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The FDA announces that it will make it easier to import some baby replacements to ease the shortage




The United States typically produces 98% of the infant formula they use, and imported infant formulas come mainly from Mexico, Ireland and the Netherlands, the agency said in a statement. However, due to the shortage, the FDA outlines a process in which it “would not oppose the importation of certain infant formulas intended for a foreign market,” as well as the US distribution of products made domestically for export to other countries.

“Companies that want to take advantage of these flexibility should submit information to the FDA to quickly assess whether the product can be used safely and whether it provides adequate nutrition,” the agency said. “For example, labeling, information on nutritional adequacy and safety testing, and information on inspection history.”[ads1];

The administration will prioritize applications “that have a good chance of success, that indicate a kind of clear quality and safety and nutritional adequacy and all that, and that have the potential to move significant products into the United States quickly,” an official in the White Houses. told CNN, including imports from countries such as Ireland, Chile, Australia, New Zealand, the United Kingdom and the Netherlands, which have security inspection systems similar to those in the United States.

The FDA said it is already in discussions with some manufacturers and suppliers regarding additional supplies, but officials warn that even importing formula from abroad will not provide immediate relief.

“With these flexibilitys in place, we expect that products that can quickly meet safety and nutritional standards can hit U.S. stores in a matter of weeks,” FDA Commissioner Dr. Robert Califf said in a statement.

Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said in a media call on Monday that “it depends in part on what kind of information we get from others, but I think we look at weeks in terms of getting the imported product on the market. . “

The news comes as the White House works with key manufacturers to help provide logistical support under the lack of baby replacements, an official said in a statement Monday.

The White House is in ongoing talks with the four major infant formula manufacturers – Reckitt, Abbott, Nestle / Gerber and Perrigo – to work with them to identify transportation, logistics and supplier barriers to increasing infant formula production in their United States – and the FDA “Approved facilities, to expand the quantity and speed of FDA-approved formula shipped into the country, and to ensure that the formula is quickly shipped to dealers from factories,” the White House official said.

CNN reported earlier Monday that the Biden administration faces a host of questions and criticisms for the national lack of baby replacements that have anxious and angry parents jumping from store to store in search of baby food. The administration offered a new website, HHS.gov/formula, to provide resources to families in need, but when a CNN reporter tested some of these options, the exercise resulted in apologetic customer service representatives, a waiting time that lasted over an hour and serious challenges in finding infant formula through some of the key proposals listed on the new Health and Human Services website.
The White House is also in “ongoing communication” with Target, Amazon, Walmart and other major retailers, the official said, “to identify parts of the country that may be at risk of critically low access to infant formula, and who have offered to work. with manufacturers and dealers to bring more formula to those parts of the country, including with U.S. government transportation and logistics support. “
President Joe Biden held virtual meetings Thursday with the management of Target and Walmart, as well as formula producers Reckitt and Gerber, respectively. Officials have since been in “close communication to follow up on these conversations,” according to the official.

There are also attempts to strengthen the supply chain, by seeking out the formula manufacturers’ suppliers.

“We also contact suppliers to infant formulas to inform them that their materials are essential to increase infant formula production in the United States, and they should prioritize production and delivery,” the official said.

During a performance on CNN’s “New Day” on Monday, Califf said the administration is “doing everything we can” to address the shortcoming.

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

After Abbott restarts the site, it will take six to eight weeks before the products reach store shelves, the company said Monday.

The pressure on how much effect the move will make to make it easier to import some formulas will have, Califf said that the situation more generally will “gradually improve” over a few weeks.

This Thursday, Califf testified before the subcommittee on agricultural appropriations on the FDA’s budget request for 2023 and on the supervision of infant formula.

The shortage of baby replacements has been exacerbated by the closure of the country’s largest formula factory, the Abbott Nutrition plant in Sturgis, Michigan.

Production stopped at the plant in February after reports that four infants who ate breast milk substitutes produced at the plant had become ill from rare and serious infections caused by Cronobacter sakazakii bacteria. Two of the babies died. A whistleblower also has detailed allegations to the FDA that Abbott hid safety issues months before the infant formula was recalled in February.

In the end, however, testing from the FDA and US Centers for Disease Control and Prevention found that the genetic sequences of the plant’s Cronobacter samples did not match any of the bacteria isolated from the sick children or the formula in their homes. Genetic samples from the sick babies also did not agree with each other, which indicates that there was no connection between their cases, Abbott said in a press release.

In addition, Abbott said no baby substitute distributed to consumers tested positive for Cronobacter or Salmonella.

Pressed on how soon supplies will return to normal, HHS secretary Xavier Becerra declined to give details, 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 that it addresses the security concerns raised for them and that “it should be done within a few weeks.”

“We do not operate their facilities. Only they can address the safety issues identified through our inspections. They have been working on this for some time. We have informed them of what they need to do,” Becerra told CNN’s Kate Bolduan on “At this hour ยป.

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

Abbott said last week that it could resume production at the plant in Michigan, pending FDA approval, within two weeks, but it could take a few more weeks before the formula is made available on the shelves.

On CNN, Becerra also defended the administration’s response to Abbott’s recall and complaint, saying, “We have moved as fast as we can.”

“The FDA is moving at a deliberate pace to ensure that if you are going to do something as drastic as encouraging a manufacturer to pull a product off the shelves, that there is good evidence for it. That’s why it takes some time,” he said. .

This story has been updated with further reporting.

CNN’s Brenda Goodman, DJ Judd, MJ Lee, and Jacqueline Howard contributed to this report.



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