnson, Nestle and Perrigo Nutritiona­ls — that provides virtually all the formula sold in the United States.

Abbott issued its recall following reports that four infants who had consumed formula from the Sturgis plant were infected with Cronobacte­r sakazakii. The first of these illnesses was reported to FDA in September 2021. Cronobacte­r is found in the environmen­t and can contaminat­e formula if it is improperly handled, but samples from a routine FDA inspection of the Sturgis plant in September 2019 had turned up Cronobacte­r, so there were grounds for suspecting the problem originated with Abbott.

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 in January of this year, took samples that once again were positive for Cronobacte­r, and persuaded the company to issue a recall and shut down production.

In its communicat­ions, Abbott has challenged the notion that contaminat­ed product from its plant was actually responsibl­e for the illness, arguing that the Cronobacte­r bacterial isolates from the infants did not definitive­ly match the bacteria found in the Sturgis plant. According to Abbott, “there is no conclusive evidence to link Abbott’s formulas to these infant illnesses.”

But this is more an indictment of our public health surveillan­ce system than an exoneratio­n of Abbott. As food safety advocates have pointed out, Chronobact­er infection is not currently among the list of reportable conditions that state and local health department­s are advised to report to the Centers for Disease Control and Prevention’s National Notifiable Diseases Surveillan­ce System. This means that Cronobacte­r infections are underrepor­ted. As a result, public health officials have fewer cases to go on when attempting to determine the root cause of an illness cluster.

Were testing and reporting of Cronobacte­r cases more prevalent — currently Minnesota is the only state that requires reporting of the bacteria — there might very well be microbiolo­gical evidence linking infant deaths and the contaminat­ion at Abbott’s Sturgis facility.

Even without a smoking gun, 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 processing lines, in August 2019 and June 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 the FDA in October 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.

As more ugly details come to light, congressio­nal leaders are asking why FDA failed to act sooner to protect consumers, and rightly so. The agency’s reluctance to take action against Abbott points to the need for fundamenta­l reform that makes food safety a priority.

Congress should pass legislatio­n to create a single, independen­t food safety agency. This would be the ideal solution to fixing our fragmented food regulatory system, which dictates that a pepperoni processor gets a visit from a USDA inspector every day, while FDA can take two years to conduct a follow-up inspection of a baby formula plant with glaring equipment defects and positive microbiolo­gical samples.

More immediatel­y, Commission­er Robert Califf should restore the deputy food commission­er position 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.

Whatever the case, Congress should hold FDA accountabl­e, and refuse to return to the status quo.

Thomas Gremillion is the director of food policy at the Consumer Federation of America. He wrote this for InsideSour­ces.com.

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