Babies Need More Formula Now Act of 2022
This bill addresses the regulation of infant formula, including by authorizing the Food and Drug Administration (FDA) to waive certain requirements related to importation.
The FDA may waive labeling requirements related to the importation (or distribution or sale) of infant formula from a country with requirements that provide a similar assurance of safety as U.S. requirements.
The FDA must, when appropriate, enter into arrangements to harmonize U.S. regulatory requirements pertaining to infant formula with the requirements of other nations.
The bill imposes time lines for the FDA to respond to submissions for market approval for new infant formula.
The FDA must also issue guidance as to what types of changes in the ingredients of infant formula, if any, may not require a new growth study to meet FDA requirements.
The bill also authorizes a person to import, without prior notice to the FDA, up to a three-month supply of infant formula for personal use from a country with formula safety standards similar to U.S. standards, such as Canada.
Before recommending or requiring a recall of infant formula due exclusively to a labeling deficiency, the FDA must ensure that the recall will not negatively affect the supply of formula in the United States.
The bill also requires the FDA to (1) notify Congress no later than 24 hours after initiating a formula recall, and (2) provide certain information to formula manufacturers about restarting production after an inspection of a manufacturing facility impacted by a recall.