FDA Announces It Will Make It Easier To Import Certain Formulas To Ease Shortage

The United States produces 98% of the formula it normally uses, and imported formula comes mainly from Mexico, Ireland and the Netherlands, the company said in a statement. But due to the shortage, the FDA “does not oppose the importation of certain baby products intended for the foreign market” and outlines the U.S. supply of domestically-made products for export to other countries. . Countries.

“Companies wishing to take advantage of this flexibility must submit information to the FDA to quickly assess whether the product is safe to use and provides adequate nutrition,” the company said. “For example, information on labeling, nutrient and safety adequacy testing, and facility inspection history.”

Management will have “a good chance of success and will prioritize applications that represent clear quality and safety and adequate nutrition,” a White House official said. He told CNN he has security surveillance systems similar to those in the United States, including those imported from Ireland, Chile, Australia, New Zealand, the United Kingdom and the United States. -Low.

The FDA said it is already in talks with some manufacturers and suppliers about additional supply, but officials warn that even importing the formula from overseas won’t bring immediate relief.

“With this flexibility, we expect products that can quickly meet safety and nutrition standards to hit U.S. stores within weeks,” FDA Commissioner Dr. Robert Khalif said in a statement. communicated.

Susan Mane, director of the FDA’s Center for Food Safety and Consumption Nutrition, said at a press conference Monday, “It depends on what kind of information we get from others, but we review it weekly. Put the imported product on the market.

The news comes as the White House works with major manufacturers Help provide logistical support During childhood Lack of formula An official said in a statement Monday.

“The White House is in constant dialogue with four manufacturers of formula for older children, Reckitt, Abbott, Nestlé/Gerber and Ferrico, working with them to identify barriers to traffic, logistics and suppliers to increase production of formula. in the United States – and FDA-approved facilities To expand the size and speed of FDA-approved formulas shipped in the country and provide faster transitions from formula factories to retailers,” a House official said. White.

CNN released the news earlier on Monday The Biden administration is facing a barrage of questions and criticism over the national formula shortage, which has left anxious and angry parents rushing from store to store in search of baby food. Admin launched a new website, HHS.gov/formulaTo provide resources to families in need, but when a CNN reporter tested some of these options, the exercise apologized to customer service representatives. Top recommendations listed on the New Health and Human Services website.
White House The manager said he was “in constant contact” with Target, Amazon, Walmart and other major retailers, adding that “certain areas of the country have been identified and the formula for children is very weak and offered to working with manufacturers”. We have to find an additional formula. “
President Joe Biden holds virtual meetings with Target and Walmart executives on Thursday As formula makers Reckitt and Gerber, respectively. According to officials, officials are “in close contact to follow up on these conversations.”

Efforts are also being made to increase the supply chain by accessing formula manufacturers’ suppliers.

“We are liaising with suppliers of infant formula manufacturers to let them know that their products are important to increasing production of formula for American children, and that they should prioritize production and distribution,” the manager said.

Khalif, who attended CNN’s “New Day” event on Monday, said management is “doing everything we can” to address the shortage.


The company said Monday it would take six to eight weeks for products to hit store shelves after the Abbott site relaunched.

Highlighting the effectiveness of the measure to facilitate the importation of certain formulas, the caliph said that in “a few weeks” the situation would “gradually improve” to a much greater extent.

This Thursday, Khalif testified before the Agricultural Appropriations Subcommittee overseeing the FDA’s 2023 Budget Request and Child Formula.

The infant formula shortage has been exacerbated by the closure of Abbott Nutrition’s Sturkis, Michigan plant, the nation’s largest infant formula plant.

Production at the facility was halted in February after four children who ingested the factory-made formula were reportedly infected with a rare and serious infection caused by the bacteria Chronobacter Sakasaki. Two children died there. Even a whistleblower Detailed claims to the FDA Abbott was hiding safety concerns months before the formula withdrawal in February.

However, in the end, tests conducted by the FDA and the United States Centers for Disease Control and Prevention revealed that the genetic sequences of the plant’s chronobacter samples did not match those isolated from infected children or the formula. from their home. Abbott said in a press release that the genetic samples from the sick children did not match and there was no correlation between their cases.

Additionally, Abbott said no infant formula distributed to consumers has tested positive for Chronobacter or Salmonella.

Insisting on how quickly supply will return to normal, HHS Secretary Xavier Beserra declined to comment on what CNN said on Monday as “the one who can tell you the timeline.”

Beserra said he was working with the federal government to ensure the security issues raised by them were resolved and that “this should be done in a few weeks.”

“We don’t operate their factories. Only they can address the security issues identified by our research. They have been doing this for some time. We advised them on what they should do,” Beserra told CNN’s Kate Bold. “This time.”

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

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

On CNN, Becerra echoed management’s response to Abbott’s recall and complaint, saying “we’re moving as fast as we can.”

“If you’re going to do something drastic like induce a manufacturer to pull a product off the shelf, the FDA is moving forward at a planned pace to make sure there’s good evidence for that. That’s why it’s going to take time. “, did he declare. .

This story has been updated with additional reports.

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

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