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 FDA Alerts
June 1, 2022

Do not make or feed homemade infant formula to babies

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A warning was issued by the FDA to parents and caregivers about feeding infants homemade formula. Babies require adequate nutrients to help them grow and develop. The best source of these nutrients comes from human breastmilk. However, some families may not be able to, or may choose not to, breastfeed their baby; others may need to supplement breast feedings. In these situations, approved, commercially available infant formula is best.

Manufacturers of infant formula must follow FDA regulations. This includes using safe ingredients and certain amounts of nutrients (protein, iron, and vitamins) that meet the needs of the developing baby. Manufacturers also need to test the formula to be sure it is not contaminated before being sold to the public. FDA conducts annual inspections of facilities that produce infant formula to ensure these regulations are being met.

Homemade formula is not regulated. It may contain unsafe ingredients, be contaminated, or lack adequate nutrients for the baby’s growth and development. Before you make and feed your baby homemade formula, consider these risks, which can harm your baby:

  • Unsafe ingredients: A number of homemade formula recipes call for unpasteurized (raw) cow’s or goat’s milk (or some other milk). Raw milk may contain bacteria (E. coli, Salmonella, and/or Listeria) that can cause severe infections that can be deadly. Other milk products include nutrients that are not recommended for infants. Or, they may have too much of one nutrient and not enough of another.
  • Contamination: Homemade infant formula preparation often requires a number of time-consuming cooking steps which, if not followed exactly, may lead to contamination. In addition, many of the ingredients need to be purchased online from different companies who may not follow safe handling guidelines.
  • Unbalanced nutrients: Without the proper amount of protein, fat, carbohydrates, vitamins, and minerals, babies may develop health problems. Some signs of health problems include poor weight gain, excessive weight gain, vomiting, fever, diarrhea, blood-streaked stool, or a change in the baby’s overall appearance and mood.

FDA received reports of several infants who were hospitalized due to low calcium levels after being fed homemade formula. According to the American Academy of Pediatrics (www.ismp.org/ext/668), feeding a baby homemade formula, even for a few days or weeks, will put your baby at greater risk of getting sick or having long-term health problems.

Here’s what you can do: Consider breastfeeding your baby. If breastfeeding is not an option, or you need to supplement breastfeeding, feed your baby approved, commercially available formula. Ask your healthcare providers which formula would be best for your baby.

Advice from FDA is a feature brought to you by FDA. You can find this information and more on FDA’s Consumer Health Information website at: www.ismp.org/ext/928. This website features the latest updates on medicines and products regulated by FDA. Sign up for a free email subscription at: www.ismp.org/ext/262.

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Do not make or feed homemade infant formula to babies