The U.S. Food and Drug Administration is looking to set a new framework to further improve and maintain the supply of infant formula to ensure that American consumers have access to safe and nutritious infant formula.
Infant formula is an essential food product that is the sole source of nutrition for many babies in the U.S. The recent shutdown of a major infant formula plant and unforeseen natural weather events has put a spoke in the supply chain of infant formula.
However, the FDA sets rigorous standards for companies and their manufacturing facilities to ensure the formula is both safe and nutritious.
The FDA issued guidance in May 2022 to temporarily exercise enforcement discretion to address the temporary shortage of infant formula. The agency has prioritized review of requests from firms that can supply large volumes of both safe and nutritious formula to get back the product onto U.S. shelves quickly.
The FDA’s flexibilities have enabled the agency to help dramatically increase infant formula supplies to address the shortage. To date, it has resulted in a total estimated quantity of more than 400 million, 8-ounce bottles worth of formula from nine countries for children in the U.S.
The agency’s flexibility has also resulted in creating more resiliency in the U.S. infant formula supply chain and reducing the risk of reliance on too few production facilities supporting the U.S. It also helped bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis to address the formula shortage.
To help provide for the long-term availability and marketing of many of these brands of infant formula, The FDA has determined to set a more streamlined pathway.
The agency is now looking to provide a single technical assistance contact for any company aiming to enter the U.S. infant formula market. This will make it easier for potential new entrants to navigate the FDA’s regulatory review process. It is also expected to encourage more entrants into the market, including new domestic firms.
Further, the FDA will provide a pathway for companies that import, sell, and/or distribute formula under its temporary enforcement discretion policy to continue to supply infant formula to the U.S. past November, when the May guidance is set to expire.
The FDA also intends to host meetings this summer with companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to determine what additional steps would be needed to provide a pathway to long-term, uninterrupted marketing for safe and nutritious formula.
The FDA expects that these continued efforts will help the new entrants to the U.S. market for infant formula to better understand their options to continue producing and supplying instant formula to the U.S. in the future also.
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