July 30, 2021

FDA Tells Parents: Do Not Make Homemade Infant Formula

The FDA is warning parents: do not make homemade infant formula, since it is difficult to achieve the correct proportions and amounts of nutrients that babies need for proper growth and development. The government has received reports of infants who have been hospitalized because they are suffering from low calcium levels (hypocalcemia). Those babies had been fed homemade infant formula.

FDA Tells Parents: Do Not Make Homemade Infant Formula

Officials are asking parents or caregivers of infants who have consumed homemade infant formula to contact their healthcare provider and report symptoms to their local Health Department, or file a report through FDA’s Voluntary Medwatch form. Homemade infant formula is not the same as homemade baby food.

The problem is that infant formula is the only source of nutrition for infants. This product is strictly regulated by the FDA for that reason. There are certain requirements for many nutrients in formula. If the formula doesn’t contain those nutrients at or above the minimum level, or within a specified range, it is considered adulterated. There are minimum amounts for 29 different nutrients, and maximum amounts for nine of those nutrients.

In addition to the problem of insufficient nutrients, there is always the possibility that homemade infant formula could be contaminated with pathogens that could make them very sick. The notice states, “These problems are very serious, and the consequences range from severe nutritional imbalances to foodborne illnesses, both of which can be life-threatening.”

It is also important that parents talk to their infant’s doctor about selecting formula. Some babies have specific nutritional requirements, or may have a problem such as inborn error of metabolism, and others may need a supplement for a nutrient such as iron.

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