Infant formula

March 22, 2017


Infant formula

Natural Standard Monograph, Copyright © 2013 ( Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions.

Related Terms

  • Alimentum®, amaranth oil, ARA, arachidonic acid, B vitamins, baby formula, breastfeeding, breast milk, calcium, carrageenan, casein, choline, copper, cow's milk, DHA, diglyceride, docosahexaenoic acid, Earth's Best®, Elecare®, folic acid, formula, Gentlease®, Good Start®, infant, inositol, iodide, iron, L-carnitine, lecithin, linoleic acid, magnesium, manganese, monoglyceride, Neocate®, niacin, Nutramigen®, pantothenic acid, Parent's Choice®, phosphorus, prebiotics, Pregestimil®, premature infants, preterm infants, probiotics, Saccharomyces boulardii, safflower, soy, taurine, vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B9, vitamin B12, vitamin C, vitamin D, vitamin K, whey.


  • According to the Federal Food, Drug, and Cosmetic Act (FFDCA), infant formula is defined as food that serves a special dietary purpose as a complete or partial substitute of human breast milk. The U.S. Food and Drug Administration (FDA) defines infants to be no more than 12 months of age.

  • Replacements for breast milk began centuries ago. According to secondary sources, mothers who could not nurse either made food for the infants, known as dry feeding, or used wet nurses who breastfed the infants for the mothers. Scientific investigation of breast milk alternatives did not begin until the late 19th Century. In 1915, processed milk was developed with a fat content to mimic human breast milk, and modified evaporated milk formulas soon became widely accepted and used for many decades. Infant formulas have evolved from early compositions. After years of research and development they have been formulated to contain the proteins, fats, carbohydrates, vitamins, and minerals necessary for infant growth and development.

  • Many of the formulas are fortified with docosahexaenoic acid (DHA) and arachidonic acid (ARA). According to secondary sources, DHA and ARA are found in higher levels in breastfed infants than those who are not breastfed, which is the reason there has been an increased interest in adding these acids to infant formula. The body can make these fatty acids from sources found in plant and marine oils; DHA and ARA can also be obtained directly from the diet. DHA and ARA are components of the brain and are important for developing cognitive skills.

  • While there is conflicting evidence concerning the relative value of artificial feeding, including using infant formula, it is inferior to breastfeeding for both full-term and premature infants, according to the International Formula Council (IFC). Artificial feeding is associated with more illness and death in infants when compared to breastfed infants. This may be due to the immune protective nature of breast milk as well as the ability of breast milk to satisfy the complete nutrient needs of infants.

  • According to the American Academy of Pediatrics (AAP), exclusively breastfeeding an infant is the optimal method of feeding and is enough to provide the needed nutrients for growth and development for the first six months. Infants that are weaned from breast milk before 12 months of age should receive iron-fortified infant formula, not cow's milk.


  • General: Breastfeeding is the preferred method of feeding when possible, according to the International Formula Council (IFC). According to the American Academy of Pediatrics (AAP), the best method of feeding for the first six months is exclusively breastfeeding, which provides infants with all of the needed nutrients for growth and development.

  • According to the IFC and the AAP, if breastfeeding is not possible or if breastfeeding is discontinued before the age of one year, commercially available, iron-fortified formula is the best alternative.

  • Parents should consult their pediatricians to help them select formula for their infants.

  • The U.S. Food and Drug Administration (FDA) requires that the "use by" date be printed on each formula container. Before this date, the manufacturer ensures that the formula contains all of the nutrients that are minimally required by the FDA and that it is of acceptable quality.

  • Types of formulas: There are different types of infant formula: ready-to-feed, concentrated liquid, and powder. For ready-to-feed and concentrated liquid formulas, shake the container thoroughly to mix the formula before pouring. Do not add water to ready-to-feed formulas, according to the IFC. Carefully measure the water needed to mix into concentrated liquid and powder formulas, according to the package labeling.

