To avoid next baby mix crisis, make food safety a priority – Mainline Media News
The Food and Drug Administration has reached an agreement with Abbott Laboratories to resume production at the company’s plant in Sturgis, Michigan. The announcement gives hope for relief for three-quarters of American parents who are hoping for a baby formula and struggling in recent weeks to find a product.
But the incidents that led to the shortage have raised serious doubts among America’s food regulators. To avoid the next crisis, politicians should take bold steps to make food safety a priority at the FDA, and ideally beyond it.
The closure of the Sturgis plant following the voluntary recall of Abbott on 17 February is the immediate cause of the baby mix shortage. Sturgis is the company’s main manufacturing facility, and Abbott is one of four companies – along with Mead Johnson, Nestle and Perrigo Nutritionals – that provides virtually all of the formula sold in the United States.
The Abbott company issued its recall following reports that four infants who consumed a mixture of the Sturgis plant were infected with Cronobacter sakazakii. In September 2021, the FDA reported the first of these diseases. Chronobacter is in the environment and can contaminate the mixture if mishandled, but samples from the Sturges plant’s usual FDA inspection in September 2019 found Chronobacter, so there was reason to suspect the problem arose with Ebat.
Following the infant deaths and an informant allegation that the company hid other positive Cronobacter test results, the FDA revisited the Sturgis plant in January this year, took samples that were positive again on Cronobacter, and persuaded the company to issue a recall and discontinue production. .
In its reports, Abbott disputes the notion that the infected product from her plant was actually responsible for the disease, arguing that the bacterial isolates of Cronobacter from infants do not definitively match the bacteria found on the Sturgis plant. According to Abbott, “there is no convincing evidence of a link between Abbott’s formulas and these childhood illnesses.”
But it is more a charge of our health care system than the release of Abbott. According to food safety advocates, Chronobacter infection is currently not on the list of reporting conditions that state and local health departments are encouraged to report to the National Disease Control and Prevention System of the Centers for Disease Control and Prevention. This means that Cronobacter infections are underestimated. As a result, health officials are left with fewer cases to pursue when trying to determine the root cause of a cluster of diseases.
If testing and reports of Cronobacter cases were more common – Minnesota is now the only state requiring reports of bacteria – there may well be microbiological evidence linking infant death and infection at the Abbott Sturgis facility.
Even without a smoking gun the facts represent a disastrous case against Abbott. According to the Justice Department’s complaint against the company, Abbott found Cronobacter in a finished product manufactured on two production lines, in August 2019 and June 2020, as well as in numerous environmental samples. A recent FDA audit documented “310 aquatic events including water, moisture and condensate leaks in dry powder infant production areas”.
And an informant’s report released by the FDA in October 2021 alleges that the company falsified product safety records, released untested products, failed to correct labels that interfered with tracking, and hid information from FDA auditors.
As more ugly details emerge, Congress leaders are asking why the FDA has failed to act earlier 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 must pass a law establishing a single independent food safety agency. This would be an ideal solution to fix our fragmented food regulatory system, which provides that the pepperoni processor visits the USDA inspector every day, while the FDA may take two years to conduct a follow-up inspection of the baby formula plant with striking equipment defects and positive microbiological samples.
More immediately, Commissioner Robert Calif must reinstate the Deputy Commissioner for Nutrition, which was removed during the Trump administration. This would combine the FDA’s food program under one leader with accountability to the Commissioner and authority over the various FDA components related to food.
In any case, Congress must hold the 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.