Designed for easy digestion—with clinically proven outcomes.
Designed for healthy full-term infants 0-12 months of age, ByHeart’s Whole Nutrition Infant Formula features a patented protein blend that gets closest to human milk. Plus, it’s made with organic grass-fed whole milk (never skim), carbohydrates from lactose (like human milk), and certified-clean* ingredients with no corn syrup, soy or palm oil. ByHeart is clinically proven** for easier digestion, less spit-up, softer stools, more efficient growth, and longer stretches between nighttime feeds***.
* Based on Clean Label Project, Purity Award certification
** Compared to a leading infant formula
*** At four months of age
Research-backed ingredients set us apart.
An 80:20 whey-to-casein ratio, human milk’s two most abundant proteins—alpha-lactalbumin and lactoferrin—partially hydrolyzed proteins and organic, grass-fed whole milk.
80:20 whey-to-casein ratio like early human milk
Whey and casein are the two major classes of protein in mammalian milks.¹ They are digested and absorbed differently – whey remains liquid in the stomach and is digested faster, while casein forms curds and is digested more slowly.² These differences in gastric emptying speed can impact digestion and absorption. Our formula mimics the 80:20 whey-to-casein ratio found in colostrum³ to support digestion and tolerability.
Alpha-lactalbumin: A Protein High in Essential Amino Acids
Alpha-lactalbumin (alpha-lac) is a high-quality whey protein that has been shown to promote growth, digestion, and tolerability.⁴ Rich in essential amino acids, alpha-lac is the most abundant protein in mature human milk and it can be isolated from bovine milk and added to infant formula.⁴ We’re the only US-made* infant formula to intentionally add alpha-lactalbumin and to include it at mature human milk levels.
*With globally sourced ingredients
Lactoferrin: An Immune-Supporting Protein
Lactoferrin is an iron-binding glycoprotein found in high levels in colostrum. Lactoferrin has many biological roles including, but not limited to, iron absorption and transport, immune system modulation, antimicrobial and antiviral activities, cognition and gut health support.⁵ We add lactoferrin at levels approved by the FDA.
Combination of Intact & Partially Hydrolyzed Proteins
Human milk contains both intact (whole) proteins and partially hydrolyzed (broken down) proteins – in fact, proteases in the mammary gland selectively pre-digest proteins before they are consumed by the infant!⁶ Both types of proteins offer unique benefits in terms of nutrition and properties that affect functionality and tolerability outcomes like reflux, gassiness and fussiness.⁶ While you will commonly see either intact or hydrolyzed proteins in infant formula, we include both.
¹Davoodi, SH et al. (2016). Iran J Pharm Res. 15(3):573. ²Boirie, Y et al. (1997). Proc Natl Acad Sci U S A. 94(26):14930-14935. ³Liao, Y et al. (2017). J Proteome Res. 16(11):4113-4121. ⁴Layman, DK et al. (2018). Nutr Rev. 76(6):444-460. ⁵Lönnerdal, B et al. (2009). Curr Opin Clin Nutr Metab Care. 12(3):293-297. ⁶Nielsen, SD et al. (2017). J Mammary Gland Biol Neoplasia. 22(4):251-261.
There’s a whole lot to love about whole milk: MFGM, palmitic acid in the optimal SN-2 position, and PUFAs naturally derived from organic, grass-fed whole milk.
MFGM from Whole Milk
The main purpose of the milk fat globule (MFG) is to deliver fatty acids to their intended destinations in the body; however, components of the membrane, also known as the milk fat globule membrane (MFGM) such as sphingomyelin, choline, cholesterol, and phospholipids, also support metabolic function, cognitive development, immune and gut health.¹ Given that the triglycerides in human milk and whole cow’s milk are surrounded by the MFGM, it follows that skimming milk removes the fat (triglycerides) and the MFGM along with it. This is an important concept because infants require fatty acids for growth and development, so the practice of skimming milk means that lipids must come from extraneous sources like vegetable oils. Using whole milk as a formula ingredient retains innate lipids and the MFGM and lessens the reliance on vegetable oils to provide essential fatty acids.