  • Formulas that are ready-to-feed and concentrated liquid contain additional ingredients, including lecithin, carrageenan, and mono- and diglycerides, to avoid liquid separation and prolong shelf life. Infants who are allergic to these ingredients should avoid using ready-to-feed and concentrated liquid formulas. If an infant shows signs of an allergy (e.g., rash, abdominal pain, respiratory symptoms), a doctor should be notified to explore viable substitute formulas that are available.

  • Infants who are formula-fed do not need additional supplements or vitamins, as these formulas already have added vitamins and nutrients, as set by FDA regulations. Because of these regulations, generic-brand formulas contain all the nutritional needs as brand-named formulas. If a low-iron formula is fed, however, parents may choose to supplement their infants with iron, especially after four months of age.

  • Preparing formulas: Before preparing infant formula, hands should be washed with soap, according to the IFC. Read the instructions on the formula container and follow directions exactly. According to Heading Home with Your Newborn: From Birth to Reality, a book published by the AAP, boiling or purifying both bottled and filtered water may be needed at least for the first month or two. Make sure to boil water for one minute (both tap water and bottled water) to ensure that it is free of bacteria. However, according to the IFC, depending on the living area and water supply quality, boiling may not be warranted. Consult with a pediatrician for specific directions. Clean the bottle and the nipple as well with hot soapy water.

  • Also, according to the IFC, warm the formula by putting the bottle into a container of hot water or a bottle warmer. Never use a microwave to warm formula, as this may result in hot spots within the liquid that could burn an infant's mouth. It may also damage the nipple. Ensure that the formula is at the right temperature by mixing well and then testing a few drops on the inside of one's wrist.

  • Storing formulas: Formulas that have been mixed with water, such as concentrated liquid and powder, should be fed immediately. However, if they have not been fed to an infant, they can be stored for a given amount of time according to the label on the container. According to the AAP, formula can also be refrigerated for 24 hours, which will decrease bacteria growth. After feeding, throw away any formula still left in the bottle after one hour, as there will be bacteria in the formula that is normally present in the baby's saliva, according to the IFC.


  • General: The U.S. Food and Drug Administration (FDA) requires infant formula to have minimum amounts of 29 nutrients and maximum amounts of nine of these nutrients. In addition, there are many components that are also added to enhance the beneficial effects of infant formula, such as emulsifiers and stabilizers, docosahexaenoic acid (DHA), arachidonic acid (ARA), probiotics, prebiotics, taurine, L-carnitine, choline, inositol, and biotin (vitamin B7). Soy lecithin phosphatidylserine, a common emulsifier to help in suspending the mixture, should not be used in baby products or infant formula, according to Lipogen (phosphatidylserine manufacturer).

  • Required ingredients in U.S. infant formulas:

  • General: In order for a specific formula to be approved for use by the FDA, it must have minimum amounts of 29 nutrients and maximum amounts of nine of these nutrients. If a formula does not meet these requirements, it is considered to be adulterated, unless it is exempt. A formula can be exempt if it is to be used in an infant population that has problems with metabolism, has low birth weight, or warrants specific medical requirements or needs.

  • Fats: Fats in infant formula are usually made from vegetable oils, such as corn, soy, safflower, and coconut oils, according to secondary sources. Formulas are available that contain predigested fats, known as medium-chain triglycerides (MCT), and therefore do not need to be broken down by the infant. However, they are not recommended routinely for healthy infants. In addition, fatty acids such as ARA and DHA may be added to infant formula to support brain development and function.

  • Proteins: Based on secondary sources, proteins in infant formula come in a variety of types, based on the infant's needs. Cow's milk is the most common and typical type of formula, containing purified cow's milk whey and casein. For infants who are allergic to cow's milk, soy protein-based formulas are available. However, many infants who are allergic to cow's milk may also be allergic to soy proteins. Infants who have cow's milk allergies may also try, per doctor's order, partially hydrolyzed (e.g., Good Start®, Gentlease®) and extensively hydrolyzed formulas (e.g., Alimentum®, Nutramigen®, Pregestimil®), in which the proteins are already partially or completely broken down. In addition, amino acid-based formulas (e.g., Neocate®, Elecare®) are also available for those who have cow's milk allergies and cannot tolerate soy protein-based, partially hydrolyzed, or extensively hydrolyzed formulas. Although these amino acid-based formulas are the least likely to cause allergic reactions, they are also the most expensive.

