Keith Nunes 2019

KANSAS CITY – While the focus of the baby formula shortage in the United States is rightly on supplying the needs of parents across the country, attention also must be paid to the responses of the Food and Drug Administration and Abbott Nutrition. How both handled the crisis has the potential to further undermine consumer confidence in regulators and manufacturers.

Robert M. Califf, MD, the commissioner of food and drugs, painted a dark picture in testimony about the baby formula shortage before Congress May 26.

“We lost confidence that Abbott Nutrition had the appropriate safety and quality culture and commitment to fix these problems quickly,” Dr. Califf said in his testimony about the issues agency inspectors found when they inspected Abbott Nutrition’s baby formula manufacturing plant in Sturgis, Mich., following a foodborne illness outbreak caused by the pathogen Cronobacter sakazakii and linked to the plant.

Issues identified included a lack of process controls to ensure baby formula did not become contaminated; that plant personnel did not ensure all food contact surfaces were properly maintained; that inspectors found cracks in spray dryers used to make the formula; and water leaks and condensation in the plant.

Abbott Nutrition was notified about the FDA’s intent to inspect the Sturgis plant, according to Dr. Califf’s testimony. The inspection date was planned for early January and Abbott Nutrition was informed on Dec. 31, 2021. Abbott Nutrition notified the FDA of a COVID-19 outbreak at the plant, and the inspection was delayed until Jan. 31.

“Insanitary conditions of this kind are unacceptable in all food manufacturing facilities, but especially in areas producing dry powdered formulas that serve as the sole source of nutrition for infants,” Dr. Califf said. “Finding pathogens in finished product during routine testing also generally indicates a potentially serious loss of sanitary process control during manufacturing.

“FDA would expect any manufacturer with a robust quality assurance program to identify and quickly take corrective action when such conditions are present.”

Abbott Nutrition disagreed with the FDA’s findings, with Christopher J. Calamari, president of the Abbott Nutrition North America business unit, testifying that, at the request of the FDA, third-party food safety experts were employed to review the food safety plans and procedures at Sturgis and found they “met all requirements.” Mr. Calamari also testified that while Cronobacter sakazakii was found through environmental testing, it was in non-product contact areas.

The contradictory testimonies cast a negative light on both parties. For example, if the situation at Sturgis was so bad, how did it escape the FDA’s notice, especially when it later came to light that a whistleblower reported the shortcomings at the plant to the agency? And what does it say about the leadership of Abbott Nutrition that a key cog in its multi-billion dollar nutrition business was shut down over such fundamental food safety practices?

The International Food Information Council’s recently released Food & Health survey found that 68% of those surveyed expressed confidence in the safety of US food and beverages. Twenty-four percent of survey respondents said they are “very confident,” up from a low of 10% in 2016. Amid other high-profile product recalls, the baby formula incident poses a threat to drag that high level of confidence back down.