Good Intentions that May Lead to Bad Outcomes: Home-Made Infant Formula

For newborn babies and infants, proper nutrition is vital to their healthy growth and development. For optimum nutrition benefits, mothers are encouraged to breastfeed their infants, but sometimes for various reasons they are either unable to, choose not to, or need to supplement breastfeeding. 

For those mothers who are not breastfeeding their infants, commercially prepared infant formula is the best alternative. These products have been, and continue to be, thoroughly tested for nutrient adequacy and safety. The U.S. Food and Drug Administration (FDA) sets and enforces specific limits on safe levels of key ingredients, such as certain vitamins and minerals, for all commercially available infant formulas. Commercial infant formulas must meet all the requirements of the Infant Formula Act, which was developed to safeguard the nutritional health of infants, with very specific ingredient, manufacturing, testing, and labeling requirements.

Despite the high standards and rigorous testing of commercially prepared infant formulas set by the FDA, some parents are concerned about the possible presence of ingredients in these products that have been developed through biotechnology. Some of these concerns stem from claims that biotechnology may cause food allergies.  But, Wesley Burks, MD,  pediatric allergist and chairman of the department of pediatrics at the University of North Carolina Medical School, assures us that foods developed using biotechnology do not lead to food allergies. “Allergic disease truly has changed in the last 20 to 30 years. There’s lots of reasons …why it’s different…There’s a hygiene hypothesis, changes in our gastrointestinal system…the environment…Those \[reasons\] are much, much, much more likely to have a part in the change of allergic disease than anything related to food biotechnology. It’s not even on my list of things that I think about …because of what I know about the safety and approval process in the development of these foods.”  (IFIC Foundation videos, “Physicians Offer Expert Advice on Food Biotechnology”) In addition, trusted health organizations such as the American Medical Association have endorsed the responsible use of biotechnology to enhance food production.

“As a pediatrician and someone who takes care of children and often is speaking with moms who are pregnant, I feel that these foods are completely safe for children. I personally have reviewed the safety data and the evidence that’s put together when these foods are about to be put into the general marketplace, and I find that these foods are completely safe. There’s no evidence that foods produced using biotechnology pose any risk to children or pregnant mothers.”

Ronald Kleinman, MD, pediatrician and physician in chief at Massachusetts General Hospital for Children (From the IFIC Foundation videos, “Physicians Offer Expert Advice on Food Biotechnology”)

When it comes to concerns about the safety of foods produced with biotechnology for women and children, Laurie Green, MD, practicing obstetrician and gynecologist, and partner at the Pacific Women for OB/GYN Care in San Francisco, says, “There are so many things people worry about. The things that would be really important like household products that might cause harm, it gets lost in the shuffle because there’s almost too much information…\[Biotech foods\] have been used for 20 years in 29 countries and consumed by millions and millions of people including pregnant women and children over nearly two decades.” (IFIC Foundation videos, “Physicians Offer Expert Advice on Food Biotechnology”)

Out of fear, some advocates have convinced parents that they should be concerned and that they should take matters into their own hands. While it is understandable that parents would want to take any measure possible to minimize a potential risk to their child, good intentions can sometimes lead to dangerous outcomes.  For example, various individuals and organizations have taken to the internet to endorse homemade infant formula recipes as a way to avoid products containing ingredients produced with biotechnology; however, there are serious food safety risks of doing so that far outweigh any perceived risk of food biotechnology.

Consumption of homemade formulas can lead to potentially serious health consequences for babies. There is no nutritional analysis for these home recipes, and consuming improper quantities of nutrients can cause poor growth and development.  Some recipes call for the use of unpasteurized or raw milk, raising the risk of the presence of E. coli, Listeria, Campylobacter spp, or Salmonella—pathogens that can cause serious health risks.  Registered dietitian and director of nutrition at Washington University in St. Louis, Connie Diekman, MEd, RD, CSSD, LD, says, “Consuming raw milk increases the potential risk of foodborne illness since the bacteria often found in milk have not been destroyed by pasteurization. Young children, pregnant women and those with compromised immune systems are especially at risk for getting sick when they consume raw milk. As a registered dietitian, I would discourage anyone from consuming raw milk.”

According to the American Academy of Pediatrics (AAP), commercial infant formula is the “only safe source of food for nonbreastfed infants up to 6 months old and an important food source for nonbreastfed infants through their first year. 

Keith Ayoob, EdD, RD, FADA, a practicing pediatric nutritionist and associate professor in the Department of Pediatrics at Albert Einstein College of Medicine sums it up best: “I can applaud the intent of mothers wanting to take an active role in feeding their infants when they can't breastfeed.  This is an issue, however, where reality and safety have to trump intent.  Commercially prepared formulas are far less risky than homemade baby formula.  They provide complete nutrition for the infant; for a mother who cannot breastfeed, they are the go-to option.”

The AAP recommends that infants drink only breast milk or commercial infant formula until age 4 to 6 months, and to continue with breast milk or commercial infant formula until at least 12 months of age.  In addition, because of digestion/absorption and other issues  that can impact an infant’s growth and development, the AAP does not recommend introducing whole cow’s milk until after 12 months of age. When a child is ready for other foods to be introduced, the AAP also strongly recommends feeding products that have been pasteurized to kill bacteria and parasites often found in raw beverages. Robert V. Tauxe, MD, MPH, deputy director of the Centers for Disease Control and Prevention’s (CDC) Division of Foodborne, Waterborne, and Environmental Diseases, and co-author of the latest CDC report on attribution of foodborne illnesses to food commodities in the US, confirms that the CDC is concerned about the trend of consumers drinking raw milk and says, “The practice of pasteurizing milk is one of the greatest public health achievements of the 20th century.”

Parents are strongly encouraged to discuss infant feeding issues and questions with an experienced health professional such as their child’s personal pediatrician (and not the internet!) before embarking on a do-it-yourself infant formula experiment. Babies’ safety, health, development, and growth depend on it.

For more information, go to:

Why Formula Instead of Cow's Milk? AAP Healthy Children article

“Got Milk? Don’t Get Raw Milk: A Cautionary Tale” CDC Video

Food Safety and Raw Milk CDC Fact Sheet

Facts About Food Biotechnology - IFIC Foundation

Physicians Offer Expert Advice on Food Biotechnology- IFIC Foundation videos

A Consumer's Guide to Food Safety Risks - IFIC Foundation