The U.S. Food and Drug Administration (FDA) has decided to increase the supply of safe infant formula in the U.S., in light of the recent shortage. On May 16, FDA filed a consent decree of permanent injunction with formula producer Abbott Nutrition, as well as announced a guidance that outlines increased flexibilities regarding 1) import of certain infant formula products and 2) requirements that apply to infant formula production, which will allow formula manufacturers to increase production. Prior to the consent decree and guidance decisions, FDA has been making continuous efforts to increase the supply of safe infant formula in the U.S.
The consent decree with Abbott Nutrition follows the company’s voluntary recall of powdered formula products that were produced at its Sturgis, Michigan facility due to Cronobacter sakazakii contamination, which was announced on February 17, 2022. Under the proposed consent decree, which is subject to court approval and entry, Abbott Nutrition has agreed to take corrective actions at its Sturgis facility. The proposed consent decree allows Abbott Nutrition to resume production while ensuring that the powdered infant formula produced at its Sturgis facility is safe. When Abbott Nutrition decides to restart production at its Sturgis facility, it must conform to the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is detected, the company must notify FDA, identify the source of the problem, and conduct a root-cause investigation before resuming production.