Press Release - FDA Takes Important Steps to Improve Supply of Infant and Specialty Formula Products

Today, the U.S. Food and Drug Administration is providing an update on its work to increase the availability of infant and specialty formula products. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition's Sturgis, Michigan facility, and Abbott initiated a voluntary recall of certain products. Since that time, the agency has been working with Abbott and other manufacturers to bring safe products to the U.S. market.

"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. We are doing everything in our power to ensure there is adequate product available where and when they need it," said FDA Commissioner Robert M. Califf, M.D. "Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. 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."

Prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition facility, the FDA was working to address supply chain issues associated with the pandemic including those impacting the infant formula industry. The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S. In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand. Notably, more infant formula was purchased in the month of April than in the month prior to the recall.

Leveraging all of the tools at its disposal to support the supply of infant formula products, the FDA is:

• Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods. The infant formula industry is already working to maximize their production to meet new demands. Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas.

• Helping manufacturers bring safe product to the market by expediting review of notifications of manufacturing changes that will help increase supply, particularly in the case of the specialized formulas for medical needs.

• Monitoring the status of the infant formula supply by using the agency's 21 Forward food supply chain continuity system, combined with external data. 21 Forward was developed during the pandemic to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting food supply chains.

• Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go.

• Expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S.

• Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records.

• Exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase volume of product available as quickly as possible.

• Reaching out to retailer stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.

• Not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility. In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection. The FDA is working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.

It's important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers. The FDA established an Incident Management Group to continue coordinating longer-term activities, which is focused on working with other major infant formula manufacturers to increase supply and helping to ensure that production of infant formula products can safely resume at Abbott Nutrition's Sturgis facility, among other activities.

The agency continues to advise against making infant formulas at home and encourages caregivers to work with their child's health care provider for recommendations on changing feeding practices, if needed.

The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.
Related Information

• FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022)
• Jan. 31-March 18, 2022 FDA Inspection Form 483
• Powdered Infant Formula Recall: What to Know | FDA
• CDC Information on Cronobacter Infection and Infants