Lactoferrin in baby formula
The federal record gives an exact number for this, and it is smaller than the marketing suggests.
Short answer
Some does, and no formula has to. Lactoferrin is not one of the 29 nutrients US law requires in infant formula, so a maker adds it by choice. Where it is added to a cow's-milk-based formula for term babies, the FDA record puts the level at 100 mg per 100 g of powder, which works out to roughly 13 mg per 100 mL once the bottle is made up. Mature human milk measures about 100 mg per 100 mL, so a formula at the cleared level carries somewhere near an eighth as much.
Some baby formula contains added lactoferrin and most does not, because no formula is required to carry any. Where a maker does add it to a cow's-milk-based formula for term babies, the FDA's own record gives the level: 100 mg per 100 g of powder, which comes to roughly 13 mg per 100 mL once you have mixed the bottle.
That number is the useful part of this page. Mature human milk measures about 100 mg of lactoferrin per 100 mL. So a formula at the cleared level is in the region of an eighth of breast milk, and the only way to find out whether the tub in your kitchen has any at all is the ingredient list.
The amounts in the federal record
Two companies have taken cow's-milk lactoferrin for term infant formula through the FDA's GRAS notice process, and both notices state their intended use in milligrams. This is public, exact and checkable, which makes it better than anything printed on a box.
| Notice | Notifier | Form | Stated level |
|---|---|---|---|
| GRN 465 | Morinaga Milk Industry | Powdered term formula | 100 mg per 100 g |
| GRN 465 | Morinaga Milk Industry | Liquid concentrate | 26 mg per 100 mL |
| GRN 465 | Morinaga Milk Industry | Ready-to-feed | 13 mg per 100 mL |
| GRN 669 | Synlait Milk | Term formula solids | 100 mg per 100 g, about 13 to 14 mg per 100 mL as fed |
| GRN 669 | Synlait Milk | Follow-on formula, as fed | 15 mg per 100 mL |
Read the two notices together and they agree closely. Both land on 100 mg per 100 g of dry formula, and both work out to 13 or 14 mg per 100 mL by the time a baby drinks it. Powder and liquid look like wildly different numbers for the same thing, and they are not: one is measured dry and the other is measured with the water already in.
One caution about what a closed notice means, and it is the same caution that belongs on every page citing this inventory. A notice closed with "FDA has no questions" is a safety judgement about one ingredient, in one food, at one level. It is not an approval, the company makes the determination and FDA responds to it, and it says nothing at all about whether the ingredient does anything for a baby.
How that compares to breast milk
Human milk is the obvious yardstick and the comparison is not flattering.
A 2021 review in Nutrients collects the measured concentrations. Human colostrum, the first milk of the first few days, runs 5 to 6 mg of lactoferrin per mL. Mature breast milk settles at around 1 mg per mL. Converted to the units the formula notices use, that is 500 to 600 mg per 100 mL early on, dropping to about 100 mg per 100 mL later.
Set the formula figure against those:
- Formula at the cleared level, about 13 mg per 100 mL, is near an eighth of mature breast milk.
- Against human colostrum it is around 2%.
Treat both of those as two sourced figures divided, because that is what they are. One comes from a federal notice and the other from a review of measured milk samples, and nobody has put the two side by side in the same study. The ratio is still the right order of magnitude, and it is large enough that rounding does not rescue it.
There is a second difference the milligrams hide. Breast milk carries human lactoferrin and these formulas carry the cow version, and the two proteins share 69% of their amino acid sequence by the same review's count. Similar is not identical. Our page on foods high in lactoferrin covers the same protein in the rest of the dairy aisle, where the gap between raw and processed is the thing that matters.
Why no formula has to include it
US law is specific about what goes in infant formula, and lactoferrin is not on the list.
The nutrient requirements sit at 21 CFR 107.100. FDA's own consumer guidance describes what that regulation does: it sets minimum amounts for 29 nutrients and maximum amounts for 9 of them, and a formula falling short is an adulterated product unless it is an exempt formula for babies with particular medical needs. Read the regulation's nutrient table and lactoferrin does not appear in it anywhere.
So added lactoferrin sits in the same category as several other things you see advertised on formula boxes. A maker may put it in and may leave it out, and a formula with none of it meets every federal requirement exactly as well as a formula with some.
FDA also does not approve infant formulas before they go on sale. Makers have to notify the agency before marketing a new or reformulated product, and formulas have to meet the nutrient rules, but no approval stamp exists for anyone to claim. If a box or an ad implies otherwise about lactoferrin or anything else, that is marketing.
Has it been tested in babies?
In preterm babies, yes, at supplement doses, and the largest trial found nothing.
The ELFIN trial randomized 2,203 very preterm infants to 150 mg of bovine lactoferrin per kg of body weight a day or to placebo. Late-onset infection occurred in 29% of the lactoferrin group and 31% of the placebo group, a gap small enough to be chance. It was published in the Lancet in 2019 and it is on this site because it came out negative.