Palmitic Acid from Whole Milk in The Optimal SN-2 Configuration
The positioning of fatty acids in the triglycerides of a fat source can impact outcomes. For example, SN-2 palmitic acid is important for softer stools and better absorption of fatty acids and minerals.² A quick refresher on triglyceride science tells us that triglycerides are composed of three fatty acids esterified (bound) in the SN-1, SN-2, and/or SN-3 positions on a glycerol backbone. The highest percentage of triglycerides in human milk are composed of palmitic acid in the SN-2 position.³ Conversely, many infant formulas contain palm oil, which has a very low proportion of palmitic acid in the SN-2 position and a higher proportion in the SN-1 or SN-3 positions, which are associated with calcium soaps and constipation.² Whole cow’s milk provides an innate source of palmitic acid in the SN-2 position, comparatively more than vegetable oils.
More PUFAs from Grass-fed Cows
Omega-3 and Omega-6 polyunsaturated fatty acids (PUFAS) are foundational nutrients for brain and nerve cell development.⁴ Babies need a delicate balance of omega-6 to omega-3’s for growth and development, where common sources of these fatty acids in infant formula are seed oils and whole milk. Oils are necessary to include in infant formula to meet fatty acid requirements, yet the use of organic whole milk from grass-fed cows lessens the reliance on seed oils.⁵˒⁶ We include DHA (an omega-3 fatty acid) within the World Health Organization’s recommended range.
¹Kosmerl E et al. (2021). Microorganisms. 9(2):1-22. ²Yao, M et al. (2014). J Pediatr Gastroenterol Nutr. 59(4):440. ³3Hunter, JE et al. (2001). Lipids. 36(7):655-668. ⁴Huffman, SL et al. (2011). Matern Child Nutr. 7 Suppl 3(Suppl 3):44-65. ⁵Simopoulos AP. (2002). Biomed Pharmacother. 56(8):365-379. ⁶Daley, CA et al. (2010). Nutr J. 2010;9(1):10.
The same carbohydrate source as human milk.
Lactose is the predominant carbohydrate source in human milk and it supports growth, digestion, immune and gut health.¹ Up to 98% of the lactose in human milk is used to support normal growth and development, while a small fraction remains undigested and helps to soften stools and provide a food source for commensal gut bacteria.² Many standard infant formulas rely on maltodextrin or corn syrup solids as carbohydrate sources instead of lactose, which have potential implications on the gut microbiome,³ preference for sweet taste,⁴ and maladaptive metabolic responses.⁵
Nearly all infants are equipped with adequate lactase (the intestinal brush border enzyme that hydrolyzes lactose); therefore, while lactose can be easy to blame for formula-related tolerance issues, true lactose intolerance in infants is exceedingly rare and infant formulas containing lactose are well-tolerated by most term infants.⁶ While there are clinical classifications of lactose intolerance in infants (e.g., developmental lactase deficiency in infants <34 weeks gestation, secondary lactose intolerance, or congenital lactase deficiency), these conditions are uncommon and low-lactose and lactose-free formulas for healthy, term infants are rarely indicated.⁷
¹Ballard, O et al. (2013). Pediatr Clin North Am. 60(1):49-74. ²Jakobsen, LMA et al. (2019). J Proteome Res. 18(8):3086-3098. ³Jones, RB et al. (2020). Gut Microbes. 12(1). ⁴Hampson, HE et al. (2022). Nutrients. 14(5):1115. ⁵Anderson, CE et al. (2022). Am J Clin Nutr. 116(4):1002-1009. ⁶DI Costanzo M et al. (2018). Ann Nutr Metab. 73 Suppl 4(Suppl 4):30-37. ⁷Heine RG et al. (2017). World Allergy Organ J.10(1).
Galacto-oligosaccharide (GOS): A well-studied prebiotic for gut health.
