Goat milk-based infant formula: What pediatricians need to know

The American Academy of Pediatrics (AAP) recommends exclusive breastfeeding for approximately 6 months after birth and supports continued breastfeeding “as long as mutually desired for 2 years or beyond.”¹ The benefits of breastfeeding are clear. It is dynamic and living food and there is no exact substitute for it. It’s important for health care providers and society at large to encourage and support breastfeeding.

Goat-milk formula | Image Credit: © deviddo - stock.adobe.com

Approximately 3 million American families rely on infant formula to feed their babies. Based on the most recent breastfeeding report card from the Centers for Disease Control and Prevention (CDC), 75% of American babies are supplemented or exclusively formula-fed at 6 months of life.² And, parents deserve to confidently feed their babies a nutritionally appropriate product that is consistently available. Historically, the AAP-approved options for infant formula sold in the United States were cow-milk-based, soy milk-based, or specialty infant formulas. Goat milk-based infant formulas have been used for decades worldwide, but only recently entered the US formula market.

In 2023, the FDA and the AAP both updated their guidance to include goat milk as an acceptable base for infant formula.³ Goat milk-based infant formula is a nutritionally complete, appropriate first-line option for a baby’s first year and a welcome addition that we should be knowledgeable of as pediatricians in the United States. This article provides a history of commercially made infant formulas. It contextualizes the challenges in diversifying the US infant formula supply and why it has taken so long for goat-milk based infant formula to join the ranks of US infant formula options. It also offers guidance on counseling families about infant nutrition options.

The history of infant formula

Breast milk has always been the gold standard for infant nutrition. But through the ages, people have sought out alternatives by necessity or choice. Wet nursing occurred as early as 2000 BC⁴ and continued into the 19th century until the invention of crude feeding vessels and human milk substitutes made from a variety of animal milks. Babies were fed with mammalian milks from cows, goats, mares, and donkeys. Babies who were fed unmodified animal milk experienced dehydration, indigestion, and a higher mortality rate.⁵

German scientist, Johann Franz Simon, published the first chemical analysis comparing human milk and cow’s milk in 1838. It demonstrated that cow’s milk had a higher protein content and a lower carbohydrate content than human milk. He theorized that cow milk protein, which produced larger curds than human milk, caused the tolerability issues that cow milk-fed babies experienced.5 This landmark work led to the development of a human milk substitute with a similar composition of ingredients.5 Infant formula is truly a chemical ‘formula’ using a base, such as cow milk, and then modifying it to approximate the macronutrients and micronutrients in human milk.

The first commercially made infant formula, developed in 1860 by German chemist Justus von Leibig, was a powdered mixture of cow’s milk, wheat flour, malt flour, and potassium bicarbonate that was mixed with heated cow's milk.⁴ Other animal milks were used to prepare infant formulas but cow milk became the standard formula base because it was the most readily available. Commercially made infant formula was first introduced in the 19th century, but it took another 100 years to become widely used primarily due to cost.⁶ In 1869, Leibig’s Soluble Infant Food cost $1 a bottle. In the 1870’s, Nestle’s Infant Food was the first nutritionally complete infant formula concentrate and it sold for 50 cents a bottle.

Despite having 27 different patented brands of infant foods by 1883, none of them were nutritionally complete. Many lacked enough protein, and none were fortified with micronutrients. Physicians became actively involved in infant nutrition science towards the end of the 19th century. An American pediatrician, Dr. Thomas Morgan Rotch, developed “the percentage method,” a way to modify cow’s milk for individual babies. Doctors would adjust the ingredient ratios by monitoring the infant’s stools.5 This scientific feeding method was popular from 1893 to 1915, but it was labor intensive and eventually physicians recommended a simpler recipe that families could make at home. Generations of parents prepared homemade formula with evaporated milk, water, and sugar until the 1960’s, when mass production of commercially made infant formula made it easy to use and more affordable. Infant formulas using cow milk as a base have long dominated the global marketplace. Soy milk has also been used as a formula base for families seeking a non-milk alternative to breast milk or babies with specific medical needs. Even though it was absent from the US marketplace, goat milk-based formulas have been widely accepted by health care professionals and parents globally for decades. Commercially made Infant formulas are the most suitable breast milk substitutes, but remarkably, standardization is relatively new.

