Statement From:
Robert M. Califf, M.D., MACC
Commissioner of Food and Drugs - Food and Drug Administration
Susan T. Mayne, Ph.D.
Director - Center for Food Safety and Applied Nutrition (CFSAN)
The need to diversify and strengthen the U.S. infant formula supply is more important than ever. The recent shutdown of a major infant formula plant, compounded by unforeseen natural weather events, has shown just how vulnerable the supply chain has become.
Infant formula is an essential food product that is the sole source of nutrition for many babies in the U.S. Companies and their manufacturing facilities must meet rigorous FDA standards that ensure the formula is both safe and nutritious. These standards are necessary to protect our children and will not be sacrificed for long-term supply considerations.
In May 2022, the FDA issued a guidance announcing the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula to address the temporary shortage. The agency has prioritized review of requests from firms that can: 1) produce documentation to demonstrate the safety and nutritional adequacy of the product; 2) make the largest volume of product available; and/or 3) get product onto U.S. shelves quickly. The FDA intends to consider enforcement discretion requests until the temporary shortage is addressed.
The FDA’s flexibilities have enabled the agency to help dramatically increase infant formula supplies to address the shortage, while also protecting the health of infants, many of whom rely solely on infant formula during a critical period of growth and development. 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 enforcement discretion described in the May guidance is set to remain in effect until Nov. 14, 2022.
Many of the companies providing these formula products have expressed interest in continuing to serve the American market permanently. For some companies, the agency’s flexibility has resulted in their ability to use a greater breadth of their existing, global manufacturing footprint, creating more resiliency in the U.S. infant formula supply chain and reducing the risk of reliance on too few production facilities supporting the United States.
These flexibilities have been successful in helping to bring safe and nutritionally adequate infant formula products into the U.S. marketplace on a temporary basis to address the formula shortage. Given that success, the FDA has determined that a more streamlined pathway that leverages information we have received for the products for which we are temporarily exercising enforcement discretion would help provide for the long-term availability and marketing of many of them. As a result, the FDA intends to:
· Provide a single technical assistance contact at the FDA for any company aiming to enter the U.S. infant formula market, making it easier for potential new entrants to navigate the FDA’s regulatory review process. This is similar to a practice commonly used by other FDA centers that has resulted in novel medical therapeutics entering the U.S. market in a more efficient manner. The FDA hopes to encourage more entrants into the market, including new domestic firms.
· 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.
· Provide a pathway for companies that import, sell, and/or distribute formula under the FDA’s temporary enforcement discretion policy to continue to supply infant formula to the U.S. past November. In September, the FDA intends to issue further guidance on the topic of how companies that have already received temporary enforcement discretion could meet FDA requirements to continue to supply infant formula to the U.S. beyond that time.
Ensuring that the youngest and most vulnerable individuals have access to safe and nutritious formula products is a top priority for the FDA. The FDA expects that our continued efforts will help infant formula manufacturers who are new entrants to the U.S. market better understand their options to continue producing and supplying formula to the U.S. in the weeks, months and years ahead.
Related Information
· Infant Formula Information and Ongoing FDA Efforts to Increase Supply
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Grocers Welcome FDA Flexibilities on Infant Formula
FMI president/CEO provides statement on agency's moves to increase supply of formula in U.S.
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.