  • According to a randomized clinical trial, low levels of protein in infant formula are associated with lower weight up to two years of age and may decrease the risk of obesity in the future.

  • Carbohydrates: According to media outlets, the FDA does not state which sugars may be used in formula, as long as it is generally regarded as safe (GRAS). It does not set a specific amount of sugar per serving in infant formula either (although it does with fats and proteins). Sugars added in all infant formulas provide enough energy to help infants digest the proteins in cow's milk- or soy-based formulas.

  • Organic formulas (e.g., Earth's Best®, Parent's Choice®) are available that contain organic lactose, which is extracted from organic milk.

  • For infants who have galactosemia (an inability to break down galactose, a sugar that contains lactose) or who do not have lactase (an enzyme used to break down lactose), lactose-free formulas are available. However, lactase absences often begin after 12 months of age, and this condition is confirmed and diagnosed using specific tests.

  • Linoleic acid (safflower): Linoleic acid is an important constituent of safflower oil. Currently, safflower oil, which has very few monounsaturated fats, is processed into high-oleic safflower oil. This high-oleic version is a good source of monounsaturated fat, which sometimes is substituted for olive oil due to its beneficial effects in coronary heart disease. Linoleic acid is supplemented in infant formula to increase infants' fat intake. Infants need a higher fat intake to help their rapid growth and brain development.

  • In one clinical trial, infant formula supplemented with safflower oil increased the energy density of formula for very-low-birth weight preterm infants with some gastrointestinal side effects. Safflower oil was also used as a lipid source in a lower-fat formula for older infants. Although safflower oil seemed to be successful in both studies, more high-quality studies are needed.

  • B vitamins: B vitamins, including B1, B2, B3 (niacin), B5 (pantothenic acid), B6, B9 (folic acid), and B12, are required in all infant formulas by the FDA.

  • Vitamin B1 (thiamine) is involved in many body functions, including nervous system and muscle functioning, electrolyte balances, several enzyme processes, the breakdown of carbohydrates, and the production of hydrochloric acid, which is important in food digestion. The body stores very little thiamine, and depletion can occur within 14 days. Deficiency may lead to beriberi, which causes complications in the nervous system, muscles, heart, and gastrointestinal system.

  • Vitamin B2 (riboflavin) is involved in important metabolic processes and is needed for normal cell function, growth, and energy production. Deficiencies in vitamin B2 may cause weakness, throat swelling or soreness, tongue swelling, skin cracking or sores at the corners of the mouth, skin irritation, or anemia.

  • Vitamin B3 (niacin) helps the nervous and digestive systems function properly, maintains healthy skin, and helps the body convert food to energy. Deficiencies in niacin, also known as pellagra, present with skin conditions, diarrhea, dementia, and even death.

  • Vitamin B5 (pantothenic acid) is a component of coenzyme A (CoA), needed for many important chemical reactions in the cells. It plays a role in the breakdown of carbohydrates, proteins, and fats, as well as the synthesis of hormones and cholesterol. Deficiencies are extremely rare and only occur in individuals who are severely malnourished. It may play a role in attention-deficit hyperactivity disorder (ADHD); however, there is currently insufficient evidence to form a clear conclusion.

  • Vitamin B6 (pyridoxine) is needed to make certain brain chemicals (serotonin and norepinephrine), as well as for myelin formation. Myelin is a component of nerves. Deficiencies in pyridoxine may affect the peripheral nerves, skin, mucous membranes, and blood cell system, as well as the central nervous system in children. Intravenous administration of pyridoxine by a healthcare provider may be used to treat newborns with pyridoxine-dependent seizures that result from the use of high-dose pyridoxine in pregnant mothers or from genetic pyridoxine dependency.

  • Vitamin B9 (folic acid) is needed to make red blood cells by working together with vitamin B12 to ensure proper iron function in the body. Deficiency in folic acid may lead to anemia.

  • Vitamin B12 helps maintain healthy nerve cells and red blood cells as well as make DNA. Because the body can store several years' supply of B12, deficiency is very rare and only occurs in various diseases that affect the absorption of vitamin B12.

