What's in Baby Formula?
Nutrient Specifications
FDA's Code of Federal Regulations
The FDA's Code of Federal Regulations requires all infant formulas to contain the following nutrients at a level not less than the minimum level specified and not more than the maximum level specified for each 100 kilocalories of the infant formula. The table below lists each nutrient and their respective function for human health, along with examples of how these may be listed in the ingredient list on the label.
Nutrients
Nutrient
Function
Common Ingredient
Name Example(s)
Name Example(s)
Protein
Protein is in every living cell and our body requires it from foods to build and maintain bones, muscles, and skin. Protein quality depends on an essential amino acid pattern.
nonfat milk, whey protein concentrate
Fat
Fat is one of the key macronutrients that your baby needs for proper growth and development. In fact, fat provides about half the energy content of milk. There are different types of fat: monounsaturated; saturated; polyunsaturated; and trans fatty acids. DHA is a polyunsaturated omega-3 fatty acid that supports brain and eye development.
coconut oil, safflower oil, soybean oil, palm olein
Linoleic Acid
Linoleic acid is a polyunsaturated omega-6 fatty acid. Linoleic acid is part of cell components and is used to produce signaling molecules in the body.
linoleic acid
Vitamins
Vitamin
Function
Common Ingredient
Name Example(s)
Name Example(s)
Vitamin A
Vitamin A supports good vision, a healthy immune system, and cellular growth. Beta-carotene is a type of Vitamin A derived from plants that acts as an antioxidant.
vitamin A palmitate
Vitamin D
Vitamin D is an important nutrient for bone, muscle, and immune health. It plays a major role in calcium uptake and metabolism.
cholecalciferol
Vitamin E
Vitamin E is an antioxidant for immune health and for healthy skin and eyes.
vitamin E acetate
Vitamin K
Vitamin K helps blood clot and prevents excessive bleeding; low levels of Vitamin K can raise the risk of uncontrolled bleeding. Vitamin K deficiencies are very common in newborn infants.
phytonadione
Thiamine (Vitamin B1)
Thiamine is an essential vitamin, meaning it cannot be produced by the human body and must come from the diet. Severe thiamine deficiency, known as beriberi, is almost unknown in developed countries like the United States. Almost all cells use thiamine. This vitamin converts food into energy.
thiamine hydrochloride
Riboflavin (Vitamin B2)
Riboflavin is important for normal cell growth and activity. This vitamin supports growth and development and impacts skin, the lining of the digestive tract, blood cells, and brain function.
riboflavin
Vitamin B6
Vitamin B6 supports normal brain development and is important for the nervous system and immune health.
pyridoxine hydrochloride
Vitamin B12
Vitamin B12 is required for proper brain function and development. It also plays a critical function in nerves, blood cells, and many other parts of the body. Vitamin B12 deficiency in infants causes lethargy, failure to thrive, irritability, and poor brain growth and development.
cyanocobalamin
Niacin1
Niacin aids the digestive system, skin, and nerves to function properly. Niacin is also important for converting food into energy.
niacinamide
Folic Acid
Folic acid helps your baby make healthy new cells and is critical to human health. For women, getting enough folic acid before and during pregnancy can prevent major birth defects of her baby's brain or spine.
Folate
Pantothenic Acid
Pantothenic acid is required for growth and helps the body metabolize—or break down and use food. It is also required for producing fatty acids and plays a role in the production of hormones and cholesterol.
pantothenic acid
Biotin2
Biotin is a component of enzymes in your baby's body that supports healthy metabolism. It is required for growth and producing fatty acids.
biotin
Vitamin C
Vitamin C helps tissue and bone grow and repair themselves. Vitamin C deficiency in infants causes lethargy, failure to thrive, irritability, and poor brain growth and development.
ascorbic acid
Choline2
Choline is naturally present in breast milk and supports brain and eye development. It is also a neurotransmitter that supports cellular signaling; prenatal choline plays a role in hippocampal (memory) development.