The history of infant formula regulation

The AAP Committee on Nutrition adopted the first guidelines for vitamin and mineral composition in infant formulas in 1967 and for iron fortification in 1969.⁵ Other organizations also issued general guidelines for formula composition. But after 141 babies suffered hypochloremic alkalosis from eating two different soy formula brands between 1978 and 1979, the Infant Formula Act (IFA) of 1980 was enacted. It mandated FDA regulation of both composition and manufacturing of infant formulas sold in the United States. The IFA was updated in 1986 and the most recent revision was in 2014. Infant nutrition experts feel that it is time for another update to reflect the latest knowledge in nutrition science.⁶ The current IFA does not address the inclusion of bioactive ingredients (such as docosahexaenoic acid, arachidonic acid, oligosaccharides, and probiotics), energy density, or specific nutritional composition for premature infants.

Revisions to iron requirements and protein requirements are also considerations. Infant formula is now one of the most highly regulated food products worldwide. But nutritional composition standards vary amongst international regulatory agencies. Adopting global infant formula composition standards would broaden options and prevent shortages.⁶

For an infant formula to be legally sold and marketed in the United States, the product must pass comprehensive nutrient testing with all ingredients GRAS-approved (Generally Recognized As Safe), demonstrate normal infant growth in a clinical trial, and submit proof of safety in manufacturing practices. The infant formula must contain 30 nutrients at established minimum and maximum levels.⁷ This rigorous process allows the product to be FDA-registered. Infant formulas that are FDA-registered adhere to annual safety inspections. The FDA does not technically “approve” infant formula to be sold. Until recently, goat milk-based infant formulas have not been sold in the United States. The FDA registration process is time-consuming and expensive and may have been a deterrent for companies interested in the US market.

Kabrita became the first and only goat-milk based infant formula and European infant formula to meet all FDA requirements^8,9 and be formally FDA-registered. It has been sold here since January 2024.

Infant formula shortage of 2022 creates demand and leads to changes: Why we need to diversify our US infant formula options

In February 2022, Cronobacter sakazakii contaminated an Abbott Nutrition plant in Michigan, which sickened four infants and led to two deaths.⁹ The crisis exposed the fragility of the United States infant formula supply that was due in large part to the market being controlled by a few companies producing the majority of formulas in a few manufacturing plants. The United States lost 20% of its infant formula supply overnight when the Michigan plant closed.¹⁰ The out of stock rates for infant formula in United States stores peaked at 74% by the summer of 2022.¹¹ Three million American parents scrambled to find food to feed their babies. Parents sought donor milk from unregulated online sources, some diluted the baby formula they had on hand to make it last longer, and yet others made their own formula concoction. The situation was even more dire for babies requiring medically necessary formulas.

Because of the magnitude of the shortage, the US government initiated Operation Fly Formula. Infant formula from other nations that met general US nutritional and safety standards were imported to alleviate the crisis. The FDA issued emergency “enforcement discretion” to allow temporary legal sale of international infant formulas if the manufacturers could provide information regarding the safety and nutritional adequacy of their products.¹² During the shortage, European and Australian goat milk-based infant formula manufacturers, Kendamil and Aussie Bubs, imported formula through Operation Fly.¹³ Now that the enforcement discretion is subsiding, both companies are working towards meeting all FDA requirements to be permanently sold in the United States.¹⁴ Other goat milk-based infant formulas will likely follow.

Goat-milk based infant formula is here to stay: What you need to know about it.

After decades of recommending cow milk-based formula as the preferred alternative for non-breastfed or supplemented babies, the AAP updated their advice in October 2023.³ The recommendations now include goat milk-based infant formula as a first-line option along with cow milk-based products, and soy milk-based products for certain medical issues. American pediatricians now recommend goat milk formula as appropriate and complete nutrition for a baby’s first year. Goat milk-based infant formula is a standard, first-line nutrition option for supplemented or non-breastfed babies. It is not just a niche product for fussy babies with problems tolerating cow-milk-based infant formula.

Both cow and goat milk-based infant formulas are nutritionally complete. However, there are differences in their basic composition, and studies suggest that goat milk-based infant formula is better tolerated as compared to cow milk-based infant formulas.^15,16 Over 50% of parents of infants report that their babies have some degree of gastrointestinal discomfort in the early months of life–including breastfed babies and those who are partially or fully formula-fed.¹⁷ Yet goat milk-based formula-fed babies compared to cow milk-based formula-fed babies are reported to experience fewer of these symptoms. For example, a case series study found that goat milk-based infant formula was associated with an improvement in stool characteristics.¹⁸

After 3 weeks, infants fed with goat milk-based infant formula had softer stools as per the Bristol Stool Scale. Study results also found a slight reduction in total crying time over a 24-hour period, as reported by parents.16,18 While mammalian milks are all different, goat milk shares more similarities in composition to human milk than cow milk does. Specifically, the protein composition is more similar and protein is the key ingredient that can impact the digestive process. Because the goat milk whey

protein more closely resembles human milk, the rapid transit through the gut makes it easier to digest. Studies comparing babies fed goat milk-based infant formula to human milk to cow milk-based infant formula demonstrate similar transit times (50% whey digested within 2 hours in goat milk-based infant formula and human milk compared to 35% cow milk infant formula whey digested within 2 hours).¹⁹