  • Vitamin A: Vitamin A is important in proper visual function, especially for night vision. It is also an important antioxidant; however, the exact benefits are unclear. Deficiencies in vitamin A are rare but may lead to dry eyes, night blindness, or even total blindness. There has been evidence that vitamin A should be administered in children diagnosed with measles in areas where deficiencies in vitamin A may be present. It has been shown that supplementation may decrease the length and impact of the disease. Diarrhea, pneumonia, and death from measles have been decreased with vitamin A supplementation. However, the management of measles should be under the supervision of a qualified healthcare provider.

  • In underweight or normal-weight children aged younger than five years, one study has found no effect of a moderate dose of vitamin A supplementation on the duration of uncomplicated pneumonia. However, children with high basal serum retinol concentrations may receive a beneficial effect with vitamin A supplementation.

  • Vitamin C: Vitamin C is necessary for the body to form collagen in bones, cartilage, muscles, and blood vessels, as well as to help the absorption of iron. There is limited evidence that vitamin C in breast milk may decrease an infant's risk of developing childhood allergies. It is unclear that supplementation exceeding the Dietary Reference Intake recommendations may be beneficial or safe. In premature infants, there have been no significant benefits or harmful effects when they have been supplemented with low amounts (10 milligrams per kilogram daily) or high amounts (30 milligrams per kilogram daily) throughout the first 28 days of life. Vitamin C may also help prevent iron deficiency by increasing the absorption of iron.

  • Vitamin D: Vitamin D is very important in promoting good bone health. It maintains normal blood levels of calcium and phosphorus and provides protection from osteoporosis, high blood pressure, cancer, and several autoimmune diseases. Vitamin D deficiency in children may lead to rickets, causing deformed skeletons.

  • Infants who are exclusively breastfed have a higher risk of developing vitamin D deficiency. Supplementation may be necessary within the first two months of life. It has been reported that infants who have been supplemented with vitamin D during the first year of life may be less likely to develop type 1 diabetes than infants fed lesser amounts of vitamin D. A 2008 review recommends that infants and children, including adolescents, should be supplemented with 400 IU of vitamin D daily, based on evidence from new clinical trials.

  • Vitamin E: Vitamin E has antioxidant activity; however, the exact benefits are unclear, except when treating vitamin E deficiencies due to decreased fat absorption. There is an increased risk of vitamin E deficiency in premature infants, especially those with very low birth weight. Many studies have been conducted to look at the role of vitamin E in the prevention of potentially serious complications such as bleeding into the brain, eye damage, or death. However, conclusions are variable and contradictory. Supplementation should be under the supervision of a health care professional.

  • Vitamin K: Vitamin K is important in normal clotting of the blood, and deficiencies may lead to decreased clotting factors and increased bleeding. A deficiency in vitamin K in newborns may lead to vitamin K deficiency bleeding (VKDB). Therefore, the American Academy of Pediatrics (AAP) recommends that all newborns should be administered with a single injection of vitamin K1 to prevent VKDB. Excessive amounts of vitamin K supplementation may be severe in premature infants and may lead to hemolytic anemia, brain damage, or death. If an infant formula is not fortified with vitamin K, a pediatrician should be consulted to seek other options for vitamin K supplementation.

  • Calcium: Calcium is the most abundant mineral in the human body with many important functions, such as muscle contraction, blood vessel constriction and relaxation, secretion of hormones and enzymes, and proper nervous system signaling. Calcium is also very important in the support of bone structure.

  • Growth of very-low-birth-weight infants directly correlates with calcium intake and retention in the body. Bone mineralization is also more decreased in these infants than those born at term. The use of formula fortified with higher levels of calcium may allow improved bone mineralization in very-low-birth-weight infants.

  • Phosphorus: Phosphorus is needed for the formation of bones and teeth and, with calcium, promotes healthy bones and soft tissues. Phosphate is the most common form of phosphorus in the body and the most abundant intracellular anion (negatively charged ion). It is needed for energy storage and metabolism, for the utilization of many B vitamins, for buffering body fluids, for the excretion of hydrogen ions by the kidney, for proper muscle and nerve function, and for maintaining calcium levels. Both too little phosphate (hypophosphatemia) and too much phosphate (hyperphosphatemia) may lead to serious complications and serious electrolyte imbalances.

