FDA Announces Plan to Diversify Baby Formula Industry to Increase Availability

In the middle of the first week of July, the United States Food and Drug Administration announced a new plan intended to begin to address the baby formula shortage in the United States.  Of course, this shortage came out of the shutdown of the country’s largest domestic formula production plant, over safety concerns, but the issues are a bit more complicated.

In a joint statement with FDA Commissioner Dr. Robert Califf, FDA Director of the Center for Food Safety and Applied Nutrition explains, “The need to diversify and strengthen the US infant formula supply is more important than ever.”

Now, the US has attempted to boost baby formula supply since the February closure of the Abbott plant, in Michigan.  For one, they tried to reopen the plant on June 4 after the company committed to improved safety and sanitizing protocols.  Unfortunately, though, the plant closed again just a few weeks later due to severe weather damage.

Under emergency approval to address those shortages, the plan will assist overseas producers who have sent their supplies to the United States.  It will also help to secure me long-term authorization for these foreign suppliers to market their baby formula products in the US.

They go on to lament that the recent shutdown of one of the biggest infant formula plants in the country, combined with unpredictable natural weather events, has demonstrated how vulnerable the US supply chain has become.

On the whole, the Biden administration has authorized the federal agency to provide a means for producers who are only temporarily selling their formula in the United States, to meet the existing regulatory requirements.  This will allow them to keep their products on the market which, in turn, will provide consumers with more options and aso make these supplies more impervious to both current and future supply shortages.

In addition to this, the FDA has also revealed a plan to host meetings and provide these producers with a simplified, single point of contact to assist their [temporary, expedited] regulatory approval.

Califf and Mayne also note, “Infant formula is an essential food product that is the sole source of nutrition for many babies in the US Companies and their manufacturing facilities must meet rigorous FDA standards that ensure the formula is both safe and nutritious.  These standards are necessary to protect our children and will not be sacrificed for long-term supply considerations.”