Galacto-oligosaccharide (GOS) is a well-studied prebiotic fiber that promotes beneficial Lactobacilli and Bifidobacteria, enhances gut barrier function, inhibits pathogen adhesion, and promotes softer stools.¹˒² GOS is derived from lactose and may be included in infant formula to improve tolerance and achieve gut health outcomes more similar to infants fed human milk.
¹Ambrogi, V et al. (2023). Crit Rev Food Sci Nutr. 63(6):753-766. ²Ratsika, A et al. (2021). Nutrients. 13(2):1-33.
The first infant formula to win three Clean Label Project awards.
The Clean Label Project is a consumer protection group that independently evaluates products for substances not found on the product label (e.g., heavy metals, pesticides, and more). We were the first infant formula company to win all three Clean Label Project awards: The CLP First 1,000 Days Promise, CLP Purity Award, and CLP Certified Pesticide Free.
We’re just as meticulous about the ingredients we DON’T include.
- No corn syrup
- No gluten
- No GMOs*
- No maltodextrin
- No soy
- No hexane-extracted DHA
- No artificial growth hormones**
- No palm oil
*Ingredients not genetically engineered
**No significant difference has been shown between milk or milk ingredients derived from rbST-treated and non-rbST-treated cows
We control every step, from research and development to ingredient sourcing to fulfillment, shipment, and the final product that arrives at caregivers’ doors.
As one of the first new US infant formula manufacturers in 15 years (we’re one of only five in the entire country) we are fully integrated—meaning we have sole responsibility of our product from initial design, to delivery, to the customer. This is a big deal. Because what you own, you can control.
Providing the foundation for long-term health for babies.
Research has shown that early nutrition has lasting implications for long-term health and development. Here we highlight some fundamental vitamins and minerals that have been added to ByHeart to support growth and development during the first 1,000 days of life.
Omega-3 fatty acids are necessary for outcomes like brain development and visual acuity.1,2 While DHA often receives ample attention, the ratio between DHA and ARA (another essential fatty acid) is particularly important in early life, as DHA and ARA work together to support infant health.1,3
While choline is neither a vitamin nor mineral (it is rather an organic, water-soluble compound), it is an essential nutrient typically categorized with B vitamins due to its similarities.12 Choline is important for outcomes including overall growth and development, particularly brain and nervous system development.13
Zinc is important for cell division and growth, bone health, immune system and brain development.7 Interestingly, zinc is a cofactor for hundreds of enzymes and is involved in hormone production and gene expression.7
Vitamin D enhances the absorption and utilization of calcium.4,5 Calcium is crucial for bone mineralization, which supports skeletal growth and strong bones and teeth.6 Vitamin D also supports immune system and brain development, and respiratory health.4-6
Iodine is vital for thyroid hormone synthesis and brain development.7 Research has demonstrated a link between iodine deficiency and adverse metabolic and neurocognitive outcomes (in fact, it is the most common cause of preventable intellectual disabilities worldwide).14,15
Iron is critical for brain development, the formation of red blood cells, immune development, and cognition.7 ByHeart features lower iron than many other infant formulas because we understand that while too little iron is problematic, so is too much.8,9 Healthy term infants are equipped with iron stores at birth that support iron needs during their first 4-6 months, in addition to the dietary iron consumed from formula or breastmilk.8,9 Fun fact, lactoferrin (another star ingredient in ByHeart) is a protein found in human milk that enhances non-heme iron bioavailability.10,11
Selenium is a potent antioxidant that protects cells from oxidative stress.16 It also plays key roles in immune system and brain development, thyroid hormone metabolism, and overall growth.16
Birch EE, Carlson SE, Hoffman DR, et al. The DIAMOND (DHA Intake And Measurement Of Neural Development) Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid. Am J Clin Nutr. 2010;91(4):848-859. doi:10.3945/AJCN.2009.28557
Drover JR, Hoffman DR, Castañeda YS, et al. Cognitive function in 18-month-old term infants of the DIAMOND study: a randomized, controlled clinical trial with multiple dietary levels of docosahexaenoic acid. Early Hum Dev. 2011;87(3):223-230. doi:10.1016/J.EARLHUMDEV.2010.12.047
Colombo J, Jill Shaddy D, Kerling EH, Gustafson KM, Carlson SE. Docosahexaenoic acid (DHA) and arachidonic acid (ARA) balance in developmental outcomes. Prostaglandins Leukot Essent Fatty Acids. 2017;121:52. doi:10.1016/J.PLEFA.2017.05.005
Christakos S, Dhawan P, Porta A, Mady LJ, Seth T. Vitamin D and Intestinal Calcium Absorption. Mol Cell Endocrinol. 2011;347(1-2):25. doi:10.1016/J.MCE.2011.05.038
Wagner C, Greer F; Section on Breastfeeding and Committee on Nutrition. Prevention of Rickets and Vitamin D Deficiency in Infants, Children, and Adolescents. Pediatrics. 2008;122(5):1142–1152. https://doi.org/10.1542/peds.2008-1862
Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington, DC: National Academies Press; 1997.
Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: National Academy Press, 2001.
Gallahan S, Brower S, Wapshott-Stehli H, Santos J, Ho TTB. A Systematic Review of Isotopically Measured Iron Absorption in Infants and Children Under 2 Years. Nutrients. 2024;16(22):3834. https://doi.org/10.3390/nu16223834
EFSA Panel on Dietetic Products, Nutrition and Allergies. Scientific Opinion on the essential composition of infant and follow-on formulae. EFSA J. 2014;12(7):3760, 45-49. doi:10.2903/j.efsa.2014.3760
Mikulic N, Uyoga MA, Mwasi E, et al. Iron Absorption is Greater from Apo-Lactoferrin and is Similar Between Holo-Lactoferrin and Ferrous Sulfate: Stable Iron Isotope Studies in Kenyan Infants. J Nutr. 2020;150(12):3200-3207. doi: 10.1093/jn/nxaa226.
Lönnerdal B. Nutritional roles of lactoferrin. Curr Opin Clin Nutr Metab Care. 2009;12(3):293-297. doi:10.1097/MCO.0B013E328328D13E
Institute of Medicine. Food and Nutrition Board. Dietary Reference Intakes: Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC: National Academy Press; 1998.
Leermakers ET, Moreira EM, Kiefte-de Jong JC, Darweesh SK, Visser T, Voortman T, et al. Effects of choline on health across the life course: a systematic review. Nutr Rev. 2015;73:500-22.
Bougma K, Aboud FE, Harding KB, Marquis GS. Iodine and Mental Development of Children 5 Years Old and Under: A Systematic Review and Meta-Analysis. Nutrients. 2013;5(4):1384. doi:10.3390/NU5041384
World Health Organization. United Nations Children’s Fund & International Council for the Control of Iodine Deficiency Disorders. Assessment of iodine deficiency disorders and monitoring their elimination. 3rd ed. Geneva, Switzerland: WHO, 2007.
Institute of Medicine. Food and Nutrition Board. Dietary Reference Intakes: Vitamin C, Vitamin E, Selenium, and Carotenoids. Washington, DC: National Academy Press; 2000.
We don’t just make claims, we prove them. Our formula was designed to support outcomes including:
- Easier digestion*
- Less spit-up*
- Softer stools*
- More efficient growth*
- Higher serum essential amino acids*
- Longer stretches between nighttime feeds*†
- Brain & eye development
- Immune health
- Gut health
A clinical trial 25 years in the making.
We ran one of the largest clinical trials for infant formula in 25 years—including 311 healthy, term infants over 6 months (we were also the first new brand to add a comparison to human milk). All this allowed us to understand the full impact of our innovation. Learn more about our clinical trial outcomes, published in the Journal of Pediatric Gastroenterology and Nutrition.

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*2 or more cans (6 cans max) at ByHeart.com
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