July 14, 2024

FDA Developing New Framework For Expanded Access to Infant Formula

The FDA is developing a new framework for expanded access to infant formula options for parents and caregiver in the wake of the Abbott Nutrition plant shutdown after Cronobacter contamination was found this spring. In May 2022, the FDA issued guidance that the agency was going to temporarily exercise enforcement discretion on a case-by-case basis for some requirements to address this shortage.

FDA Developing New Framework For Expanded Access to Infant Formula

The FDA has prioritized review of requests from firms that can document the safety and nutritional adequacy of their products, can make the largest volume of product available, and can get their products onto shelves in this country quickly.

The infant formula supply has dramatically increased in the weeks since that guidance was issued. Many infants and other people rely on infant formula as their sole source of nutrition. To date, more than 400 million 8-ounce bottles’ worth of formula have been added to the domestic supply. This enforcement discretion will remain in effect until November 14, 2022. Further guidance will be used in September.

Since some of these companies want to continue to serve the American market long term, the FDA is going to provide a single technical assistant contact at the FDA for these corporations, making it easier for them to navigate the review process. This is similar to the practice used by other FDA centers for novel medical therapeutics.

And this summer, the FDA is going to host meetings with companies that import, sell, and/or distributor formula to determine the steps needed for a pathway to long-term uninterrupted marketing. The FDA would like this pathway to extend past November 2022.

As always, check with your pediatrician for the nutritional needs of your child. And always use safe preparation methods when you prepare powdered infant formula, stressing cleanliness at all times.

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