‘We never want to have this happen again,' FDA official testifies about formula shortage

‘We never want to have this happen again,' FDA official testifies about formula shortage


In a rare instance of bipartisan agreement on Thursday, US lawmakers severely criticized the Food and Drug Administration for its handling of the shortage of infant formula.

The US House Oversight and Accountability Subcommittee on Health Care and Financial Services hearing was one of many Congress held to better understand the factors that contributed to the recent shortage of formula and how to prevent future problems.

Rep. Lisa McClain (R-Michigan) said that FDA had not been completely forthcoming with Congress and public.

Why was the FDA not prepared for the crisis' She asked this question in her opening remarks.

She claimed that the agency had failed to give priority to food safety. The FDA has failed to take the necessary steps to prevent another similar crisis.

Rep. Katie Porter (D-California) said that she agreed with McClain, that a new shortage is possible, and that it would be a 'deadly serious problem'

Porter said that there was a lot to blame. It's obvious with today's witness choice that Republicans want the FDA to be blamed, and I will admit that I agree with them that some of this blame is justified. Two more recalls of infant formula have already occurred in 2023. The FDA still has room to improve its internal processes, act sooner on issues, and conduct additional inspections.

Dr. Susan Mayne of FDA's Center for Food Safety and Applied Nutrition testified on Thursday that three major US manufacturers control 90% of the US formula market. This consolidation is a serious concern that contributed substantially to shortages.'

The shortage, which began in 2021, was made worse when Abbott Nutrition, the nation's largest manufacturer of infant formula, recalled several products in February 2022. It also had to stop production at its Sturgis, Michigan plant after FDA inspectors discovered potentially dangerous bacteria.

The plant inspection was linked to an outbreak of Cronobactersakazakii, which sickened and killed at least two infants. However, investigations found no genetic link between the bacteria in samples taken from the facility and the bacteria that were present in the water or powder that was used to mix formula for the infants.

Mayne said that it was hard to track the cases, and determine the severity of the outbreak. It is common to find the bacteria in the environment, but we know very little about it.

The FDA has asked the US Centers for Disease Control and Prevention (CDC) to declare Cronobacter as a notifiable illness. This would require providers to notify local or state health officials of cases, so that public health experts could more quickly identify the source of contamination.

An FDA inspection at the Sturgis facility found that in addition to bacteria, there were unsanitary conditions as well as several violations of food safety regulations.

In February 2021, the FDA was alerted by a whistleblower to safety concerns at the Abbott plant. This was months before the recall of Abbott's formula. The complaint claimed that workers had falsified records, hid information and lacked proper sanitation practices at the plant.

Mayne, like other FDA officials who have testified before Congress, said that she wasn't made aware of the complaint immediately. She described it as a 'failure of escalation'

Mayne stated, 'I wish I was made aware of the whistleblower's complaint but, just to repeat, it has been acted upon.' She did note that it was "less than ideal" how quickly an FDA inspection was conducted at the plant, and how quickly they were able to take action.

The FDA had no formal process to escalate the complaint when the whistleblower filed it. Since then, the process has changed to ensure that leadership is immediately notified if a complaint falls under certain criteria, such as hospitalizations, deaths or vulnerable populations. A consumer complaint that involves a hospitalization or infant death is also escalated immediately to the leadership.

Mayne said that the FDA will not be able to prevent future shortages. She said that the industry must do more to improve food safety in order to provide 'the safest infant formula possible.'

A better regulatory system is also something the agency would like to see. In 2023 there have already been two recalls of infant formula. The manufacturer was not required to notify FDA about contamination prior to the formula leaving the factory in either case.

This voluntary reporting is not mandatory. If the FDA had to report all positive tests, it would be able to take immediate action if they were required.

Mayne stated that 'our food safety experts and our compliance experts can collaborate with manufacturers'. They could identify quickly which product to concentrate on in order to avoid a shortage.

Recent FDA actions have improved the FDA. In February, the FDA announced it was restructuring its food division in order to be more responsive. It also created an office for critical foods. Mayne stated that the FDA will also be hiring infant formula inspectors.

She said that the supply of infant formula is in general good condition, but distribution problems still exist.

Stocks are at a level that is higher than before the recall. Some rural areas have a difficult time getting the formulas they need.

Mayne stated that formula manufacturers are producing more than what is purchased each week in order to increase the supply. Mayne said that the Biden administration also tried to import formula from overseas manufacturers.

Another shortage is possible, especially if one of our main manufacturers goes offline for a significant period of time.

Mayne stated that he did not want this to happen again.

The FDA budget has been cut by about 22 percent in 2023. Mayne stated that the FDA budget would be cut by 22%, which is a significant amount.

She said that the FDA would suffer a 32% loss in domestic inspections, and a 22% drop in foreign inspections. These cuts will also have a disproportionate impact on its food programs. They receive a large portion of their funding through the budget.

Mayne stated that 'We wouldn't be able to do what the American consumer expects us to do'.