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07/07/2022

Grocers Welcome FDA Flexibilities on Infant Formula

FMI president/CEO provides statement on agency's moves to increase supply of formula in U.S.
Marian Zboraj
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Grocers Welcome FDA Flexibilities on Infant Formula
The FDA is working to identify solutions for sourcing infant formula products at grocery stores.

Improving its efforts to source infant formula, the U.S. Food and Drug Administration (FDA) has granted additional flexibilities to increase the supply of these products at grocery stores across the country.

The FDA said in May that it was allowing importation to bring more formula to the United States as supply chain issues and a recall of products made by Abbott Nutrition caused an infant formula shortage. The agency outlined a process by which it would not object to the importation of specific infant formula products intended for a foreign market, or the U.S. distribution of products manufactured here for export to foreign countries.

These flexibilities have been successful in helping bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis. Given that success, the FDA determined a more streamlined pathway that leverages information it has received for these products would help provide for the long-term availability and marketing of many of them.

In light of FDA’s announcement to grant additional flexibilities, Leslie G. Sarasin, CEO and president of Arlington, Va.-based FMI – The Food Industry Association, issued the following statement: “From the outset of the Abbott Nutrition recall, FMI has been in regular communication with the Biden-Harris administration to share the challenges our member companies continue to face in securing infant formula and the steps we believe are needed to address those challenges. We therefore appreciate FDA’s announcement to provide additional regulatory flexibility to increase the types of products imported from overseas that meet the agency’s standards for safe, nutritious infant formula. We also welcome FDA’s recognition that we need longer-term solutions to ensure a steady supply of infant formula to safeguard against similar supply disruptions in the future.

Added Sarasin: “We are encouraged that the Biden-Harris administration is taking action to address the uneven distribution of imported infant formula to food retailers, which creates an obstacle to getting critical infant formula products to families across the nation, particularly those participating in the Women, Infants and Children (WIC) program.”

WIC’s strict rules have made it hard for the program to be responsive to critical shortages throughout the pandemic as well as the formula crisis, noted Michael Gay, owner and manager of Food Fresh, in Claxton, Ga. “I often have not had enough formula for a mom to fill her prescription when she comes into the store,” he recently told the U.S. House committee on the national infant formula shortage. “While Georgia will be implementing electronic WIC in the coming months, currently families are still using paper vouchers to access their WIC benefits in stores. If a mom comes to my store with a prescription for four cans of formula, and I only have two cans on the shelf, she can only get two cans for the month because she must turn in her prescription voucher with her purchase. She cannot return later to purchase the other two cans.”

Trade organizations like FMI are supporting FDA’s commitment to ensuring that grocery stores, large and small, have an adequate supply of infant formula to meet their customers’ needs.

“As additional formula is imported and the Abbott facility in Michigan begins production again, food retailers stand ready to work with our supply chain partners to get sufficient quantities of safe, nutritious infant formula back on grocery shelves as quickly as possible,” said Sarasin.

FMI works with and on behalf of the entire food industry to advance a safer, healthier and more efficient consumer food supply chain. The organization brings together a wide range of members across the value chain — from retailers that sell to consumers, to producers that supply food and other products, as well as the wide variety of companies providing critical services — to amplify the collective work of the industry.  

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