# Plain Language Summary: Babies Need More Formula Now Act of 2022

This bill was introduced in response to infant formula shortages and aims to make it easier to get formula to families quickly. The main idea is to reduce regulatory barriers that slow down the availability of infant formula while still maintaining safety standards.

The bill allows the FDA to waive certain labeling requirements for infant formula imported from countries with safety standards similar to the United States, like Canada and the European Union. This means foreign-made formula could reach American shelves faster during shortages without needing to be completely relabeled for the U.S. market. The bill also temporarily allows individuals to import up to a three-month personal supply of formula from approved countries for 90 days after the law takes effect, though the FDA would post warnings that imported formula may not meet all U.S. standards and families are encouraged to talk to their pediatrician first.

To speed up approval of new formula products, the bill requires the FDA to respond to new formula submissions within 90 days (or 75 days for new manufacturers or formulas with new ingredients), and requires the FDA to issue guidance on which ingredient changes don't require expensive new safety studies. The bill also creates new transparency requirements, including annual reports to Congress about formula submissions and inspections, and requires the FDA to notify Congress within 24 hours if a formula recall is initiated, along with detailed reports about supply impacts and plans to restore production.

Additionally, the bill requires the FDA to consider the impact on overall formula supply before ordering recalls for labeling problems alone, and mandates that different FDA offices meet regularly to coordinate on formula safety and supply issues. The goal throughout is to balance faster access to formula with maintaining the safety oversight that protects infants.

Babies Need More Formula Now Act of 2022

Stefanik, Elise M.

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.