FDA proposes to temporarily use enforcement discretion with respect to certain requirements for baby formula that may not comply with certain statutory and regulatory standards, and is requesting information from manufacturers about their products’ safety and nutritional adequacy.
This guidance document will remain in effect until November 14, 2022, and we will evaluate whether any extension is necessary.
This action is designed to increase infant formula supplies in the United States while protecting the health of infants, for whom infant formula is often the sole source of nutrition during a critical period of growth and development.
