The U.S. Food and Drug Administration (FDA) has been working to increase the supply of infant and specialty formula products in the U.S., and recently published an update on its efforts. Supply chain issues precipitated by the COVID-19 pandemic have impacted the availability of infant formula nationwide. FDA’s update follows a foodborne illness outbreak linked with infant formula produced by Abbott Nutrition.
FDA reports that it was working to address the shortages of infant formula prior to the recall and investigation of Abbott Nutrition’s infant formula products. Since that time, however, FDA has been working with Abbott Nutrition and other manufacturers to bring safe infant formula products to the U.S. market. FDA notes that infant formula manufacturers, aside from Abbott Nutrition, have been meeting or exceeding capacity levels to meet demand. FDA lists several steps it is taking to support the supply of infant formula products, such as:
- Meeting regularly with major infant formula manufactures to increase their production of infant and medical formulas
- Expediting the review of notifications of manufacturing changes that will help increase supply
- Using FDA’s 21 Forward food supply chain continuity system and external data to monitor the status of infant formula supply
- 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 permitted foreign products 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 available product as quickly as possible
- Allowing Abbott Nutrition to release product to individuals needing urgent, life-sustaining supplies of specialty and metabolic formulas, which have been on hold at the company’s Sturgis, Michigan facility, on a case-by-case basis.
FDA has also established an Incident Management Group to coordinate long-term activities, such as working with major infant formula manufacturers to increase supply and ensuring that production of infant formula products can safely resume at Abbott Nutrition’s Sturgis facility.
Update, May 25, 2022: FDA has informed Kendal Nutricare, a company based in the U.K., that the agency is exercising enforcement discretion for the importation of certain infant formula under the KendamilExternal Link Disclaimer brand. Kendal Nutricare estimates that about 2 million cans of infant formula will land on U.S. store shelves beginning in June. FDA also announced that it will not object to the release of approximately 300,000 cans of EleCare amino acid-based infant formula (previously produced at Abbott Nutrition’s Sturgis, Michigan, facility) to individuals needing urgent, life-sustaining supplies of the specialty formula on a case-by-case basis. The formula will undergo enhanced microbiological testing before release.