  • The FDA has approved phosphate as a use for occasional constipation in adults and children, both orally and rectally as an enema.

  • Iodine: Iodine is needed for humans to make thyroid hormone. Iodine deficiency may lead to thyroid gland dysfunction (including goiter) and other brain, gastrointestinal, and skin abnormalities in children and adults. Severe intellectual disability, known as "cretinism," is a rare result of severe iodine deficiency during early development. Stunted growth, apathy, impaired movement, or speech or hearing problems may also occur. Infants who are vulnerable to the effects of iodine deficiency should consider supplementation per doctor's orders.

  • Metals: Many metals are added to infant formula, including magnesium, iron, zinc, manganese, and copper.

  • Magnesium is involved in more than 300 chemical reactions. A review did not show a clear in benefit using magnesium sulfate to protect the brain of the preterm fetus that may have an increased risk of blindness, deafness, cerebral palsy, and other major disabilities. However, the review found that prenatal supplementation of magnesium may improve motor function in the early childhood of premature infants.

  • Iron is needed to form hemoglobin, which carries oxygen on red blood cells throughout the body and is needed for cell and tissue growth. Research has shown that it is also important in mental development. People who are iron deficient may be irritable and anemic. According to the International Formula Council (IFC), the most common nutritional problem in infants is iron deficiency. Infants are born with iron stores that will last for the first 4-6 months of life. However, infants must be supplemented with iron before this store runs out. Research suggests that iron deficiency early in childhood may lead to changes in behavior that may be irreversible, even when the deficiency is corrected. The AAP recommends that infants should be gradually introduced to solid foods that are rich in iron, as breast milk does not provide the sufficient amount of iron needed. However, infant formula containing 4-12 milligrams of iron per liter may be considered iron-fortified and will also supply enough iron for the infant.

  • Zinc is needed for the proper function of more than 300 different enzymes and plays an important role in numerous biological processes. It is also a cofactor for superoxide dismutase (SOD), an antioxidant enzyme, as well as being involved in carbohydrate and protein breakdown reactions. Deficiency may lead to growth retardation, diarrhea, eye and skin conditions, and a loss of appetite. Many studies in developing countries have shown zinc supplementation to be effective in children with acute diarrhea, and it may decrease the severity and duration of symptoms, especially in children who have low zinc levels.

  • Zinc supplementation may also counteract hypothyroidism and decrease the number of infections in children with Down syndrome. However, it does not seem to improve depressed immune systems. Further research is needed before a conclusion can be made. Zinc supplementation with iron may improve the linear growth (length) of stunted infants with low hemoglobin, based on current evidence. Supplementation does not seem to lessen the duration of abnormally fast breathing, inadequate oxygen, chest indrawing, inability to feed, lethargy, severe illness, or hospitalization in children with pneumonia.

  • Manganese helps with the formation of connective tissue, bones, blood-clotting factors, and sex hormones in the body, based on secondary sources. It also helps the body break down fat and carbohydrate, absorb calcium, and regulate blood sugar. Manganese is important in normal brain and nerve function and serves as a component to SOD. Deficiencies in manganese may cause bone malformation, weakness, and seizures.

  • Copper is a component of multiple enzymes and plays a role in regulating gene expression and forming connective tissue, as well as in the functioning of the mitochondria. It also helps in the absorption, storage, and metabolism of iron and must be maintained in very narrow ranges. Deficiency may occur in infants fed only cow's milk formulas, which generally have lower copper contents. Premature or low-birth-weight infants and infants with prolonged diarrhea or malnutrition are also at risk for developing copper deficiencies. Decreased levels of copper may retard growth and may call for copper supplementation. However, this should be done under the supervision of a healthcare professional. Copper supplements are currently not available for infants in the United States.

