Ossoff grills FDA on baby formula safety as new concerns emerge

ATLANTA, Ga. - New concerns are emerging over the safety of the nation’s baby formula supply and possible contaminants that aren’t fully known even to experts.

It also comes the same week U.S. Sen. Jon Ossoff grilled the U.S. Food and Drug commissioner on possible personnel shake-ups that could leave oversight of formula production vulnerable.

According to recent reporting from The New York Times, the Food and Drug istration and Department of Agriculture lost a key committee studying bacterial issues with consumer products, like baby formula, and further monetary cuts to those agencies could reduce regulatory personnel at the local level.

Baby formula is a vital source of nutrients for infants and can wreak havoc on the market if there are shortages. It happened in 2022, when Abbott Nutrition, a massive producer of formula, found a deadly contamination in their supply and immediately shut down.

“And the reason they found it is because they had enough regulators to look for it and find it before it becomes a problem,” said Kimarie Bugg, a nurse who works with Reaching Our Sisters Everywhere, a nonprofit in Decatur that helps women and mothers.

Bugg said even small disruptions to the baby formula supply can be detrimental in local communities. In the case of the Abbott shutdown, she said, mothers turned to dangerous alternatives when shelves ran dry.

“What we saw was people sharing breastmilk and also, actually not giving the babies the proper things that they need,” Bugg said.

She’s referring to transitional formula, a type of product given to infants as they transition away from formula altogether.

During the 2022 shortage, it was all that was left in stores in many cases, forcing mothers to go without or make the potentially dangerous decision to use the wrong formula.

“Our biggest concern is that babies don’t get the food that they need,” said Bugg. “It definitely is a slippery slope, and babies are impacted tremendously.”

Recently, Ossoff questioned FDA Commissioner Dr. Matrin Makary over the possible cuts to staff that oversee the safety of consumer products like baby formula.

When asked, Makary said he was not aware of any cuts to regulatory staff, but added that several were on the list for removal.

“No one was cut in the reduction of force,” he said. “They were scheduled for the reduction in the future, down the road, it has not happened yet.”

Just a few days before the hearing, the FDA announced a new study on baby formula contamination, the first since 1998. Set to begin on June 4 of this year, the study’s aim is to review standards, supply chains, and nutrients like added sugar and seed oils in formula.

A recent study conducted by nonprofit researcher Consumer Reports showed that of 41 types of baby formula tested in the study, about half of the samples contained “potentially harmful levels” of at least one contaminant, including lead.

Transcript of questioning by Ossoff

SEN. OSSOFF: “Thank you, Mr. Chairman and Dr. Makary, good to see you.”

COMMISSIONER MAKARY: “Good to see you.”

SEN. OSSOFF: “Thank you for ing us. I was pleased to see that the Secretary has made the safety of infant formula a priority for the department, is that correct?”

COMMISSIONER MAKARY: “That’s right. And the FDA will be convening world experts on infant formula, June 4, and we’re going to be having a robust discussion, because parents want infant formula options with a better supply chain, without added sugar and seed oils.”

SEN. OSSOFF: “Did you see a recent Consumer Reports study which found that of 41 tested infant formulas more than 30 were found to have potentially dangerous levels of lead?”

COMMISSIONER MAKARY: “Yeah, heavy metals in infant formula is something that’s getting a lot of attention, as it should, and so that is part of Operation Stork Speed to take a hard look at that, and it is one of the priorities of our infant formula roundtable at the FDA on June 4.”

SEN. OSSOFF: “And it’s the Human Foods Division of your agency responsible for infant formula safety, at least in large part, yes?”

COMMISSIONER MAKARY: “Yes.”

SEN. OSSOFF: “Trying to make sure I understand some of the relevant personnel decisions, given the concern that families in Georgia have about the safety of infant formula, the safety of the food supply.

“James Jones, the Deputy Commissioner for Human Foods, submitted a resignation letter February 17, included the quotes, ‘The indiscriminate firing of 89 staff in the Human Foods Program is beyond short sighted. The Foods Program staff at FDA is the envy of the world and its technical, professional and ethical standards.’

“It goes on, ‘the employees fired this past weekend are the most recent hires and generally come to Federal service with the most recent education and represent the future of the agency. They included staff with highly technical expertise in nutrition, infant formula, food safety response, and even 10 chemical safety staff hired to review potentially unsafe ingredients in our food supply.’

“That was February 17. You were asked on April 17 whether any of the personnel reductions had included personnel responsible for food safety or infant formula safety.

“You said, ‘there were no cuts to scientists or reviewers or inspectors, absolutely none.’

“You were asked on April 23 on CNN and said again, ‘there were no cuts to scientists or inspectors.’

“But then just two day later, an HHS spokesperson confirmed that, in fact, scientists had been fired and that you were scrambling to rehire them. Is that, did you in fact, say on April 23 there were no cuts to scientists or inspectors? Just before we get into the details, is that an accurate quote?”

COMMISSIONER MAKARY: “No scientific reviewer was cut as part of the reduction in force.”

SEN. OSSOFF: “But, you said there were no cuts to scientists or inspectors. Didn’t you say that?”

