What to Know: FDA ‘Doing Everything in our Power’ to Address Infant Formula Shortage

Product recall, supply chain woes contribute to shortage

May 12, 2022

The nation continues to grapple with a shortage of infant and specialty formula that only has intensified in recent weeks, U.S. public health officials announced.

In an update this week, the FDA said it was taking action to address the formula shortage stemming from COVID-19 supply chain issues and a formula product recall earlier this year. The agency also recommended caregivers talk with their child’s health care providers for more information and resources.

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so,” FDA Commissioner Robert M. Califf, MD. “We are doing everything in our power to ensure there is adequate product available where and when they need it.”

Here’s what you need to know:

• Central causes:  During February, the FDA warned consumers about a recall of certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility. Even before the recall, these products were already hard to find on store shelves due to supply chain issues from COVID-19.
• By the numbers:  The nationwide out-of-stock percentage for infant formula was 43 percent during the week ending May 8, according to Datasembly analysis.
• Return to operations:  In a statement Wednesday, Abbott said it would take six to eight weeks before product was available from its Michigan facility once it is back up and running (pending FDA approval).
• Next steps:  The FDA has pinpointed several strategies to bolster the supply including:
  • Expediting review of notifications of manufacturing changes that will help increase supply
  • Compiling data on trends for in-stock rates at both national and regional levels
  • Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records
  • Reaching out to retailer groups to consider purchasing limits on some products
• Quotable:  “Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products,” Califf said.

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

More information about the infant formula shortage is available online. In addition, the FDA has compiled a frequently-asked-questions guide.