  • Sodium: Sodium works with potassium to conduct electrical impulses on cell membranes and allows for the proper function of the nerves, according to secondary sources. It also helps the kidneys regulate the amount of body fluid volume. However, according to the American Heart Association (AHA), too much sodium may lead to high blood pressure. Low-sodium formulas are available for infants who need reduced sodium intake per doctor's recommendations.

  • Potassium: Potassium works with sodium to conduct electrical impulses on cell membranes and allows for the proper function of the nerves. It is also important in maintaining fluid and electrolyte balances. Potassium deficiencies may cause weakness, lack of energy, stomach disturbances, muscle cramps, and abnormal heart rhythms, and they may be life threatening. It is added into infant formula to mimic the amounts found in breast milk.

  • Chloride: Chloride is the major anion found in the extracellular fluid. It helps maintain fluid balances in the body. Too much or too little chloride may have severe complications and may even be fatal. According to the Centers for Disease Control and Prevention (CDC), there was a report in mid-1979 of a significant number of infants who were diagnosed with metabolic alkalosis due to chloride deficiencies. Symptoms of metabolic alkalosis may include confusion, light-headedness, muscle twitching, nausea, vomiting, numbness in the face or extremities, and prolonged muscle spasms. Development of metabolic alkalosis may be linked to the exclusive use of chloride-deficient soy formulas for a prolonged period of time. This incident led to the Infant Formula Act of 1980, which amended the Federal Food, Drug, and Cosmetic Act (FFDCA), and set standards for quality and safety, as well as requiring nutrients at specific levels in infant formula.

  • Additional ingredients:

  • General: Along with the 29 nutrients required by the FDA, there are also numerous additional ingredients that may be added to infant formula for different needs. These include emulsifiers, stabilizers, DHA, choline, ARA, probiotics, prebiotics, taurine, L-carnitine, and biotin (B7). Due to its complexity, researchers have not been successful in adding immune proteins into formulas, and therefore formulas do not give infants as much immune support as breast milk does.

  • Emulsifiers and stabilizers: Emulsifiers serve as interfaces between water and oil, which would otherwise separate. Formulas that are ready-to-feed and concentrated liquid contain additional ingredients, including lecithin, carrageenan, and mono- and diglycerides, to avoid liquid separation and to prolong shelf life. Infants who are allergic to these ingredients should avoid using ready-to-feed and concentrated liquid formulas. If the infant shows signs of an allergy (e.g., rash, abdominal pain, respiratory symptoms), a doctor should be notified to explore other viable substitute formulas that are available.

  • Soy lecithin phosphatidylserine, a common emulsifier to help in suspending the mixture, should not be used in baby products or infant formula, according to Lipogen (phosphatidylserine manufacturer).

  • Docosahexaenoic acid (DHA): DHA has been reported as essential for the growth and development of the brain in infants, and appears to be taken up by the brain in higher amounts than other fatty acids. DHA in the diet has also been associated with visual development in infants. In animal studies, administration of DHA for a long period of time has improved memory-related learning ability. Supplementation with DHA in an infant who is DHA deficient may lessen the severe associated growth retardation.

  • Arachidonic acid (ARA): ARA is an unsaturated fatty acid that is used to make many molecules involved in blood clotting and immune function. It is an omega-6 fatty acid, which is one of the two types of fats that are needed to stay healthy, the other being omega-3 fatty acids. According to secondary sources, without the needed amount of ARA, the infant may have decreased growth and ability to fight infections. A balance between omega-6 and omega-3 fatty acids is necessary. Because infant formulas also contain DHA (a form of omega-3 fatty acids) together with ARA, they can help repair cell and tissue damage, improve brain function, and support heart function.

  • Probiotics: Probiotics are beneficial bacteria (sometimes referred to as "friendly germs") that help in digestion and maintain the health of the intestinal tract. They also help keep the number of potentially harmful organisms in the gut (bacteria and yeast) under control. Probiotics have been found to stimulate the immune system and help the digestion and absorption of proteins, fats, calcium, and phosphorus. There is evidence that young children (aged 6-36 months) who receive infant formulas with bifidobacteria Bb12 (a probiotic) supplementation may achieve faster growth than children without the supplementation. Probiotic supplementation may also prevent diarrhea.