COMMISSIONER MAKARY: “My understanding was that there were no cuts to the scientific staff, but specifically the scientific reviewers, is what I was referring to.”

SEN. OSSOFF: “You said there were, I mean, I just...

COMMISSIONER MAKARY: “Jim Jones is an economist.”

SEN. OSSOFF: “Very straightforward question. You said there were no cuts to scientists or inspectors, correct?”

COMMISSIONER MAKARY: “Scientific reviewers is what I was referring to...”

SEN. OSSOFF: “No, you said...”

COMMISSIONER MAKARY: “That’s the vast majority of scientists there. Jim Jones is an economist.”

SEN. OSSOFF: “And then five days before you had said there were no cuts to scientists. You said that right?”

COMMISSIONER MAKARY: “I was referring to scientific reviewers. There are a couple research...”

SEN. OSSOFF: “But scientists had been fired, correct?

COMMISSIONER MAKARY: “There have been a couple, there have been research scientists in some labs that have been doing some research. Some of that research is good, some of it is not good. And so there have been no cuts to scientific review...”

SEN. OSSOFF: “In fact, in fact, scientists who study the safety of infant formula had been fired. Correct?”

COMMISSIONER MAKARY: “I’m not aware of any scientists, studies infant formula that has been cut...”

SEN. OSSOFF: “Well here’s the reporting in The New York Times, which says ‘the HHS spokesman said those employees called back had been inadvertently fired, and the decision to rehire specialists on outbreaks of food related illnesses and those who study the safety of products like infant formula.’ So, is this reporting accurate? Had, in fact, scientists who study outbreaks of food related illnesses and the safety of infant formula been fired?”

COMMISSIONER MAKARY: “The reason it’s not accurate, Senator, is that people were not fired. They were scheduled for the reduction in force. And this was before I got there. When I got there, we did an assessment, and so some of those individuals out of the 19,000 were restored. Jim Jones was an economist, and he was upset about the DOGE cuts, so he self-DOGED. I didn’t, he was not fired. I wish he would have stayed, but he chose to leave.”

SEN. OSSOFF: “Have all, have all scientists responsible for food safety and infant formula safety been rehired or reinstated?”

COMMISSIONER MAKARY: “Look, we have not reduced in force the scientific review staff. I know where you’re going with this. We’re not allowed to let go of a single person...”

SEN. OSSOFF: “I’m trying to get clarity on your statement. You said, you said ‘there were no cuts to scientists,’ and then the HHS spokesperson said, ‘actually there were cuts to scientists, and now we’re trying to rehire them.’ I mean, so it, it gives the impression you’re not sure about the personnel actions ongoing in your own agency...”

COMMISSIONER MAKARY: “Again, no one was cut...”

SEN. OSSOFF: “...And that’s the indication from your testimony here again today.”

COMMISSIONER MAKARY: “No one was, no one was cut in the reduction of force. They were scheduled for the reduction in the future, down the road. It has not happened yet. So the people scheduled to be cut, we did a review and found some research scientists. When I made those statements, it was very specific. I was very clear. We’re talking about scientific reviewers, because the trains have to run on time. And if you’re concerned about a back the labs...”

SEN. OSSOFF: “My time is up, my time is up, but you were very specific. You said ‘there were no cuts to scientists,’ and then five days later ‘there were no cuts to scientists.’ Those are your direct quotes. ‘There were no cuts to scientists,’ but there were cuts to scientists.”

COMMISSIONER MAKARY: “No, there were no cuts to scientists because people were scheduled for the reduction force in the future, and the people scheduled were reevaluated, and we restored a couple research scientists, and I was referring not only to them, but to...”

SEN. OSSOFF: “How many?”

COMMISSIONER MAKARY: “...to the scientific reviewers.”

SEN. OSSOFF: “How many, how many scientists responsible for preventing outbreaks of food related illnesses and the safety of infant formula have been restored or reinstated?”

COMMISSIONER MAKARY: “There were no scientists that were in charge of preventing outbreaks that were...”SEN. OSSOFF: “I didn’t say, ‘in charge...’”

COMMISSIONER MAKARY: “But I mean, this is the problem in government. Somebody has a fancy sounding name like ‘infant formula safety,’ and no one can ever touch them, even if they’re not doing their job, even if they’re redundant...”

SEN. OSSOFF: “Ok, I’ll tell you what. I’ll send you, so that you can get accurate information to the committee, I’ll send you some very detailed questions about this, and you’ll respond in full, yes?”

COMMISSIONER MAKARY: “Yes. Just keep in mind, the agency was half its size in 2007 we didn’t have...”

SEN. OSSOFF: “You’ll respond in full...”

COMMISSIONER MAKARY: “Outbreaks and rampages and food outbreaks...”

SEN. OSSOFF: “We had a huge infant formula safety crisis in this country just a few years ago. Do you recall that?”

COMMISSIONER MAKARY: “That was because of several problems, including...”SEN. OSSOFF: “You will respond in full to the questions that I send you?”

COMMISSIONER MAKARY: “I’m always happy to respond.”

SEN. OSSOFF: “Thank you so much, Dr. Makary, thank you.”

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