Additionally, the casein protein components of goat milk are also more similar to human milk casein. Goat milk casein contains more beta casein, which is found in human milk, and it contains less A1 beta-casein which is abundant in cow milk. A1 beta-casein produces firmer, harder curds when it is being digested making it more difficult to digest. Goat milk, by contrast, with less A1 beta-casein, produces softer, looser, and more easily digestible curds. These key differences may result in fewer gastrointestinal discomfort symptoms in goat milk-based infant formula compared to cow milk-based products.^20,21 This may explain why goat-milk based infant formula is reported to be better tolerated than cow-milk based infant formula.

One key ingredient found exclusively in human milk, human milk oligosaccharides (hMOS), is the second most abundant carbohydrate found in breast milk after lactose. There are more than 200 different hMOS found in breast milk, and they vary in amount, diversity, and functionality.²³ These oligosaccharides function as prebiotics, immune modulators, pathogen inhibitors, and improve barrier function in the gut. Even though modern infant formulas often contain prebiotics, they do not duplicate all the functions of those that naturally occur in human milk. Milk from cows and goats also contain oligosaccharides but the levels are lower than in human milk. But goat milk naturally contains five times higher oligosaccharide levels and more diversity compared to cow milk.^22,23 Some studies demonstrate anti-inflammatory effects of goat milk oligosaccharides as they stimulate growth of bifidobacteria preferentially.²²

Several clinical trials are ongoing and are exploring the use of goat milk formula for specific health conditions. The GIraFFE Study24 is evaluating the impact of goat milk-based infant formula on the risk of allergy and atopic dermatitis. The TIGER Study²⁵ compares goat milk versus cow milk-based infant formula on the prevalence of functional gastrointestinal disorders.

Myths and misconceptions

All commercially made infant formulas sold in the United States use cow, goat or soy milks as bases that have been modified to be nutritional complete with 30 essential macronutrients and micronutrients, including iron, folate, and vitamin D.

We learned in our pediatric training that infants who consume goat’s milk can become anemic, due to low levels of iron and folate. The same is true for cow milk. For this reason, we do not recommend feeding unmodified cow or goat milk to babies.

Remember, commercially made infant formulas use a protein base of cow, goat, or soy and then modify it to meet an infant’s nutritional needs. That’s why it is called a formula!

How do we advise families about infant nutrition?

The AAP recommends that cow, soy, or goat milk-based infant formulas are acceptable as first-line nutrition for non breastfed or breastfed-supplemented babies in the first year of life. For babies with a diagnosed cow milk protein allergy (IgE mediated or non-IgE mediated enteropathy or proctocolitis), the AAP recommends extensively hydrolyzed formulas and elemental formulas. Parents are keenly interested in nutritional science when selecting an infant formula. The decision can feel overwhelming and families seek clear guidance from their pediatrician. We need to explain the key differences in macronutrients, the value of high-quality ingredients, and

the potential benefits of bioactive nutrients in some infant formulas to help them feel confident in their decisions.

References:

1. Meek JY, Noble L, AAP Section on Breastfeeding. Policy Statement: Breastfeeding and the use of human milk. Pediatrics. 2022;150(1):e2022057988. doi:10.1542/peds.2022-057988

2. Centers for Disease Control and Prevention. Breastfeeding Report Card. https://www.cdc.gov/breastfeeding/data/reportcard.htm. Accessed January 27, 2024.

3. Fuchs GJ, Abrams SA. Choosing a baby formula. American Academy of Pediatrics. Healthychildren.org. https://www.healthychildren.org/English/ages-stages/baby/formula-feeding/Pages/cho osing-an-infant-formula.aspx. Published October 20, 2023. Accessed February 10, 2024.

4. Stevens EE, Patrick TE, Pickler R. A history of infant feeding. J Perinat Educ. 2009 Spring;18(2):32–39 doi:10.1624/105812409X426314

5. Schuman AJ. A concise history of infant formula (twists and turns included). Contemporary Pediatrics. 2003;20(2):91-98.

6. Abrams SA, Bergner EM. Perspective: is it time to revise the current nutrient requirements for infant formulas principally established in 1980? Adv Nutr. 2023;14:426-431. doi: 10.1016/j.advnut.2023.02.006

7. FDA Code of Federal Regulations. CFR Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=107.100. Published October 17, 2023. Accessed February 10, 2024.

