FDA Pathway Supports Long-Term Stability, Diversity of Safe and Nutritious Infant Formula Supply in the U.S.

For Immediate Release:

September 30, 2022

Today, the U.S. Food and Drug Administration published guidance that will help provide a pathway for infant formulas operating under enforcement discretion in the U.S. to remain on the market. This will help ensure the U.S. continues diversifying its infant formula market and make families less susceptible to shocks in the infant formula market.

Specifically, the FDA is continuing, under certain conditions, to exercise enforcement discretion relating to the importation and sale in domestic commerce of certain infant formula products as part of its effort to provide stable, longer-term access to safe and nutritious infant formula across the country. The FDA is communicating directly with, and has made available to manufacturers, the steps to take to continue marketing certain formulas under enforcement discretion while they work to meet all U.S. regulatory requirements. In July 2022, the agency committed to developing a new framework for continued and expanded access to infant formula products for U.S. parents and caregivers.

Full PR: https://www.fda.gov/news-events/press-announcements/fda-pathway-supports-long-term-stability-diversity-safe-and-nutritious-infant-formula-supply-us

Guidance  Guidance for Industry: Infant Formula Transition Plan for Exercise of Enforcement Discretion | FDA

Constituent Update  FDA to Continue Providing Flexibility to Infant Formula Manufacturers Under Certain Conditions to Stabilize Supplies | FDA

Thank you.

Rosario Quintanilla (she/her/hers)
Public Affairs Specialist,
Office of Communications and Project Management
Office of Regulatory Affairs
U.S. Food and Drug Administration
Tel: 949-608-4407 or cell 949-812-0600