The FDA publishes new guidance to prevent more shortages of baby formula 

The U.S. Food and Drug Administration (FDA) has published new guidance, with the hopes that supply will be improved and the chances of more shortages are reduced. 

For most of this year, parents have struggled to buy infant formula across the US due to supply shortages. In July, data suggested that 30% of all infant formula products were out of stock. 

This was mostly due to a major producer being shut down early in the year, and even when operations were restarted after four months, there were still significant supply issues. 

According to the agency, it plans to make sure the market is more diverse, as this will make supply issues less likely in the future. 

The FDA commissioner Robert Califf said in a statement: “We’ve made important progress toward improving the infant formula supply in the U.S. and paving the way for a more robust and diverse marketplace for the future. However, the FDA can’t do it alone.

We’ll need to work with all stakeholders to evaluate what other steps could be taken to encourage a more diverse and resilient infant formula marketplace. 

Manufacturers from around the world have demonstrated their commitment to helping bolster U.S. supply and, in turn, we are committed to continuing these flexibilities for their products to safely remain on the market while ensuring they meet our standards.” 

Under the new guidance, the FDA will temporarily allow more discretion for both US-based and international companies supplying baby formula. It will mean even companies that don’t comply with regulations will be able to submit information to the FDA for safety to be considered. 

This guidance will remain in place until October 2025, and the FDA hopes it will boost the supply of formula across the country and help to avoid the situation being repeated.

Since the shortages of this year, the agency has relaxed some of its rules which has increased supply, and it hopes that the new guidance will help this pattern to continue.