A former top official for the Food and Drug Administration (FDA) warned lawmakers on Tuesday that the U.S. is only one crisis away from experiencing another infant formula shortage and called for heightened regulations on manufacturers and greater organization within his former agency.
Frank Yiannas, who served as the FDA’s deputy commissioner for food policy and response for four years before resigning in January, appeared before the House Subcommittee on Health Care and Financial Services to discuss the causes of the infant formula shortage and what actions could be taken to prevent it from happening again.
In his opening remarks, Yiannis said the factors that led up to the shortage continue to be “elusive,” adding that he did not believe the infant formula industry has changed much in the year since the recall on products was issued and still lacked “resiliency.”
“In other words, the nation remains one outbreak, one tornado, flood or cyberattack away from finding itself in a similar place to that of February 17, 2022,” Yiannis said.
The former FDA staffer reiterated similar criticisms that he made known when he resigned at the start of the year, telling the panel that he felt the agency was too “decentralized,” noting that he had six different bosses across the four years that he worked for the government.
In his resignation letter, Yiannis cited the “decentralized structure of the foods program” as part of the reason for his leave. He stated at the time that he delayed his resignation in light of the infant formula crisis, which he says he did not receive notice of until “too late” in February.
Yiannis said that if he had received notification sooner than February, he would have demanded an inspection of Abbott Nutrition’s Sturgis, Mich. plant sooner than the one that was conducted in January 2022, four months after the FDA received a complaint about bacteria contaminating powdered infant formula. Infections stemming from contaminated infant formula during 2022 are believed to have caused at least four hospitalizations and two deaths.
Yiannis presented about a dozen recommendations to the committee, which both Chair Lisa McClain (R-Mich.) and ranking member Katie Porter (D-Calif.) welcomed as concrete actions that the federal government could take to prevent a similar shortage from occurring.
Chief among the recommendations was to make Cronobacter sakazakii bacterial infections a nationally notifiable disease, which would require health providers to notify health officials of a diagnosis of the illness. Minnesota and Michigan are currently the only two states that require reporting of such illnesses.
As was noted during the hearing, four companies, including Abbott Nutrition, control roughly 90 percent of the U.S. infant formula industry. Porter condemned the current state of the industry as being far too “monopolistic” and lacking a competitive marketplace.
The consensus of the hearing appeared to be that there was blame to share among both Abbott Nutrition, the FDA and the industry at large.
“There’s no pass for the FDA here,” Porter said in her closing remarks. “What’s more, big businesses can do better. Regardless of who’s looking over their shoulder, it is their job to produce safe, quality products. That’s the cost of doing business in food.”
McClain in particular zeroed in on what she described as failure by the FDA to prioritize food safety.
”I have been outspoken in my frustration with the FDA’s response to the infant formula shortage,” she said. “The FDA is responsible for the safety of 78 percent of the U.S. food supply. But the FDA is not prioritizing food safety. Instead of owning its failure, the FDA has used COVID-19 as an excuse to neglect inspections and justify poor performance.”
FDA officials have been invited to testify before the committee next month.
