On February 24, 2021, the FDA advises parents and caregivers to not make or feed homemade infant formula to infants.
The FDA said that they recently received adverse event reports of hospitalized infants suffering from hypocalcemia (low calcium) that had been fed homemade infant formula.
Infant formula can be the sole source of nutrition for infants and is strictly regulated by the FDA. The FDA 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, according to what the FDA said.
Because the FDA does not regulate homemade infant formula recipes, they may lack nutrients vital to an infant’s growth. 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 the 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. If there are any symptoms to infants who have consumed a homemade infant formula, parents or caregivers should contact their healthcare provider and report any symptoms to their local Health Department.
Additional information can be found at Questions & Answers for Consumers Concerning Infant Formula.