Infant Formula Information and Ongoing FDA Efforts to Increase Supply
Safety and Supply | Resources for Parents and Caregivers | Latest News
The U.S. Food and Drug Administration is working with government partners and industry to ensure that safe and nutritious infant formula is available wherever and whenever parents and caregivers need it.
Safety and Supply
The FDA’s efforts to help improve the safety and supply of infant formulas following the 2022 powdered infant formula recall include:
Increasing formula options, strengthening the supply chain: In 2022, the FDA helped address supply issues through its enforcement discretion policy, under which certain infant formulas that the FDA had reviewed for information relating to safety and nutritional adequacy entered the U.S. market on a temporary basis.
Many of the manufacturers supplying those products want to stay in the U.S. market permanently and are working to meet all U.S. regulatory requirements. We are working with them to help provide consumers more infant formula options and to strengthen the supply chain. The interested companies and their specific formulas are listed in the tables on the FDA’s enforcement discretion webpage.
Preventing Cronobacter sakazakii illnesses: The FDA is working with stakeholders to develop a strategy to prevent Cronobacter sakazakii illness associated with the consumption of powdered infant formula.
Enhancing inspection training: The FDA expanded and updated training for investigators and other FDA staff involved in inspecting foreign and domestic facilities that produce infant formula, including some that produce medical foods.
Tracking the supply chain: A tool built to help track supply chain shortages during the COVID-19 pandemic is being leveraged to help track and anticipate disruptions across the infant formula supply chain.
Evaluating FDA’s response, implementing change: The FDA conducted an internal evaluation of its infant formula response, commissioned an external evaluation of its Human Foods Program, and has proposed a redesign of its Human Foods Program to enhance coordinated prevention and response activities. Additionally, we’re working on implementing new authorities from Congress, including creating a new Office of Critical Foods to oversee infant formula and medical foods, and have developed a national strategy on infant formula to address supply chain resiliency and provide additional consumer education.
Infant Formula Resources for Parents and Caregivers
The FDA has created and compiled resources to help parents and caregivers safely use imported infant formula products as well as those made in the U.S. For more, visit Infant Formula Resources for Parents and Caregivers.