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
• Press Release: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula 
• Press Release: FDA Encourages Importation of Safe Infant Formula and Other Flexibilities to Further Increase Availability 

Source:

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)