  • Long-term consumption of probiotics is considered safe, and few side effects have been reported in studies. Individuals have experienced excessive production of gas due to the activity of probiotics in the colon. This is specific to each person and normally decreases with use. However, it is important to consult healthcare professionals before administering probiotic-containing formulas to infants.

  • Prebiotics: Prebiotics (such as lactulose) are complex sugars that fuel the healthy bacteria in the gut (called probiotics), while suppressing harmful organisms. According to secondary sources, prebiotics are not broken down in the small intestine but remain in the digestive tract, where they are digested by colonic bacteria and increase healthy bacteria growth. Prebiotics such as galactooligosaccharides (GOS) are widely accepted as safe for consumption and have been given to pregnant mothers and infants with no side effects. Scientists from Numico, a European company that specializes in baby food and clinical nutrition, published several studies looking at the prebiotic effects of a GOS and fructooligosaccharide (FOS) mixture in infants.

  • According to secondary sources, prebiotics have been shown to keep cholesterol levels in check and therefore benefit the heart in adults. The Auvergne Human Nutrition Research Centre and the Faculty of Medicine and Pharmacy in France conducted research showing that inulin, a prebiotic known as FOS, may decrease atherosclerosis (hardening of the arteries) by 30%. Also, in preliminary research, prebiotics may increase white blood cells and cells involved in fighting off infections, based on secondary sources. In one test group, children who ate yogurt with inulin had fewer daycare absences and doctor visits, and took fewer antibiotics.

  • Taurine: Taurine is added to many infant formulas based on the decreased ability to form taurine from cysteine in this population. It is important in many processes of the body, including in electrically active tissues, such as the brain and heart. It also has functions in the gallbladder, eyes, and blood vessels, and may have some antioxidant and detoxifying properties. Because taurine is an amino acid, it is generally well tolerated in clinical trials for up to one year. Based on studies in preterm infants, taurine may increase the absorption of fat and decrease fatty acid elimination. Infants who have decreased taurine may also have poor eye and liver function, which may be corrected with taurine supplementation.

  • L-carnitine: Use in preterm infants suggests carnitine supplementation may aid in maintaining or increasing plasma carnitine levels and possibly weight gain. In addition, soy-based infant formulas are fortified with carnitine to levels found in breast milk. L-carnitine is generally regarded as safe with no significant complications, according to clinical trials. Some of the side effects include skin rash, diarrhea, nausea, and insomnia, as well as brief hair loss.

  • In low-birth-weight infants (weighing less than 5.5 pounds), L-carnitine may cause less weight gain and should be used cautiously. However, this effect is not seen in preterm infants (born before 37 weeks of pregnancy). One study, however, shows that L-carnitine may pose a potential food safety risk, as it significantly increased the growth of a specific type of bacterium (Listeria monocytogenes) in infant formula at seven degrees C.

  • Choline: Choline is a major building block of lecithin. It is used to make acetylcholine, a chemical used to propagate nerve impulses. Therefore, choline is believed to have effects on the brain. Choline is also formed from the breakdown of a muscle relaxant (succinylcholine), which is used in anesthesia. Therefore, choline may have similar muscle-relaxing effects. Choline is part of the cell wall and membranes and is involved in fat and cholesterol breakdown and transport. It helps the body break down fat and transport it away from the liver.

  • Choline is likely effective when ingested as a supplement in infant formula. Infant formulas not made from natural milk are required by the FDA to contain choline. The Committee on Nutrition of the American Academy of Pediatrics recommends that seven milligrams of choline per 100 kilocalories be added to infant formula, which is also the level required by the FDA. Recommended daily intake by the U.S. Food and Nutrition Board of the Institute of Medicine for infants 6-12 months is 150 milligrams daily, and for infants up to six months it is 125 milligrams daily.

  • Adding choline is generally regarded as safe (GRAS); however, high amounts of choline may cause low blood pressure, steatorrhea (undigested fat in stool), nausea, vomiting, salivation, diarrhea, constipation, anorexia, dizziness, sweating, and headache.

