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The Latest on the Infant Formula Shortage

FDA official offers timeline to return to normal supply

May 26, 2022

For the second time in two days, Dr. Robert Califf, FDA commissioner, testified before federal lawmakers about the nationwide infant formula shortage and the timeline to get formula back on shelves.

On Thursday, Califf appeared before the Senate Health, Education, Labor, and Pensions Committee to discuss the latest updates in the formula shortage. His appearance follows his testimony before the House Energy and Commerce Subcommittee on Oversight and Investigations a day earlier.

During February, the FDA warned consumers about a recall of certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility, prompting closure for the facility. The sudden closure of the facility significantly hurt the supply of available formula since production is limited to only a few locations in the U.S.

Even before the recall, the formula was in short supply. Califf outlined challenges in the response to the shortage and the next steps to bolster supply.

“There is nothing higher priority than this particular issue that we are discussing today,” Califf said. “It is the highest priority. We are assigning every resource that we can to work on this problem.”

Here is the latest on the formula shortage:

  • The scale of the shortage:  According to Datasembly, the out-of-stock rate for formula was about 45 percent for the week ending May 14.
  • Return to production:  Earlier this month, Abbott entered into a consent decree with the FDA, outlining the process to return production at the company’s Sturgis, Michigan facility. The company anticipates it could restart the site within two weeks of FDA approval and that it would take six to eight weeks before product is available on shelves.
  • Increasing the number of suppliers:  Infant formula production is concentrated among a few national formula producers. The FDA received 26 new applications after it reduced some of the paperwork for foreign manufacturers to import product, Califf said. An added emphasis has been placed on specialty formulas that are especially limited, he said.
  • National measures:  The Biden administration invoked the Defense Production Act to increase supply and has accelerated imported formulas from Europe.
  • Quotable:  “I can’t be exact about this, but my expectation is that within two months we should be beyond normal and with a plethora (of supply),” Califf said. “What you’ll see is that due to all these measures being taken, the shortage is going to be getting better and better.”

Creating a stockpile and building in supply chain resiliency will be critical to addressing and preventing future shortages, Califf said.

The FDA continues to warn against making homemade infant formulas and recommends caregivers work with their child’s health care providers for recommendations on feeding practices.

The hearing is available to review online.

 



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