FDA enforcement discretion and faster new product approval to increase infant formula supply in the U.S.

The FDA is expediting the paperwork and review process to allow infant formula permitted abroad to enter the U.S. – including nearly 6.5 million bottles of formula manufactured by Nestlé in Germany. They are also streamlining the approval process for new products.

A voluntary recall and facility shutdown by Abbott Nutrition has created a supply disruption for certain types of infant formula. President Biden announced a series of measures to address the resulting crisis for families around the country, including action by the FDA to help make up the shortfall.

The FDA is targeting:

• Foreign manufacturers who do not currently supply the U.S. (but might like to);

• Domestic manufacturers who produce infant formula for export (but might be encouraged to keep it here);

• Current U.S. producers who could create new products (for example, to meet specific dietary needs).

The enforcement discretion does not stretch to products that lack essential nutrients or fail to alert consumers to the existence of allergens. A new guidance document lists the specific information required for this fast-tracked process.

Vireo Advisors LLC, working with our clients, has specific expertise in safety assessment and certification for new infant formula ingredients. We will be following these latest developments closely.