choline chloride
Inositol2
Emerging research suggests inositol may play a role in brain development. Inositol is also abundant in colostrum (the first breast milk produced during pregnancy) and mature breast milk.
inositol
Minerals
Mineral
Function
Common Ingredient
Name Example(s)
Name Example(s)
Calcium
Calcium is important for cellular signaling, protein stability, blood clotting, and muscle contraction.
calcium carbonate
Phosphorus
Phosphorus is important for cellular signaling, energy metabolism, and structural components other than bone, such as DNA and RNA.
potassium phosphate
Magnesium
Magnesium is a bone mineral component that plays a role in DNA and RNA protein synthesis, and cellular energy production. It also maintains cellular electrolytes and stabilizes membranes. Low magnesium is related to diabetes, heart disease, blood pressure, and osteoporosis.
magnesium chloride
Iron
Iron is critical to oxygen transport and is a co-factor for enzymes in energy generation and neurotransmitter synthesis. This mineral also supports immune-cell health. Iron deficiency is the most prevalent deficiency in toddlers worldwide; iron deficiency can cause irreversible impairments to cognition.
ferrous sulfate
Zinc
Zinc is central to DNA, RNA and protein synthesis. Zinc deficiency impairs growth, causes a loss of appetite, and is a major contributor to stunting growth worldwide.
zinc sulfate
Manganese
Manganese is required for normal growth and health. This mineral is a part of several enzymes and helps your body break down fats, carbohydrates, and proteins.
manganese sulfate
Copper
Copper is a co-factor for oxidation in several human systems: cardiovascular; immune; and neurologic (brain development). Copper also plays a role in skeletal and skin integrity.
cupric sulfate
Iodine
Iodine is an essential component of thyroid hormones. After iron deficiency, iodine deficiency is the most prevalent among children. Deficiency or excess iodine causes goiter—thyroid gland excess growth—and cretinism, which is a condition of severely stunted physical and mental growth.
potassium iodide
Sodium
Your baby requires some sodium because it supports nerve and muscle function. Sodium also helps maintain the right balance of fluids in the body.
sodium citrate
Potassium
Potassium is a mineral and electrolyte that is essential for bodily function. When levels of potassium are not balanced, issues can occur, such as hyperkalemia and hypokalemia, muscle cramps, low blood pressure, and changes in heart rhythm. Potassium levels change with sodium levels to keep muscles working properly throughout your baby's body, especially your baby's heart. As sodium levels rise, potassium levels decrease. The reverse is true; as sodium levels decrease, the levels of potassium increase.
potassium phosphate
Chloride
Chloride aids with digestion and works with other electrolytes, such as sodium and potassium, to help maintain proper body fluids. Chloride also moves fluid in and out of cells in the body. If chloride levels drop, it can cause dehydration.
calcium chloride
Selenium
Selenium plays a critical role in human metabolism. Selenium deficiency allows some viruses to be more potent.
sodium selenite
Nutrients
Select a nutrient to view more information:
Nutrients
Protein
Fat
Linoleic Acid
Function:
Protein is in every living cell and our body requires it from foods to build and maintain bones, muscles, and skin. Protein quality depends on an essential amino acid pattern.
Common Ingredient / Name Example(s):
nonfat milk, whey protein concentrate
Function:
Fat is one of the key macronutrients that your baby needs for proper growth and development. In fact, fat provides about half the energy content of milk. There are different types of fat: monounsaturated; saturated; polyunsaturated; and trans fatty acids. DHA is a polyunsaturated omega-3 fatty acid that supports brain and eye development.
Common Ingredient / Name Example(s):
coconut oil, safflower oil, soybean oil, palm olein
Function:
Linoleic acid is a polyunsaturated omega-6 fatty acid. Linoleic acid is part of cell components and is used to produce signaling molecules in the body.
