Nutrient Specifications— FDA's Code of Federal Regulations

The FDA's Code of Federal Regulations (Subpart D) 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.

Nutrients

Function

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.

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.

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.

Vitamins

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 D

Vitamin D is an important nutrient for bone, muscle, and immune health. It plays a major role in calcium uptake and metabolism.

Vitamin E

Vitamin E is an antioxidant for immune health and for healthy skin and eyes.

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.

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.

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.

Vitamin B₆

Vitamin B₆ supports normal brain development and is important for the nervous system and immune health.

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.

Niacin¹

Niacin aids the digestive system, skin, and nerves to function properly. Niacin is also important for converting food into energy.

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.

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.

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.

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.

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.

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.

Minerals

Calcium

Calcium is important for cellular signaling, protein stability, blood clotting, and muscle contraction.

Phosphorus

Phosphorus is important for cellular signaling, energy metabolism, and structural components other than bone, such as DNA and RNA.

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.

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.

Zinc

A type 2 nutrient 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.

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.

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.

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.

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.

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.

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.

Selenium

Selenium plays a critical role in human metabolism. Selenium deficiency allows some viruses to be more potent.

*Not from human milk.

¹The generic term "niacin" includes niacin (nicotinic acid) and niacinamide (nicotinamide).

²Required 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]