FDA Warns Against Homemade Infant Formula

The FDA is warning that homemade infant formula should not be used. ALINA HVOSTIKOVA/Stocksy

The Food and Drug Administration emphasized that homemade infant formula recipes can lack vital nutrients, like calcium, that an infant needs …

The FDA is warning that homemade infant formula should not be used. ALINA HVOSTIKOVA/Stocksy
  • The Food and Drug Administration emphasized that homemade infant formula recipes can lack vital nutrients, like calcium, that an infant needs to grow.
  • For many infants, baby formula is their sole source of nutrition, so it's key that it has all the vital nutrients.
  • The FDA strictly regulates formula to ensure that key nutrients and vitamins are included in appropriate amounts.

There could be many reasons parents choose to make infant formula at home, but according to the Food and Drug Administration (FDA), none of them are good enough to risk the health of your baby.

“Infant formula can be the sole source of nutrition for infants and is strictly regulated by the FDA,” the FDA said in an alert on Wednesday.

“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.”

The FDA emphasized that homemade infant formula recipes “have not been evaluated by the FDA” and can lack vital nutrients, like calcium, that an infant needs to grow.

Infant formula is the only nutrition baby receives, and nutrients matter

For many infants, baby formula is their sole source of nutrition, so it's key that it has all the vital nutrients.

For that reason, the FDA strictly regulates infant formula to ensure that key nutrients and vitamins are included in appropriate amounts.

“Babies not receiving adequate nutrition from homemade formulas run the risk of malnutrition, stunted growth, and stunted neurodevelopment,” Dr. Kecia Gaither, double board certified in OB-GYN and maternal fetal medicine and director of perinatal services at NYC Health + Hospitals/Lincoln, told Healthline.

According to the FDA, if infant formula doesn’t contain these nutrients at or above the minimum level needed for healthy development, it’s considered adulterated.

The FDA specifies minimum amounts for 29 different nutrients and maximum amounts for nine of them.

Although there are cases when the FDA waives those requirements, it’s only for infants “who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.”

Homemade infant formula can be contaminated

The FDA also warned that homemade formula has many “potential problems” besides inadequate nutrition, including contamination.

According to the FDA, these problems are very serious. The health consequences range from severe nutritional imbalances to foodborne illnesses, both of which can be life threatening.

“Contaminated formulas can result in vomiting, diarrhea, dehydration, and possible demise,” Gaither confirmed.

Dr. Steven A. Abrams, writing for HealthyChildren.org, said even using formula intended for older babies to feed infants can present serious problems. This is because the nutritional needs of small infants aren't the same as for toddlers.

“Also, toddler formula doesn't have to be FDA reviewed like infant formulas is,” wrote Abrams.

Picking a formula for your infant

The American Academy of Family Physicians (AAFP) recommends breast milk for infant nutrition if possible. But if that doesn't work for families, parents can safely choose commercially available infant formula.

The AAFP adds that the large variety of formula options can be confusing for parents, but they can all be separated into three categories:

  • Soy formulas are recommended for congenital lactase deficiency (lactose intolerance) and galactosemia, the inability to digest a certain sugar in milk.
  • Hypoallergenic formulas have hydrolyzed proteins, which can be effective for feeding infants with a milk protein allergy.
  • Antireflux formulas can reduce spitting up and vomiting.

According to Gaither, it’s best to consult with a pediatrician and pediatric nutritionist for “options to address the best formulas/options for your baby, particularly if your baby has underlying health conditions.”

FDA recommendations for people who have used homemade formula

According to the FDA, both parents and caregivers for infants who have consumed homemade formula should contact their pediatrician if they need to report any symptoms and receive care.

The FDA added that to report a complaint or adverse event related to infant formula, like illness or serious allergic reaction, you can:

  • Call an FDA Consumer Complaint Coordinator if you need to speak directly to someone about the problem. Phone numbers vary state to state.
  • You can complete a MedWatch form online.
  • You can mail a paper MedWatch form directly to the FDA. Download the form here.

The bottom line

The FDA has issued a warning against the use of homemade infant formula because it can put your baby’s health at risk.

Experts say that babies not receiving adequate nutrition from homemade formulas run the risk of malnutrition, stunted growth, and stunted brain development.

The American Academy of Family Physicians recommends breast milk as the best way to feed baby, but the wide variety of available formula options are safe substitutes.

Experts say it’s best to speak with your child’s pediatrician before deciding which formula option is best.