Be careful how far you carry that. ELFIN tested a therapeutic dose in very preterm babies in neonatal units, which is a long way from a few milligrams added to a term baby's bottle. A null result in the first setting is not a measurement of the second, and the second has far less evidence behind it rather than better evidence. What can be said plainly is that no trial has shown that adding lactoferrin to term infant formula changes anything about a baby's health. The wider picture of what lactoferrin is used for has the same shape in adults: cleared uses and claimed uses are not the same set.
One thing worth knowing if your baby had a stool test
Parents sometimes arrive here from the other direction, holding a lactoferrin stool result for a baby, and there is a practical point that connects the two.
Labcorp's documentation for its fecal lactoferrin test states that the assay does not detect dietary bovine lactoferrin. A formula with cow lactoferrin in it will not push a stool result up. Breast milk is the opposite case: human milk carries a great deal of lactoferrin, and the same lab flags samples from nursing infants as carrying a false-positive risk. The measured amounts are large, and what lactoferrin in stool is sets out the figures from healthy breastfed babies.
That is a fact about the test. It tells you nothing about what any particular result means. A number from a stool test means something next to a baby's symptoms, feeding history and examination, and the clinician who ordered it has all three.
What to look for on the label
If you want to know whether a formula contains lactoferrin, the ingredient list is the only place that will tell you, and it will tell you yes or no rather than how much.
Lactoferrin appears in the ingredients when it has been added. A formula that does not name it does not contain added lactoferrin. What you will not find is a quantity, because the nutrition panel on a formula declares the nutrients the regulation covers, and lactoferrin is not one of them. The amounts in the table above are the levels these ingredient suppliers notified to FDA for their intended use, and not a measurement of any product on a shelf.
The difference between a formula with added lactoferrin and one without comes to somewhere around 13 mg per 100 mL, in a protein whose benefit at that level in term babies no trial has demonstrated. Whether a formula agrees with your baby and whether you can reliably get hold of it will matter more than this ingredient does.
Where this comes from
- U.S. Food and Drug Administration. GRAS Notice Inventory, GRN No. 465: Cow's milk-derived lactoferrin — notified by Morinaga Milk Industry Co., Ltd, filed 22 March 2013 and closed 18 February 2014 with FDA having no questions. Intended use as printed: an ingredient in cow's milk-based term infant formulas at 100 mg per 100 g of powdered formula, 26 mg per 100 mL of liquid concentrate and 13 mg per 100 mL of ready-to-feed formula. A resubmission of GRN 423. Checked 2026-11-07
- U.S. Food and Drug Administration. GRAS Notice Inventory, GRN No. 669: Cows milk-derived lactoferrin — notified by Synlait Milk Ltd, filed 27 September 2016 and closed 9 March 2017 with FDA having no questions. Intended use as printed: non-exempt cow's-milk-based formula for term infants at 100 mg per 100 g of formula solids, stated as approximately 13 to 14 mg per 100 mL as fed, and follow-on formula at 15 mg per 100 mL as fed. Checked 2026-11-07
- 21 CFR 107.100 — Nutrient requirements for infant formulas — the nutrient table every non-exempt US infant formula has to meet. Lactoferrin appears nowhere in it: the regulation's text returns no occurrence of the word. Checked 2026-11-07
- U.S. Food and Drug Administration. Questions & Answers for Consumers Concerning Infant Formula — the nutrient specifications at 21 CFR 107.100 set minimum amounts for 29 nutrients and maximum amounts for 9 of them. FDA does not approve infant formulas before they are marketed, though makers must notify FDA before marketing a new or reformulated one. On choosing between formulas: parents should ask their infant's health care provider
- Sangild PT, Vonderohe C, Melendez Hebib V, Burrin DG. Potential Benefits of Bovine Colostrum in Pediatric Nutrition and Health. Nutrients 2021;13(8):2551 — review: lactoferrin measures 5 to 6 mg/mL in human colostrum, falling to about 1 mg/mL in mature human milk, and 0.02 to 0.35 mg/mL in mature cow's milk. Human and cow lactoferrin share 69% of their amino acid sequence. The University of Copenhagen holds a patent on bovine colostrum for pediatric patients and the first author is named as its inventor, which the paper discloses
- ELFIN trial investigators group. Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial. Lancet 2019;393(10170):423-433 — randomized controlled trial, 2,203 very preterm infants given 150 mg per kg a day: infection in 29% on lactoferrin against 31% on placebo, a difference inside the range expected from chance. Very preterm babies on a supplemental dose, which is a different question from lactoferrin added to term formula
- Labcorp test directory: Lactoferrin, Fecal, Quantitative (test 123016) — the stool assay does not detect dietary bovine lactoferrin. A supplement containing human lactoferrin carries a false-positive risk, as do samples from nursing infants
This page is general information, not medical advice, and not a recommendation to take anything. It cannot interpret your test result. Lactoferrin supplements are made from cow's milk and are unsuitable if you have a milk protein allergy. If you are pregnant, breastfeeding, giving anything to an infant, or being treated for a health condition, talk to a doctor or pharmacist first.