8. Xu M, Wang Y, Dai Z, Zhang Y, Li Y, Wang J. Comparison of growth and nutritional status in infants receiving goat milk-based formula and cow milk-based formula: a randomized, double-blind study. Food Nutr Res. 2015;Dec 10:59:28613. doi:10.3402/fnr.v59.28613

9. Centers for Disease Control and Prevention. Cronobacter and powdered infant formula investigation. https://www.cdc.gov/cronobacter/outbreaks/infant-formula.html. Updated May 24, 2022. Accessed February 10, 2024.

10. U.S. International Trade Commission. U.S. infant formula shortage and supply and trade dynamics. Executive briefing on trade. https://www.usitc.gov/publications/332/executive_briefings/ebot_us_infant_formula_sh ortage_and_supply_and_trade_dynamics.pdf. Published December 2022. Accessed February 10, 2024.

11. Patel V. Baby formula plant that shut down and fueled crisis restarts production. New York Times. https://www.nytimes.com/2022/06/04/us/abbott-labs-baby-formula.html. Published June 4, 2022. Accessed February 9, 2024.

12. FDA. Guidance for industry: infant formula enforcement discretion policy. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidanceindustry- infant-formula-enforcement-discretion-policy. Published May 18, 2022. Accessed February 10, 2024

13. U.S. Department of Health and Human Services. Press Release: Eleven Operation Fly Formula flights completed by September 29. https://www.hhs.gov/about/news/2022/10/06/11-operation-fly-formula-flights-completed-by september29.html#:~:text=Under%20Operation%20Fly%20Formula%2C%20the ,get%20to%20store%20shelves%20faster. Published October 6, 2022. Accessed February 10, 2024

14. Aussie Bubs. Operation Fly Formula, explained. https://aussiebubs.com/blogs/bubs-blog/operation-fly-formula-explained. Published May 16, 2022. Accessed February 10, 2024

15. Verduci E, D’Elios S, Cerato L, et al. Cow's milk substitutes for children: nutritional aspects of milk from different mammalian species, special formula and plant-based beverages. Nutrients. 2019;Jul 27;11(8):1739. doi:10.3390/nu11081739

16. Infante D, Prosser C, Tormo R. Constipated patients fed goat milk protein formula: A case series study. J Nutr Health Sci. 2018;5:203. doi:10.15744/2393-9060.5.203

17. Iacono G, Merolla R, D’Amico D, et al. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005;37(6):432-8. doi: 10.1016/j.dld.2005.01.009

18. Litmanovitz I, Bar-Yoseph F, Lifshitz Y, et al. Reduced crying in term infants fed high beta-palmitate formula: a double-blind randomized clinical trial. BMC Pediatrics. 2014; 14:152. doi:10.1186/1471-2431-14-152

19. Maathuis A, Havenaar R, He T, Bellmann S. Protein digestion and quality of goat and cow milk infant formula and human milk under simulated infant conditions. J Pediatr Gastroenterol Nutr. 2017;65:661-666. doi:10.1097/MPG.0000000000001740

20. Almaas H, Cases A-L, Devold TG, et al. In vitro digestion of bovine and caprine milk by human gastric and duodenal enzymes. Int Dairy J. 2006;16:961-968. doi: 10.1016/j.idairyj.2005.10.029

21. He T, Woudstra F, Panzer F et al. Goat milk based infant formula in newborns: a double-blind randomized controlled trial on growth and safety. J Pediatr Gastroenterol Nutr. 2022;75(2):215-220. doi:10.1097/MPG.0000000000003493

22. Van Leeuwen SS, Te Poele EM, Chatziioannou EC, Benjamins E, Haandrikman A, Dijkhuizen L. Goat milk oligosaccharides: their diversity, quantity, and functional properties in comparison to human milk oligosaccharides. J Agric Food Chem. 2020;68(47):13469-13485. doi:10.1021/acs.jafc.0c03766

23. Oliveira DL, Costabile A, Wilbey RA, Grandison AS, Duarte LC, Roseiro LB. In vitro evaluation of the fermentation properties and potential prebiotic activity of caprine cheese whey oligosaccharides in batch culture systems. Biofactors. 2012;38:440-9. doi:10.1002/biof.1043

24. Goat Infant Formula Feeding and Eczema Study. (Giraffe) Study. https://www.giraffe-study.com/. Accessed February 10, 2024.

25. Transition to Infant Formula Feeding on Gastrointestinal Regurgitation (TIGER) Study. https://classic.clinicaltrials.gov/ct2/show/NCT05363553. Accessed February 10, 2024