  • Inositol: Inositol, required for all non-milk-based formulation by the FDA, is needed for proper functioning of the nerves, brain, and muscles in the body. It is involved in cell signaling, the process of cells communicating with each other in the body. It also helps the liver break down fats and cholesterol. Deficiency in inositol may cause clotting problems and liver disease, as well as hair loss, constipation, and eye abnormalities. Infant formula that is not milk-based is fortified with inositol to mimic the amounts contained in breast milk.

  • Biotin (B7): Biotin (B7) is only required by the FDA for non-milk-based formula. It is important in the proper functioning of certain enzymes, and deficiencies may lead to many complications involving the skin, intestinal tract, and nervous system. Metabolic problems such as very low blood sugars between meals, high blood ammonia, or acidic blood may also occur. Biotin is added to non-milk-based formula to mimic the amounts seen in breast milk.

  • Phosphatidylserine (PS): Lipogen states in a communication dated April 17, 2006, that soy lecithin PS is not intended to be used in products such as baby foods or infant formula that are specifically marketed for use by infants. It also should not be used in infants who have a possible soy allergy.


  • According to the American Academy of Pediatrics, breastfeeding is the optimal way of infant feeding for many reasons. Breast milk not only provides the adequate amount of nutrients required for the infant's growth and development, it also provides an appropriate balance of these nutrients. This decreases the risk for the infant to be deficient in essential nutrients. Breast milk does not stress the infant's digestive system and kidneys. Also, breast milk contains many immune proteins that can serve as a protection against infections to which the infant may be exposed in the first weeks of life when the baby has not yet fully developed his or her immune system. Breastfeeding promotes a physical and emotional bond between the mother and child, and it is easy and cost effective.

  • Soy-based formulas are available for infants who have allergies to cow's milk, because milk from goats and other animals or formulas containing large amounts of intact animal proteins are inappropriate substitutes. Extensively hydrolyzed (where the proteins have already been broken down) and amino acid-based formulas are also safe options.

  • Special formulas are available for premature infants, infants who are unable to break down or absorb nutrients, and infants with genetic problems with metabolism. Such formulas help these infants meet their nutritional requirements. However, these formulas should only be given with the guidance of a doctor.

Author Information

  • This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (


Natural Standard developed the above evidence-based information based on a thorough systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to Selected references are listed below.

  1. American Heart Association.

  2. American Pregnancy Association.

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  4. Centers for Disease Control and Prevention (CDC).

  5. Chesney RW, Helms RA, Christensen M, et al. The role of taurine in infant nutrition. Adv Exp Med Biol. 1998;442:463-76. View Abstract

  6. Galeano NF, Darling P, Lepage G, et al. Taurine supplementation of a premature formula improves fat absorption in preterm infants. Pediatr Res. 1987 Jul;22(1):67-71. View Abstract

  7. Kazal LA Jr. Prevention of iron deficiency in infants and toddlers. Am Fam Physician. 2002 Oct 1;66(7):1217-24. View Abstract

  8. Knol J, Scholtens P, Kafka C, et al. Colon microflora in infants fed formula with galacto- and fructo-oligosaccharides: more like breast-fed infants. J Pediatr Gastroenterol Nutr. 2005 Jan;40(1):36-42. View Abstract

  9. Koletzko B, von Kries R, Closa R, et al. Lower protein in infant formula is associated with lower weight up to age 2 y: a randomized clinical trial. Am J Clin Nutr. 2009 Jun;89(6):1836-45. View Abstract

  10. Natural Standard: The Authority on Integrative Medicine.

  11. Scholtens PA, Alles MS, Bindels JG, et al. Bifidogenic effects of solid weaning foods with added prebiotic oligosaccharides: a randomised controlled clinical trial. J Pediatr Gastroenterol Nutr. 2006 May;42(5):553-9. View Abstract

  12. Sleator RD, Banville N, Hill C. Carnitine enhances the growth of Listeria monocytogenes in infant formula at 7 degrees C. J Food Prot. 2009 Jun;72(6):1293-5. View Abstract

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  15. University of Maryland Medical Center.

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The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.


March 22, 2017