Breastfeeding Warnings

How Safe Is Homemade Baby Formula?

Baby formula is so expensive because, according to manufacturers, a lot of research goes into creating a high-quality substitute for breastmilk. Marketing and the huge amount of formula purchased through government-subsidized programs such as WIC, also keep the retail price artificially higher than it would be otherwise. The cost of baby formula across popular brands can average between $1,200 and $1,500 during a baby’s first year, according to the U.S. Surgeon General. This has forced many parents and caregivers into feeding infants homemade formula.

However, the United States Food and Drug Administration (FDA) is advising parents and caregivers to stop feeding infants homemade formula. Babies require adequate nutrients to help them grow and develop. The best source of these nutrients comes from human breast milk. However, some families may not be able to, or may choose not to, breastfeed their baby; others may need to supplement breastfeeding. In these situations, 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:

  1. 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 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.
  2. 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 that may not follow safe handling guidelines.
  3. 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.

Recently, FDA learned of several infants who were hospitalized due to low calcium levels after being fed homemade formula. The American Academy of Pediatrics (AAP) is warning parents not to feed homemade formula to infants. Babies should be fed only breastmilk or iron-fortified infant formula that has been prepared according to the directions on the package.

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 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.

You can also find Useful Information on: Is Ibuprofen (Advil Motrin) Safe During Breastfeeding?


Dr. Oche Otorkpa PG Cert, MPH, PhD

Dr. Oche is a seasoned Public Health specialist who holds a post graduate certificate in Pharmacology and Therapeutics, an MPH, and a PhD both from Texila American University. He is a member of the International Society of Substance Use Professionals and a Fellow of the Royal Society for Public Health in the UK. He authored two books: "The Unseen Terrorist," published by AuthorHouse UK, and "The Night Before I Killed Addiction."
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