FDA head insists baby formula shortage due to ‘distribution’ issues

The head of the Food and Drug Administration claimed Monday that the disappearance of baby formula from store shelves across the US is due to a “distribution problem” rather than a lack of supply.

“I don’t want this to sound in any way like we’re not concerned about the parents who are struggling to find formula for their children,” FDA Commissioner Robert Califf told CNN. “That’s definitely happening in parts of the country. But you know, the number of stock on shelves is about 90% before … the recall, and it dropped to about 79% at its lowest and we’re on the way back up now.”

The Biden administration has been criticized for not doing enough sooner to address the crisis – which stemmed from a February recall by supplier Abbott Laboratories of name-brand formulas made at its plant in Sturgis, Mich.

Robert Califf said that the disappearance of baby formula from store shelves across the US is due to a “distribution problem” rather than a lack of supply.
AP Photo/Pablo Martinez Monsivais, File

Califf reiterated that “there is formula out there,” before acknowledging that the purported distribution issue should be investigated.

“Each manufacturer has its own distribution system, but there is no overall system that gets the right formula to the right place,” he said. “The current system works great as long as there’s nothing disturbing it. But when the plant shut down, it definitely caused problems. So you are correct to call attention to it and we’re working on it.”

In a separate interview with NBC’s “Today” show, Califf said it was “within the realm of possibility — and in fact, I think, quite likely” for the Abbott plant to be back up and running within two weeks.

A nearly empty baby formula display shelf is seen at a Target store in Orlando.
Stores across the United States have struggled to stock enough baby formula.
Paul Hennessy/SOPA Images/LightRocket via Getty Images

“Having said that, there will be a full investigation of the timeline, and we’ll do everything possible to correct any errors and timing that we had so that we don’t repeat any mistakes that may have been made.”

“We always want to be as fast as we can possibly be while also being diligent remembering — as shown by this example that if we do close a plant, then we have a supply shortage — so we have to get this right,” he later said.

In the meantime, Califf said, the FDA is moving to make baby formula meant for overseas markets available in the US over the next few weeks to alleviate the current shortage.

robert califf CNN
“I don’t want this to sound in any way like we’re not concerned about the parents who are struggling to find formula for their children,” FDA Commissioner Robert Califf told CNN.

“Over the weekend, one of the things that we worked on continuously was putting forth a set of rules that would enable the use of formula that was intended for other countries, some of it even manufactured in the US intended for other countries,” Califf told CBS News.

“You can image that it’s really important that we make sure that the constituents – remembering that the formula has over 30 different constituents that have to be in the formula – and also that the instructions for use are in English, or a language that the consumer can understand, because mixing up the formula – getting the right formula for the infant is critical,” he continued.

The FDA commissioner revealed that the agency “should be” able to announce further steps in the process later Monday and told CNN that parents should expect announcements on the use of formula meant for other countries “by the end of the day.”

“Over time, they should have a big effect because we’ll have access to a lot more formula from different manufacturers,” he said. “This will gradually improve over a period of a few weeks, but we really do anticipate that within a few weeks, we’ll have things back to normal.”

Currently only nine people are assigned to address baby formula within the entire FDA – a situation Califf wants to change as soon as possible.

“We’re working on the exact number that we think would be ideal, and let’s just say it’s several times more than the number that we currently – currently have,” he told CNN.

Shelves almost empty of baby formula with signs warning customers that they are limited to 8 cans per customers at a large Sydney supermarket on November 12, 2015 in Sydney, Australia.
Currently only nine people are assigned to address baby formula within the entire FDA.
Christopher Pearce/Getty Images

Califf is scheduled to appear before the House Appropriations Committee on Thursday to go over the FDA’s budget request for FY 2023. During the hearing, he will likely face questions about the small team and agency’s overall response to the baby formula shortage.

“It’s a major emphasis of mine to get this budget increase so that we have adequate staff,” he told CBS News. “I do want to note that the nine people have been working night and day. In fact, over the entire weekend, we had multiple groups pitching in to deal with this shortage.”

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