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US formula shortage persists and will 'take a while to fix'

(CNN) The nationwide baby formula shortage that federal leaders once said would be fixed within weeks has dragged on for months, despite tons of imports and key steps forward in domestic production.

Formula stock rates have been dropping since the end of February, when the US Food and Drug Administration shut down a major formula plant and issued a recall of products manufactured there after an inspection found dangerous bacteria in several areas. The closure exacerbated shortages caused by supply chain disruptions, leaving families struggling to find formula for infants and people with specific nutrition needs.

More than 20% of formula products -- powder, ready-to-drink and liquid -- have been out of stock for the past six weeks, according to data released Wednesday by market research firm Information Resources Inc. Before the recall, about 10% of infant formula products were typically out of stock.

Formula stock hit a low in late June; 22.4% of products were out of stock during the week ending June 26.

Since then, the Abbott plant in Michigan that was at the heart of the recall has resumed production. Flooding from severe storms halted production for most of June, but it's been back up and running for about three weeks.

Still, stock rates have improved by less than 1 percentage point in that time. Last week, 21.9% of formula products were out of stock.

FDA Commissioner Dr. Robert Califf told a Senate Appropriations subcommittee on Wednesday that there is a "robust pipeline" of formula coming in. Production is finally outpacing purchasing as families have eased up on stockpiling, too.

But "there was a deficit that's going to take a while to fix," he said.

Throughout the shortage, federal leaders have been reluctant to share a timeline for when things might get back to normal. But Califf's comments this week were more tempered than they've been.

In May, Califf said that supply should be back to normal within a matter of weeks.

Over the past two months, the Biden administration has announced more than a dozen missions to bring formula into the US through Operation Fly Formula. The announcements total more than 4 million pounds of formula -- and the latest one says that enough to make about 61 million 8-ounce bottle equivalents will be delivered by the end of this week.

But according to IRI, in 2021, an average of about 561,000 pounds of dry powder formula was sold each day, or about 17 million pounds each month. That means the Operation Fly Formula missions announced to date account for just about a week of typical powder formula sales in the US.

Kroger has received some supply from the Operation Fly Formula shipments but told CNN this week that it has not seen a "big impact" on inventory yet.

Nationwide, the latest IRI data shows that stock rates for powder formula specifically are even worse than overall formula rates -- and continue to drop. More than 31% of powder formula products were out of stock last week, up from 27% a month earlier.

At Wednesday's Senate meeting, Sen. John Hoeven, R-North Dakota, said he "can't overstate" his concern around the formula shortage.

"We have to make sure that we don't have something like that happen again. Going forward, I think that FDA should treat essential foods such as infant formula in the same manner the agency treats essential medicines," he said.

Rep. Rosa DeLauro, D-Connecticut, chair of the House Appropriations Committee, has also been critical of the FDA's handling of safety concerns at Abbott's Michigan facility and has introduced a bill that would create a Food Safety Administration as a single HHS agency that would be responsible for food safety.

"First, let me be clear: we should not have to choose between supply and safety, especially when it comes to a product we feed our babies. This product should face the most rigorous standards of safety, to ensure that it is safe to feed our children," she said in a statement to CNN. "The shortage persists because we are overly reliant on one manufacturer to get infant formula back on the shelf."

DeLauro posted a video to Twitter on Tuesday in which she asked Americans to send photos of the baby formula aisles of stores in their areas to document the status of the shortage.

"We need to get safe infant formula back on the shelves, but we need to know which communities are in the most need. Please, help us find out," she said in the video.

Califf said at Wednesday's hearing that store shelves might look different because formula manufacturers are packaging products in larger containers.

"When there is a shortage, people change what they make to make it so that, for example, maybe larger containers to optimize bringing forward the product for purchasing. So some of the things that people are used to seeing on the shelf may not be there, even if the total amount of formula is the same or higher than it was," he said.

IRI data does suggest that the variety of products made available to consumers has shrunk; less than half as many products are being sold now than during the same time last year.

In any case, "it's not going to be a sudden fix," Califf said.

He said the FDA is understaffed and underfunded and needs more resources to be able to respond to shortages, but the safety of the US food supply "is one of my absolute top priorities," and a full review of the foods program is underway.

CNN's Virginia Langmaid, Brenda Goodman and Carma Hassan contributed to this report.
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