The United States typically produces 98% of the infant formula it uses, the agency said in a statement, and the imported formula mainly comes from Mexico, Ireland and the Netherlands. But because of the shortage, the Food and Drug Administration is outlining a process by which it “will not object to the import of certain infant formula products intended for the foreign market,” as well as US distribution of products made locally for export to other countries. Countries.
“Companies seeking to take advantage of this flexibility should provide information to the Food and Drug Administration to assess whether the product can be used safely and if it provides adequate nutrition,” the agency said. “For example, labeling, information on nutritional adequacy and safety tests, and information about the facility’s inspection history.”
The administration will prioritize applications that “have a good chance of success, that indicate some sort of quality, clear safety, nutritional adequacy and all of that, and that have the potential to move an important product into the United States quickly,” a White House official told CNN, including imports from Countries such as Ireland, Chile, Australia, New Zealand, the United Kingdom, and the Netherlands, which feature safety inspection systems similar to those in the United States.
The U.S. Food and Drug Administration said it is already in discussions with some manufacturers and suppliers regarding additional supplies, but officials caution that even importing the formula from abroad won’t offer immediate relief.
“With this flexibility in place, we anticipate that those products that can quickly meet safety and nutrition standards can reach US stores within weeks,” FDA Commissioner Dr. Robert Califf said in a statement.
“It depends in part on the kind of information we get from others, but I think we’re looking at weeks in terms of bringing the imported product to market,” Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, said in a media call Monday.
“The White House is in ongoing talks with the four largest infant formula manufacturers — Reckitt, Abbott, Nestlé/Gerber, and Perigo — to work with them to identify transportation, logistical, and supplier hurdles to increase formula production in the United States — and FDA-approved facilities, to expand the quantity and speed of formula. FDA approved shipments to the country, ensuring the formula travels quickly to retailers from factories,” the White House official said.
There are also efforts to support the supply chain, with outreach to fixture manufacturers suppliers.
“We are also reaching out to suppliers to infant formula manufacturers to inform them that their materials are essential to boosting infant formula production in the United States, and that they should prioritize their production and delivery,” the official noted.
During an appearance on CNN’s “New Day” on Monday, Califf said the administration was “doing everything they can” to resolve the shortfall.
Cliff noted efforts to work with manufacturers to increase production, work on the supply chain and work closely with Abbott to open its closed factory as soon as possible.
After the Abbott site restarts, the company said Monday, it will take six to eight weeks for the products to reach store shelves.
Pressed about how effective the move will be to facilitate the importation of some formulas, Califf said the situation on a larger scale would “gradually improve” over “a few weeks”.
This Thursday, Cliff will testify before the Agricultural Appropriations Subcommittee on the US Food and Drug Administration’s 2023 budget request and on infant formula stewardship.
Baby milk shortages have been exacerbated by the shutdown of the nation’s largest formula milk plant, Abbott Feeding Facility in Sturgis, Michigan.
In the end, tests by the Food and Drug Administration and the US Centers for Disease Control and Prevention found that the genetic sequences of Cronobacter samples from the plant did not match any of the bacteria isolated from sick children or the formula indoors. In a press release, Abbott said the genetic samples from the sick children did not match each other, indicating that there was no link between their cases.
Additionally, Abbott said, no infant formula distributed to consumers has tested positive for Chronobacter or Salmonella.
Pressing when supplies will return to normal, HHS Secretary Xavier Becerra declined to give details, saying on CNN Monday that “it is Abbott who can tell you the schedule.”
Besera said the federal government is working with the company to make sure it addresses the safety concerns they have been raised and that it “should be done within weeks.”
“We don’t run their factories. Only they can address safety concerns that have been identified through our inspections. They’ve been working on this for a while. We’ve been giving them advice on what they need to do,” Becerra told CNN reporter Kate. Bolduan in “At This Hour”.
“We will do everything we can, we will pull all the levers we can help them move as fast as we can, but they control their factory. They own it and run it. They are the ones who have to do the repair.”
Abbott said last week it could resume production at its Michigan facility, pending FDA approval, within two weeks, but it could take a few more weeks for the formula to be available on shelves.
On CNN, Besera also defended management’s response to Abbott’s recall and complaints, saying, “We are moving as quickly as we can.”
“The FDA is moving with deliberate speed to make sure 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 of that. That’s why it takes time,” he said.
This story has been updated with additional reports.
CNN’s Brenda Goodman, DJ Good, MJ Lee, and Jacqueline Howard contributed to this report.
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