U.S. Unveils "Access to Baby Formula Act of 2022"

On May 20, 2022, the U.S. released the Access to Baby Formula Act of 2022 (H.R. 7791) (hereinafter the Act), which amended the Child Nutrition Act of 1966 to establish waiver authority to address certain emergencies, disasters, and supply chain disruptions (particularly the shortage of infant formula in the United States) affecting participants (i.e., mainly enterprises) of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). 

Major revision:

• Infant formula cost containment contract requirement

Each infant formula cost containment contract renewed or entered into on or after the enactment date of the Act (the program) includes remedies for infant formula recall, involving how infant formula manufacturers protect against disruption to program (WIC) participants in the State. Besides, the infant formula manufacturer shall also comply with the contract's provisions as aforesaid.

• Memorandum of understanding

The Department of Agriculture and the Department of Health and Human Services shall ensure a memorandum of understanding within 30 days from the date of enactment of this Act. The memorandum includes procedures to promote coordination and information sharing regarding any supply chain disruption (including supplemental food recall).

• Emergencies and Disasters

In emergency and disaster situations, where the existing regulatory requirements cannot be met and thewaive authority does not substantially weaken the supplemental foods' nutritional quality, it is allowed to modify or waive corresponding administrative measures. The waiver period can fully cover the emergency period and 60 days after the end of such emergency period. 

• Other favorable policies

In the case of supply chain disruptions (including recalls of infant formula products), the existing regulatory requirements cannot be met and the waive authority does not substantially weaken the nutritional quality of supplemental foods, the vendors can use authorized supplemental foods as substitutes of identical (exact brand and size) food items.

The Act removed any medical documentation requirements relating to non-contractual brand infant formula issuance.

The competent authority waive the maximum monthly allowance for infant formula and waive any additional qualified administrative requirement to address the supply chain disruption, including a supplemental food product recall.

The effective period of the above-mentioned relevant measures is 45 days from the date of approval and can be extended by Secretary's announcement 15 days before the expiration of the validity period. The maximum period will not exceed 60 days after the corresponding supply chain interruption is lifted.