Common Ingredient / Name Example(s):
linoleic acid
Vitamins
Select a vitamin to view more information:
Vitamins
Vitamin A
Vitamin D
Vitamin E
Vitamin K
Thiamine (Vitamin B1)
Riboflavin (Vitamin B2)
Vitamin B6
Vitamin B12
Niacin1
Folic Acid
Pantothenic Acid
Biotin2
Vitamin C
Choline2
Inositol2
Function:
Vitamin A supports good vision, a healthy immune system, and cellular growth. Beta-carotene is a type of Vitamin A derived from plants that acts as an antioxidant.
Common Ingredient / Name Example(s):
vitamin A palmitate
Function:
Vitamin D is an important nutrient for bone, muscle, and immune health. It plays a major role in calcium uptake and metabolism.
Common Ingredient / Name Example(s):
cholecalciferol
Function:
Vitamin E is an antioxidant for immune health and for healthy skin and eyes.
Common Ingredient / Name Example(s):
vitamin E acetate
Function:
Vitamin K helps blood clot and prevents excessive bleeding; low levels of Vitamin K can raise the risk of uncontrolled bleeding. Vitamin K deficiencies are very common in newborn infants.
Common Ingredient / Name Example(s):
phytonadione
Function:
Thiamine is an essential vitamin, meaning it cannot be produced by the human body and must come from the diet. Severe thiamine deficiency, known as beriberi, is almost unknown in developed countries like the United States. Almost all cells use thiamine. This vitamin converts food into energy.
Common Ingredient / Name Example(s):
thiamine hydrochloride
Function:
Riboflavin is important for normal cell growth and activity. This vitamin supports growth and development and impacts skin, the lining of the digestive tract, blood cells, and brain function.
Common Ingredient / Name Example(s):
riboflavin
Function:
Vitamin B6 supports normal brain development and is important for the nervous system and immune health.
Common Ingredient / Name Example(s):
pyridoxine hydrochloride
Function:
Vitamin B12 is required for proper brain function and development. It also plays a critical function in nerves, blood cells, and many other parts of the body. Vitamin B12 deficiency in infants causes lethargy, failure to thrive, irritability, and poor brain growth and development.
Common Ingredient / Name Example(s):
cyanocobalamin
Function:
Niacin aids the digestive system, skin, and nerves to function properly. Niacin is also important for converting food into energy.
Common Ingredient / Name Example(s):
niacinamide
Function:
Folic acid helps your baby make healthy new cells and is critical to human health. For women, getting enough folic acid before and during pregnancy can prevent major birth defects of her baby's brain or spine.
Common Ingredient / Name Example(s):
Folate
Function:
Pantothenic acid is required for growth and helps the body metabolize—or break down and use food. It is also required for producing fatty acids and plays a role in the production of hormones and cholesterol.
Common Ingredient / Name Example(s):
pantothenic acid
Function:
Biotin is a component of enzymes in your baby's body that supports healthy metabolism. It is required for growth and producing fatty acids.
Common Ingredient / Name Example(s):
biotin
Function:
Vitamin C helps tissue and bone grow and repair themselves. Vitamin C deficiency in infants causes lethargy, failure to thrive, irritability, and poor brain growth and development.
Common Ingredient / Name Example(s):
ascorbic acid
Function:
Choline is naturally present in breast milk and supports brain and eye development. It is also a neurotransmitter that supports cellular signaling; prenatal choline plays a role in hippocampal (memory) development.
Common Ingredient / Name Example(s):
choline chloride
Function:
Emerging research suggests inositol may play a role in brain development. Inositol is also abundant in colostrum (the first breast milk produced during pregnancy) and mature breast milk.
Common Ingredient / Name Example(s):
inositol
Minerals
Select a mineral to view more information:
Minerals
Calcium
Phosphorus
Magnesium
Iron
Zinc
Manganese
Copper
Iodine
Sodium
Potassium
Chloride
Selenium
Function:
Calcium is important for cellular signaling, protein stability, blood clotting, and muscle contraction.
Common Ingredient / Name Example(s):
calcium carbonate
Function:
Phosphorus is important for cellular signaling, energy metabolism, and structural components other than bone, such as DNA and RNA.
Common Ingredient / Name Example(s):
potassium phosphate
Function:
Magnesium is a bone mineral component that plays a role in DNA and RNA protein synthesis, and cellular energy production. It also maintains cellular electrolytes and stabilizes membranes. Low magnesium is related to diabetes, heart disease, blood pressure, and osteoporosis.
Common Ingredient / Name Example(s):
magnesium chloride
Function:
Iron is critical to oxygen transport and is a co-factor for enzymes in energy generation and neurotransmitter synthesis. This mineral also supports immune-cell health. Iron deficiency is the most prevalent deficiency in toddlers worldwide; iron deficiency can cause irreversible impairments to cognition.
Common Ingredient / Name Example(s):
ferrous sulfate
Function:
Zinc is central to DNA, RNA and protein synthesis. Zinc deficiency impairs growth, causes a loss of appetite, and is a major contributor to stunting growth worldwide.
Common Ingredient / Name Example(s):
zinc sulfate
Function:
Manganese is required for normal growth and health. This mineral is a part of several enzymes and helps your body break down fats, carbohydrates, and proteins.
Common Ingredient / Name Example(s):
manganese sulfate
Function:
Copper is a co-factor for oxidation in several human systems: cardiovascular; immune; and neurologic (brain development). Copper also plays a role in skeletal and skin integrity.
Common Ingredient / Name Example(s):
cupric sulfate
Function:
Iodine is an essential component of thyroid hormones. After iron deficiency, iodine deficiency is the most prevalent among children. Deficiency or excess iodine causes goiter—thyroid gland excess growth—and cretinism, which is a condition of severely stunted physical and mental growth.
Common Ingredient / Name Example(s):
potassium iodide
Function:
Your baby requires some sodium because it supports nerve and muscle function. Sodium also helps maintain the right balance of fluids in the body.
Common Ingredient / Name Example(s):
sodium citrate
Function:
Potassium is a mineral and electrolyte that is essential for bodily function. When levels of potassium are not balanced, issues can occur, such as hyperkalemia and hypokalemia, muscle cramps, low blood pressure, and changes in heart rhythm. Potassium levels change with sodium levels to keep muscles working properly throughout your baby's body, especially your baby's heart. As sodium levels rise, potassium levels decrease. The reverse is true; as sodium levels decrease, the levels of potassium increase.
Common Ingredient / Name Example(s):
potassium phosphate
Function:
Chloride aids with digestion and works with other electrolytes, such as sodium and potassium, to help maintain proper body fluids. Chloride also moves fluid in and out of cells in the body. If chloride levels drop, it can cause dehydration.
Common Ingredient / Name Example(s):
calcium chloride
Function:
Selenium plays a critical role in human metabolism. Selenium deficiency allows some viruses to be more potent.
Common Ingredient / Name Example(s):
sodium selenite
*Not from human milk.
1 The generic term "niacin" includes niacin (nicotinic acid) and niacinamide (nicotinamide).
2 Required only for non-milk-based infant formulas.
(b) Vitamin E shall be present at a level of at least 0.7 International Unit of vitamin E per gram of linoleic acid.
(c) Any vitamin K added shall be in the form of phylloquinone.
(d) Vitamin B6 shall be present at a level of at least 15 micrograms of vitamin B6 for each gram of protein in excess of 1.8 grams of protein per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container.
(e) The ratio of calcium to phosphorus in infant formula in the form prepared for consumption as directed on the container shall be no less than 1.1 and not more than 2.0.
(f) Protein shall be present in an amount not to exceed 4.5 grams per 100 kilocalories regardless of quality, and not less than 1.8 grams per 100 kilocalories of infant formula in the form prepared for consumption as directed on the container when its biological quality is equivalent to or better than that of casein. If the biological quality of the protein is less than that of casein, the minimum amount of protein shall be increased proportionately to compensate for its lower biological quality. For example, an infant formula containing protein with a biological quality of 75 percent of casein shall contain at least 2.4 grams of protein (1.8/0.75). No protein with a biological quality less than 70 percent of casein shall be used. [50 FR 45108, Oct. 30, 1985, as amended at 80 FR 35841, June 23, 2015]