Keep Infant Formula Safe and On the Shelves Act of 2022

Keep Infant Formula Safe and On the Shelves Act of 2022

This bill requires the Food and Drug Administration (FDA) to periodically inspect infant formula manufacturing facilities and addresses related issues.

The FDA must periodically conduct inspections, including unannounced inspections, of infant formula manufacturer facilities. If the FDA makes a notable regulatory finding at such a facility, the manufacturer must undergo a comprehensive food safety audit that includes a root cause analysis, enhanced testing, and comprehensive environmental samples.

A manufacturer of infant formula or essential medical food must notify the FDA no later than five business days after becoming aware of circumstances that could lead to a shortage of the relevant product in the United States.

Further, the FDA must create and annually update a list of U.S. manufacturing facilities that could be converted to manufacture infant formula during a shortage. In the event of a shortage, the FDA may require infant formula manufacturers to provide certain information, such as the quantity of formula in a manufacturer's inventory.

The bill also establishes under statute that food, including infant formula, is a critical material essential to the national defense and therefore subject to authorities under the Defense Production Act of 1950. (Such authorities authorize the President to take various actions, such as requiring businesses to prioritize certain government contracts and incentivizing the domestic industrial base to expand the production of critical materials.)

The Occupational Safety and Health Administration must issue a fact sheet and provide technical assistance to infant formula manufacturers to promote compliance with occupational health and safety standards.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov