February 24, 2021
- Parents and other caregivers of infants who make their own homemade infant formula using a recipe.
- Homemade infant formulas
The FDA is advising parents and caregivers to not make or feed homemade infant formula to infants. Parents or caregivers of infants who have consumed a homemade infant formula should contact their healthcare provider and report any symptoms to their local Health Department.
Summary of Problem and Scope
Infant formula can be the sole source of nutrition for infants and is strictly regulated by the FDA. The agency has requirements for certain nutrients in infant formulas, and if the formula does not contain these nutrients at or above the minimum level or within the specified range, the infant formula is adulterated. Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant’s growth.
The FDA has recently received adverse event reports of hospitalized infants suffering from hypocalcemia (low calcium) that had been fed homemade infant formula.
The FDA generally regulates commercially available infant formulas, which are marketed in liquid and powder forms, but typically does not regulate recipes for homemade formulas. The FDA does not recommend that parents and caregivers make infant formulas at home because of serious health and safety concerns. The potential problems with homemade formulas include contamination and absence of or inadequate amounts of critical nutrients. These problems are very serious, and the consequences range from severe nutritional imbalances to foodborne illnesses, both of which can be life-threatening. Because of these severe health concerns, the FDA strongly advises parents and caregivers not to make and feed their infants homemade infant formulas.
The FDA will continue to warn parents and caregivers not to make and feed their infants homemade formula.
Recommendations for Consumers
Parents and caregivers with infants who have consumed homemade formula should contact their health care provider to report any symptoms and receive care.
To report a complaint or adverse event (illness or serious allergic reaction), you can
- Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
Visit www.fda.gov/fcic for additional consumer and industry assistance.