FDA Announces It Will Ease Importation of Certain Infant Formulas to Alleviate Shortage | CNN Politics




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The U.S. Food and Drug Administration said Monday it was making it easier to import certain infant formula as it works to address a nationwide shortage.

The United States typically produces 98% of the infant formula it uses, with imported formula coming mainly from Mexico, Ireland and the Netherlands, the agency said in a statement. But because of the shortage, the FDA describes a process by which it “would not object to the importation of certain infant formula intended for a foreign market”, as well as the distribution in the United States of products manufactured in the country for export to other countries. countries.

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

The agency said it was already in talks with some manufacturers and suppliers about additional supply.

FDA Commissioner Dr. Robert Califf said in a statement, “With these flexibilities in place, we anticipate that products that can quickly meet safety and nutrition standards could hit US stores within weeks.

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

“The White House has ongoing conversations with the four major infant formula manufacturers – Reckitt, Abbott, Nestlé/Gerber and Perrigo – to work with them to identify barriers to transportation, logistics and suppliers to increase the production of preparations in the United States and FDA-approved facilities, to increase the quantity and speed of FDA-approved preparation shipped in the country, and ensure that the formula moves quickly to retailers from factories”, the White House official said.

CNN reported earlier Monday that the Biden administration is facing a barrage of questions and criticism over the national infant formula shortage that has anxious and angry parents jumping from store to store in search of baby food. babies. The administration proposed a new website, HHS.gov/formula, to provide resources to families in need, but when a CNN reporter tested some of those options, the exercise resulted in an apology from officials. customer service, a wait time that lasted well over an hour, and serious challenges finding formula through some of the top suggestions listed 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 that may be at risk of a critical supply of infant formula, and offered to work with manufacturers and retailers to bring more formula to those parts of the country, including with transportation and logistics support from the U.S. government.

President Joe Biden held virtual meetings Thursday with executives from Target and Walmart, as well as formula makers Reckitt and Gerber, respectively. Officials have since been in “close communication to follow up on those conversations,” according to the official.

Efforts are also being made to strengthen the supply chain, by raising awareness among formula manufacturers’ suppliers.

“We are also reaching out to suppliers of infant formula manufacturers to let them know that their materials are critical to boosting infant formula production in the United States and that they should prioritize their production and delivery,” a Noted the manager.

During an appearance on CNN’s “New Day” on Monday, U.S. Food and Drug Administration Commissioner Dr. Robert Califf said the administration is “doing everything we can” to address the shortage. .

Califf highlighted efforts to work with manufacturers to ramp up production, work on the supply chain, work closely with Abbott to open its shuttered factory as soon as possible.

Pressed on how much of an effect the decision to make it easier to import certain formulas will have, he said the situation more broadly will “gradually improve” over the course of “a few weeks”. This Thursday, Califf is testifying before the Agricultural Appropriations Subcommittee on the FDA’s 2023 budget request and infant formula oversight.

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

Pressed on how soon the supply will return to normal, HHS Secretary Xavier Becerra declined to elaborate, telling CNN on Monday that “Abbott is the one who can tell you the timeline.”

Becerra said the federal government is working with the company to ensure it addresses safety concerns raised to it and that “it should be done within weeks.”

“We don’t run their factories. They are the only ones who can solve the safety problems identified during our inspections. They’ve been working on it for a while, we’ve briefed them on what to do,” Becerra told CNN’s Kate Bolduan on “At This Time.”

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

Abbott said last week it could restart production at its Michigan plant, pending FDA approval, within two weeks, but it could take a few more weeks before the formula hits shelves. .

On CNN, Becerra also defended the administration’s response to Abbott’s recall and complaint, saying, “We acted as quickly as we could.”

“The FDA is moving with deliberate speed to ensure that if you’re going to do something as drastic as urging a manufacturer to pull a product off the shelves, there’s good evidence for it. That’s why it takes a bit of time,” he said.

This story has been updated with additional reports.