FDA Announces Making It Easier to Import Some Baby Foods to Reduce Deficits

The US typically produces 98% of the infant formula it uses, with imported formulas coming primarily from Mexico, Ireland and the Netherlands, the agency said in a statement. But because of the shortage, the FDA is outlining a process where it “would not object to the importation of certain infant formula products destined for a foreign market,” as well as the distribution in the US of products made domestically for export to other countries. .

“Companies seeking to take advantage of this flexibility must submit information to the FDA to quickly evaluate whether the product is safe to use and whether it provides adequate nutrition,” the agency said. “For example, labeling, nutritional adequacy and safety testing information, and facility inspection history information.”

The agency says it is already in talks with a number of manufacturers and suppliers about additional offerings.

FDA Commissioner Dr. Robert Califf said in a statement: “With this flexibility, we expect those products that can quickly meet safety and nutritional standards can make it to US stores within weeks.”

The news comes as the White House is working with key manufacturers to provide logistical support during the baby food shortage, a White House official said in a statement on Monday.

“The White House is in ongoing discussions with the four major infant formula manufacturers – Reckitt, Abbott, Nestle/Gerber and Perrigo – to work with them to identify transportation, logistics and supplier hurdles to increasing formula production in their U.S. – and FDA-approved facilities, to expand the number and rate of FDA-approved formula shipped to the country, and to ensure that formula moves quickly from factories to retailers,” he said. the White House official.

CNN reported earlier Monday that the Biden administration is facing a barrage of questions and criticism over the national baby food shortage, causing anxious and angry parents to jump from store to store in search of baby food. The administration offered a new website, HHS.gov/formula, to provide assistance to families in need, but when a CNN reporter tried out some of those options, the exercise resulted in apologetic customer service representatives, a wait that lasted more than a year. . hours and serious challenges in finding baby food through some of the top suggestions on the new HHS website.
The White House is also in “ongoing communication” with Target, Amazon, Walmart and other major retailers, the official said, “to identify areas of the country at risk of critically low infant formula supply, and have offered to working with manufacturers and retailers to bring more formulas to those parts of the country, including with support from the US government on transportation and logistics.”
President Joe Biden held virtual meetings Thursday with the executives of Target and Walmart and formula makers Reckitt and Gerber, respectively. Officials have since had “close communication to follow up on those talks,” the official said.

Efforts are also being made to strengthen the supply chain, reaching the suppliers of formula manufacturers.

“We are also contacting suppliers of infant formula manufacturers to inform them that their materials are critical to driving infant formula production in the U.S. and that they should prioritize their production and supply,” the official noted. on.

Speaking on CNN’s “New Day” on Monday, U.S. Food and Drug Administration Commissioner Dr. Robert Califf that the administration is “doing everything we can” to fix the shortfall.

Califf pointed to efforts to work with manufacturers to increase production, work on the supply chain and work closely with Abbott to open the closed factory as soon as possible.

Pressed on how much effect the move will have to make importing some formulas easier, he said the overall situation will “gradually improve” in a “few weeks.” This Thursday, Califf will testify before the Subcommittee on Agricultural Appropriations about the FDA’s 2023 budget request and infant formula oversight.

The baby food shortage has been exacerbated by the FDA’s closure of the nation’s largest infant formula plant, the Abbott Nutrition facility in Sturgis, Michigan.

Production at the factory was halted in February after reports that four infants who drank the factory-made formula had fallen ill with rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. A whistleblower also made extensive allegations to the FDA that Abbott hid safety concerns months before its infant formula was recalled in February.

Pressed on how soon delivery will be back to normal, HHS Secretary Xavier Becerra declined to provide details, saying on CNN Monday that “Abbott is the one to tell you the timeline.”

Becerra said the federal government is working with the company to ensure it is addressing the security concerns raised with them and that “it should be done in a matter of weeks.”

“We don’t run their factories. Only they can address the security issues identified during our inspections. They’ve been working on this for a while, we’ve advised them what to do,” Becerra told CNN’s Kate Bolduan on “At this hour. “

“We will do everything we can, we will pull all the levers to help them move as fast as possible, but they control their factory. They own and operate it, they are the ones who have to do the repair.”

Abbott said last week it could restart production at its Michigan plant in two weeks, pending FDA approval, but it could be a few more weeks before the formula is available on shelves.

On CNN, Becerra also defended the government’s response to Abbott’s recall and complaint, saying, “We moved as quickly as possible.”

“The FDA is moving fast on purpose to make sure that if you’re going to do something as drastic as urging a manufacturer to take a product off the shelves, there’s good evidence for it. That’s why it takes some time,” he said. †

This story has been updated with additional reporting.

CNN’s Brenda Goodman and Jacqueline Howard contributed to this report.

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