Is Homemade Infant Formula Safe?
[NationalPoisonControlCenter] A national shortage of infant formula in 2022 prompted many families to consider making it themselves. But is homemade baby formula safe?
The first infant formula was developed and sold in 1865, and by 1883 there were 27 patented brands of infant food available. Use of infant formula surged in popularity over the next century, and by the 1970’s the widespread use of infant formula in the United States caused breastfeeding rates to dip to record low numbers. Currently, approximately 75% of infants born in the United States receive infant formula at some point within the first year of life.
The manufacture and sale of infant formula is a multi-billion-dollar industry in the United States. There are 3 main formula manufacturers in the United States, and store-brand or generic formulations account for only 10% of infant formula sales nationwide. Currently, commercially available infant formulas are available in powder, liquid, and ready-to-feed varieties. Infant formulas are commonly made from a cow’s milk or soymilk base, and have additional ingredients added to closely mimic the composition of human breast milk and provide other nutritional benefits. The manufacturing process for infant formula is highly regulated by the United States Food and Drug Administration (FDA) to ensure that commercially available formula products are safe and contain standard amounts of protein, lipids, carbohydrates, and vitamins. Commercially available infant formulas are not permitted to contain certain ingredients, including hydrogenated fats, fructose, and some amino acids.
Although the use of infant formula remains popular in the United States, some parents prefer to feed their babies non-traditional sources of nutrition due to financial limitations or other personal concerns. Infant formula can be costly. A one-year’s supply of name-brand (not generic) formula can cost more than two thousand dollars and may be unaffordable for many families. Some parents are concerned about the possible presence of potentially poisonous ingredients such as pesticides, bisphenol-A, and heavy metals in commercially available infant formulas, while others believe that traditional formulas are associated with impaired immunity or gastrointestinal disease. For these and other reasons, some parents choose to feed their babies homemade infant formula.
Recipes for homemade infant formula can be found online, in blogs, and on social media. These recipes are often created and promoted by individuals who are not credentialed as nutritionists or registered dieticians, and many do not provide instructions for safe handling or storage of the homemade formula preparations. The recipes may include ingredients such as raw or powdered goat’s milk, liver, and almond milk as a formula base or protein source. These alternative protein sources may not provide infants with the correct amounts of calories, calcium, or vitamin D to maintain health, and may promote the development of food allergies. The use of these ingredients in homemade infant formula can result in potentially significant adverse health effects. For example, goat’s milk contains two to three times the protein content of standard infant formula or human breast milk and also contains high levels of chloride and potassium. Infants who consume undiluted goat’s milk have developed electrolyte disturbances, anemia, and severe allergic reactions. Although commercially available infant formula is fortified with vitamin D, alternative milk products such as almond, soy, and coconut milk may not contain enough vitamin D to support healthy infant growth and development. Severe vitamin D deficiency, including rickets (a disorder of bone growth) may occur in infants who consume homemade formula made from alternative milk sources.
Supply chain challenges, in addition to infant formula recalls due to bacterial contamination with Cronobacter species, led to a national shortage of infant formula in 2022 and prompted many families to consider using homemade infant formulas as a replacement for standard formula products that were not widely available. Due to the health and safety concerns associated with homemade formula, the FDA and the American Academy of Pediatrics do not recommend the use of homemade infant formulas. However, even during a widespread formula shortage, there are safer alternatives than using homemade infant formula. In the United States, store-brand (generic) infant formulas provide nutritional support that is comparable to name-brand formulas, are significantly less costly than name-brand formulas, and are also regulated by the FDA. There are multiple varieties of store-brand infant formula including sensitive, hypoallergenic, and soy-based products. Perrigo, the manufacturer of most store-brand infant formulas available in the United States, offers a resource guide on its website to assist parents in finding store-brand formula alternatives to name-brand formula products that may be in limited supply.
Kelly Johnson-Arbor, MD, FACEP, FUHM, FACMT
Medical Toxicologist 
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